Minutes 246th Registration Board PDF

Minutes for 246th Meeting of Registration Board held on
10-11th December, 2014.
Item No. Detail of Item Page No(s)
Item No.I Confirmation of minutes of 245th meeting Registration Board 06-08
Item No.II Agenda points referred by Members, Registration Board 08-10
Item No.III Cases for conduction of Clinical Trials – Pharmacy Services Division 11-15
Item No.IV Matters referred for deliberation by Registration Board 16-56
Item No.V Registration of drugs - Pharmaceutical Evaluation Cell 57-272
Item No.VI Miscellaneous cases - Pharmaceutical Evaluation & Registration Division 273-385
Item No.VII Registration of Biological Drugs – Biological Evaluation & Research Division 386-410
Item No.VIII Quality Control Cases – Quality Assurance & Lab Testing Division 411-461
Item No.IX Registration of Medical Devices – Medical Devices Division 462-472
Item No.X Local Manufacturing of Biological Drugs. 473-480
Item No.XI Applications for transfer of registrations 481-496
Minutes 246th Meeting Registration Board Page 1

246th meeting of Registration Board was held on 10-11th December, 2014 in the
Committee Room, M/o National Health Regulation Services and Coordination, Islamabad. The
meeting was chaired by Mr. Ghulam Rasool Dutani, Director, Pharmaceutical Evaluation &
Registration Division. The meeting started with the recitation of Holy Verses. The meeting was
attended by the following:-
1. Lt General (R) Karamat Ahmed Karamat. Member
2. Prof.Dr.Rafi uz Zaman Saeedul Haq Member

Assocaite Dean, Faculty of Pharmacy, University of
Lahore, Islamabad
3. Brig (R). Dr. Muzammil Hasan Najmi, Member
Associate Dean, Basic Sciences Division,
Foundation Medical University, Rawalpindi.
4. Brig.Dr.Aslam Khan, Member

Professor of Medicine, Military Hospital Rawalpindi.
5. Dr. Muhammad Arshad, Member

President, Pakistan Veterinary Medical Council
6. Abdul Razak Member

Director Drugs Testing Laboratory
Government of Sind, Karachi.
7. Dr.Muhammad Khalid Khan Member
Government of Khyber Pakhtunkhwa, Peshawar.
8. Dr.Amanullah Khan Member
Government of Baluchistan, Quetta.
9. Shaikh Ansar Ahmad Member
Director Biological Drugs, DRAP
10. Dr.Noor Muhammad Shah Member
Director MD&MC, DRAP
11. A.Q.Javed Iqbal Member
Director QA &LT, DRAP
12. Dr. Obaidullah, Deputy Director General (Reg.I). Secretary/Member

Dr. Muhammad Arshad did not attend the meeting on 10.12.2014 and Dr. Muhammad
Khalid Khan did not attend the meeting on 11.12.2014. Both days, meeting started at 09:30 AM
and continued till 08:00 PM.
Dr.Masud ur Rehman DDG (Biological), Dr. Abdur Rasheed DDG (Pharmacovigilance),
Dr. Tariq Siddique (DDG R.II), Muhammad Arif (DDC R.I), Muhammad Amin (DDC R.V),
Babar Khan (Incharge, PEC), Muneeb Ahmad Cheema ADC (PEC), Ammad Zaka ADC (PEC),
Atiq ul Bari ADC (PEC), Tehreem Sara (DDC MD&MC), Asif Jalil (ADC MD&MC) and
Khalid Mehmood (DDC QC) assisted relevant Directors and Secretary of the Board with agenda.
Mr.Shamim Ahmad and Abuzar Faizy, Mr.Nadeem Alamgeer and Muhammad Farooq
Memon attended the meeting as observer on behalf of PPMA, Pharma Beauru and PCDA
respectively.
In addition to routine agenda, the Board discussed and decided various other matters, as
follows:
1. In future agenda will be circulated about 07 days before the meeting.
2. Registration Board deliberated on agenda point referred by Director DTL, Quetta

regarding attending the meeting by observers (PPMA, Pharma Bureau and PCDA). The
Board decided that respective observer will leave the meeting by ownself, when agenda
related to its company will be discussed. All observers also consented to the decision
3. Registration Board authorized its Chairman for grant of registration for export purpose on
contract manufacturing basis excluding controlled drugs and new drug as per contract
manufacting policy.
4. Dr.Aslam Khan Director Malaria Control Program and Dr.Qutub-ud-Din Kakar, WHO
National Professional Officer briefed the Board about irrational use of antimalarial drugs
in the country particularly injectable anti-malarial therapy and development of emerging
artemisinin resistance. Keeping in view briefing by experts, Registration Board decided
that Malaria Control Program will hold a consultative meeting of all the stakeholders

including DRAP, prescribers, provincial governments, pharmaceutical manufacturers etc
for framing recommendations on the matter.
5. Registration Board discuused comments of its members, stakeholders and international

practices and agreed that for all topical preparations viz. eye / ear preparations, external
preparations (cream / ointment / gel / lotion / spary) and aerosols, steroid manufacturing
may be permitted on campaign manufacturing basis in general manufacturing areas for
these dosage forms provided that manufacturer has segregated dispensing booths,
validation and controls studies for processes and adequate system to minimize any
potential risk of cross contamination. Registration Board decided to forward above
recommendation to Licensing Division for ultimate decision by Central Licensing Board.
6. Registration Board deliberated on the storage requirement for Misoprostol and keeping in
view EMA’s assessment report decided that Misoprostol 1% HMPC dispersion
(processed material) will be permitted for use in tablet dosage form with storage
condition of 5+3 °C.
7. Registration Board discussed matter regarding non-availability of finished drugs in

country of origin and advised stake holders (PPMA, Pharma Bureau and PCDA) to
forward their comments till 15.01.2015 to already constituted committee for framing its
recommendations for considerartion by Registration Board.
8. Registration Board advised stake holders (PPMA, Pharma Bureau and PCDA) to forward
their comments on case of re-registration of drugs till 15.01.2015 for considerartion by
Registration Board.
9. While discussing case for grant of registration for export purpose, Mr.A Q Javed Iqbal,
Director QA &LT opined that for export purpose only those formulations should be
registered, which are already registered in Pakistan. For new fornulations (which are not
registered in Pakistan), manufacturers should first conduct stability studies and then
registration for export purpose be granted. Prof. Muzammil H Najmi also endorsed it.
Registration Board after deliberation decided that inorder to facilitate export of quality

drugs (non-me too drugs), export registration will be granted and manufacturer will
comply following conditions before export of drug:
 Manufacturer will export the product after complying all the conditions as required under
Drug Act, 1976 including No objection certificate from concerned DRAP office.
Moreover, Federal Inspector of drugs will take sample from each consignemnet for
analysis from CDL, Karachi.
 Manufacturer will also furnish export documents endorsed from custom authorities in
order to ensure the export of the product.
These conditions will also be applicable to products approved for exports

(Sofosbuvir) by Chairman, registration Board.
10. Chairman again advised all members, PPMA and Pharma Bureau to forward their
scientific comments and relevant references on manufacturing requirements till
15.01.2015 for following classes of drugs:
a. Immunosuppresants.
b. Clomiphene and letrozole
c. Prostaglandins and its analogues.
d. Vancomycin
11. On the direction of the Honorable Ombudsman, the case for local manufacturing of
biological drugs was re-examined by Registration Board. Representatives of local
manufacturers (Hilton, Getz, Nextar and Macter) were also heard and the Board then
decided the matter in light of directions of Ombudsman.
12. Registration Board discussed the matter regarding issuance of registration letter of
products for which product specific inspections have been conducted and recommended
by the panel of inspectors or cases where product specific inspections are not required /
exempted as per Import Policy for Finished Drugs. The Board authorized its Chairman
for issuance of registration letter in both aforementioned cases. In cases where there is
any ambiguity in inspection reports or products not recommended by panel of inspectors
then such cases will be placed before Regisrtration Board for decision.

Item No I: Confirmation of minutes of 245th meeting Registration Board.
245th meeting of Registration Board was held on 28-29th September, 2014 and minutes
were circulated to all members through e-mail. Two members forwarded following comments, as
follows:
 Dr. Amanullah Khan (Director, DTL, Quetta):
Agenda Item No II:
The following comments may be added as discussed in the 245th Registration Board Meeting regarding
Registration of Sofosbuvier which is very important drug and very badly required for the country man.
“The stability study shall be conducted by the manufacturer and accordingly stability data must be
submitted to the Registration Board before the launch of their product into the market, my point is this
that registration may be granted to the firms with the undertaking that they will provide stability study
before the launch of their product into the market as per previous practice.”
Case No. 50. Cases deferred by Registration Board.

M/s Ideal Pharma, Lahore- Product Specific Inspection-
There is typographic error and needs correction for record purpose, the inspection for product specific
inspection was carried out by two members only that is Director DTL, Quetta and area FID.
 Mr.A.Q.Javed Iqbal, Director QA & LT, DRAP.
g. Import of raw materials for experimental purpose and stability studies etc.
Director QA stated that any such Import for trial batch is not discouraged subject to meet all
codal formalities required for the production of commercial batch as per defined policy
Item No.VII: Miscellenous cases. Case No.15.

Change in company name from M/s.
Bayer Schering Pharma AG to M/s. Bayer Pharma AG.
Company also informed that German authorities have confirmed the GMP of manufacturer of this
product & product is available in Switzerland and UK which is part of EMA/ SRA.
Minutes were approved after incorporation of above points.
Registration Board in 245th meeting discussed and approved following case but erroneously
decision was not recorded in minutes. However, later on Chairman, Registration Board approved
correction in minutes as decided by the Board.

Case No.30 Registration of Drugs for export purpose-Not me too Drugs.
Following firms have requested for registration of following drugs for export purpose
only which are not me-too. Details are as under:-
S. Name of Name of product(s) Date of application,

No. Company Diary No. & Form
1. M/s Procoxam Forte 1500mg 13-05-2014
PharmEvo Tablet 688
Karachi Each tablet contains:- Rs.20,000/-
Glucosamine HCl ....1500mg
2. -do- Procoxam 625mg Tablet 13-05-2014
Each tablet contains:- 686
Glucosamine HCl …..625mg Rs.20,000/-
3. M/s Calvita Syrup 15-04-2014
Medisure Each 5ml contains:- 668
Labs, Calcium lacatate Rs.20,000/-
Karachi
Gluconate…………..40mg
Vitamin A ………….1200IU
Vitamin D3 ………….100IU
Vitamin B1 HCl …….1mg
Vitamin B2 5-sodium
phosphate …….. …….1mg
Vitamin B5 HCl.. …0.5mg
Nicotinamide ………..5mg
Dexpanthenol ……….2mg
Vitamin C…….. …….50mg
Vitamin E acetate ……1mg
4. M/s Vitacal Syrup 26-06-2014
Kaizen Calcium lacatate 701
Pharma, Gluconate…………..40mg Rs.20,000/-
Karachi Vitamin A ………….1200IU
Vitamin D3 ………….100IU
Vitamin B1 HCl …….1mg
Vitamin B2 5-sodium
phosphate …….. …….1mg
Vitamin B5 HCl.. …0.5mg
Nicotinamide ………..5mg
Dexpanthenol ……….2mg

Vitamin C…….. …….50mg
Vitamin E acetate ……1mg
5. M/s Apitonic Syrup 27-08-2014
Genix Each 5ml contains:- 719
Pharma, Cyproheptadine HCl Rs.20,000/-
Karachi
(anhydrous) BP ……..2mg
Thiamine HCl (B-1) ...2mg
Riboflavin BP (as 5-
phosphate sodium)…2mg
Pyridoxine HCl ….0.75mg
D-Panthenol BP ….2.5mg
Nicotinamide BP ….22.5mg
6. -do- Calceg Injection 100mg/ml 27-08-2014
Each ml contains:- 720
Calcium gluconate Rs.20,000/-
(10%)……. …….10mg
7. -do- Tyca Tablet 90 27-08-2014
Each tablet contains:- 726
Ticagrelor ………90mg Rs.20,000/-
Decision: Registration Board approved minutes of 245th meeting with above correction
/ amendment in already approved minutes.
Item No II: Agenda points referred by Members, Registration Board.
 Dr. Amanullah Khan, Director DTL, Quetta:
a. PPMA Representation from North zone.
Reference to the above , it is submitted that for the last few DRB Meetings it is observed
that PPMA from North Zone/Region nominates that member for to attend the DRB Meetings
whose case is part of the agenda and in my opinion its a matter of conflict of interest. Therefore
it is requested that in the forthcoming meeting of DRB , this matter may be placed as agenda
item before the DRB and take decision whether such conflict of interest nomination may be
allowed or otherwise. Furthermore it is expected that PPMA from both the regions may
nominate(s) a member for DRB for a specified period.

Decision: Registration Board deliberated on the point and it was decided that
respective observer will leave the meeting by ownself, when agenda related to its company
will be discussed. All observers also consented to the decision.
b. Registration of drugs under Drugs Act, 1976.
Reference DRAP letter No. F.1-20/2000-Reg-I(Pt) dated 23rd April 2014 on the subject cited
above, in this regard it is submitted that DRAP has constituted a panel to carryout inspection
abroad at Argentina, the panel comprised of the following officials,
(I) Dr. Amanullah Khan, Director Drugs Testing Laboratory Government of

Balochistan, Quetta/ Member Drug Registration Board DRAP.
(II) Ms Sara Naeem, Assistant Drugs Controller, DRAP Lahore.
As per said letter there were four (04) importers / firms who have requested for the
import of their products from Argentina and accordingly on the request of the importers/firms the
panel was constituted to carry out inspections of their Principals abroad for the purpose of
registration of drugs under Drugs Act, 1976. The following is the list of firms/importers who had
requested for registration of drugs under the Drugs Act 1976.
i. M/s Pine International Lahore.
ii. M/s Atco Pharma International (Pvt) Ltd Karachi.
iii. M/s Oncogene Pharmaceuticals Karachi.
iv. M/s Nawab Sons, Karachi.
As per procedure of the DRAP the letter for inspection is issued only when all the
prerequisite documents/information for the Registration of the Drugs is completed and
accordingly the said letter is also issued on the same grounds by the competent authority,
however regret to mention that M/s Pine International Lahore has declined to carryout
inspection of their Principal abroad so there is need that the Firm has to clear their position and
explain their position for refusing inspection abroad and why action may not be taken against
them in wasting the time of the officials/inspectors and by enlarge of the DRAP.
Regret to mention that M/s Oncogene Pharmaceuticals Karachi as per DRAP, changed
their principal without approval from the DRAP which is not accepted ethically and officially.
They kept the inspection in grey and at any stage never accepted their mistake of change of
Principal and ultimately on 16th October 2014 the coordinator of the inspection team from Atco
Pharma has forwarded an e-mail from Mr Zubair Khalil owner of M/s Oncogene

Pharmaceuticals Karachi, and explained that DRAP has refused our request for change of
Principal and further added that i will be obliged if Atco Pharma etc takes my case to DRAP for
not carryout inspection abroad. As a Member Drug Registration Board i am not comfortable with
such offensive statement issued from M/s Oncogene Pharmaceuticals Karachi and there is need
to ask them explain their position on such offended statement.
M/s Atco Pharma International (Pvt) Ltd Karachi and M/s Nawab Sons, Karachi also
declined to carry out their inspection abroad by giving no reason.
Keeping in view an exercise of more than six months wherein the Inspectors from time to
time has to reschedule their official activities for the purpose to carryout inspection abroad
smoothly , but regret to say that the inspectors have been kept in dark by the firms/importers and
there was nobody who could come up with truth that we are not in position to carryout
inspection , as from the beginning it was apparent that the importers/firms were not interested to
carryout inspection abroad and it was also apparent that among the firms/importers blame game
has started which was not a good sign for inspection.
I would like that the case may be kept as Agenda Point in the forthcoming meeting of
DRB and a decision may be taken against the firm/importers who are responsible for this Act.
The cases may be dealt as per Drug Act and as per Policy of DRAP to stop such practices in
future and the offenders may be treated as per policy/Drug Act and I also request for the
cancellation of their requested products.
Decision: Registration Board advised pharmaceutical Evaluation & Registration

Division to present update status of these cases in its forthcoming meeting.
 Mr.A.Q.Javed Iqbal, Director QA & LT, DRAP.
c. This point should be brought into discussion of next meeting that Board should define
uniform guidelines to scrutinize variations if it is related to API / quality of Drug substance in
light of ICH guidelines (Q 8, Q9 & Q10) for all originators and for generic products as well.
Moreover the all respective change should be assessed under the scope of applied variations.
Decision: Registration Board discussed the matter and it was decided that QA & LT
Division will develop guidelines for this purpose in consultation with PPMA and Pharma
Bureau.

Item No.III Cases for conduction of Clinical Trials – Pharmacy Services Division
Case No.01. Polio End-game strategies-Poliovirus Type 2 challenge study. A Five Arm
Community Based Randomized Trial, Karachi. Pakistan.
Aga Khan University has applied for the clinical trial to be conducted in collaboration
with WHO in assistance with EPI Programme.
The key feature of the trial is as under:
Title Polio End-game strategies-Poliovirus Type 2 challenge study. A Five Arm

Community Based Randomized Trial, Karachi. Pakistan.
Phase III
Background Polio disease is present in only three countries including Pakistan. Since the
injectable polio vaccine has better results, WHO “Polio Endgame Strategy ”
is to slowly withdraw the current vaccines replace all oral polio vaccine with
injectable polio vaccine.
Objective The over all purpose of this study is to compare the suggested five different
polio vaccine strategies to see which produces the best immunity for Pakistani
Children and prevents the spread of polio.
Participating Pakistan
Country/Sites. Outreach Primary clinics in Karachi at Rehri Goth, Ali Akber Shah Goth,
Ibrahim Hyderi and Bhains Colony.
Number of 1000 children each study group (arm) will have 200 children.
participants
Duration of One year (June 2014-15)
Trial.
Study  Oral Bivalent vaccine – Available from EPI
Interventions.  Oral Trivalent Vaccine – Available from EPI
 Inactivated Polio Vaccine (IPV) – To be imported
 Inactivated Polio Vaccine2 (IPV2) – To be imported
 Oral Monovalent Vaccine2 (mOPV2) – To be imported at a later stage
in the study. An amendment and request will be sent to DRA at that
time.
Study  To determine which vaccine best protects the children from polio
Outcomes
Quantity of  IPV= 1510 Doses
Drug to be  IPV= 230 Doses
Imported.  Other vaccines are already registered and standard of care. These will
be purchased from EPI.
Registration Oral Bivalent, trivalent polio vaccine is provided to EPI by WHO.
Status of drugs
in Pakistan.

Monitor of the  Dr. Maha Mohamed Saadeldine Salama
Trial. Head Clinical Research Sector/VACSERA, Cairo Egypt.
Sponsor  World Health Organization (Geneva)
Bilthoven Biologicals BV (BBIO) has been a manufacturer of IPV and monovalent bulk
components since 1994. The company has now developed an investigational monovalent high
dose inactivated poliovirus vaccine (m-IPV2 HD) in alignment with the Global Polio Eradication
Initiative (GPEI) and World Health Organization (WHO)’s strategic advisory group of experts
(SAGE) recommendation for the eradication of polio. The m-IPV2 HD vaccine contains 32 D-
antigen (D-Ag) units of inactivated type 2 poliovirus, which is four times the current dose of type
2 polioviirus in the trivalent inactivated poliovirus vaccine (t-IPV). This high dose of antigen
should permit the one step immunization of children against type 2 polioviirus while avoiding
the safety issues associated with the attenuated type 2 poliovirus used in the oral poliovirus
vaccine (OPV).
Bulk virus was initially produced in monkey kidney cells and is now produced in Vero
cell line. Full nonclinical toxicology testing was performed on the trivalent polio vaccine.
Manufactured using bulk viruses produced in monkey kidney cells. Extensive clinical data were
also obtained for this formulation. When production of IPV was switched from sub cultured
monkey kidney cells to Vero cells, a limited number of preclinical and clinical studies were
conducted to compare the safety and the efficacy of IPV produced in Vero cells (IPV-Vero) to
the safety and the efficacy of IPV produced in subculture monkey kidney cells (IPV-MK). A
nonclinical toxicology study in rats showed no unexpected toxicological findings.
There are currently no clinical data with the m-IPV-HD. However, clinical studies
showed that t-IPV-Vero is a safe, well-tolerated vaccine that induces as effective immune
response similar to that of IPV-MK. The safety and effectiveness of IPV-Vero is further
supported by post-marketing surveillance bases on a 15-year follow-up of more than 90 million
IPV-Vero vaccine doses distributed worldwide in close to 60 countries.

As per procedure in vogue the submitted trial was referred to three experts for expert
opinion to facilitate the decision making process by the Registration Board. The same is
summarized as under:
S.No. Expert Name Opinion

1. Syed Sohail Zahoor It is hereby informed that the subject study is well planned to
Zaidi, Chief Scientist determine the improved effect of vaccination with combined
(Virology) Head of formulations i.e bivalent OPV + IPV vaccines to fill-in the
Department of Virology gaps in immunity type 2 polioviruses among Pakistani
Children.
The study will be conducted with the financial and technical
support of WHO Head Quarters, Geneva and does not pose
any apparent burden on the GoP/National or international stake
holders providing assistance for the Polio Eradication program
in the country.
I hope that the findings and outcomes of this interventional
study will improve our understanding and help to devise
progressive recommendations for vaccination to achieve the
goal of Polio eradication.
2. Mr.Mazharullah The five arms plan for End Game Polio Virus, the pattern of
Memon, Principal dosing as described are suitable for the subject study and the
Scientific subject clinical trial is suggested in my opinion and there is no
Officer/Manager financial burden on the Government of Pakistan.
Quality Control
Laboratory.
3. Dr. Haider Sherazi, Comments are still awaited in spite of reminders
Neonatology, PIMS,
Islamabad.
The institution has also requested for import of the following trial material to supplied by the WHO
through EPI:
Drug Name Quantity required

Inj IPV 1510 Doses
Inj IPV2 230 Doses
Decision: Registration Board discussed trial for its all prons and cons keeping in view
the prevalence of polio in the country. Dr.Abdur Rasheed, DDG (Pharmacovigilance)

informed that Dr. Haider Sherazi has also given his expert views in favor of the trial.
However, after thorough deliberation the Board deferred the case for presentation by
Principal Investigator of the trial.
Case No.02. Phase III (b) Clinical Trial for use of Buprenorphine for treatment and
detoxification of injectable drug users in Pakistan.
Pakistan is signatory to the Millennium Development Goals (MDGs). Goal 6 state that
Pakistan will halt and begin to reverse the spread of HIV/AIDs Globally the most
recommendation intervention to halt the spread of HIV/AIDs infections among the group of
injectable drug users is Buprenorphine which is being used by the drug users for Detoxification,
treatment or at lease substitute the other injectable drugs with oral dosage form.
National AIDs Control Programme, Ministry of National Health Services, Regulation &
Coordination Islamabad has submitted a project proposal to the subject cited above. It is
hypothesized that Buprenorphine has challenges of misuse considering the non regulated
environment if produced and made available in higher doses.. Safety, as reflected by Adverse
Events (AEs) and severe Adverse Events (SAEs), withdrawal severity, stabilization dose and
treatment retention during the study will also be explored.
This is an open-label study, 1,000 (One Thousand) IDU’s seeking treatment for opiate
dependence will be enrolled in 5 centers across Pakistan. Participants are expected to be
predominantly males and non-pregnant and non-lactating females who are at least 18 years-of-
age at the time of enrollment. Following screening, there will be a 28 day stabilization period on
Buprenorphine. All participants will be inducted onto the drug over a period of 3 days with doses
not to exceed 8mg on the first day, 12 mg on the second day and 16mg of third day. Until the end
of the third week doses may be adjusted in 4 or 8mg increments to a total dose of 8, 16, 24mg
based on clinical need, as judged by the treating physician/investigator. The duration of study
participation for each participant will be a maximum of approximately 6 months, including
screening, stabilization, tapering, post-tapering and follow-up, results from this study will add to
the knowledge bases of the clinical use of Buprenorphine in Pakistani population and provide
clinicians/regulatory bodies with data to guide the process of Buprenorphine treatment.

Principal investigator has submitted ethical approval issued by the National Bioethics
Committee (NBC Pakistan) on 5.11.2014. The trial material is proposed to be arranged from two
following sources if approved by the Registration Board:-
S.No Name of Firms 2mg tablets 8mg tablets

1. M/s. Valor Pharmaceutical, Islamabad 1,80,000 tabs 1,80,000 tabs
2. M/s. Wilshire Labs, Lahore 1,80,000 tabs 1,80,000 tabs
Decision: Dr.Basir Achakzai, Director National AIDS Control Programme and his
team presented in detail background of the case with special refrenece to Pakistan scenario.
The Board also discussed that internationally such therapies are available in combination
with Naloxone for patients admitted in hospital. After detailed deliberation, registration
Board deferred the case dor following:
 National AIDs Control Programme will revise its protocol in line With International
Best Practices recommended / adopted for this purpose.
 Pharmacy Services Division, DRAP will forward revised protocols to Narcotic

Control Division anf following expert for their views:
o Prof.Dr.Rizwan Taj, PIMS, Islamabad.
o Maj.Gen.Saleem Jehangeer, AFIMH, Pawalpindi.
o Prof.Dr.Ghulam Rasool, Quetta.

Item No.IV Matters referred for deliberation by Registration Board
a. Comments of Director Malaria Control, Islamabad regarding injectable anti-
malarial therapy.
Registration Board in 245th meeting discussed following comments of Director Malaria

Control, Islamabad.
“The matter has been discussed with the National Professional Officer, MCE, WHO Pakisan
and technical team of this Directorate. Due to emerging Artemisinin resistance in the South East
Asia, which also threatened Pakistan, because of uncontrolled / irrational use of parental
Artemisinin Monotherapy derivatives including Artemether in uncomplicated P. Falciparium
case and also in clinical Malaria cases by the unregulated Private Sector. During the recent 6th
Inter Country Meeting of National Malaria Control Managers held at Cairo, Egypt on 13th – 14th
August, 2014 WHO EMRO Region showed their serious concern on production of Artemisinin
monotherapy and injectable chloroquine in Pakistan. According to the approved National Anti-
Malaria Drug Policy only Injection Artesunate is recommended for confirmed severe
Falciparium Malaria cases in hospital settings and as pre-referral treatment in RHCs /BHUs.
Directorate of Malaria Control intends to convene a meeting with Drug Regulatory Authority of
Pakistan along-with other stake holders to share the views on emerging artemisinin resistance
and irrational use of antimalarial drugs in the country. It is also requested to halt further
registration Antimalarial Drugs”.
Registration Board in 245th meeting deferred all injectable anti-malarial drugs and invited
Director Malaria Control, Islamabad in forthcoming meeting for detailed discussion.
Discussion: Dr.Aslam Khan Director Malaria Control Program and Dr.Qutub-ud-Din Kakar,
WHO National Professional Officer briefed the Board about irrational use of antimalarial drugs
in the country particularly injectable anti-malarial therapy and development of emerging
artemisinin resistance. Crux of the briefing is as follows:
a. Resistance to antimalarial drugs is the biggest challenge to malaria control in the country
resulting from “increased drug pressure” due to irrational use of antimalarial drugs
particularly the “monotherapies”.

b. Malaria is re-emerging due to “failure” of control interventions particularly the low coverage
of “effective treatment” and vector control.
c. Effective treatment is the “Foundation stone” of malaria control today which is dependent on
correct lab diagnosis and effective medicines. Effective treatment is the most effective tool to
reduce transmission potential due to reduction in parasite reservoir in human hosts.
d. Malaria Control programmes have been left with limited choices of treatment for confirmed
cases and there has been no development made in the development of new effective and safe
drugs in near future. This calls for rational and restricted use of available regimens where the
mainstay of treatment is Artemesinin Combination Therapies.
e. In Pakistan the positivity rate in suspected cases has been lower than 5% in highly endemic
areas and <1% in low endemic province of Punjab, treatment of malaria cases on clinical
grounds is mostly wrong in 98% of suspected cases, which is the major reason of misuse of
these drugs. No antimalarial drug should be dispensed in Pakistan without confirmatory test,
is the national policy and promotion of produced “anti-malarial” molecules by the industry
has led to the indiscriminate prescriptions by the untrained physicians, paramedics and
kwakes.
f. As per policy injectable quinine and Artesunate only can be sued in the treatment of
complicated and severe malaria cases, which are only seen in a fraction malaria cases due to
falciparum species only. The total estimated number of confirmed cased due to falciparum
malaria in the country are not >200,000 cases and the number of true severe malaria cases
will not be more than 20,000 warranting treatment with injectable quinine and Artesunate.
g. Treatment of severe cases of malaria is a medical emergency requiring intravenous
medication with above mentioned drugs and can only be dealt in at Secondary or tertiary care
hospitals only.
h. Huge quantities of Artesunate injections have been provided by the Global Fund from WHO
Pre-Qualified manufacturer (Guillin Pharma) sufficient to cover all the country needs of
dealing with severe cases.
i. Resistance is rapidly developing against artemisinin group and within short time the care
delivery system will be unable to treat the complicated cases at hospitals.

Decision: Registration Board appreciated the concern raised during the briefing. It
was then decided that Malaria Control Program will hold a consultative meeting of all the
stakeholders including DRAP, prescribers, provincial governments, pharmaceutical
manufacturers etc for framing recommendations on the matter.
b. Transfer of registered drugs.

Under Rule 27 of Drugs (Licensing, Registering & Advertisement) Rules 1976, a
certificate for registration is issued for a period of five years unless earlier suspended or
cancelled. As per practice in vogue, if a firm applies for transfer of registration, such cases are
transferred according to the following provisions incorporated in schedule F vide SRO
877(I)/2000 dated 09th December, 2000:-
An application for:-
(i) transfer of registration from one importer or manufacturer to another,
(ii) transfer from import to local manufacture,
(iii) import in bulk and repacking locally, and
(iv) change of name of registered drug, shall be considered as for grant of a new
registration and shall be made as per rule 26(1).
Registration Board in its 240th meeting also approved the following SOPs to stream line
the transfer of registrations and delegated its powers to the Chairman Registration Board to
approve such cases:-
Transfer of registration:
i) With change in manufacturing site:

a. Application with Form-5 and required fee as per relevant SRO.
b. Copy of registration letter and renewal status.
c. NOC for CRF clearance.
d. Copy of approved section by Central Licensing Board.
e. Copy of last inspection report.
f. NOC from existing manufacturer / registration holder permitting for transfer of
product.
g. Statement / undertaking that applicant do not have registration of same products.
If so, it has to apply for cancellation of product.
h. Accelerated stability studies of 6 months with to conduct real time stability
studies up to assigned shelf life & report if any result falls outside shelf life
specifications with proposed action).

i. Validated method of analysis, master formula and product development data
ii) Change in name / title of manufacturer (site of manufacturing remains the same)
a. Application on Form-5 with required fee as per relevant SRO.
d. Approval of new name / title from CLB.
e. Undertaking that the formulation, API source & Specifications, manufacturing
process, analytical test methods, release & shelf life specifications have not
changed.
However, schedule F was amended as per SRO 1117(I)/2012 dated 10th September, 2012
and above provisions defined for transfer of registration vide SRO 877(I)/2000 dated 09th
December, 2000 have been omitted now.
In view of above, directions /guidance of Registration Board is solicited to process cases

of transfer of registration of drugs.
Decision: Registration Board deliberated on the matter and it was decided that
following procedure will be adopted for these cases.
 Registration will be cancelled from name of existing registration holder. The

applicant will comply all requiremenrs for grant of registration and then
registration Board will decide the case for grant of registration keeping in view
safety, efficacy and quality parameters.
 For imported drugs, Import Policy for Finished Drugs will be followed.
 A reference will be sent to Cost & Pricing Division whether such cases for grant of
registration shall be considered at existing MRP or otherwise.
 Cases will be divided into any of following category and requisite documents will be
as follows:
o Registration of drug for local manufacturing.

a. Application with Form-5 and required fee as per relevant SRO.
d. Copy of approved section by Central Licensing Board.
e. Copy of last inspection report.

f. NOC from existing manufacturer / registration holder permitting for cancellation
of product from its name and grant to new registration holder / manufacturer.
g. Statement / undertaking that applicant do not have registration of same products.
If so, it has to apply for cancellation of product.
o Registration of drug for import (Change of authorized agent in Pakistan only).

a. Application on Form 5A with required fee as per relevant SRO.
b. Copy of registration letter and last renewal status.
c. Notorized termination letter (original) from manufacturer for previous importer.
d. Notorized authority letter/sole agent letter (original) from manufacturer.
e. NOC from existing importer / registration holder permitting for cancellation of
product from its name and grant to new importer / registration holder.
o Registration of drug when title of firm has been changed by firm and approved
by Central Licensing Board (manufacturing site remains the same).
Registration Board discussed that in this case registration will not be cancelled from
previous name as there is no change in manufacturing site and only title of registration
holder has been changed. Thus case will be processed for change of title of the firm and
firm will submit following documents.
a. Application on Form-5 with required fee as per relevant SRO.
d. Approval of new name / title from CLB.
e. Undertaking that the formulation, API source & Specifications, manufacturing
process, analytical test methods, release & shelf life specifications have not been
changed.
c. Re-registration of drugs.
Under Rule 27 of Drug (Licensing Registration and Advertising) rule, 1976, a certificate
of registration, shall unless earlier suspended or cancelled, be in force for a period of five
years from the date of registration of the drug and may thereafter be renewed for periods not
exceeding five years. Provided that an application for the renewal of registration shall not be
entertained unless it has been made within sixty days after the expiry of the registration and
when and application has been made as aforesaid the registration shall subject to the orders
passed on the application for renewal continue in force for the next period of five years.

Previously, in case a firm applies for re-registration of drug i.e after expiry of renewal
of registration of a drug, such cases were processed for re-registration on payment of full
registration fee and submission of form-5. Chairman Registration Board was authorized to
approve such cases on file.
Decision: Registration Board advised stake holders (PPMA, Pharma Bureau and
PCDA) to forward their comments till 15.01.2015 for considerartion by Registration Board.
d. Registration of 10 Products per section for New Drug Manufacturing Licence/

Additional Section.
Registration Board in 245th meeting constituted following committee to review policy of

registration of 10 products per section to new manufacturers/ additional sections.
- Prof. Muzamil Hassan Najmi, Member Registration Board

- Mr. A Q Javed, Director QA, DRAP.
- Mr. Arif Chowdhry, DDC Reg-I
The Committee forwarded following recommendations:
 To achieve the standards as laid down in GMP, the present practice of granting
registrations of ten products in a section to the new licensees may be continued.
 The operational status of the manufacturer may be assessed by a panel inspection after 60
days of commencement of manufacturing activity.
 Subject to compliance of GMP, as determined by the inspection panel, another ten

products per section may be granted to the new licensees on priority.
Decision: Registration Board was informed that DRAP’s Policy Board has also
discussed and deferred instant matter for further deliberation. The Board decided that
above points will be forwarded to DRAP’s Policy Board as recommendation from
Registration Board.

e. Non-Availability of finished drugs in country of origin.
Registration Board in 245th meeting discussed that in some cases, finished drug of a
manufacturing site is neither available / authorized for sale in country of origin / manufacture
nor approved by any of regulatory authority of USFDA, Australian TGA, Japan or EMA, but
applicant intend to import finished product from that site. The Board constituted following
committee to look into the matter keeping in view international practices in such cases and
frame its recommendations.
‐ Prof. Muzamil Hassan Najmi, Member Registration Board.

‐ Mr. A Q Javed, Director QA & LT
‐ Mrs. Sara Mahreen ADC, PEC
Mrs. Sara Mahreen could not join the committee due to her posting in DRAP, Lahore and
Mr.Ammad Zaka, ADC was assigned the task.
The Committee forwarded following recommendations:
 If any such drug which is not available in country of origin and not approved by reference
regulatory authorities i.e., USFDA, Australian TGA, Japan or EMA, it may be considered
for registration or approval of post registration variation, provided:
o Its registration has not been cancelled / withdrawn by any ICH member countries,
which are considered SRA, for safetyreasons.
o There is no new toxicity data reported about the drug requiring re-evaluation of its
status.
o It is available in atleast threeSRAcountries as notified by International Conference

onHarmonization of Technical Requirements for Registration of Pharmaceuticals
for Human use (ICH) on www.ich.org.
Decision: Registration Board advised stake holders (PPMA, Pharma Bureau and
PCDA) to forward their comments till 15.01.2015 to already constituted committee for
framing its recommendations for considerartion by Registration Board.

f. Export of drugs with same brand name of different manufacturers
M/s Ambrosia Pharmaceuticals, Islamabad has informed that they have exported
following drug:-
Name of product Regn No. for M/s Regn No. for M/s
Ambrosia in Ambrosia in Kingdom
Pakistan of Combodia
Util Capsule 40mg 046889 CAM 0279-10
(Esomeprazole)
Firm has submitted that they were surprise and shock that M/s Medisure Labs, Karachi
exporting their same molecule “Esomeprazole” with same brand name “Util” to Kingdom of
Combodia with printed same registration number granted to them in Cambodia. This kind of act
is not only hurting their marketing and market share and image in Kingdom of Combodia as their
product are more effective and superior quality but more importantly damaging the image of
DRAP. At this time their distributor in Combodia has refused to place any further orders or
accept shipments of above products till such time they receive letter from DRAP stating that
DRAP will cancel these EX registrations of M/s Medisure and also confirmed that this brand
name will not be issued to any other manufacturers / companies in Pakistan by DRAP for export
purposes in the future.
Decision: Registration Board was informed that M/s Ambrosia Pharmaceuticals,
Islamabad has also submitted similar type of complaint against M/s English Pharma,
Lahore. Thus the Board decided to call these three manufacturers in forthcoming
Registration Board meeting with relevant record for presentation of their case.
g. Registration of generic Nilotinib
Advocate Mr. Kazim Hasan, Barrister-at-Law of M/s Novartis Pharma Limited has informed
that they have been instructed by Novartis to advise the Drug Registration Board of the DRAP
that the intellectual property rights to Nilotinib vests in Novartis globally. Nilotinib is a
breakthrough treatment of Lukemia and it has been developed by Novartis. M/s Novartis has
come to know that M/s Genix Pharma has applied for generic registration of Nilotinib under the
trade name Lukopenil. Being intellectual property rights to Nilotinib vests in Novartis globally a
generic Nilotinib would be a violation intellectual property rights.

Advocate Mr. Kazim Hasan has further submitted that such registration would also constitute
a sovereign breach, as Pakistan is a signatory to international treaties which guarantee protection
of intellectual property rights. He requested that application filed by Genix Pharma for generic
registration of a Novartis product may be rejected and Drug Registration Board should not even
entertain any application for generic registration Nilotinib under any trade name.
Decision: Registration Board decided to forward instant letter to IPO, Pakistan for its
comments for consideration by the Board.
h. Recommendation of Review committee.

Registration Board in 245th meeting considered following recommendations of review
committee and advised PPMA and Pharma Bureau to forward their comments for consideration
of Registration Board. Now both stake holders forwarded their comments on these
recommendations, as follows:
 PPMA:
A. Trimethyl Phologlucinol 80mg+Phloroglucinol 80mg.
i. Products Containing Phloroglucinol are available in many countries of the world, including Italy,
France, Switzerland, Luxemburg, Belgium, China and South Korea where more than 42
Companies including Multinationals have market since many years.
ii. In Italian health system, inclusion of Phloroglucinol as a fully reimbursed product is a further
guarantee of its efficacy and safety. In June , 2011 the transparency Committee of the Prestigious
HAS, France as recommended continued inclusion on the list of medicines refundable by national
health insurance and on the list of medicines approved for hospital uses in the indication of
“Symptomatic Treatment of Pain Related to Functional Disorder of the Gastrointestinal tract
including IBS and dosages given in the marketing authorization”.
iii. The product containing this molecule in France has been in the market since very long and is one
of the highest used specialties in gynaecology. Today about 15 French and multinational
companies have marketed their brands in France only.
iv. Also in Pakistan where this is the most used specialty for renal colic, biliary colic, abdominal
colics, IBS andfor the facilitation of labor, since almost 20 years with excellent safety and
efficacy.
v. All the leading medical specialists of Pakistan in related fields confirm its usefulness and are
completely satisfied.
vi. The clinical trials conducted within Pakistan have been included in International Literatures.
Volumes of data speak about its safety and efficacy.

vii. Phloroglucinol is well documented in well reputed medical reference books including Extra
pharmacopeia Martindale and Merck Index.
viii. The molecule Phloroglucinol is not under any review by EMA (European Medicine Agency) and
FDA (Food and Drug Authority of America).
ix. Only authentic documents about the safety of a product in Europe are PSUR (Periodic Safety
Update Report), which confirms the safety of the product.
B. Omeprazole + Sodium Bicarbonate 20mg, 40mg.
i. The product is safe for use to cure GERD. Authentic clinical trials/study attached to your
reference to use product for short term only (4 to 8 weeks) depending upon the patient health
severity. Minor side effects like hypokalemia, alkalosis and problem with acids base balance only
related with long term use. Companies already not recommended product for long term use.
ii. Product is approved in USFDA and on under prescription.
C. Citicoline.
i. Availability in Multiple Countries:

Citicoline is available in multiple European, North America and Asia Pacific Countries. It
highlights the wide spread usage of Citicoline as Nootropic and Neurotonic agent with
established efficacy and safety.
ii. Evidence of Citicoline’s Mode of Action as Neuroprotective:

A study of International Society for Neurochemistry in Journal of Neurochemistry has established
Citicoline as an intermediate in the biosynthesis of phosphahatidylcholine which has beneficial
effects in number of CNS injury models and patholological conditions of brain.
iii. Reference of Citicoline in Authentic & Reputable Journals:

a. British Medical Journal has highlighted Citicoline as more effective if given within 24 hours of
stroke than placebo while referring the study of clinical trial “Stroke Management” by Elizabeth
Warburton; Josef A Alawneh; Philip L Clatworthy; Rhiannon S Morris”.
b. Journal of the American Heart Association has highlighted beneficial therapeutic effect of the
long term treatment of Citicoline in acute cerebral infarction.
c. According to Clinical Interventions in Aging, a world renowned journal, Citicoline is effective
and well tolerated in patients with mild vascular cognitive impairment.
iv. Citicoline Granted Novel Food Ingredient Status in EU

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition
and Allergies (NDA) delivered a scientific opinion on Citicoline as a novel food ingredient (NFI),
which concluded on October 2013 that Citicoline is safe under the proposed use and use levels.
The Commission Implementing Decision 2014/423/EU on July 1, 2014 authorized Kyowa Hakko,
New York, NY, to market and manufacture Citicoline as a NFI under Regulation (EC) No 258/97 of
the European Parliament and of the Council.
v. Huge prescription base in Pakistan

According to the latest “Sales” data, around 700,000 injections of 250mg whereas 1,000,000 tablets
have been selling in a year in Pakistan. It reflects strong confidence of leading neurologists and
neuro-surgeons in efficacy and safety of the product which leads to such a massive prescription base.
D. Diacerein.
i. The molecule is registered with the European Medicines Agency.

ii. The product is very effective for the treatment of Osteoarthritis Specially in advanced age
iii. The product is available and authorized to be used in the European Union Including France.
E. Calcium Dobesilate.
i. The molecule is included in the European Pharmacopoeia.

ii. Molecule is registered and available in Switzerland (COPP available)
iii. Molecule is registered in more than sixty countries of the world and marketed in more than fifty
countries.
iv. The molecule has been registered and marketed since 1972 and available in European Union
since 1975.
F. Smectite.
i. The molecule is available in France, Greek and USA.

ii. The molecule is extremely useful in the treatment of Acute Diarrhea.
iii. It is a time tested and important product for treatment of Dierrhea specially in children.
iv. The molecule is available in the European Union including Switzerland, Germany, Austria, Italy,
Spain and countries of Eastern Europe as well as South America and South Anastasia.
v. It is an important molecule to prevent Hepatotoxicity.
G. Saccharomyces Boulardi.
i. Clinical efficacy has been established for chronic disease like Crohn disease, Ulcerative Colitis,
Irritable Bowel Syndrome, Parasitic infection & Human Immunodeficiency virus related
Diarrhea. An overdose of saccharomyces boulardii and long term use ae not likely to cause life-
threatening symptoms.

ii. USFDA are withdrawing a notice of eligibility and recommendation of safety data for
consideration as OTC product and recommended product monograph for antidiarrheal drug..
iii. Product is already approved and recommended by TGA.
iv. In many of countries like in Vietnam, Product registered as drug and in Pakistan this product is
under price control and if product transfers to OTC division then market price might be change
and ultimately effect on patient.
H. Piracetam.
i. Availability in Multiple Countries:
Piracetam is available as “Central Stimulant” and “Nootropic Agent” in large number of countries
including multiple European, South America and Asia Pacific Countries. Among them the most
significant are Germany, France, Belgium, India, Malaysia, Turkey, Singapore etc.
ii. Authentic References:
‐ Assay method given in “British Pharmacopoeia” highlighting the authenticity of the product.
‐ Piracetam has been mentioned in “Martindale - The extra Pharmacopoeia” 36th Edit on with
mode of action and its therapeutic uses.
iii. Mode of Action:
Mode of Action of Piracetam is well-explained which highlights its beneficial influence on

neuronal and vascular functions. Further Piracetam also improves the function of neurotransmitter
acetylcholine.
iv. Wide-spread Usage of Piracetam by leading Neurologists & Neuro-Surgeons in Pakistan:
There are significant number of Piracetam users all around the Pakistan who are very much
satisfy with therapeutic results as Nootropic and Neurotonic Agent.
v. Huge Prescription Base in Pakistan:
According to the latest “Sales” data, around 400,000 syrups have been selling in a year in
Pakistan. It reflects strong confidence of leading neurologists and Neuro-surgeons in efficacy and
safety of the product which leads to such a massive prescription base.
I. Thiocolchicoside.
i. Committee for Medicinal Products for Human use (CHMP) of the European medicines agency in
its assessment report no. EMA/40340/2014 dated 17th January, 2014 as made the following
conclusion.
a. Having considered all available data from pre-clinical studies, Pharmacoepidemiological studies,
published literature, post-marketing experience on the safety of thiocolchicoside containing
medicinal products for systemic use with regards to its genotoxicity, the Committee considered

that thiocolchicoside containing medicinal products for systemic use remain an effective adjuvant
treatment of painful muscle contractures in acute spinal pathology.
b. However, having considered the risks, thiocolchicoside containing medicinal products for
systemic use should only be administered to patients over 16 years of age in acute conditions.
With treatment duration limited to 7 (oral) and 5 (IM) consecutive days. In that respect, the
CHMP was of the view that the indication in “Parkinson’s disease and drug-induced
Parkinsonism with special consideration to neurodyslectic syndrome” should be removed as this
is a chronic condition which requires longer treatment duration. The package size should be
adapted to new recommended treatment-days.
c. The committee considered also that thiocolchicoside containing medicinal products for systemic
use should be contraindicated during the entire pregnancy period. These products should also be
contraindicated in women of childbearing potential not using contraception and during lactation.
The CHMP also recommended further changes to the product information including information
on fertility.
d. The Committee as consequence concluded that the benefit-risk balance of thiocolchicoside

containing medicinal products for systemic use as adjuvant treatment of painful muscle
contractures acute spinal pathology in adults and adolescents from 16 years onwards remains
favorable, subject to the restrictions, warnings, other changes to the products information,
additional pharmacovigilance activities and risk minimization measures agreed.
ii. The molecule is available in France, Greece, Italy, Portugal, Malta, Spain, Hungary, Czech
Republic, India and many countries of the Fareast.
iii. The molecule has been in use in Europe since last more than 30 years.
J. Dry Powder Suspension of Famotidine.
Famotidine has many advantages in the Dry Powder form (reconstitute before use) as compared
to liquid suspension due to the following reasons.
i. International Availability of Dry Powder Suspension by the Innovator: Please see the
attached Annexure, I, which clearly shows that in USA, the research company Merck & Co is
manufacturing Famotidine in Dry Powder Suspension. We have attached Product information
available freely on internet for your perusal and record.
ii. Proof of availability of this formulation i.e. Dry Powder Suspension is attached as Annexure II –
IV, which shows that renowned companies such as Zydus Pharmaceutical USA, Paddock
Laboratories Inc., Minneapolis and Lupin Pharmaceuticals Inc., USA are manufacturing and
marketing their products in USA which is approved by USA FDA. We have attached the product
details downloaded from Internet.
iii. Pharmacopeial Monograph: For your kind record, please note that Dry Powder Suspension is
mentioned in the Monograph of Famotidine in USP (Please see Annexure - V ). It is mentioned in

the monograph that total impurities in the Oral suspension should not be more than 2.0%. it is
very unlikely that Famotidine that is not stable in water could meet criteria of impurities of 2% if
provided in the form of liquid suspension.
iv. Comments on Stability: Famotidine stability in aqueous solution is temperature dependent,
therefore storage condition for Famotidine injection is recommended at 2-8oC(See Annexure VI).
Various studies are available in the literature which supports termal degradation of Famotidine in
Aqeouse Solution at room temperature (See Annesure VII), hence liquid suspension degrade at
room temperature.
v. Based on the above authentic references, it may be noted that Dry Powder Suspension is more
stable and is used within 30 days after reconstitution (USA product brief). Therefore this
formulation is the benchmark as marked by its researcher. Therefore liquid suspension at room
temperature is not stable and should be look into for patient safety.
K. Silymarin
Silymarin is mentioned in more than one standards books like:
1) Martindale: The complete drug Reference, which is a comprehensive & reliable reference
source on drug & medicines used throughout the world.
2) U.S.P 34: Silymarin is prescribed in more than 50 countries of the world, we are enclosing
herewith reference of substantial internationally available brands.
S.No Brand name Manufacturing/Availability

Austria,Bahrain,Balgaria,China,Colombia,Georgia
Germany, Italy,Hungary,Mexico,Philippine, Poland,
1 Lagalon
Portugal,Romania, South Africa, Spain,
Switzeland,Slovakia,Thailand, Venezuela.
2 Simepar Switzerland
3 Cefasilymarin Germany
4 Samarin 140 Thailand
5 Doindi Vietnam
6 Silymarin Forte Romania
7 Silymarin Duo Macedonia
8 Hepasil Bangladesh

9 Esimerin Plus India
10 Good Liver India
11 Heptosil 200ml India

12 Livoriv-B India
13 Livosil-B India
14 Silyvit India
15 Tezaliv India
It is an important molecule used in various liver disorders. Various studies regarding

usage of Silymarin are available in different medical Journals.
Various manufacturers have also forwarded their comments on various formulations.
Recommendations of review committee considered by Registration Board in 245th meeting

are as follows:
S. Drug Name Approv Status in Research Concluding

No Generic (Brands) al by Authentic published in Remarks &
Internat Textbooks Reputed/ Recommendation
ional (Pharmacol Authentic
Regulat ogical basis Journals
ory of
Bodies therapeutic
s-Goodman
& Gilman,
Basic &
Clinical
pharmacolo
gy-B G
Katzung,
Current
Medical
Diagnosis &
Treatment
– 2013)
1. Keto Injection Yes Recommend Numerous Ketamine is

Each vial contains:- FDA ed for use in chemically related to
Ketamine HCl EMA & general phencyclidine and
 Ketamine 500 mg others anesthesia. therefore has a
(General Anesthetics) potential for abuse.
The drug is included in
the controlled list and
is placed in Schedule
III in USA.
In view of its useful
role in anesthesia,
Ketamine is
recommended to be
retained as a
registered drug.
However, it should be
dealt with narcotics
and appropriate
restrictions may be
applied to prevent its
abuse.
Recommended for
registration.
2. Fluoxetine + Olenzapine FDA The Available Fluoxetine is an

Citrate only individual SSRI and can
Each capsule contains:- drugs are interact with MOAIs
Fluoxetine HCl 25 mg recommende to cause serotonin–
Olenzapine Citrate d but the syndrome. Since it is
 Olenzapine 12 mg combination converted into a very
(Antidepressant) has not been long acting
mentioned. metabolite, the
interaction can occur
during 4 weeks after
cessation of
Fluoxetine. The risk
of QT prolongation
and causing Torsade
de pointes also
exists.
The Fixed-Dose
combination may
be allowed with
relevant warning
and to be dispensed
on prescription by
qualified
psychiatrist only.

Recommended for
registration.
3. Each capsule contains:- Tentativ The No independent Omeprazole, a PPI,
Omeprazole 20 mg e individual scientifically is a prodrug which
Sodium Bicarbonate 1100 approval drugs are designed studies requires acidic
mg by FDA recommende available to environment for
(Proton Pump Inhibiter) only. d but the support the conversion into
Not combination combination of active form. It blocks
approve has not been these two drugs. the H/K ATPase
d by mentioned. irreversibly and
EMA, reduces the gastric
PMDA, acid secretion to very
TGA low levels (most
potent among all
anti- secretory
drugs).
Sodium bicarbonate
is a rapidly acting
systemic antacid. It
absorbs into blood
and long-term use
may cause systemic
alkalosis, besides
other toxicity.
It is irrational to
combine the two
drugs as the antacid
may impair
activation of
Omeprazole. Further,
in the face of strong
acid-inhibiting effect
of Omeprazole, it is
superfluous to
administer an antacid
on regular basis.
The combination
adds to the cost and
increases adverse
effects.
Not Recommended
for registration.
4. Each capsule contains:- Tentativ The No independent Omeprazole, a PPI,

potent among all
anti- secretory
drugs).
Sodium bicarbonate
is a rapidly acting
absorbs into blood
and long-term use
may cause systemic
alkalosis, besides
other toxicity.
It is irrational to
combine the two
may impair
activation of
superfluous to
on regular basis.
The combination
increases adverse
effects.
Not Recommended
for registration.
5. U-Fit 10 mg Dry Suspension Famotidi NA NA Famotidine is widely
Each 5ml contains:- ne in dry available in Tablet,
Famotidine 10 mg suspensi Capsule, Suspension,
(Antiulcer) on form Chewable &
is not Dispersible tablet
approve forms. Dry
d by any suspension does not
reputed seem to offer any

internati advantage over the
onal existing formulations
agency and is not supported
by international
market scenario.
Not Recommended
for registartion.
6. Sacopan Sachets Not Some studies The probiotics are in
Each sachet contains:- approve about the role of evaluation stage and
Saccharomyces d by probiotics in their benefits in IBS,
Boulardii 250mg FDA, IBS and CD Crohn’s disease, C.
(anti Diarrhoeal) EMA, infection have difficle infection etc.
have not been
PMDA been published established. In
Approve but their role immune-compromised
d by requires more patients these may
TGA elucidation. cause life-threatening
only infection. In most of
the countries these are
available as food-
supplements or OTCs.
Some of these are
already available as
additives in milk
formulas for infants.
May be de-registered
as drug and allowed
as food supplements.
7. Ritocin-B Dry Suspension Not Erythromyci Studies have Mucolytics are

200 mg approve n as single been published useful in
Each 5ml contains:- d by drug is showing in vitro management of
Erythromycin Ethyl FDA, recommende effect of COPD after
Succinate. EMA, d by books bromhexine as administration by
 Erythromycin 200mg TGA & for mucolytic. inhalation. Evidence
Bromhexine HCl 4mg PMDA. infections by There is no is lacking for any
(Macrolide) susceptible evidence for benefit after oral
organisms. such action in administration.
Bromhexine vivo after oral All oral
is not even administration. formulations
mentioned. containing
bromhexine as
single drug or in
combination with
other drugs, are
recommended to be

de-registered.
8. Spardix Tablets 100mg Not Mentioned Studies have Several of the
Each tablet contains:- approve as member been published Fluoroquinolones
Sparfloxacin 100 mg d by of showing activity have been reported
(Anti-infective, FDA, fluoroquinol of sparfloxacin to cause QT
Fluoroquinolone) EMA, one group. against Gram prolongation and
TGA & positive cardiac arrhythmias.
PMDA. bacteria. The potential is
Reports are highest for
published Sparfloxacin.
describing In view of the
potassium unfavorable
channel risk/benefit ratio,
blocking the drug is not
activity causing recommended for
QT prolongation registration.
and life-
threatening
torsade de
pointes
arrhythmias.
9. ES ZIN 20mg Tablets Each Not The No independent The comments given
tablet contains:- approve individual scientifically above at No.3 also
Esomeprazole 20mg d by drugs are designed studies hold good for this
Magnesium 700mg FDA, recommende available to preparation.
Sodium Bicarbonate 20mg EMA, d but the support the All dosage
TGA & combination combination of strengths
PMDA. has not been these drugs. recommended for
mentioned. de-registration.
10. ES ZIN 40mg Tablets Each Not The No independent The comments given
tablet contains:- approve individual scientifically above at No.3 also
Esomeprazole 40 mg d by drugs are designed studies hold good for this
Magnesium 700 mg FDA, recommende available to preparation.
Sodium Bicarbonate 40mg EMA, d but the support the All dosage
TGA & combination combination of strengths
PMDA. has not been these drugs. recommended for
mentioned. de-registration.
11. Calzob-500 Capsules Not Not The published Calcium dobesilate
Each capsule contains:- approve mentioned clinical trials was developed for
Calcium dobesilate 500mg d by in any have shown that prevention of
(Vasotherapeutics, FDA, standard calcium diabetic retinopathy.
Coagulants, Haemostatics) EMA, textbook. dobesilate does Theoretically its
TGA & not reduce the mechanism of action
PMDA. occurrence of (inhibition of aldose

diabetic reductase and
retinopathy in reduction of capillary
patients. permeability)
supports its use for
this purpose.
However, in
evidence-based
medicine, benefits of
this drug could not
be established.
Recommended for
de-registration.
12. Ciprozan Tablets 1gm One Gm One Gm The strength is The slow release
Each film coated SR-tablet SR extended- within the tablet of 1 Gm is not
contains:- dosage release therapeutic in vogue but has
Ciprofloxacin ……… 1 gm form not tablet range of dose been described by
(Quinolone Antibiotic) approve mentioned described in the standard
d by by B G published textbook and lies
FDA, Katzung studies. within the
EMA, therapeutic range of
TGA & dose. The applicant
PMDA. may be asked to
provide full
justification for the
formulation, quoting
examples of
countries where
similar forms are
available.
Final decision may
be pended till point
of view of the
applicant is
evaluated.
13. Diacin 50mg Not Not Some in vitro Diacerein is an anti-
Capsules Each capsule approved mentioned studies on inflammatory drug
contains:- by FDA, in any chondrocytes acting by inhibition
Diacerein 50mg TGA & standard have been of Interleukin-1beta.
( Anti-Rheumatic ) PMDA. textbook published. It has been used in
Approved
by EMA
Clinical trials osteoarthritis where
for use in have reported it may produce slight
epidermo slight but improvement. In
lysis statistically limited number of
bullosa significant countries where it is

only superiority over available, it is being
placebo. reviewed and
withdrawn due to
hepatotoxicity.
In view of the
limited usefulness
and concerns of
toxicity, diacerein is
not recommended
for registration.
14. Swanliag 5 mg Tablet Not Mentioned Studies have Although 5 mg dosage
Each tablet contains:- approved by BG been published form has been
Cyclobenzaprine 5mg by EMA, Katzung in which discontinued by FDA,
(Skeletal Muscle Relaxant) TGA & cyclobenzaprine but other dosage forms
PMDA. was found to be contain higher doses
5 mg which may be
dosage-
superior to associated with more
form placebo and side effects. By virtue
discontin equivalent to of its non-addictive
ued by other nature It may be
FDA. spasmolytics. superior to
benzodiazepines.
In view of the
scientific evidence for
efficacy of the drug,
Cyclobenzaprine may
be retained as a
registered drug.
15. Mepridone 20mg Capsules Not The Studies on Besides the
Each capsule contains:- approve individual individual drugs
combination,
Esomeprazole Magnesium d by drugs are are available but
Domperidone as an
Trihydrate Pellets eq. to  FDA, recommende not on this individual drug is not
Esomeprazole 20 mg EMA, d but the combination. approved by FDA. It
Domperidone 30mg TGA & combination has been associated
(Proton Pump Inhibitor / PMDA has not been with cardiac
Anti-Dopaminergic) mentioned. arrhythmias. The
combination is
irrational and carries
the risk of toxicity.
Recommended to
be de-registered.
16. Each Sachet contains:- Tentativ The No independent Omeprazole, a PPI,

potent among all
anti- secretory
drugs).
Sodium bicarbonate
is a rapidly acting
absorbs into blood
and long-term use
may cause systemic
alkalosis, besides
other toxicity.
It is irrational to
combine the two
may impair
activation of
superfluous to
on regular basis.
The combination
increases adverse
effects.
Not Recommended
for registration.
17. Floronol Tablets Not Not No scientifically Phloroglucinol is a
Each tablet contains:- approve mentioned designed synthetic phenol
Phloroglucinol hydrate 80 d by by any clinical studies having
mg Trimethyl FDA, standard are available. In antispasmodic
Phloroglucinol 80 mg (Anti EMA, textbook vitro and properties. However
Spasmodic) TGA & toxicological its use in medicine
PMDA studies have has remained
been published. restricted due to
toxicity concerns. It

is mainly used in
explosive industry.
The adverse effects
reported by FDA
include neutropenia,
hepatotoxicity, renal
failure, metabolic
acidosis,
hyperkalemia and
allergic reactions.
In view of severely
unfavorable
benefit/risk ratio all
preparations
containing
phloroglucinol are
recommended to be
de-registered.
18. EsmoDome 20 Tablets Not The Studies on Besides the

Each tablet contains:- approve individual individual drugs combination,
Esomeprazole Magnesium d by drugs are are available but Domperidone as an
 Esomeprazole 20 mg FDA, recommende not on this individual drug is not
Domperidone Maleate EMA, d but the combination. approved by FDA. It
 Domperidone 30 mg TGA & combination has been associated
(Antiemetics & PMDA has not been with cardiac
Antinauseants) mentioned. arrhythmias. The
combination is
Recommended to
be de-registered.
19. EsmoDome 40 Tablets Each Not The Studies on Besides the
tablet contains:- approve individual individual drugs combination,
Esomeprazole as d by drugs are are available but Domperidone as an
Magnesium……..40mg FDA, recommende not on this individual drug is not
Domperidone Maleate EMA, d but the combination. approved by FDA. It
 Domperidone 30 mg TGA & combination has been associated
(Antiemetics & PMDA has not been with cardiac
Antinauseants) mentioned. arrhythmias. The
combination is
Recommended to
be de-registered.

20. Piram 1 gm Syrup Not Not Scientifically Piracetam is used in
Each 5 ml contains:- approve mentioned conducted treatment of
Piracetam 1g d by by any clinical studies cognitive disorders
(Psychostimulants, FDA, standard have not shown and myoclonus but
Nootropic, Neurotonic) EMA, textbook any benefit of scientific evidence
TGA & piracetam. for efficacy is
PMDA lacking. Side effects
including anxiety,
insomnia, irritability,
headache, agitation,
nervousness, tremor,
and hyperkinesia,
have been reported
with its use.
Not Recommended
for registration.
21. Wincoline 250 mg Injection Not Not Efficacy has not Citicoline is cytidine
Each 2ml ampoule approve mentioned been established diphosphate choline
contains:- Citicoline d by by any in scientifically which is said to
Sodium FDA, standard conducted increase
 Citicholine 250 mg EMA, textbook. clinical trials. dopaminergic
(Nootropics & Neurotonic) TGA & receptor density in
PMDA brain. It has been
used in cognitive and
some other disorders
on this basis but
evidence for efficacy
is lacking.
Not recommended
for registration.
22. Each film coated tablet Not Not Efficacy has not Citicoline is cytidine
contains:- Citicoline approve mentioned been established diphosphate choline
Sodium d by by any in scientifically which is said to
 Citicholine 500 mg FDA, standard conducted increase
(Nootropics and EMA, textbook. clinical trials. dopaminergic
Vasotherapeutic) TGA & receptor density in
PMDA brain. It has been
used in cognitive and
some other disorders
on this basis but
evidence for efficacy
is lacking.

Not recommended
for registration.
23. Esso Forte Tablets Each Delayed This Studies on this It is rational to
tablet contains:- release particular particular combine NSAIDs
Naproxen USP 500 mg tablets combination combination are with PPIs for
Esomeprazole Magnesium are is not not found. prevention of
Trihydrate approve mentioned gastropathy. Both the
 Esomeprazole 20mg d by but drugs individually
( NSAID + PPI ) FDA combining are well established
and NSAIDs in their respective
TGA. with PPIs categories.
Not and H2 Recommended for
approve blockers is registration.
d by recommende
EMA & d in general
PMDA. for
prevention
of
gastropathy.
24. Valex Talets Not Not No scientifically Phloroglucinol is a
Each film coated tablet approve mentioned designed synthetic phenol
contains:- Phloroglucinol d by by any clinical studies having
hydrate 80 mg Trimethyl FDA, standard are available. In antispasmodic
Phloroglucinol 80 mg EMA, textbook vitro and properties. However
(Gastrointestinal/Antispasm TGA & toxicological its use in medicine
odics) PMDA studies have has remained
been published. restricted due to
toxicity concerns. It
is mainly used in
explosive industry.
The adverse effects
reported by FDA
include neutropenia,
hepatotoxicity, renal
failure, metabolic
acidosis,
hyperkalemia and
allergic reactions.
In view of severely
unfavorable
benefit/risk ratio all
preparations
containing
phloroglucinol are
Recommended to

be de-registered.
25. S.OM-D 30mg Capsules Not The Studies on Besides the
Each capsule contains:- approve individual individual drugs combination,
Esomeprazole Enteric d by drugs are are available but Domperidone as an
Coated Pellets eq. FDA, recommende not on this individual drug is not
 Esomeprazole 40 mg EMA, d but the combination. approved by FDA. It
Domperidone 30mg TGA & combination has been associated
(Proton Pump Inhibitor / PMDA has not been with cardiac
antiemetic) mentioned. arrhythmias. The
combination is
Recommended to
be de-registered.
26. Thicol 4mg Capsules Not Not No reference Thiocolchicosideis a

Each capsule contains:- approve mentioned found in muscle relaxant with
Thiocolchicoside……..4 mg d by by any authentic anti-inflammatory and
(Muscle Relaxant) FDA, standard journals analgesic effects. It
acts as a competitive
EMA & textbook.
GABAA receptor
TGA antagonist and also
glycine receptor
antagonist. A variety
of adverse effects have
been reported with this
drug. Particularly of
concern are its ability
to cause seizures and
potential to cause
tratogenecity and male
infertility.
Not recommended for
registration.
27. Darcin ER 15mg Tablets Approve Recommend Available. Darifenacin is a M 3

Each extended release tablet d by ed for use in selective
contains:- EMA & genito- antimuscarinic drug
Darifenacin 15 mg TGA. urinary used for control of
(Anti-Cholinergic) Tentativ disorders. urinary incontinence
e in adults. A
approval congener, solifenacin

granted is already registered.
by FDA. Recommended for
registration.
28. Darcin ER 7.5mg Tablets Approve Recommend Available. Darifenacin is a M 3
Each extended release tablet d by ed for use in selective
contains:- EMA & genito- antimuscarinic drug
Darifenacin ………. 7.5mg TGA. urinary used for control of
(Anti-Cholinergic) Tentativ disorders. urinary incontinence
e in adults. A
approval congener, solifenacin
granted is already registered.
by FDA. Recommended for
registration.
29. CarionJect 500mg Injection Approved This Few but It is a new parenteral
Each 10 ml injection by FDA particular available. form of iron.
contains:- Iron Ferric (750mg/1 preparation Comparable to the
Carboxymaltose 5 ml) & not existing formulations
TGA
 Iron Element 500mg mentioned. in efficacy and safety
(500mg/1
(Haematinic) 0ml)
profiles.
Recommended for
registration.
30. C-Zyme Tablet Not Not No reference A completely
Each tablet contains:- approve mentioned found in irrational
Metoclopramide HCl 6mg d by by any authentic combination
Sodium dehydrocholate 20 FDA, standard journals. containing drugs
mg Bromelain 35000 PU EMA, textbook. whose efficacy is not
Pancreatin 210 FIPPU TGA & established.
Simethicone 50 mg PMDA. Not recommended
for registration.
31. Carolate Injection Not This Available Neostigmine is
Each 1ml ampoule approve particular generally used to
contains:- Glycopyrrolate d by combination reverse muscle
0.5 mg Neostigmine FDA, is not paralysis induced by
methylsulphate 2.5mg EMA, mentioned curare-like drugs
TGA & but use of during anesthesia.
PMDA. atropine-like This action is exerted
drugs to on nicotinic
counter the receptors but is
muscarinic accompanied with
effects of unwanted muscarinic
anticholinest stimulation. This is
erases is countered by
recommende administration of
d. antimuscarinic drugs
like glycopyrrolate.

Recommended for
registration.
32. Isotretinoin Cap/ Recdommen Available Isotretinoin is 13-cis
Isotretinoin Tablet ded for retinoic acid. It is used
severe acne in treatment of cystic
and certain acne, squamous cell
carcinoma of skin and
malignant
certain other
disorders. malignancies. In view
of its established
efficacy, the drug is
recommended to be
retained.
Any issues related to
dosage
form/formulation
may be resolved after
obtaining view point
of manufacturers.
33. Amoxicillin + Sulbactum The general It is rational to

principal for combine penicillin
combining with beta lactamase
penicillins inhibitors but
with beta Amoxicillin is
lacatmase generally combined
inhibitors is with clavulanate.
described. The manufacturers
may be asked to
provide reasons for
using sulbactam
along with references
in the favor of this
combination.
May be deferred for
the time being.
34. Silymarin Not Not No scientifically Silymarin is a dried
approve mentioned designed studies extract obtained from
d by by any available in Milk thistle plant.
FDA, standard authentic Efficacy in hepatic
EMA, textbook. journals. disorders has not
TGA & been proved in
PMDA. authentic clinical
trials. Adverse
effects have been
reported in patients

using milk thistle
capsules.
Not recommended
for registration.
35. Aescin Not Not No scientifically Aescin is a mixture
approve mentioned designed studies of saponins present
d by by any available in in horse chestnut
FDA, standard authentic plant. It is claimed to
EMA, textbook. journals. have anti
TGA & inflammatory and
PMDA. vasoprotective
effects but this has
not been proved in
scientifically
designed clinical
studies
Not recommended
for registration.
36. Solcoseryl Not Not No scientifically Solcoseryl is

approve mentioned designed studies deproteinated blood
d by by any available in of calves. It has been
FDA, standard authentic used in a variety of
EMA, textbook. journals. formulations for
TGA & various purposes but
PMDA. scientific evidence
for efficacy is
lacking. Not
recommended for
registration.
37. Serratiopeptidase Not Not No scientifically Serratiopeptidase is a
approve mentioned designed studies proteolytic enzyme
d by by any available in present in silkworm
FDA, standard authentic gut which helps it to
EMA, textbook. journals. dissolve the cocoon.
TGA & It has been used as
PMDA. an anti-inflammatory
agent without any
scientific evidence of
efficacy.Takeda
Pharmaceuticals, the
brand leader
Japanese company,
had agreed for
voluntary withdrawal

from market in 2011.
Not recommended
for registration.
38. Smectite Not No clinical Smectite is mineral

mentioned studies available clay having
by any to support adsorbent properties.
standard efficacy. It is similar to kaolin
textbook. in its medicinal
value.
Not recommended
for registration.
Decision: Keeping in view recommendations of Review Committee and comments of

stake holders, Registration Board decided as follows:
 Following formulations will be considered for registration by Registration Board
and thus the Board advised P E & R Division to place all deferred cases in agenda of
the meeting.
i. Ampoule (1ml) containing Glycopyrrolate 0.5 mg Neostigmine + methylsulphate
2.5mg
ii. Injection (10 ml) containing Iron Ferric Carboxymaltose  Iron Element 500mg.
iii. Extended release tablet containing Darifenacin 7.5mg, 15mg.
iv. Tablet containing Naproxen USP 500 mg + Esomeprazole Magnesium Trihydrate 
Esomeprazole 20mg.
v. Tablet containing Cyclobenzaprine 5mg.
vi. Capsule containing Fluoxetine HCl 25 mg + Olenzapine Citrate  Olenzapine 12
mg.
vii. Injection containing Ketamine HCl  Ketamine 500 mg
 Registration Board discussed comments of stakeholders for following formulations

and decided that Review Committee will review these comments for framing its final
recommendation. The Board also advised the committee to take assistance of any
expert (if required) and can also call any stakeholder for their views. These
formulations are as follows:
viii. Trimethyl Phologlucinol 80mg+Phloroglucinol 80mg.
ix. Omeprazole + Sodium Bicarbonate 20mg+1100mg, 40mg+1100mg.
x. Citicoline.
xi. Diacerein.
xii. Calcium Dobesilate.

xiii. Smectite.
xiv. Saccharomyces Boulardi.
xv. Piracetam.
xvi. Thiocolchicoside.
xvii. Dry Powder Suspension of Famotidine.
xviii. Silymarin
 Keeping in view recommendations of Review Committee, Registration Board

decided to proceed further for cancellation of registration as per procedure laid
down in Drugs (L R & A) Rules, 1976 of following items.
xix. Suspension containing Erythromycin Ethyl Succinate  Erythromycin 200mg +
Bromhexine HCl 4mg
xx. Sparfloxacin 100mg
xxi. Tablets containing Esomeprazole 20mg + Magnesium 700mg + Sodium Bicarbonate 20mg
xxii. Tablets containing Esomeprazole 40mg + Magnesium 700mg + Sodium Bicarbonate 20mg
xxiii. Capsule and tablet containing Esomeprazole 20mg, 40mg + Domperidone 30mg
xxiv. Serratiopeptidase.
xxv. Solcoseryl
xxvi. Aescin
xxvii. Tablet containing Metoclopramide HCl 6mg + Sodium dehydrocholate 20 mg + Bromelain
35000 PU + Pancreatin 210 FIPPU + Simethicone 50 mg.
 Registration Board advised Review Committee to finalize recommendation for

following formulations. The Board also advised the committee to take assistance of
any expert (if required) and can also call any stakeholder for their views. These
formulations are as follows:
xxviii. Amoxicillin + Sulbactum
xxix. Isotretinoin Capsule/ Tablet
xxx. Film coated Sustained release containing 1 gm Ciprofloxacin
f. Manufacturing requirement for various classes of drugs.

Registration Board in 245th meeting discussed manufacturing requirements for various
classes of drugs, and Chairman advised all members, PPMA and Pharma Bureau to forward their
scientific comments and relevant references on manufacturing requirements for following classes
of drugs:
- Steroids.
- Immunosuppresants.
- Clomiphene and letrozole
- Prostaglandins and its analogues.

- Storage requirement of Misoprostol
- Vancomycin
Two members and PPMA has forwarded their comments on manufacturing requirements for
steroids, as follows:
 Dr. Amanullah Khan (Director, DTL, Quetta).

For all steroidal preparations except topical preparations must have separate
manufacturing area, so it may be added that topical preparations may be manufactured in the
same approved area and exempted from separate area.
 Lt General (R) Karamat Ahmed Karamat.

Reference to the Board meeting proceedings, all non-inflammatory steroids like
prednisolone, Dexamethasone are manufactured in the same general area on campaign basis.
Topical steroids like eye preparations/drops, otic drops, creams and ointments are manufactured
through wet process and should be allowed to manufacture across the board as everywhere in the
world. However, sensitive steroids which fall under category A like penicillin, cytotoxic
substances, Beta lactam and sex hormones may be considered to be manufactured in the
dedicated area.
 PPMA.
Requirement by international regulatory agencies / cGMP
Internationally the dedicated facility is recommended for certain hormones, as evident from the
following:
Medicinal Control Agency U.K Requirements:
The Orange book published by Medicine Control Agency (MCA) of U.K in chapter 3 dealing
with premises and equipment, of guide to Good Manufacturing Practices for Medicinal Products,
under section 3.6 states requirements which are very close to section 5.2 of Pakistan drug rules.
“In order to minimize the risk of serious medical hazard due to cross contamination, dedicated
and self contained facilities must be available for the production of particular medicinal products,
such as highly sensitizing materials {e.g Penicillin} or biological preparations {e.g from live
microorganism}. The production of certain additional products, such as certain antibiotics,
Certain hormones, certain cytotoxics, certain highly active drugs and non medicinal products

should not be conducted in the same facilities. For those products, in exceptional cases, the
principle of campaign working in the same facilities can be accepted provided that specific
precautions are taken and the necessary validation made. The manufacture of technical poisons,
such as pesticides and herbicides, should not be allowed in premises used for the manufacture of
medicinal products.
As can be observed that requirement is for certain hormones.

Canadian GMP:
11. Prevention of cross-contamination druring manufacturing is the responsibility of the

fabricator and packager. They must demonstrate that the premises are designed in such a manner
that the risk of cross-contamination between products is minimized.
11.1 In order to minimize the risk of a serious health hazard due to cross-contamination,
additional controls, including the need for self-contaiment, should be considered for particular
drugs such as:
-Certain hormones (e.q. estrogen)

-Certain cytotoxic drugs
-other highly active drugs
Factors to consider are the manufacturing process, use of closed systems, dedication of product
contact equipment parts, HVAC controls, engineering controls such as fail safe systems, coupled
with validation and ongoing monitoring using highly sensitive analytical methods.
11.2 Campaign production can be accepted where, on a product by product by basis,

proper justification is provided, validation conducted and rigorous, validated controls and
monitoring are in place and demonstrate the minimization of any risk of cross
contamination.
As can be observed tht requirment is for certain hormones, Specifically Canadian cGMP
refers to Estrogens, Further Canadian GMP allows campaign production provided validation
conducted.
Indian cGMP
Schedule M describing GMP & requirements of Premises Plant & equipment for pharmaceuitcal
product, under section 8.2 states as under:
The licensee shall ensure processing or sensitive drugs like Beta-Lactum antibiotics, Sex
hormones and cycotoxic substances in segregated areas or isoliated production areas within the

building with independent air-handling unit and proper pressure differentials. The effective
segregation of these areas shall be demonstrated with adequate records of maintenance and
services.
As can be observed tht requirment is for certain hormones which are sex hormones.
Technical perspective
In order to exercise better control on Steroids, the PPMA Technial Committee members
observed that there should be clarity between the definition of “Anabolic Steroids” and
“Corticosteroids”.
References reveal that in human body, adrenal glands produce an anti-inflammatory steroid
similar to cortisone {corticosteroids}. Simulating human body secretion, synthetic Cortisone are
developed and prescribed to treat asthma, rashes, and various kinds of swelling or inflammation.
Whereas, another kind of steroids are calles anabolic steroids. The term anabolic means building
up of a bodily substance. Anabolic steroids are related to the major sex hormones, which are
produced in both men and women and their synthetic substitutes are uese as supporitve therapy.
Ref. Hormone Abuse Overview, http://www.hormone.org/Abuse/overview.com
Above references cleary state that all Steroids doesn’t fall under the category of “Highly
sensitizing materials”. Furhter, that the Steroids are classified as Corticosteroids (Anti-
Inflammatory hormones) and Anabolic Steroids (Sex hormones) and later are requirmed to be
manufactured under special controlled conditions.
Based on above submissions, our recommendations are;
1. That all Steroids do not fall in the category of “Highly sensitizing materials”
2. Anabolic/Sex hormones e.q. Progesterone., Testosteron and Contraceptive hormone
needs special conditions for manufacturing.
3. Corticosteroids, Dexamethasone, Prednisolone and others are used as anti-inflammatory
drugs which are not included in the category of “highly sensitizing materials” as such
should be allowed tomanufacture in general purpose are exercising standard controls to
avoid cross contamination.
4. Since several companies have been granted license to manufracture sex hormones in their
existing facility, campaign manufacturing may be allowed if necessary precautions have
been taken and that future plans for seprate facility are in place.

 M/s Sante Pharmaceuticals, Karachi.
1. Drugs (Licensing, Registration & Advertisement) Rules 1976. Schedule B- 5.2.

Dedicated Facility for production states that:
Dedicated and self -contained facilities for the production of particular drugs shell be provided in
addition to general facilities such as highly sensitizing materials ( e.g. penicillin) or biological
preparation (e.g. live microorganism) or cytotoxic substances or veterinary immunological preparations
or sterile products or for that matter such other highly active pharmaceutical products, antibiotics,
hormones as may be identified by the Central Licensing Board at any stage in order to minimize the risk
of serious medical hazard due to cross- contamination. In exceptional cases of emergency, the principal of
campaign working in the same facilities may be allowed by the Central Licensing Board provided that
specific precautions are taken and necessary validations are made.
2. In 195th Meeting of Central Licensing & Registration Board held on 24th Nov. 2005 a
presentation was made by PPMA and Pharma Bureau
 Item No.3.
Dedicated /Segregated Facilities for Particular Drugs : Detailed history of dedicated facilities was
discussed.
A team of Pharma Bureau and PPMA members presented their view about the matter of segregated
facilities for “Quinolones / Antibiotics (except Beta lactam antibiotics) and psychotropic / Narcotic drugs.
They explained that the dedicated facilities are required for highly sensitizing drugs e.g. Penicillin,
Cephalosporin, and Biological which fall under category A drugs.
 Decision of Registration Board:
It was decided that the permission to manufacture the Quinolone products will be allowed on the
basis of campaign manufacturing, subject to compliance to the GMP and cGMP regulation.
HVAC system and cleaning validation is mandatory.
3. EU guideline for GMP for Medicinal Products and Veterinary Use Part I Chapter
5:Production
Section 3.6: Production Area states that:
Dedicated facilities are required for manufacturing when a medicinal product present a risk;
a) Which cannot be adequately controlled by operational and/ technical measures.
b) Scientific data does not support threshold values ( e.g. allergic potential from highly sensitizing
materials such as beta lactam) or
c) Threshold values derived from toxicological evaluation are below the level of detection
4. GMP and requirements of Premises, Plant and Equipments of PHARMACEUTICAL

PRODUCTS
PART II-SECTION 3, SUB-SECTION (i)] - Ministry of Health -New Delhi- INDIA

SCHEDULE M. Production area.—
 In order to avoid the risk of cross-contamination, separate dedicated and self contained facilities
shall be made available for the production of sensitive pharmaceutical products like penicillin or
biological preparations with live micro-organisms. Separate dedicated facilities shall be provided
for the manufacture of contamination causing and potent products such as Beta lactam, Sex
Hormones and Cytotoxic substances.
5. ICH guideline
“Self-contained facilities shall be made available for the production of highly
sensitive pharmaceutical products like penicillin or biological preparations with live micro-
organisms. Separate dedicated facilities shall be provided for the manufacture of
contamination causing and potent products such as Beta lactam, Sex Hormones and
Cytotoxic substances.”
6. Based on the current guidelines by EU Orange Guide, ICH, WHO, Indian GMP guidelines, Saudi
FDA and others;
“Dedicated facility is required for highly sensitive products like Beta lactam, Sex
Hormones, Cephalosporin and Cytotoxic products”
DEFINITION OF HORMONES
1. Different types of steroid hormones, a class of hormones chemically similar to each other, have
different functions. For example, the adrenal glands produce an anti-inflammatory steroid similar
to cortisone. Cortisone may be prescribed to treat asthma, rashes, and various kinds of swelling or
inflammation.
2. The term anabolic means building up of a bodily substance. Anabolic steroids are related to the
major male hormone testosterone, which is produced in the testes in men and in the adrenal
glands in both men and women. These chemicals are recognized for their effects on building up
muscle.
3. Anabolic steroids should not be confused with corticosteroids, which are used routinely as anti-
inflammatory medications to help treat illnesses in which inflammation is part of the disease
process.
4. Steroids include the dietary fat cholesterol, the sex hormones estradiol and testosterone, and the
anti-inflammatory drug Dexamethasone.
5. Steroid: One of a large group of chemical substances classified by a specific carbon structure.
Steroids include drugs used to relieve swelling and inflammation, such as Prednisone and
Cortisone.
IMPACT OF CROSS CONTAMINATION
There are certain categories of hormones

1. Sex Hormones
Sex hormones comes under category A. In category A, Sex hormones like progesterone (female
sex hormone), testosterone (male sex hormone) contraceptive hormones (estrogens). They fall
under “Highly sensitizing materials” where cross contamination in very less quantity (microgram)
can cause risk of serious health hazard. The cross contamination of male sex hormone with in a
manufacturing process can produce changes in the secondary behavior in female like extra hair
growth, voice change etc. and vice versa female sex hormone cross contamination during
manufacturing operation can cause serious health hazard like diminishing of sexual desire,
enlargement of mammary glands etc. therefore in order to minimize the risk of serious health
hazard due to cross contamination addition control during manufacturing operation, used of
closed system, dedicated product contact equipment parts, HVAC control are necessary.
2. Anabolic Steroids
They also fall in category A and are those used for muscle building weight gain and weak
anabolic activities. Same principal followed during the manufacturing operation for cross
contamination.
3. Corticosteroids (Dexamethasone, Prednisolone & Hydrocortisone)
Corticosteroids should not be confused with sex hormones as they do not fall in category A of
highly sensitive materials and used in topical preparations as anti inflammatory drugs in Eye
preparation, Otic preparation and Eye / Skin Ointments. The cross contamination of
corticosteroids during the manufacturing operation can not impact the same health hazards as sex
hormones even in micro grams quantities hence no dedicated self contained facility is suggested
by international guideline agencies like Eur. ICH, and orange guide where they recommend use
of same facility with following instructions on campaign bases and cleaning validation.
RISK ASSESSMENT / ANALYSIS OF CROSS CONTAMINATION DURING

MANUFACTURING OPERATION
What is the risk involved in case a cross contamination of corticosteroids occur during the manufacturing
operation in spite of observing instructions and guidelines provided by the international agencies due to
certain negligence and improper supervision? The quantities of API (Active Pharmaceutical Ingredients
i.e. Dexamethasone, Prednisolone, Mometasone, Betamethasone, and Triamcenolone) is very minute i.e.
in 0.1%, 0.2% up to 0.5%. The entire manufacturing process is wet process, after the dispensing of API it
is transferred to glass jar under Laminar Air Flow hood in a diluent system comprising of HPMC / water
dispersion, then these glass jars with glass beads are placed on Ball Mill to get the desired particle size
finally blend was transferred to main bulk container in liquid form there is no less chances of dust
generation during the process. During the product change over a cleaning validation procedure is
followed by QC who only allows next batch processing after their approval.
There are two strong arguments in favor of using the same facility for steroid and non-steroid
preparations.

1. If there is any risk of health hazard involved due to cross contamination of corticosteroids during
the manufacturing operation the international agencies like European Union (Orange Guide),
WHO and ICH will never recommend the same facility on campaign basis following the cleaning
validation method as in case of sex hormones because corticosteroids are not classified under the
highly sensitizing materials even the cross contamination of corticosteroids cannot impact any
bad health hazard.
2. Currently topical steroid containing preparations are produced in same facility (Non Steroids)
under toll manufacturing agreement for international brands like Allergan, Alcon, Bausch &
Lomb etc. and there audit for facility will also conducted by their corporate office under
international GMP guidelines, who allows them to manufacture steroids and non steroids in the
same facility. So far no adverse drug reaction was reported internationally and nationally which is
due to cross contamination.
CONCLUSION
1. All Steroids do not fall in the category of “Highly sensitizing materials”.
2. Sex hormones e.g. Progesterone, Testosterone and Contraceptive hormone may be classified in
category A.
3. Anabolic Steroids are those used for muscles building and used by weightlifters, wrestlers and
sportsmen may be classified in category A
4. Corticosteroids (Dexamethasone, Prednisolone, Mometasone, Betamethasone, and
Triamcenolone) are used as anti-inflammatory drug and are not potent and highly sensitizing
materials.
 Corticosteroids do not fall in the category of highly sensitive materials and the companies
like Alcon, Allergan, Bausch & Lomb and many Local Companies are manufacturing eye
drops, ointments, creams etc. containing steroids like Dexamethasone, Prednisolone,
Mometasone, Betamethasone and Triamcenolone in the same facility with following the
instructions on campaign basis.
MANUFACTURING OF EYE DROPS, OINTMENT & CREAMS

 In eye drops the entire manufacturing method is wet process except dispensing of materials.
 The concentration of steroids in Topical and Tropical preparations
Ophthalmic Preparation is 0.1 to 0.2 %
Otic Preparations (Drops and Ointments) is 0.1 to 0.2%
 The steroids are dispensed in dispensing booth with laminar flow having strong extraction
system.
 These steroids are immediately transferred under laminar flow, into glass jars containing a
mixture of water and HPMC
 Tightly close Jars are placed on ball mill to reduce the particle size of steroids.
 Then ready slurry is transferred into bulk under laminar flow.

Eye Drops, Eye Ointments, Otic Drops and Creams are being manufactured by local manufacturers
having Dexamethasone, Prednisolone, Hydrocortisone in the same manufacturing facility for the last
many years.
Decision: Registration Board discuused comments of its members, stakeholders and

international practices and agreed that for all topical preparations viz. eye / ear preparations,
external preparations (cream / ointment / gel / lotion / spary) and aerosols, steroid
manufacturing may be permitted on campaign manufacturing basis in general manufacturing
areas for these dosage forms provided that manufacturer has segregated dispensing booths,
validation and controls studies for processes and adequate system to minimize any potential
risk of cross contamination. Registration Board decided to forward above recommendation to
Licensing Division for ultimate decision by Central Licensing Board.
 Storage requirement of Misoprostol.
- M/s Pfizer Pakistan, Karachi.
There is an obligation to maintain a temperature of -200C and has to kept in an air tight
container.
- M/s Rasco Pharma, Lahore.
The firm has provided assessment report (EMA) of misoprostol API which is reproduced as
under:-
 Misoprostol, as described in the Ph.Eur., is an only liquid which is very unstable and
difficult to be process into a drug product in liquid form. The stability of misoprostol is
significantly enhanced when it is dispersed in hypromellose. Hence, misoprostol
dispersed in hypromellose is used as an intermediate in the manufacture of misoprostol
tablet. The dispersion consists of a powder that can be stored at 5+3 °C, whereas the
actual active substance is an oily liquid that needs to be stored at -20 °C.
 The certificate of analysis of the misoprostol API of the firm shows that the product is
Misoprostol 1% HMPC dispersion (White to off-white powder) and it is to be stored at 2-
8 °C.
Decision: Registration Board deliberated on the matter indetail and keeping in view
EMA’s assessment report decided that as per EMA,s report, Misoprostol 1% HMPC
(processed material) dispersion will be permitted for use in tablet dosage form with
storage condition of 5+3 °C.

Chairman again advised all members, PPMA and Pharma Bureau to forward their
scientific comments and relevant references till 15.01.2015 on manufacturing requirements
for following classes of drugs:
a. Immunosuppresants.
b. Clomiphene and letrozole
c. Prostaglandins and its analogues.
d. Vancomycin

Item No. V Registration of drugs – Pharmaceutical Evaluation Cell.
Case No.01. Correction in minutes M-245
S/N Name and 1. Brand Name 1. Type of Form 1.Finished Decision in Correction Decision
address of 2. Dosage Form 2. Type of Product 245th required by
manufacturer 3. Composition application Specification meeting of the
/ Applicant 4. Pharmacological 3. Demanded 2. Facility the applicant
group Price / Pack size where drug has Registration
4. Initial date, to be Board
diary. 5. Date on manufactured
which fee with status
becomes whether
complete approved by
according to type CLB or not
of application /or 3. Last GMP
Form inspection
report with date
& status.
1. M/s. Ali Gohar Jentadueto Form 5 A International: Approved. The firm The Board
& Company 2.5mg/850mg 01-07-2013 Jantadueto applied for acceded to
(Pvt) Limited, Tablets Rs.50000/- 2.5/850 (FDA) packs of the request
Local: Me too
Karachi. Each Film Coated Rs. 7130/ 10’s & 30’s of the firm
(M 243)
Manufacturer Tablets contains:- Per packs of 60 as under with
M/s. Linagliptin…..2.5 Tablets. just before approval of
Boehringer mg
meeting of following
Metformin
Ingelheim Registratio price & pack
Hydrochloride…….
Pharma GmbH 850mg n Board sizes.
& Co. KG, (Drugs used in that’s why
Located in Diabetes, it was 1. Rs. 7130/
Binger Strasse combination of oral missed in Per packs of
173, 55216 blood glucose agenda & 60 Tablets.
Ingelheim am lowering drugs). minutes.
Rhein, 2. CIF price
Germany. Rs. 0.9 x 10 for 10’s pack
USD for size:
10’s 0.9 x 10 USD
Rs. 0.9 x 30 for 10’s
USD for
30’s & 3. CIF price
Rs. 7130/ for 30’s pack
Per packs of size:
60 Tablets. 0.9 x 30 USD
for 30’s
(Word CIF
as appeared
in firm’s
request was
inadvertantl

y missed for
10’s & 30’s
pack sizes).
2. M/s. Ali Gohar Jentadueto Form 5 A International: Approved. The firm The Board
& Company 2.5mg/1000mg 01-07-2013 Jantadueto applied for acceded to
(Pvt) Limited, Tablets Rs.50000/- 2.5/1000 (FDA) packs of the request
Local: Me too
Karachi. Each Film Coated Rs.7130/ 10’s & 30’s of the firm
(M 243)
Manufacturer Tablets contains:- Per packs of 60 as under with
M/s. Linagliptin…..2.5 Tablets just before approval of
Boehringer mg
meeting of following
Metformin
Ingelheim Registratio price & pack
Hydrochloride…….
Pharma GmbH 1000mg n Board sizes.
& Co. KG, that’s why
Located in (Drugs used in it was 1. Rs. 7130/
Binger Strasse Diabetes, missed in Per packs of
173, 55216 combination of oral agenda & 60 Tablets.
Ingelheim am blood glucose minutes.
Rhein, lowering drugs). 2. CIF price
Germany. Rs. 0.9 x 10 for 10’s pack
USD for size:
10’s 0.9 x 10 USD
Rs. 0.9 x 30 for 10’s
USD for
30’s & 3. CIF price
Rs. 7130/ for 30’s pack
Per packs of size:
60 Tablets. 0.9 x 30 USD
for 30’s
(Word CIF
as appeared
in firm’s
request was
inadvertantl
y missed for
10’s & 30’s
pack sizes).

S/N Name and Brand Name Type of Form Decision of Remarks on the Decision
address of Previous formulation (if any)
manufacturer / (Proprietary Initial date, Meeting including
Applicant name + Dosage diary International status
Form + in stringent drug
Strength) Fee including
differential regulatory agencies /
Composition fee authorities.
Pharmacological Demanded
Group Price / Pack
size
Finished
product
Specification
3. M/s. Medisearch Molus Form-5 Approved. The Formulation Deferred till

Pharmacal (Pvt) Dry Suspension Letter will be was erroneously review of
ltd, 5-Km, When 20-12- issued after approved by the formulation
reconstituted 2013(1308) rectification Drug Registration by Review
Raiwind Manga
Each 5ml Rs.20,000/- of Board. This Committee.
Road, Lahore. contains:- shortcomings. Formulation is
Montelukast As per (M-243) under review by the
Sodium…..5mg SRO/60ml Review Committee.
(anti-asthmatic)
(Manufacturer’s
Spec.s)
4. M/s Allmed Pvt. Reevo Tablets Form5 Deferred for Initially the Firm Deferred for
Ltd. Each tablet confirmation of had applied for the
(Formerly, contains: 06-08-2010 pharmacologic Levocarnitine……… following:
EverGreen Levocarnitin…… Rs.8000/- ……250mg per 1) Fee for
al group as
Pharmaceuticals, ………….250mg 11-10-2012 Tablet formulation on application
Pvt. Ltd. (Aminoacid Rs.12,000/- applied by
Form 5. Before the on Form 5D
Plot.No.590, derivative/suppli firm. formation of
Sundar Industrial ment) Rs.350/10’s (M-244) for 330 mg
Pharmaceutical
Estate Lahore. Evaluation Cell some
Tablet
Registration strength.
applications were 2) Evaluation
sent to various DRAP of Form 5D.
officers for 3)
evaluation including Confirmation
this one. Agenda of of
these applications pharmacolog

was prepared for M- ical group as
242 but could not be applied by
discussed. Later on the firm.
the Firm submitted
Form 5-D for this
formulation and
changed the
formulation to
Levocarnitine…330m
g mg per Tablet. The
left over agenda of
M-244 was discussed
in M-244 but the
change was not
incorporated. The
Registration Board
considered the
formulation as
Levocarnitine…250m
g per Tablet and
deffered it merely for
confirmation of
pharmacological
group as applied by
firm. Registration
Board may ask the
firm to submit the
firm to submit
differential fee
required for
application on Form
5-D and evaluate the
application
accordingly.

Evaluator – III
Case No.02. Registration of a Patent Drug – Iodine Complex
M/s MTI Medical (Pvt) Limited Lahore has informed that they have developed Iodine complex
molecule in their Research & Development Laboratories and the said molecule has been awarded patent in
Pakistan. The firm submitted that they have conducted preclinical studies in UVAS (University of Veterinary
& Animal sciences, Lahore) and human studies in different teaching hospitals in Pakistan. Results of these
studies have been published in international and national journals which show that addition of iodine complex
with standard therapy of Hepatitis gives significant results.
S/N Brand Name Composition Type of Form

(Proprietary name +
Dosage Form + Pharmacological Group (as Initial date, diary
Strength) submitted by the firm)
Fee including differential fee
Finished product Specification
Demanded Price / Pack size
1. IODIRIN Tablets Each tablet contains: Form-5E
200mcg Iodine complex equivalent to
elemental Iodine…….200mcg 23-10-14 Dy. No: 1271
Iodine deficiency disorder/ 50,000/-

Antithyroid
Not provided
Manufacturer
2. IDOMARINE Capsules Each capsule contains: Form-5E
50mg Iodine complex equivalent to
elemental Iodine…….50mg 23-10-14 Dy. No: 1271
Iodine deficiency disorder/ 50,000/-

Antithyroid/ Immunomodulator
Not provided
Manufacturer
3. RENESSANS Capsule Each capsule contains: Form-5E
200mg Iodine complex equivalent to
Antiviral/ Hepatic Preps/ 50,000/-


Not provided
Manufacturer
4. RENESSANS Each 5ml contains: Form-5E
Suspension 15mg/ 5ml Iodine complex equivalent to
Antiviral/ Hepatic Preps/ 50,000/-

Not provided
Manufacturer
The firm has also claimed that the above mentioned molecule is a major breakthrough avoiding and
treating some deadly diseases and diseases due to iodine deficiency, therefore requested to register the drug on
fast track basis in public interest. In this regard, they have submitted registration applications on Form-5 E in
different dosage forms. Details of which are tabulated below.
2. The request of the firm has been evaluated / assessed by the cell. Prima facie the following
observations have been noticed:
a. The applicant has been granted patent for the said molecule named as “Iodine Complex” for cure
against Hepatitis C. Here, the question arises that whether patent is valid for purpose of getting
the registration for a patent drug or not.
b. The application has been filed on Form 5-E for the purpose of registration of a patent drug and
currently the Pharmaceutical Evaluation Cell has no approved check list for the said form. There
are many clauses of the said form wherein the applicant is unable to answer properly. Evaluation
reports clearly depicts the same.
c. The Safety & Efficacy aspects of the drug are important to be evaluated in the instant case (being
new molecule not else- where approved in the world). At present, the Cell for the said purpose
(especially in cases of new drug molecule), relies on the approvals by the Stringent or Reference
Drug Regulatory Agencies of the world like USFDA, EMA, TGA, Health Canada & PMDA
Japan etc. While the drug under discussion has no such approval from any of the drug regulatory
agency in the world.
5. In the light of the above observations, the case was handed over to Pharmacy Services Division, who has
taken up the case. The said Division has forwarded the submitted clinical trial data / research publication
of the applicant to the Executive Director of PMRC for the validity of the trials / research conducted.
Their reply is awaited. The case is therefore, placed for consideration before Registration Board.
Decision: Dr. Muhammad Ajmal and his team appeared and presented before the Board
about development of above formulations and results of clinical trials conducted on the above

formulations. Registration Board then directed the applicant to provide all the documents
related to development of formulations and their clinical studies for confirmation of safety and
efficacy Prof. Dr. Muzammil H.Najmi, Member Registration Board for further evaluation.
Recommendations / views the expert will be considered by the Board for further processing of
case.
Case No.03. Grant of registrations of newly approved DMLs (Drug Manufacturing Licenses).
Evaluator – II
S/N Name and Brand Name Type of Form Remarks on the Decision
address of formulation (if any)
manufacturer / (Proprietary name + Initial date, diary including
Applicant Dosage Form + International status
differential fee in stringent drug
Composition regulatory agencies /
Demanded Price / authorities
Pharmacological Pack size
Group Me-too status
Finished product GMP status as

Specification depicted in latest
inspection report
(with date) by the
Evaluator
1. M/s Sigma Klar 250mg Tablet Form 5 BNF: Klaricid Approved

Pharma Each film coated Tablet 17-11-2014 (232) (Abbott Healthcare)
International Pvt. contains:- Rs. 20,000/-
Claritek 250mg Tablet
Limited E-50, Clarithromycin(USP)… As Per SRO/
Getz Pharma Pvt. Ltd.
N.W.I.Z., Port 250mg Pack 10’s Karachi
Qasim Karachi (Macrolide Antibiotic)
(Tablet General: (USP Spec,s) New Licensee
No. F.6-6/2014-
Lic (M-237 dated
17-10-2014)
2. -do- Klar 500mg Tablet Form 5 BNF: Klaricid Approved
Each film coated Tablet 17-11-2014(228) (Abbott Healthcare)
contains:- Rs. 20,000/-
Claritek 250mg Tablet
Clarithromycin(USP)… As Per SRO/

500mg Getz Pharma Pvt. Ltd.
(Macrolide Antibiotic) Pack 10’s Karachi
(USP Spec,s)
New Licensee
3. -do- Monti 10mg Tablet Form 5 Singulair 10mg Approved
Each film coated Tablet 17-11-2014(229) Tablet of Merck & Co.
contains:- Rs. 20,000/- Inc. USA
Montelukast Sodium as As Per SRO/
Myteka 10mg Tablet
Montelukast…10mg Pack 14’s Hilton Pharma Pvt.
(Bronchodilators & Ltd. Karachi
Anti-asthma
(Leukotriene New Licensee
antagonist))
(Manufacturer’s Spec.s)
4. -do- Cip 250mg Tablet Form 5 CIPROXIN 250mg Approved
Each film coated Tablet 17-11-2014(235) Tablet Bayer Australia
contains:-Ciprofloxacin Rs. 20,000/- Limited
as Ciprofloxacin As Per SRO/
HCl…250mg GETCIPRO 250mg
(Quinolones Antibiotic) Tablet Getz Pharma
Pack 10’s
(B.P Spec,s) (Pvt.) Ltd. Karachi
New Licensee
5. -do- Cip 500mg Tablet Form 5 CIPROXIN 500mg Approved
Each film coated Tablet 17-11-2014 Tablet Bayer Australia
contains:-Ciprofloxacin Rs. 20,000/- Limited
as Ciprofloxacin As Per SRO/
HCl…500mg GETCIPRO 500mg
(Quinolones Antibiotic) Pack 10’s Tablet Getz Pharma
(B.P Spec,s) (Pvt.) Ltd. Karachi
New Licensee
6. -do- Levof 250mg Tablet Form 5 LEVAQUIN 250mg Approved
Each film coated Tablet 17-11-2014(234) Tablet Janssen Pharma
contains:- Rs. 20,000/- USA
Levofloxacin (as As Per SRO/
hemihydrate)…250mg Pack 10’s LEFLOX 250mg
(Quinolones Antibiotic) Tablet Getz Pharma
(USP Spec,s) (Pvt.) Ltd Karachi
New Licensee
7. -do- Levof DS 500mg Tablet Form 5 LEVAQUIN 500mg Approved
Each film coated Tablet 17-11-2014(233) Tablet Janssen Pharma
contains:- Rs. 20,000/-

Levofloxacin (as As Per SRO/ USA
hemihydrate)…500mg Pack 10’s
(Quinolones Antibiotic) LEFLOX 500mg
(USP Spec,s) Tablet Getz Pharma
(Pvt.) Ltd Karachi
New Licensee
8. -do- Moxif 400mg Tablet Form 5 VIGAMOX 400mg Approved
Each film coated Tablet 17-11-2014(237) Tablet Alcon Lab,
contains:- Rs. 20,000/- USA
Moxifloxacin (as As Per SRO/
Moxifloxacin Pack 5’s MOXIGET 400mg
HCl)…400mg Tablet Getz Pharma
(Quinolones Antibiotic) (Pvt.) Ltd.
(Manufacturer’s Spec.s) New Licensee
9. -do- Mecob 500mcg Tablet Form 5 METHYCOBAL Approved
Each sugar coated 17-11-2014(230) 500mcg Tablet Eisai
Tablet contains:- Rs. 20,000/- Co Ltd. JAPAN
Mecobalamin As Per SRO/
(JP)…500mcg Pack 20’s METHYCOBAL
(Co-enzyme Vitamin 50’s & 100’s 500mcg Tablet Hilton
B12) Pharma (Pvt.) Ltd
(Manufacturer’s Spec.s) Karachi
New Licensee
10. -do- Trump 37.5/325mg Form 5 BNF: Tramacet Approved
Tablet 17-11-2014(231) (Gru¨nenthal)
Each film coated Tablet Rs. 20,000/-
contains:- As Per SRO/
TONOFLEX Tablet
Tramadol HCl…37.5mg Pack 10’s
Sami Pharmaceuticals
Paracetamol…325mg
Karachi
(Opiate
analogue/analgesic ) New Licensee
(USP Spec,s)
11. M/s Sigma Coxib 200mg Capsule Form 5 CELEBREX 200mg Approved
Pharma Each Capsule Contains:- 17-11-2014 (196) Capsule of Pfizer
International Pvt. Celecoxib…200mg Rs. 20,000/- Laboratories USA
Limited E-50, (Cox-2 Inhibitor) As Per SRO/
CELBEX 200mg
N.W.I.Z., Port (Manufacturer’s Spec.s) Pack 20’s
Capsule Getz Pharma
Qasim Karachi Pvt. Ltd. Karachi
(Capsule General:
No. F.6-6/2014- New Licensee

Lic (M-237 dated
17-10-2014)
12. -do- Coxib 100mg Capsule Form 5 CELEBREX 100mg Approved

Each Capsule Contains:- 18-11-2014(Nil) Capsule of Pfizer
Celecoxib…100mg Rs. 20,000/- Laboratories USA
(Cox-2 Inhibitor) As Per SRO/
CELBEX 100mg
Capsule Getz Pharma
Pack 20’s Pvt. Ltd. Karachi
New Licensee
13. -do- Profile 20mg Capsule Form 5 BNF: Losec Approved. Firm
Each Capsule Contains:- 17-11-2014 (192) (AstraZeneca) will provide
Omeprazole enteric Rs. 100,000/- legalized GMP
coated Pellets 8.5% As Per SRO/ RISEK 20mg Capsule of the
Getz Pharma (Pvt.) manufacturer of
equivalent to pellets and then
Ltd
Omeprazole…20mg Pack 14’s registration
(Source of Pellets: New Licensee letter will be
M/s Titan Laboratories issued after
Private Limited Plot No. 1. Original Legalized approval of
E27/1, E27/2, MIDC, Chairman, RB.
Mahad Village Jite Copy of Valid
District, Raigad, GMP certificate of
Maharashtra, India) manufacturer of
(Proton pump inhibitor) Pellets is required.
14. -do- Profile 40mg Capsule Form 5 BNF: Losec Approved. Firm
Each Capsule Contains:- 17-11-2014(193) (AstraZeneca) will provide
Omeprazole enteric Rs. 100,000/- legalized GMP
coated Pellets 8.5% As Per SRO/ RISEK 40mg Capsule of the
Getz Pharma (Pvt.) manufacturer of
Ltd
Omeprazole…40mg Pack 14’s registration
(Source of Pellets: New Licensee letter will be
M/s Titan Laboratories issued after
Private Limited Plot No. 1. Original Legalized approval of
E27/1, E27/2, MIDC, Chairman, RB.

15. -do- Somep 40mg Capsule Form 5 NEXIUM 40mg Approved. Firm
Each Capsule Contains:- 17-11-2014(191) Capsule AstraZeneca will provide
Esomeprazole enteric Rs. 100,000/- legalized GMP
E-CAP 40mg of the
coated Pellets 22.50% As Per SRO/
Capsule Brookes manufacturer of
Pharmaceutical
Esomeprazole…40mg Pack 14’s Laboratories registration
(Source of Pellets: letter will be
M/s Titan Laboratories New Licensee issued after
Private Limited Plot No. approval of
E27/1, E27/2, MIDC, 1. Original Legalized Chairman, RB.
16. -do- Somep 20mg Capsule Form 5 NEXIUM 40mg Approved. Firm
Each Capsule Contains:- 17-11-2014(190) Capsule AstraZeneca will provide
Esomeprazole enteric Rs. 100,000/- legalized GMP
E-CAP 40mg of the
coated Pellets 22.50% As Per SRO/
Capsule Brookes manufacturer of
Pharmaceutical
Esomeprazole…20mg Pack 14’s Laboratories registration
(Source of Pellets: letter will be
M/s Titan Laboratories New Licensee issued after
Private Limited Plot No. approval of
E27/1, E27/2, MIDC, 1. Original Legalized Chairman, RB.

17. -do- Zith 250mg Capsule Form 5 ZITHROMAX 250mg Approved
Each Capsule contains:- 17-11-2014(194) Capsule Pfizer
Azithromycin (as Rs. 20,000/- Laboratories
Dihydrate)…250mg As Per SRO/
ZETRO 250mg
(Macrolide Antibiotic)
Capsule Getz Pharma
(USP Spec,s) Pack 6's & 10's (Pvt.) Ltd.
New Licensee
18. -do- Malrid Capsule Form 5 Not confirmed Deferred for
17-11-2014(195) views of
Each Capsule contains:- Rs. 20,000/- DIPIP 40/320mg recommendation
Dihydroartemisinin… Capsule Hilton s of WHO.
As Per SRO/
40mg Pharma (Pvt.) Ltd
Pack 8's
Piperaquine
New Licensee
Phosphate… 320mg
(Anti-Malarial)
1. Availability in
SRA’s not
confirmed. Firm
has provided
international
availability in
Italy.
19. -do- Tranex 500mg Capsule Form 5 Not confirmed Deferred for
17-11-2014(197) confirmation of
Each Capsule contains:- Rs. 20,000/- XED 500mg Capsule formulation /
Indus Pharma strength whether
As Per SRO/
Tranexamic approved in
Acid…500mg New Licensee reference
Pack 20's & 100's Stringent
(Haemostatic/
Fibrinolytic) 1. Availability in Regulatory
Agencies or not.
(Manufacturer’s Spec.s) SRA’s not
confirmed. Firm
has provided
international
availability in
Bangladesh.

20. -do- Flucap 150mg Capsule Form 5 CANESTEN 150mg Approved.
17-11-2014(198) Capsule Bayer
Each Capsule contains:- Rs. 20,000/- Healthcare
Fluconazole …150mg As Per SRO/
(Antifungal) FLUDERM 150mg
Pack 1's
Capsule Nabiqasim
Industries (Pvt.) Ltd
New Licensee
21. M/s Sigma Onitum 2gm Sachet Form 5 PROTELOS Sachet Approved.
Pharma 17-11-2014(204) Les Laboratoires
International Pvt. Each Sachet contains:- Rs. 20,000/- Servier Industrie
Limited E-50, Strontium Ranelate… 2g As Per SRO/
(Anti-osteoporotic) ONITA Sachet
N.W.I.Z., Port
PharmEVO
Qasim Karachi (Manufacturer’s Spec.s) Pack 7’s
(Sachet General: New Licensee
No. F.6-6/2014-
Lic (M-237 dated
17-10-2014)
22. -do- Monti 4mg Sachet Form 5 Singulair (MSD Approved.
17-11-2014(218)
Each Sachet contains:- Rs. 20,000/- MONTIKA 4mg
Montelukast Sodium As Per SRO/ Sachet Sami
equivalent to Pharmaceutical (Pvt.)
Ltd
Montelukast 4mg Pack 14’s
(Bronchodilators &
New Licensee
Anti-asthma
(Leukotriene antagonist)
23. -do- Malrid 15/120mg Sachet Form 5 Not confirmed Deferred for
17-11-2014(206) views of
Each Sachet contains:- Rs. 20,000/- ARMIQIN Sachet recommendation
Dihydroartemisinin… PharmEVO s of WHO.
As Per SRO/
15mg
Piperaquine Phosphate Pack 16’s New Licensee
…120mg
1. Availability in
(Anti-Malarial)
SRA’s not
confirmed. Firm
has provided
international
availability in
Taiwan

24. -do- Citrosalt 4mg Sachet Form 5 Not confirmed Deferred for
Each Sachet contains:- 17-11-2014(217) confirmation of
Sodium Bicarbonate… Rs. 20,000/- CITRO SODA Sachet approval in
1.716gm Sodium Citrate Abbott Laboratories, reference
As Per SRO/
Anhydrous… 0.613gm Pakistan Stringent
Citric Acid Regulatory
Anhydrous…0.702gm Pack 20’s & 100’s Agencies.
New Licensee
Tartaric Acid…
0.856gm 1. Availability in
(Antacids, Anti- SRA’s not
flatulents) confirmed. Firm
(Manufacturer’s Spec.s) has provided
international
availability in
India.
25. -do- Profile 20mg Sachet Form 5 FDA: Zegerid Deferred till
17-11-2014(206) review of
Each Sachet contains:- Rs. 20,000/- RISEK INSTA formulation by
Omeprazole… 20mg Powder 20mg Sachet Review
As Per SRO/
Sodium Bicarbonate… Getz Pharma (Pvt.) Committee.
Ltd
1680mg
(Proton pump Pack 10’s
New Licensee
inhibitor/antacid)
(Manufacturer’s Spec.s) 1. Formulation is
under review by
the Review
Committee of
DRB.
26. -do- Profile 40mg Sachet Form 5 FDA: Zegerid Deferred till
17-11-2014(212) review of
Each Sachet contains:- Rs. 20,000/- RISEK INSTA formulation by
Omeprazole… 40mg Powder 40mg Sachet Review
As Per SRO/
Sodium Bicarbonate Getz Pharma (Pvt.) Committee.
Ltd
…1680mg
(Proton pump Pack 10’s
New Licensee
inhibitor/antacid)
(Manufacturer’s Spec.s) 1. Formulation is
under review by
the Review
Committee of
DRB.
27. -do- ORES Sachet Form 5 BNF: Oral Approved.
17-11-2014(213) Rehydration Salts

Each Sachet contains:- Rs. 20,000/- (Non-proprietary)
Sodium Chloride… 2.6g As Per SRO/ WHO Formulation
Sodium Citrate…2.9g
Potassium Chloride… OEM Sachet Indus
Pharma Pvt. Ltd.
1.50g Pack 20's
Glucose Anhydrous…
New Licensee
13.50g
(Electrolytes)
(BP Spec,s)
28. -do- Cysteine Sachet Form 5 Not confirmed (ACC Deferred for
17-11-2014 (210) Sandoz Switzerland by confirmation of
Each Sachet contains:- Rs. 20,000/- Firm) approval in
Acetylcysteine …200mg reference
As Per SRO/
(Mucolytic Agent) MUCOLATOR Stringent
200mg Sachet Abbott Regulatory
Laboratories Agencies.
Pack 30’s (Pakistan) Ltd
New Licensee
1. Availability in
SRA’s not
confirmed. Firm
has provided
international
availability in
Switzerland.
29. -do- Laxit Sachet Form 5 Not confirmed Approved as it
17-11-2014 (211) is BNF
Each Sachet contains:- Rs. 20,000/- MOVCOL Sachet approved
Polyethylene Glycol As Per SRO/ Genix Pharma Private formulation
3350… 13.125g Limited
Sodium Chloride…
New Licensee
0.3507g Pack 10’s
Sodium Bicarbonate…
1. Availability in
0.1785g
SRA’s not
Potassium chloride…
confirmed in same
0.0466g
strength.
(Laxatives)
(Manufacturer’s Spec’s)

30. -do- Gastolyte Sachet Form 5 BNF: Dioralyte Relief Approved.
17-11-2014(216) (Sanofi-Aventis)
Each Sachet contains:- Rs. 20,000/-
Rice Powder …6g As Per SRO/ GASTROLYTE
Sodium Citrate Sachet Sanofi-Aventis
Pakistan Limited
…0.580g Sodium
Chloride …0.350g Pack New Licensee
Potassium Chloride…
0.3g 1 x 10’s
(Electrolytes)
31. M/s Sigma Klar 125mg/5ml Dry Form 5 BNF . Klaricid Approved
Pharma Suspnsion 17-11-2014(222) (Abbott)
International Pvt. Each 5ml contains:- Rs. 20,000/-
Limited E-50, Clarithromycin…125mg As Per SRO/
N.W.I.Z., Port (Macrolide Antibiotic) Pack 30ml & 60ml (Klaricid (Abbott))
Qasim Karachi (USP Spec.s)
New Licensee
(Oral Dry Powder
Suspension {Source of
General: No. F.6- Clarithromycin taste
6/2014-Lic (M- masked Granules:
237 dated 17-10- M/s Surge Lab10th KM
2014) Faisalabad road
Sheikhupura}
32. -do- Klar 250mg/5ml Dry Form 5 BNF . Klaricid Approved
Suspnsion 17-11-2014(223) (Abbott)
Each 5ml contains:- Rs. 20,000/-
Clarithromycin…250mg As Per SRO/
(Macrolide Antibiotic) (Klaricid (Abbott))
(USP Spec.s) Pack 60ml
New Licensee
{Source of
Clarithromycin taste
Stability studies of
masked Granules:
zone IV-A of
M/s Surge Lab10th KM
granules
Faisalabad road Valid GMP
Sheikhupura} certificate.
33. -do- Fantin 15mg/90mg/5ml Form 5 ATRENAM Approved.
Dry Suspnsion 17-11-2014(225) 15/90mg/5ml Dry
Each 5ml contains:- Rs. 20,000/- Suspension Areneco
Artemether… 15mg As Per SRO/ Pharma Belgium
Lumefantrine… 90mg
(Antimalarial ) Pack 15ml ARTHEGET
15/90mg/5ml Dry

(Manufacturer’s Spec.s) 30ml & 60ml Suspension Getz
Pharma (Pvt.) Ltd.
Karachi
New Licensee
34. -do- Fantin DS Form 5 ATRENAM Approved.

30mg/180mg/5ml 17-11-2014(221) 30/180mg/5ml Dry
Dry Suspnsion Rs. 20,000/- Suspension Areneco
Each 5ml contains:- As Per SRO/ Pharma
Artemether… 30mg
Lumefantrine… 180mg Pack 30ml & 60ml Belgium ARTHEGET
30/180mg/5ml Dry
(Antimalarial )
Suspension Getz
(Manufacturer’s Spec.s) Pharma (Pvt.) Ltd.
Karachi
New Licensee
35. -do- Cip 250mg/5ml Form 5 CIPROXIN Bayer Deferred till
Dry Suspnsion 17-11-2014(220) (Formulation is review of
Each 5ml contains:- Rs. 20,000/- different) formulation by
Ciprofloxacin (as As Per SRO/ Review
Ciprofloxacin HCl Pack 60ml HIFLOX Hilton Committee
Monohydrate) 250mg Pharma (Pvt.) Ltd
( Quinolones Antibiotic Karachi
) New Licensee
1. Formualtion is
under review by
the Review
Committee of
DRB.
36. -do- Zith 200mg/5ml Form 5 BNF: Zithromax Approved.
Dry Suspnsion 17-11-2014(224) (Pfizer)
Azithromycin (as As Per SRO/ ZETRO Getz Pharma
Azithromycin (Pvt.) Ltd Karachi.
Dihydrate)…200mg Pack 15ml, 22.5ml, New Licensee
(Macrolide Antibiotic ) 25ml, 30ml, &
(USP Spec.s) 60ml
37. -do- Eryt 200mg/5ml Form 5 Not confirmed Deferred for
Dry Suspnsion 17-11-2014(225) confirmation of
ERYTHROCIN Indus

Rs. 20,000/- Pharma Karachi. formulation
Each 5ml contains:- As Per SRO/ approval in
Erythromycin Ethyl New Licensee reference
succinate Monohydrate Pack 60ml Stringent
equivalent to 1. Availability in Regulatory
Erythromycin… 200mg same strength in Agencies
( Macrolide Antibiotic SRA’s not
) confirmed. Firm
(USP Spec.s) has provided
international
availability in
Jordan.
38. -do- Fosil 250mg/5ml Form 5 FOSFOCINA Deferred for
Dry Suspnsion 17-11-2014 (219) Laboratories ERN, confirmation of
Each 5ml contains:- Rs. 20,000/- Spain formulation
Fosfomycin (as As Per SRO/ approval in
Fosfomycin MIFOS 250mg/5ml reference
Calcium)…250mg Pack 60ml Dry Suspension Stringent
(Anti Bacterial Agent ) Remington Pharma Regulatory
(Manufacturer’s Spec.s) Lahore Agencies
New Licensee
1. Availability in
same strength in
SRA’s not
confirmed. Firm
has provided
international
availability in
Spain.
39. -do- Flucap 50mg/5ml Form 5 BNF: Diflucan Approved.
Dry Suspnsion 17-11-2014(227) (Pfizer)
Fluconazole…50mg As Per SRO/
FLUCANOL
(Antifungal)
50mg/5ml Dry
(USP Spec.s) Pack 35ml
Suspension Rock
Pharma Nawshehra
New Licensee
40. -do- Linz 100mg/5ml Form 5 BNF: Approved.
Dry Suspnsion 20-11-2014(Nil) Zyvox(Pharmacia)
Rs. 20,000/-

Each 5ml contains:- As Per SRO/ NEZOCIN
Linezolid 100mg 100mg/5ml Dry
(Antibacterial ) Pack 60ml Suspension Brookes
(Manufacturer’s Spec.s) Pharma (Private)
Limited
New Licensee

Evaluator – III
S/N Name and Brand Name Type of Form Remarks on the Recommendations
address of (Proprietary name + formulation (if any) by the Evaluator
manufacturer Dosage Form + Strength) Initial date, including
/ Applicant diary International status
Composition in stringent drug
Fee including regulatory agencies /
Pharmacological Group differential fee authorities
Finished product Demanded Price Me-too status

Specification / Pack size
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
41. M/s MTI LOFAMIN Tablet 250mg Form-5 Levaquin Tablet of Approved.
Medical (Pvt) Janssen Pharms
Limited, 586- Each film coated tablet Dy No: 1258 (USFDA)
587 Sunder contains: dated 20-10-2014
Industrial Levofloxacin as Leflox of Getz
Estate, hemihydarte…..250mg 20,000/- Karachi.
Raiwind Road
Lahore. Fluoroquinolone As per SRO/ The CLB in its 236th
Pack of 10’s meeting approved the
(Tablet Manufacture grant of DML by the
General) way of formulation
with sections namely:
a. Oral Liquid
General
b. Tablet General
c. Capsule General
d. Oral Dry Powder
suspension
General
42. -do- LOFAMIN Tablet 500mg Form-5 Levaquin Tablet of Approved.
Janssen Pharms
Each film coated tablet Dy No: 1262 (USFDA)
contains: dated 20-10-2014
Levofloxacin as Leflox of Getz
hemihydarte…..500mg 20,000/- Karachi.
Fluoroquinolone As per SRO/

Pack of 10’s
Manufacture

43. -do- TEMURIN Tablet 100mg Form-5 International Approved.
availability requires
Each chewable tablet Dy No: 1018 confirmation.
contains: dated 26-09-2014
Iron III Hydroxide Rubifer Chewable
Polymatose Complex 20,000/- Tablets of AGP (Pvt)
equivalent to elemental Limited, Karachi.
Iron…..100mg As per SRO/
Pack of 1x10’s,
Anti- Anemic 2x10’s
Manufacturer
(Word film coated has been

replaced with chewable as
firm applied as chewable)
44. -do- TEMURIN-F Tablet 100mg Form-5 International Deferred for
availability requires product specific
Each chewable tablet Dy No: 1261 confirmation. inspection by panel
contains: dated 20-10-2014 comprising of
Iron III Hydroxide Rubifer-F Chewable Director DTL &
Polymaltose Complex 20,000/- Tablet of AGP (Pvt) Area FID
equivalent to elemental Limited Karachi.
Iron…..100mg As per SRO
Folic acid……0.35mg Pack of 1x10’s,
2x10’s
Anti- Anemic
Manufacturer

replaced with chewable as
firm applied as chewable)
45. -do- CYTO Tablet 250mg Form-5 Cipro of Bayer Health Approved.
Care
Each film coated tablet Dy No: 1019
contains:- dated 26-09-2014 Cipro of Bayer Health
Ciprofloxacin as Care Karachi
hydrochloride….250mg 20,000/-
Fluoroquinolone As per SRO

1x10’s
BP

46. -do- CYTO Tablet 500mg Form-5 Cipro of Bayer Health Approved.
Care
contains:- dated 26-09-2014 Cipro of Bayer Health
Ciprofloxacin as Care Karachi
hydrochloride….500mg 20,000/-

Pack of 1x10’s
BP
47. -do- PRIZO Tablets 100mg Form-5 Ansaid of Pharmacia Approved.
(USFDA)
contains:- dated 26-09-2014 Ansaid of Pfizer
Flurbiprofen…..100mg Karachi
20,000/-
Cyclo-oxygenase Inhibitor,
Analgesic, Anti- As per SRO/
inflammatory Pack of 3x10’s
BP
48. -do- OSTIM Tablets 50mg Form-5 Serophene of EMD Deferred till
Serno (USFDA) decision on the
Each film coated tablet Dy No: 1020 manufacturing
contains: dated 26-09-2014 Cerophene of Hilton requirement for
Clomiphene Citrate…..50mg Pharma Karachi. this product.
20,000/-
Antioestrogen
As per SRO/
USP Pack of 1x10’s,
2x10’s and
3x10’s
49. -do- MOZEX Tablet 400mg Form-5 Avelox Tablet of Approved.
Bayer Health Care
contains: dated 26-09-2014 Avelox of Bayer
Moxifloxacin as Health Care Karachi
HCL….400mg 20,000/-

Pack of 5’s
Manufacturer

omitted in the agenda so has
been added in the minutes)

50. -do- ESTO Capsules 20mg Form-5 Nexium of Approved.
(Capsule AstraZeneca USFDA
General) Each capsules contains:- Dy No: 1047
Esomeprazole Magnesium dated 26-09-2014 Esso Capsules of
Trihydrate enteric coated Shaigan
pellets (22.5%) equivalent to 20,000/- Pharmaceuticals,
Esomeprazole……20mg Islamabad.
As per SRO/
PPI 1x10’s & 1x7’s
Manufacturer
Source: M/s Vision

Pharmaceuticals, Islamabad.
51. -do- ESTO Capsules 40mg Form-5 Nexium of Approved.
AstraZeneca USFDA
Each capsules contains:- Dy No: 1048
Esomeprazole Magnesium dated 26-09-2014 Esso Capsules of
Trihydrate enteric coated Shaigan
pellets (22.5%) equivalent to 20,000/- Pharmaceuticals,
Esomeprazole………40mg Islamabad.
As per SRO/
1x10’s & 1x14’s
PPI
Manufacturer
Source: M/s Vision

52. -do- AZOl Capsules 250mg Form-5 Zithromax of Pfizer Approved.
(USFDA).
Each capsule contains: Dy No: 1050
Azithromycin as dated 26-09-2014 Zithromax of Pfizer
dihydrate…..250mg Karachi.
20,000/-
Macrolide
As per SRO/
USP 1x6’s & 1x10’s
53. -do- GRIBOL Capsules 150mg Form-5 Diflucan of Pfizer Approved.
(USFDA)
Each capsule contains: Dy No: 1260
Fluconazole…..150mg dated 20-10-2014 Diflucan Of Pfizer
Karachi.
Antifungal 20,000/-
Manufacturer As per SRO/

1x4’s
54. -do- GOTEC Capsules 40mg Form-5 Prilosec of Approved.
AstraZeneca

Each capsule contains: Dy No: 1055 (USFDA)
Omeprazole enteric coated dated 26-09-2014
pellets (8.5%) equivalent to Risek of Getz Karachi
Omeprazole ……40mg 20,000/-
PPI As per SRO/

1x10’s, 1x14’s
BP
Source: M/s Vision

55. -do- GOTEC Capsules 20mg Form-5 Prilosec of Approved.
AstraZeneca
Each capsule contains: Dy No: 1044 (USFDA)
Omeprazole enteric coated dated 26-09-2014
pellets (8.5%) equivalent to Risek of Getz Karachi
Omeprazole ……20mg 20,000/-
PPI As per SRO/

1x10’s, 1x14’s
BP
Source: M/s Vision

56. -do- APRIN Syrup Form-5 Benadryl Allergy Oral Approved.
Oral liquid Syrup of McNeil
(General) Each ml contains: Dy No: 1051 Products UK
Cetirizine dated 26-09-2014
dihydrochloride ………1mg Baydal of Bayer
20,000/- Health Care Karachi.
Antihistamine
As per SRO
Manufacturer Pack of 30ml
and 60ml bottle
57. -do- APHOLAC Suspension Form-5 Duphalac of Solvay Deferred for:
(USFDA) 1. confirmation of
Each 5ml contains: Dy No: 1052 dosage form &
Lactulose…..3.35gm dated 26-09-2014 Duphalac of Abbot verification of
Pharma, Karachi HPLC equipped
Laxative 20,000/- with RI detector by
Firm has submitted area FID.
BP As per SRO/ invoice of purchase of 2. Fee for import.
Pack of 120ml & Refractive Index 3. Legalized GMP
240ml bottle detector. of source.
4. Stability studies.

58. TEMURIN Syrup Form-5 Availability in SRA’s Approved.
need confirmation
Each 5ml contains: Dy No: 1053
Iron III Hydroxide dated 26-09-2014 Engfer Syrup of
Polymatose Complex English Pharma Lahore
equivalent to elemental 20,000/-
Iron…….50mg
As per SRO/
Anti-anemic Pack of 60ml &
120ml bottle
Manufacturer
59. -do- AZOL Suspension Form-5 Zithromax of Pfizer Approved.
(Oral Dry (USFDA)
Powder Each 5ml contains: Dy No: 1257
Suspension Azithromycin dihydrate dated 20-10-2014 Zithromax of Pfizer
General) equivalent to Azithromycin Karachi
…..200mg 20,000/-
Macrolide As per SRO/

Pack of 15ml
USP bottle
60. -do- CYTO Suspension Form-5 Not available in Deferred till review
SRA’s of formulation by
Each 5ml contains: Dy No: 1259 Review
Ciprofloxacin as HCL taste dated 20-10-2014 Novidat of Sami Committee.
masked pellets 25% Pharma Karachi
equivalent to 20,000/-
Ciprofloxacin..…..250mg
As per SRO/
Fluoroquinolone 60ml bottle
Manufacturer
Evaluator – III (Veterinary New DML)
S/N Name and Brand Name Type of Form Remarks on the Recommendations
address of (Proprietary name + formulation (if any) by the Evaluators
manufacturer / Dosage Form + Initial date, including
Applicant Strength) diary International status
in stringent drug
Composition Fee including regulatory agencies /
differential fee authorities
Pharmacological
Group Demanded Price Me-too status
/ Pack size
inspection report

(with date) by the
Evaluator
61. M/s Izfaar TRIOZIN Injection Form-5 Trisolizin of Star Labs Deferred for
Pharmaceutical Lahore. confirmation of TOC
Industries, Each ml contains: 10-07-14 Dy. No: analyzer & Liquid
Lahore Sulphadiazine…..400mg 64 The CLB in its 236th Particle Counter.
Trimethoprim……80mg meeting of
Veterinary Liquid 20,000/- Registration Board
Injection Antibiotic approved the grant of
(General Decontrolled/ DML with following
Antibiotic) Manufacturer 50ml vial sections namely:
a. Veterinary Liquid
Injection (General
Antibiotic)
b. Veterinary Liquid
Injection (General)
62. -do- TYLOGEN Injection Form-5 Tygent Injection of Deferred for

Selmore confirmation of TOC
Each ml contains: 03-07-14 Dy. No: Pharmaceuticals analyzer & Liquid
Tylosin Tartrate….10mg 15 Lahore Particle Counter.
Gentamicin as
sulphate…..50mg 20,000/-
Antibiotic Decontrolled/
50ml vial
Manufacturer
63. -do- OXY FAR LA Injection Form-5 Oxy-LA injection of Deferred for
Each ml contains: 10-07-14 Dy. No: Pharmaceuticals, analyzer & Liquid
Oxytetracycline as 63 Lahore Particle Counter.
Hydrochloride…….200
mg 20,000/-
100ml vial
Manufacturer
64. -do- OXY FAR Injection Form-5 Oxy-5 injection of Deferred for
Hydrochloride…….50m
g 20,000/-
50ml Vial
Manufacturer
65. -do- ENRO-100 Injection Form-5 Enroxsel of Selmore Deferred for

Pharmaceuticals confirmation of TOC
Each ml contains: 03-07-14 Dy. No: Lahore analyzer & Liquid
Enrofloxacin….100mg 17 Particle Counter.
Fluoroqunolone 20,000/-
Antibacterial
Decontrolled/
50ml vial
66. -do- FLOXIN Injection Form-5 I-Fom of International Deferred for
Pharma Labs Lahore confirmation of TOC
Each ml contains: 03-07-14 Dy. No: analyzer & Liquid
Oxytetracycline as 19 Particle Counter.
HCL…..300mg
20,000/-
Flunixin as
Meglumine……20mg Decontrolled/
50ml vial
Antibiotic/ Analgesic,
Anti-inflammatory
Manufacturer
67. -do- TYLOFAR Injection Form-5 Tylosel of Selmore Deferred for
Pharmaceuticals, confirmation of TOC
Tylosin 15 Particle Counter.
Tartrate……200mg
20,000/-
Antibiotic
Decontrolled/
50ml vial
68. -do- Ketoxay LA Form-5 Oxyfen-LA of Deferred for
HCL…….200mg
Ketoprofen….30mg 20,000/-
Antibiotic/ Analgesic Decontrolled/

50ml vial
Manufacturer
69. -do- TYLOPRIM Injection Form-5 Tylotrim of Selmore Deferred for
Sulphamethoxypyridazin 15 Particle Counter.
e……150mg
Trimethoprim……30mg 20,000/-
Tylosin tartrate…..50mg
Decontrolled/
Antibiotic 50ml vial

Manufacturer
70. -do- DICOTYL Injection Form-5 Bacticom of Selmore Deferred for
Tylosin tartrate….50mg 17 Particle Counter.
Colistin
sulphate…..10mg 20,000/-
Dimetridazole…..100mg
Decontrolled/,
Antibiotic/ Anti- 50ml vial
Protozoal
Manufacturer
71. -do- IVERIN Injection Form-5 Actimec Injection of Deferred for

Selmore confirmation of
Each ml contains: 03-07-14 Dy. No: Pharmaceuticals Liquid Particle
Ivermectin….10mg 14 Lahore Counter.
Anthelmintic 20,000/-
BP Decontrolled/
50ml vial
72. -do- PARACTIN Injection Form-5 Elvomec D/S of Elko Deferred for
Karachi confirmation of
Each ml contains: 03-07-14 Dy. No: Liquid Particle
Ivermectin….20mg 14 Counter.
Anthelmintic 20,000/-
BP Decontrolled/
50ml vial
73. -do- MELOXAM Injection Form-5 Calimox of Selmore Deferred for
Pharma confirmation of TOC
Meloxicam…….7.5mg 14 Particle Counter.
Analgesic/ Anti- 20,000/-

inflammatory
Decontrolled/ 50
BP ml vial
74. -do- B-Vita Injection Form-5 B-Vita of Kakasian Deferred for
Pharma Lahore confirmation of TOC
Cyanocobalamin…..125 15 Particle Counter.
mcg
20,000/-
Vitamin

Decontrolled/
USP Pack of 50 ml
vial
75. -do- ADE-FAR Injection Form-5 Nawan Laboratories Deferred for
Karachi confirmation of TOC
Vitamin 17 Particle Counter.
A…….100,000IU
Vitamin 20,000/-
D3……40,000IU
Vitamin E…….40mg Decontrolled/
50ml vial
Vitamin and Growth
promoters
Manufacturer
76. -do- VITOBION Injection Form-5 Thiaprin Injection of Deferred for
Star Labs Karachi confirmation of TOC
Thiamine HCL……5mg 15 Particle Counter.
Riboflavin……2.5mg
Pyridoxine 20,000/-
HCL……2.5mg
Nicotinamide……37.5m Decontrolled/ 50
g ml vial
Vitamin
Manufacturer
77. -do- HEPAFAR Injection Form-5 Hepaguard of Star Deferred for
Labs Lahore confirmation of TOC
Phenoxy-2-methyl-2- 15 Particle Counter.
propionic acid…..100mg
20,000/-
Hepatoprotectant/ Liver
Tonic Decontrolled/
50ml vial
Manufacturer
78. -do- IMIDO-FAR Injection Form-5 IMIPRO of Selmore Deferred for
Pharmaceuticals, confirmation of TOC
Imidocarb 15 Particle Counter.
dipropionate……120mg
20,000/-
Antiprotozoal
Decontrolled/
50ml vial
79. -do- AAVIL Injection Form-5 Anril Injection of Deferred for

Syman Pharma Lahore confirmation of TOC
Pheniramine 15 Particle Counter.
maleate…..11.35mg
20,000/-
Antihistamine
Decontrolled/
Manufacturer 50ml vial
80. -do- ATRO Injection Form-5 Atrovet Injection of Deferred for
Each ml contain: 03-07-14 Dy. No: Pharmaceuticals analyzer & Liquid
Atropine 15 Lahore Particle Counter.
Sulphate…..1mg
20,000/-
Anti-muscarinic
Decontrolled/
BP Pack of 50ml vial

Case No.04. Grant of registrationsfor additional sectionsof already licensed manufacturers.
Evaluator – II
S/N Name and address of Brand Name Type of Form Remarks on the Decision
manufacturer / formulation (if
Applicant (Proprietary Initial date, any) including
name + Dosage diary International
Form +
Strength) Fee including status in stringent
differential fee drug regulatory
Composition agencies /
Demanded authorities
Pharmacological Price / Pack
Group size Me-too status
Finished GMP status as

product depicted in latest
Specification inspection report
(with date) by the
Evaluator
81. M/s Pharmatec Adagel Gel Form 5 BNF: Epiduo Approved.

Pakistan (Pvt.) Limited, Contains:- 13-10-2014 (Galderma)
D-86/A, S.I.T.E., Adapalene (31)
ADAPLUS
Karachi-75700. (B.P)…0.1%w/w Rs. 20,000/-
(BIOGEN
(Cream/Oint General: Benzoyl Peroxide As Per
PHARMA,Islamab
No. F.6-6/2014-Lic (B.P)…2.5%w/w SRO/15gm,
ad)
(M-237 dated 14-10- (Anti-acne 30gm
Grant of additional
2014) Preperation)
section
(Manufacturer’s
Cream/Ointment
Spec.s)
(General)
recommended.(24-
07-2014)

82. -do- Pamulin Form 5 BNF: Altargo Approved
Ointment 13-10-2014 (GSK)
Contains:- (34)
Retapamulin…1. Rs. 50,000/- Altapam
0%w/w As Per
Ointment of M/s
Atco Lab, Regn
(Antibiotic and SRO/5gm,15g
No 061764
chemotherapeutic m
for
Grant of additional
dermatological
section
use)
Cream/Ointment
(Manufacturer’s
(General)
Spec.s)
recommended.(24-
07-2014)
1. Me-too status
has been given as
Altapam Ointment
of M/s Atco Lab
(Reg. No 061764)
that needs
confirmation.
Pricing of
formulation has
been done in 9th
PAC.
83. M/s Sami Pralzo 0.25mg Form 5 BNF: Alprazolam Approved.
Pharmaceuticlas (Pvt.) Tablets 09-09-2014 (Non-proprietary)
Limited, F-95, S.I.T.E. Each tablet (240)
XANAX (PFIZER
Karachi-Pakistan contains:- Rs. 20,000/-
LABORATORIES
Alprazolam Rs.157.47/30’s LTD.,Karachi)
Tablet (Psychotropic) (USP)…0.25mg
Section (No. F.6- (Benzodiazepine) Very good, Panel
5/2014-Lic (M-236) (USP Spec.s) recommends all the
dated 8th Sep, 2014. additional sections
as per approved
layout plan. (24-06-
14)
1. Alprazolam is a
controlled drug
substance.
84. -do- Pralzo 0.5mg Form 5 BNF: Alprazolam Approved.
Tablets 09-09-2014 (Non-proprietary)

Each tablet (239)
contains:- Rs. 20,000/- XANAX (PFIZER
Alprazolam Rs.157.47/30’s LABORATORIES
LTD.,Karachi)
(USP)…0.5mg
(Benzodiazepine) Very good, Panel
(USP Spec.s) recommends all the
additional sections
as per approved
layout plan. (24-06-
14)
1. Alprazolam is a
controlled drug
substance.
85. -do- Gasicol Form 5 BNF: Gaviscon Deferred for
Tablet (General) Chewable Tablets 03-04-2014 Advance application on Form -
Section (No. F.6- Each Chewable (201) 5D alongwith
Not confirmed requisite fee & other
5/2014-Lic (M-236) tablet contains:- Rs. 20,000/-
codal formalities.
dated 8th Sep, 2014. Sodium Rs. 5 per Very good, Panel
Alginate(BP)…5 Tablet, Rs. recommends all the
00mg 80/16’s additional sections
Potassium as per approved
Bicarbonate layout plan. (24-06-
(BP)…100mg 14)
(Antacid)
1. Verification of
(Manufacturer’s
Spec.s)
photocopy of
fee receipt is
required.
2. Me-too status
needs
confirmation.
86. -do- Solfy 5mg Form 5 BNF: Vesicare Approved.
Tablets 21-10-2014 (Astellas)
Each film coated (72)
Fenaso (Highnoon)
tablet contains:- Rs. 20,000/-
Solifenacin As per PRC Very good, Panel
Succinate…5mg recommends all the
(Muscarinic additional sections
antagonist) as per approved
(Manufacturer’s layout plan. (24-06-
Spec.s) 14)

87. -do- Urigo 80mg Form 5 FDA: Uloric Approved.
Tablets 21-10-2014
Each film coated (73) Zurig (Getz)
Very good, Panel
Febuxostat…… As per PRC recommends all the
……….…80mg additional sections
(Xanthine as per approved
Oxidase layout plan. (24-06-
Inhibitor) 14)
(Manufacturer’s
Spec.s)
88. -do- Urigo 40mg Form 5 FDA: Uloric Approved.
Tablets 21-10-2014
Each film coated (71) Zurig (Getz)
Very good, Panel
Febuxostat…40m As per PRC recommends all the
g additional sections
(Xanthine as per approved
Oxidase layout plan. (24-06-
Inhibitor) 14)
(Manufacturer’s
Spec.s)
89. -do- Beritex 150mg Form 5 Not confirmed Approved.
Capsule (General) Capsules 09-09-2014
Section (No. F.6- Each capsule (241) Ferricure (S. J. &
G)
5/2014-Lic (M-236) contains:- Rs. 20,000/-
dated 8th Sep, 2014. Polysaccharide As per PRC Very good, Panel
Iron Complex recommends all the
equivalent to additional sections
Elemental as per approved
Iron…150mg layout plan. (24-06-
(Iron compound) 14)
(Manufacturer’s
1. Availability in
Spec.s)
SRA’s not
confirmed.
Firm has
provided
international
availability of
un approved
products in
USA, Canada,

UK.
Evaluator – III
S/N Name and Brand Name Type of Remarks on Recommendations Decision

address of (Proprietary name + Form the by the Evaluator
manufacturer / Dosage Form + formulation
Applicant Strength) Initial (if any)
date, diary including
Composition International
Fee status in
Pharmacological including stringent
Group differential drug
fee regulatory
Finished product agencies /
Specification Demanded authorities
Price /
Pack size Me-too status
GMP status
as depicted in
latest
inspection
report (with
date) by the
Evaluator
90. M/s Rasco PARA-RAS Infusion Form-5 PERFALGAN Firm has submitted Approved.
Pharma, 5.5 10 mg/ml, the invoices of Area FID will
Km Raiwind Each 100ml vial Dy No: 659 solution for purchase of Liquid confirm
Road, Lahore contains; dated 22- infusion (100 Particle counter and instalation &
Paracetamol 09-2014 ml vial TOC analyzer. operational
Liquid Injection (BP)…..1000mg contains 1000 qualifications
General (Small 20,000/- mg of TOC &
Volume Vial) Antipyretic/ Analgesic paracetamol) Liquid
As per of BMS UK Particle
Manufacturer SRO Counter and
1x 100ml Provas of then

Sami Karachi registration
letter will be
The issued after
inspection of approval of
firm was Chairman,
carried out on RB.
03-06-2014
by the panel
of inspectors
and
recommended
the renewal of
DML and
additional
section
namely Liquid
Injection
General
(Small
Volume Vial)
91. -do- LEVOFLOXA Infusion Form-5 Tevanic of Approved.
Sanofi Area FID will
Each 100ml vial Dy No: 660 Aventis confirm
contains: dated 22- (BNF) instalation &
Levofloxacin 09-2014 operational
hemihydarte equivalent Levocil of qualifications
to Levofloxacin 20,000/- CCL Pharma of TOC &
USP…..500mg Lahore. Liquid
As per Particle
Quinolone SRO Counter and
1x 100ml then
Manufacturer registration
letter will be
issued after
approval of
Chairman,
RB.

92. -do- LEVOFLOXA Infusion Form-5 250mg Deferred for
levofloxacin confirmation
Each 100ml vial Dy No: 665 (as of approval
contains: dated 22- hemihydarte) by the
Levofloxacin 09-2014 in 50ml reference
hemihydarte equivalent solution Stringent
to Levofloxacin 20,000/- (Tavanic of Regulatory
USP…..250mg sanofi) Agencies for
As per this strength /
Quinolone SRO Levocil of volume.
1x 100ml CCL Pharma
Manufacturer Lahore
93. -do- CIP-RX Infusion Form-5 Ciprofloxacin Deferred for
2 mg/ml confirmation
Each 100ml vial Dy No: 656 Solution for of approval
contains: dated 22- Infusion of
Ciprofloxacin lactate 09-2014 400mg/200ml formaulation
equivalent to vial of in Stringent
Ciprofloxacin 20,000/- Hospira UK Regulatory
USP….400mg Limited Agencies in
As per the same
Quinolone SRO Novidat of strength.
1x 100ml Sami Karachi
USP
94. -do- CIP-RX Infusion Form-5 Ciprofloxacin Approved.
2 mg/ml Area FID will
Each 100ml vial Dy No: 660 Solution for confirm
contains: dated 22- Infusion instalation &
Ciprofloxacin lactate 09-2014 200mg/100ml operational
equivalent to vial of qualifications
Ciprofloxacin 20,000/- Hospira UK of TOC &
USP….200mg Limited Liquid
As per Particle
Quinolone SRO Novidat of Counter and
1x 100ml Sami Karachi then
USP registration
letter will be
issued after
approval of
Chairman,
RB.

95. -do- LINZO Infusion Form-5 Zyvox of Approved.
Pfizer USA Area FID will
Each 100ml contains: Dy No: 654 confirm
Linezolid….200mg dated 22- Nezocin of instalation &
09-2014 Brookes operational
Oxazolidinone Pharma qualifications
20,000/- of TOC &
Manufacturer Liquid
As per Particle
SRO Counter and
1x 100ml then
registration
letter will be
issued after
approval of
Chairman,
RB.
96. -do- RESGYL Infusion Form-5 Flagyl of Approved.

Sanofi Area FID will
Each 100ml contains: Dy No: 657 (USFDA) confirm
Metronidazole…500mg dated 22- instalation &
09-2014 Metrozine of operational
Antiprotozoal Searle Karachi qualifications
20,000/- of TOC &
Manufacturer Liquid
As per Particle
SRO Counter and
1x 100ml then
registration
letter will be
issued after
approval of
Chairman,
RB.
97. -do- RE-VED Infusion Form-5 Teravid of Approved.

Sanofi USA Area FID will
Each 100ml contains: Dy No: 658 confirm
Ofloxacin HCL dated 22- Loxat of Siza instalation &
equivalent to 09-2014 Lahore operational
Ofloxacin……200mg qualifications
20,000/- of TOC &
Quinolone Liquid
As per Particle
Manufacturer SRO Counter and
1x 100ml then
registration
letter will be

issued after
approval of
Chairman,
RB.
98. -do- MOXILINE Infusion Form-5 Avelox of Applied volume is Approved.

Bayer Health 250ml however the Area FID will
Each 250ml vial Dy No: 662 Care USA approval of section confirm
contains: dated 22- is for Liquid instalation &
Moxifloxacin HCL 09-2014 Moxiget of Injection General operational
equivalent to Getz Karachi (Small Volume qualifications
Moxifloxacin……400mg 20,000/- Vial) of TOC &
Liquid
Quinolone Antibiotic As per Particle
SRO Counter and
Manufacturer 1x 250ml then
registration
letter will be
issued after
approval of
Chairman,
RB.
99. M/s Arsons RELAXIM Tablet 3mg Form-5 Lexotan Approved

Pharmaceuticals Tablets of with change
Industries (Pvt) Each tablet contains: 23-09-14 Roche (TGA in applied
Limited, Lahore Bromazepam…….3mg Dy. No: Approved) brand name.
(Tablet 793
Psychotropic) Benzodiazepine Tensium
20,000/- Tablets of
Manufacturer Werrick
As per Pharma
SRO Islamabad.
3x10’s
The
inspection of
the firm was
conducted on
08-05-2014
by the panel
of inspectors
and
recommended
the renewal of
DML and

grant of
additional
section of
tablets
psychotropic.
100. -do- ARVOTRIL Tablets Form-5 Clonazepam Approved

0.5mg Tablet of Teva with change
Dy No: 788 (USFDA) in applied
Each tablet contains: dated 23- brand name.
Clonazepam……0.5mg 09-2014 Clonzil of
English
Benzodiazepine 20,000/- Pharma
Lahore
BP As per
SRO
5x10’s
101. -do- ARVOTRIL Tablets Form-5 Clonazepam Approved
2mg Tablet of Teva with change
Dy No: 790 (USFDA) in applied
Each tablet contains: dated 23- brand name.
Clonazepam……2mg 09-2014 Clonzil of
English
Benzodiazepine 20,000/- Pharma
Lahore
BP As per
SRO
3x10’s
102. -do- ARTIVAN Tablets 1mg Form-5 Ativan of Approved
Pfizer with change
Each tablet contains: Dy No: 792 (USFDA) in applied
Lorazepam……1mg dated 23- brand name.
09-2014 Ativan of
Benzodiazepine Pfizer Karachi
20,000/-
BP
As per
SRO
10x10’s

103. -do- ARTIVAN Tablets 2mg Form-5 Ativan of Approved
Pfizer with change
Each tablet contains: Dy No: 791 (USFDA) in applied
Lorazepam……2mg dated 23- brand name.
09-2014 Ativan of
Benzodiazepine Pfizer Karachi
20,000/-
BP
As per
SRO
10x10’s
104. -do- XALLIUM Tablets 5mg Form-5 Diazeoam of Approved
Wockhardt with change
Each tablet contains: Dy No: 794 UK in applied
Diazepam………5mg dated 23- brand name.
09-2014 Valium of
Benzodiazepine Martin Dow
20,000/- Karachi
BP
As per
SRO
3x10’s
105. -do- ARMICUM Tablet Form-5 Hypnovel Approved
7.5mg tablets of with change
Dy No: 794 Roche New in applied
Each tablet contains: dated 23- Zealand brand name.
Midazolam as 09-2014
meleate……7.5mg Dormicum of
20,000/- Martin Dow
Benzodiazepine Karachi
As per
Manufacturer SRO
3x10’s
5. Left-over agenda (245)
a) Remaining application of previously approved new sections
Evaluator - II

address of formulation (if any)
manufacturer / (Proprietary name + Initial date, diary including
Applicant Dosage Form + International status
Demanded Price authorities
Pharmacological / Pack size
Group Me-too status

inspection report
(with date) by the
Evaluator
106. M/s Herbion EsNovex/AciNovex/ Form 5 Nexium of Approved. Firm will
Pakistan (Pvt) GastriNovex 02-05-2014 AstraZeneca provide legalized
Ltd., Kahuta Capsules 20mg Dy.No.2076 GMP of the
Road, industrial Each capsule Rs.20,000/=+Rs. Esso of Shaigan manufacturer of
Triangle, Humak, contains:-Enteric 80,000/- (05-09- Pharmaceuticals pellets and then
Rawalpindi- coated pellets of 2014) Islamabad. registration letter will
Islamabad. Esomeprazole Rs.200.00/ be issued after
Magnesium 2x7’s Grant of DML approval of
Trihydrate recommended (23-24th Chairman, RB.
eq. to January 2014)
Esomeprazole…20m
g 1. Valid and
( Antipeptic legalized GMP
Ulcerants / Proton Certificate of
Pump Inhibitor)
Source, COA and
(Manufacturer’s
Spec.s) stability studies
{Source of Pellets: according to zone
M/s Glukem IV-a of pellets are
Pharmaceuticals (P) required.
Ltd Plot # 205/2A, 1st The stability & COA
Floor , IDA, Phase-II, have been provided
Cherlapally,
by the applicant
Hyderabad-Andhra
Pradesh, India} before the meeting of
the Board.
107. -do- EsNovex/AciNovex/ Form 5 Nexium of Approved. Firm will
GastriNovex AstraZeneca provide legalized
Capsules 40mg 02-05-2014 GMP of the
Each capsule Dy.No.2077 Esso of Shaigan manufacturer of
contains:-Enteric Rs.20,000/- + Pharmaceuticals pellets and then
coated pellets of Rs. 80,000/- (05- Islamabad. registration letter will
be issued after

Esomeprazole 09-2014) Grant of DML approval of
Magnesium recommended (23-24th Chairman, RB.
Trihydrate Rs.371.00/2x7’s January 2014)
eq. to
Esomeprazole …40 1. Valid and
mg legalized GMP
( Antipeptic Certificate of
Ulcerants / Proton Source, COA and
Pump Inhibitor)
stability studies
(Manufacturer’s
according to zone
Spec.s)
{Source of Pellets: IV-a of pellets are
M/s Glukem required.
Pharmaceuticals (P) The stability & COA
Ltd Plot # 205/2A, have been provided
1st Floor , IDA, by the applicant
Phase-II, before the meeting of
Cherlapally,
the Board.
Hyderabad-Andhra
Pradesh, India}
108. -do- OmeNovex / Form 5 Losec (Astrazeneca) Approved.
SecNovex / 02-05-2014
PeptiNovex Dy.No.2078 Omega(Ferozsons)
Capsules 20mg Rs.20,000/=
Each capsule Rs.290.00/
contains:- 2x7’s Grant of DML
Omeprazole enteric recommended (23-24th
coated Pellets eq. to January 2014)
Omeprazole
…20mg
( Antipeptic
Ulcerants / Proton
Pump Inhibitor)
(Manufacturer’s
Spec.s)
{Source of Pellets:
M/s Vision
Pharmaceuticals,
Plot No.224, Street
No.1, I-10/3,
Industrial Area,
Islamabad.}

109. -do- OmeNovex / Form 5 Losec (Astrazeneca) Approved.
SecNovex / 02-05-2014
PeptiNovex Dy.No.2079 Omega(Ferozsons)
40mg Capsules Rs.20,000/=
Each capsule Rs.354.00/
contains:- 2x7’s Grant of DML
Omeprazole enteric recommended (23-24th
coated Pellets January 2014)
eq. to
Omeprazole…
40mg
( Antipeptic
Ulcerants / Proton
Pump Inhibitor)
(Manufacturer’s
Spec.s)
{Source ofPellets:
M/s Vision
Pharmaceuticals, Plot
No.224, Street No.1,
I-10/3, Industrial
Area, Islamabad.}
110. -do- FluNovex / CF- Form 5-D Not confirmed Deferred for
Novex / TheraNovex 24-02-2014 confirmation of
Extra Tablets Dy.No.194 Form 5-D approval in reference
Each film coated Rs.20,000+Rs. Stringent Regulatory
tablet contains:- 30,000/- (07-05- Agencies. It will be
Paracetamol BP 14) Grant of DML followed by
….…..650mg recommended (23-24th assessment of
Chlorphenirmine Rs.230.00/ January 2014) stability studies and
Maleate 10x10’s expert opinions by
BP………………..… 1. The firm had Brig Aslam,
…..4mg applied on Form 5 Dr.Rehana Kauser
Phenylephrine HCl , after evaluation and Dr.Shazli
BP…10mg Manzoor.
the Firm applied
(Analgesic +
Decongestant on Form 5-D and
Combination) submitted
(Manufacturer’s additional fee of
Spec.s) Rs. 30,000/-
2. International
availability not
confirmed in
stringent DRS’s.

111. -do- VitaNovex / Form 5 Not confirmed Deferred for approval
CilaNovex / 26-02-2014 in reference Stringent
BonNovex Dy.No.211 Not confirmed Regulatory Agencies
Suspension Rs.20,000 & me-too status
Each 5ml contains:- Grant of DML alongwith
Ossein Mineral recommended (23-24th installational &
Rs.144.00/
Complex …250mg January 2014) operational
60ml
Vitamin D … 400 i.u 1. International qualification of
(Calcium-Phosphorus availability not atomic absorption
Supplements) confirmed in spectrophotometer by
(Manufacturer’s area FID.
stringent DRA’s.
Spec.s) 2. Me-too status not
confirmed.
3. Firm has claimed
that they possess
Atomic Absorption
(PerkinElmer- A
Analyst 300)
spectrophometer
and has submitted
that it can be
verified by area
FID.

Evaluator – I
S/N Name and Brand Name Type of Form Internationa Remarks / Decision
address of (Proprietary l status in Observations
Manufacturer / name + Dosage Initial date, stringent
Applicant form + Strength) diary. regulatory
agencies
Composition Fee including
differential fee Me-too
Pharmacological status
Group Demanded
Price / Pack GMP status
Finished product size as depicted
specification in inspection
report
(dated)
112. M/s Hiranis Acen Effervescent Form-5D ACC™ 200 References and Deferred for
Pharmaceuticals Tablet 200mg effervescent data of various approval in
(Pvt) Ltd., Plot Each effervescent New License tablets international reference
No. E-145 – E- tablet contains: N- clinical studies Stringent
149, North N-acetylcysteine 28-05-2014 acetylcystein have been provided Regulatory
Western …………..200mg 804 R&I e 200mg along with 06 Agencies to
Industrial Zone, South Africa months accelerated establish
Port Qasim, (Manufacturer’s Rs. 800 / per and real time safety &
Karachi. Specs) 10’s stability summary. efficacy of
product.
Mucolytic agent Rs. 50,000/-
113. M/s Hiranis Glucort S.R. Tablet Form-5D CLIPPER References and Deferred for
Pharmaceuticals 5mg Each enteric Gastro- data of various expert
(Pvt) Ltd., Plot coated tablet New License resistant international opinions by
No. E-145 – E- contains:- prolonged clinical studies has Brig Aslam,
149, North Beclomethasone 28-05-2014 release tablet been provided Dr.Rehana
Western Dipropionate ... 808 R&I 5mg along with 06 Kauser and
Industrial Zone, 5mg MHRA months accelerated Dr.Shazli
Port Qasim, Rs. 1,000 / per and real time Manzoor and
Karachi. (Manufacturer’s 10’s stability summary. evaluation of
Specs) Firm has also stability
Rs. 50,000/- submitted studies by
Corticosteroid undertaking to Incharge,
submit comparative PEC.
dissolution profile
with established
brand before
marketing the
product.

114. M/s Hiranis Lafelax Liquid Form-5D LAEVOLAC References and Deferred for
Pharmaceuticals Sachet 10g/15ml data of various confirmation
(Pvt) Ltd., Plot Each 15ml sachet New License Sachet international of same
No. E-145 – E- contains:- MHRA clinical studies / strength
149, North Lactulose………6 28-05-2014 literature have been internationally
Western 7% w/v 811 R&I provided along , evaluation of
Industrial Zone, with 06 months stability
Port Qasim, (USP Rs. 250 / per accelerated and real studies,
Karachi. Specification) 10’s time stability confirmation
summary. of HPLC
Laxative Rs. 50,000/- equipped with
28/05/2014 GMP certificate of RI detector &
Source: M/s Rs. 50,000/- the source of legalized
Fresenius Kabi, 24/09/2014 Lactulose dated 13- GMP of
Austria Total fee: Rs. 02/2012 with the source.
100,000/- statement that this
certificate reflects
the status of
manufacturer at the
time of inspection
(31-01-2012) and
should not be relied
upon to reflect the
compliance status if
more than three
years have elapsed
since the date of
that inspection.
115. M/s Hiranis Diolyte Rice Form 5 DIAROLYT Approved
Pharmaceuticals Sachet E with change in
(Pvt) Ltd., Plot New License brand name.
No. E-145 – E- Each sachet
149, North contains:- 05-05-2014
Western 662 R&I GASTROLY
Industrial Zone, Rice Powder…6g TE
Port Qasim, As per PRC Sanofi
Karachi. Sodium 10’s
Citrate……. 0.58g
Rs. 20,000/-
Sodium Chloride
………….. 0.35g
Potassium Chloride
…………… 0.3g
(Manufacturer’s
Specs)

ORS
116. M/S Pharma CPRO 125mg/5ml Form 5 NOVIDAT 1. Under Deferred for
Lord (Pvt) Ltd., Suspension 125mg/5ml international review of
12 Km, Lahore Rs. 125/- per Sami availability Cipro formulation.
Road, Layyah. Dry Suspension 60ml of M/s Bayer, Italy
Panel has been
Tablet (General) Each reconstituted R&I diary No. inspection mentioned.
Capsule 5ml contains: and date not report for 2. Role of
(General) grant of ingredients has not
available
Oral Dry Powder Ciprofloxacin DML dated been provided.
Suspension 14th 3. Ciprofloxacin
………..... 125mg Rs.20,000
(General) December, 25% granules had
(Duplicate)
(Anti-infective / 2012 been proposed
Quinolone) attached. earlier. However,
now firm has
proposed dry
Reference
powder suspension
formulation:
containing
CIPRO Oral Ciprofloxacin
Suspension (M/s (base) with water
Bayer HealthCare as diluent which is
Pharmaceuticals different from the
Inc.) reference
international
Ciprofloxacin Oral brand*.
Suspension is 4. Copy of latest
GMP report
available in 5% (5
required.
g ciprofloxacin in
100 mL) and 10%
(10 g ciprofloxacin
in 100 mL)
strengths.
Ciprofloxacin Oral
Suspension is a
white to slightly
yellowish
suspension with
strawberry flavor
which may contain
yellow-orange
droplets. It is
composed of
ciprofloxacin
microcapsules and
diluent which are

mixed prior to
dispensing. The
components of the
suspension have
the following
compositions:
Microcapsules–
ciprofloxacin,
povidone,
methacrylic acid
copolymer,
hypromellose,
magnesium
stearate, and
Polysorbate 20.
Diluent–medium-
chain triglycerides,
sucrose, lecithin,
water, and
strawberry flavor.

Evaluator – III
address of (Proprietary name + formulation (if any)
manufacturer / Dosage Form + Initial date, diary including
Applicant Strength) International status
Fee including in stringent drug
Composition differential fee regulatory agencies /
authorities
Pharmacological Demanded Price /
Group Pack size Me-too status

inspection report
(with date) by the
Evaluator
117. M/s Faas Ciploxin Tablet Form-5 Cipro of Byaer Health Approved.
Pharmaceuticals 250mg Care
(Pvt) Limited, F- Dy No:977 dated
748/ L S.I.T.E. Each film coated tablet 12-06-2014 Cipro of Bayer
Karachi contains: Healthcare Karachi
Ciprofloxacin as 20,000/-
(Tablet General) HCL…..250mg Inspection of the firm
As per SRO was conducted on 18-
Anti-Infective 03-2014 by the area
FID and GMP
USP compliance was found
satisfactory.
118. -do- Ciploxin Tablet Form-5 Cipro of Byaer Health Approved.
500mg Care
Dy No:975 dated
Each film coated tablet 12-06-2014 Cipro of Bayer
contains: Healthcare Karachi
Ciprofloxacin as 20,000/-
HCL…..500mg
As per SRO
Anti-Infective
USP
119. -do- Levoquin Tablet Form-5 Levaquin Approved Approved.
250mg USFDA
Dy No:976 dated
Each film coated tablet 12-06-2014 Leflox of Getz Pharma
contains: Karachi
Levofloxacin as 20,000/-
hemihydarte…..250mg
As per SRO

Anti-Infective
Manufacturer
120. -do- Levoquin Tablet Form-5 Levaquin Approved Approved.

500mg USFDA
Dy No:974 dated
Each film coated tablet 12-06-2014 Leflox of Getz Pharma
contains: Karachi
Levofloxacin as 20,000/-
hemihydarte…..500mg
As per SRO
Anti-Infective
Manufacturer
121. -do- Omezole-D Capsule Form-5 Not available in Deferred till review
Capsule (General) stringent SRA,s of formulation.
Each capsule Dy No:974 dated Me too status is not
contains:- 12-06-2014 submitted by the firm.
Blended pellets of 100,000/-

Omeprazole 20mg a. Evidence of
EC….20mg As per SRO approval of same
Domperidone IR dosage form and
….10mg strength in FDA,
TGA, EMA,
Anti-Ulcer and Anti- MHLW, and
Emetic Health Canada is
required.
Manufacturer b. GMP certificate
of the source
Source: M/s Glukem (which shall be
Pharmaceuticals, Plot legalized) and
No. 205/2A, IDA, stability studies
Phase II, Chedapally, as per ZONE-IV
Hyderabad, India A needs to be
submitted.
122. M/s Martin Dow Sparta Sachet Form-5 Hepa-MerzMerz Deferred for
Limited, Plot No. Pharmaceuticals confirmation of
37, Sector 19, Each sachet conatins:- Dy No. 1067 dated : Germany approval in
Korangi Industrial L-Ornithine –L- 30-06-2014 reference Stringent
Area, Karachi Aspartate……3gm Hepa-Merz of Brookes Regulatory
As per brand leader Pharma, Karachi. Agencies & me too
Cholagogues and price/ Pack of 5,10 status.
Hepatic Protectors\ & 30’s
Manufacturer

123. -do- Olyte Sachet Form-5 Doalyte Relief Black Approved.
Each sachet contains:- current sachet of
Precooked Rice Dy No. 1069 dated : Aventis Pharma UK
Powder ……6gm 30-06-2014
Sodium Diarolyte of Sanofi
citrate…..0.58gm As per brand leader Avnetis Karachi
Sodium price/ Pack of 6,10
chloride…..0.35gm & 20’s
Potassium
chloride……0.30gm
124. -do- Evrease Sachet Form-5 Fybogel Mebeverine Approved.
of Reckitt Benkiser
Each sachet contains: Dy No. 1070 dated : UK
Mebeverine as 30-06-2014
Hydrochloride: Ispamer Sachet of
135mg Rs.155.52 per pack Getz, Karachi
Physillium of 10’s
Husk…..3.5gm Rs. 310.50 per pack
of 20’s
Antispasmodic and Rs.465.75 per pack
Laxative of 30’s
Manufacturer
125. M/s Elite Pharma Flucolite Infusion Form-5 Diflucan of Pfizer. Deferred for
(Pvt) Limited, 9.5 50ml confirmation of
Km Sheikhupura Dy No. 885 dated : Diflucan of Pfizer installation and
Road Lahore Each ml contains:- 25-11-2013 Labs Karachi performance
Fluconazole……2mg qualification of
20,000/- Evidence of TOC analyser &
Antifungal availability of TOC is Liquid Particle
Price not submitted required as BP Counter by Area
Manufacturer /Pack of 100ml of specifications are FID.
1’s claimed.
Panel inspection of the

firm was conducted on
28-01-13 and the
panel recommended
the liquid injectable
infusion (100ml)

126. -do- Percemol Infusion Form-5 Perfalgan of BMS, UK Deferred for
1gm/100ml confirmation of
Dy No. 883 dated : Provas of SAMI installation and
Each 100ml conatins:- 25-11-2013 Pharmaceuticals performance
Paracetamol……1gm Karachi qualification of
20,000/- TOC analyser &
Analgesic Evidence of Liquid Particle
Price not submitted availability of TOC is Counter by Area
Manufacturer /Pack of 100ml of required as BP FID.
1’s specifications are
claimed.
127. -do- Capronic Infusion Form-5 Not available in Deferred for
50mg/ml SRA,s. confirmation of
Dy No. 883 dated : following:
Each ml contains:- 25-11-2013 Me too is not provided 1. Installation and
Aminocaproic by the company. performance
acid…..50mg 20,000/- qualification of
Evidence of TOC analyser &
Hemostatis Price not submitted availability of TOC is Liquid Particle
/Pack of 100ml of required as BP Counter by Area
1’s specifications are FID.
claimed. 2. Me too status &
approval by
referenece
Stringent
Regulatory
Agencies.
128. -do- Elite Reserbelakta Form-5 Not available in Deferred for
stringent SRA’s. Firm confirmation of
Each ml contains:- Dy No. 884 dated : has submitted the folowing:
Sorbitol…..200mg 25-11-2013 applied product is 1. Installation and
Sodium available in Ukraine performance
Lactate…..1.9mg 20,000/- (Saorbilactum infusion qualification of
So+dium of Yuria Pharma) TOC analyser &
chloride…..6mg Price not submitted which also needs Liquid Particle
Calcium /Pack of 400ml of verification. Counter by Area
chloride…..0.1mg 1’s FID.
Potassium Firm submitted that 2. Me too status &
Chloride……0.3mg product is not approval by
Magnesium available locally. referenece
Chloride…..0.2mg Stringent
Evidence of Regulatory
Hyperosmoler availability of TOC is Agencies.
complex and infusion required as BP
solution specifications are
claimed.
Manufacturer

129. -do- Elite Reserbelakta Form-5 Not available in Deferred for
stringent SRA’s. Firm confirmation of
Each ml contains:- Dy No. 888 dated : has submitted the folowing:
Sorbitol…..200mg 25-11-2013 applied product is 1. Installation and
Sodium available in Ukraine performance
Lactate…..1.9mg 20,000/- (Saorbilactum infusion qualification of
Sodium of Yuria Pharma) TOC analyser &
chloride…..6mg Price not submitted which also needs Liquid Particle
Calcium /Pack of 200ml of verification. Counter by Area
chloride…..0.1mg 1’s FID.
Potassium Firm submitted that 2. Me too status &
Chloride……0.3mg product is not approval by
Magnesium available locally. referenece
Chloride…..0.2mg Stringent
Evidence of Regulatory
Hyperosmoler availability of TOC is Agencies.
complex and infusion required as BP
solution specifications are
claimed.
Manufacturer
b) Routine applications
Evaluator – II
S/N Name and address of Brand Name Type of Form Remarks on the Decision
manufacturer / formulation (if any)
Applicant (Proprietary name + Initial date, diary including
Dosage Form +
Strength) Fee including International status
Demanded Price / authorities
Pharmacological Pack size
Group Me-too status

inspection report
(with date) by the
Evaluator
130. M/s Maple Faxim-E 200mg Form-5 BNF: Xifaxanta Approved.

Pharmaceuticals (Pvt.) Tablet 15-07-2010 (Norgine) Reference
Ltd., 147/23, Korangi Each film coated (N/A) will be sent

Industrial Area, Tablet contains:- Rs.8,000/-+Rs. 12,000 Nimixa (Getz Pharma) to B & A
Karachi. Rifaximin (14-05-2013) Division,
(B.P)…200mg As per PAC Overall cGMP DRAP for
measures are followed
(Antibacterial) verification
in the Firm (31-03-
(Manufacturer’s 2014) of photocopy
Spec.s) of fee
1. Verification of challan. If
photocopies of fee confirmed,
challan is then
required. Chairman,
RB will
permit
issuance of
registration
letter.
131. -do- Faxim 550mg Tablet Form-5 BNF: Xifaxanta Approved.

Each Tablet 15-07-2010 (Norgine) Reference
contains:-Rifaximin (N/A) will be sent
(B.P)…550mg Rs.8,000/-+Rs. 12,000 Nimixa (Getz Pharma) to B & A
(Antibacterial) (25-07-2013) Overall cGMP Division,
(Manufacturer’s As per PAC measures are followed DRAP for
Spec.s) in the Firm (31-03- verification
2014) of photocopy
of fee
1. Verification of challan. If
photocopies of fee
confirmed,
challan is
required. then
Chairman,
RB will
permit
issuance of
registration
letter.
132. M/s Sami Neege 20mg Tablets Form 5 BNF. Pantoprazole Approved.
Pharmaceuticlas (Pvt.) Each delayed release (Non-proprietary) Reference
Limited, F-95, S.I.T.E. Tablet contains:- 06-07-2010 will be sent
Rs.8,000/ (69) Zentro (Bosch)
Karachi-Pakistan Pantoprazole Sodium to B & A
Sesuiquihydrate +Rs. 12000 (10-05- Division,
Good (28-11-2013)
equivalent to 2013) DRAP for
Very good (24-06-
Pantoprazole 2014) Grant of verification
(USP)…20mg As Per PRC Additional sections of photocopy

(Proton Pump Satisfactory (07-11- of fee
Inhibitor) USP 2013) Routine challan. If
Spec.s) confirmed,
1. Verification of
then
photocopy of fee
Chairman,
of Rs. 12000/- is
RB will
required.
permit
issuance of
registration
letter.
1. The Routine applications checked by the Field Officers before establishment of Cell
Evaluator - II
S/N Name and 1. Brand 1.Type of 1. Finished Comments / Decision

address of Name Form Product observation on
manufacturer/ 2. Dosage 2. Type of Specification the product (if
Applicant Form application 2. Me-too status any)
3. 3.
Composition Demanded
4. Price / Pack
Pharmacologi size
cal 4. Initial
group date, diary.
5. Date on
which fee
becomes
complete
according to
type of
application
/or Form
(total Fee)
Registration-II
133. M/s Barrett 1.DutaBar 1.Form5 Me too confirmed FDA : Avodart Deferred for
Hodgson 2.Capsule 2.Routine Advodart of GSK (GSK) confirmation of
Pakistan Pvt. 3.Each 3. Rs. formualtion in soft
Ltd. F/423, Capsule 1200/20’s gelatin capsule form.
SITE, Karachi contain: 4.28/09/2010
Dutasteride… Dy. No. 1738 Reference will be
……….0.5mg Form 5 sent to B & A
4.Alpha- Rs. 8000/- Division, DRAP for
Reductase (Original) verification of

Inhibitors 21-5-2013 photocopy of fee
Rs.12,000/- challan. If
(Photo copy) confirmed, then
Chairman, RB will
permit issuance of
registration letter.
134. -do- 1.MindSet 1.Form5 Me too status FDA : Geodon Approved with
2.Capsules 2.Routine confirmed. (Pfizer) change in applied
3.Each 3. Rs. brand name.
Capsule 900/14’s Reference will be
contains: 4.28/09/2010 sent to B & A
Ziprasidone Dy. No. 1742 Division, DRAP for
……….20mg Form 5 verification of
4.Atypical Rs. 8000/- photocopy of fee
Anti- (Original) challan. If
Psychotropic 21-5-2013 confirmed, then
Agent Rs.12,000/- Chairman, RB will
(Photo copy) permit issuance of
135. -do- 1.Form5 Me too status FDA : Geodon Approved with
1.MindSet 2.Routine confirmed. (Pfizer) change in applied
2.Capsules 3. Rs. brand name.
3.Each 1500/14’s Reference will be
Capsule 4.28/09/2010 sent to B & A
contains: Dy. No. 1741 Division, DRAP for
Ziprasidone… Rs. 8000/- verification of
…….40mg (Original) photocopy of fee
4.Atypical 21-5-2013 challan. If
Anti- Rs.12,000/- confirmed, then
Psychotropic (Photo copy) Chairman, RB will
Agent permit issuance of
136. -do- 1.Form5 Ziprox of Nabi FDA : Geodon Approved with
1.MindSet 2.Routine qasim (Pfizer) change in applied
2.Capsules 3. Rs. brand name.
3.Each 2100/14’s Reference will be
Capsule 4.28/09/2010 sent to B & A
contains: Dy. No. 1740 Division, DRAP for
Ziprasidone Rs. 8000/- verification of
……….60mg (Original) photocopy of fee
4.Atypical 21-5-2013 challan. If
Anti- Rs.12,000/- confirmed, then
Psychotropic (Photo copy) Chairman, RB will
Agent permit issuance of
137. -do- 1.MindSet 1.Form5 Me too status FDA : Geodon Approved with
2.Capsules 2.Routine confirmed (Pfizer) change in applied
3.Each 3. Rs. brand name.

Capsule 2800/14’s Reference will be
contains: 4.28/09/2010 sent to B & A
Ziprasidone… Dy. No. 1739 Division, DRAP for
…….80mg Rs. 8000/- verification of
4.Atypical (Original) photocopy of fee
Anti- 21-5-2013 challan. If
Psychotropic Rs.12,000/- confirmed, then
Agent (Photo copy) Chairman, RB will
permit issuance of
138. M/s Macter 1.Amlotel 1.Form5 Me too confirmed FDA: Generic Approved.
International Ltd. 2.Tablet 2.Routine (TORRENT Reference will be
F-216, SITE, 3.Each tablet 3.14’s / As PHARMS LTD) sent to B & A
Karachi contains: per PRC Division, DRAP for
Telmisartan… 4.22/09/2010 verification of
…………….4 Dy. No. 1709 photocopy of fee
0mg Rs. 8000/- challan. If
Amlodipine… (Original) confirmed, then
…………..…. 22-5-2013 Chairman, RB will
5mg Rs.12,000/- permit issuance of
4.antihyperten (Not registration letter.
sive attached)
139. -do- 1.Amlotel 1.Form5 Me too confirmed FDA: Generic Approved.
2.Tablet 2.Routine (TORRENT Reference will be
3.Each tablet 3.14’s / As PHARMS LTD) sent to B & A
contains: per PRC Division, DRAP for
…………..…. 22-5-2013 Chairman, RB will
sive attached)
140. -do- 1.Amlotel 1.Form5 Me too confirmed FDA: Generic Approved.
2.Tablet 2.Routine (TORRENT Reference will be
…….40mg Dy. No. 1710 photocopy of fee
Amlodipine… Rs. 8000/- challan. If
………10mg (Original) confirmed, then
4.antihyperten 22-5-2013 Chairman, RB will
sive Rs.12,000/- permit issuance of
(Not registration letter.
attached)
141. -do- 1.Amlotel 1.Form5 Me too status FDA: Generic Approved.
2.Tablet 2.Routine confirmed (TORRENT Reference will be

…………..…. 22-5-2013 Chairman, RB will
sive attached)
142. -do- 1.Prophed 1.Form5 Rovinac of Rock Int. avail not Deferred for
2.Suspension 2.Routine pharmaceutical confirmed in Str confirmation of
3.Each 5ml 3. 60ml/As DRAs. approval in reference
contains: per PRC Stringent Regulatory
Ibuprofen.100 4.22/09/2010 Psychotropic Agencies.
mg Dy. No. 1711 precursor Reference will be
Pseudoephedri Rs. 8000/- sent to B & A
ne (Original) (For Division, DRAP for
HCI……15mg 22-5-2013 Psychotropic verification of
4.Pain reliever Rs.12,000/- Precursors, photocopy of fee
/fever reducer (Not there is no challan.
nasal attached) requirement
decongestant) for dedicated /
separate
manufacturing
facility)
143. M/s Nabiqasim 1.Qutex 1.Form5 Me too status FDA: Generic Approved.
Industries Pvt 2.Tablet 2.Routine confirmed (DR. REDDYS Reference will be
Ltd. 17/24, 3.Each film 3. 10’s, 30’s/ LABS LTD) sent to B & A
Korangi coated tablet As per PRC Division, DRAP for
industrial Area, contains: 4.16/09/2010 verification of
Karachi. Quetiapine Dy. No. 1699 photocopy of fee
fumarate eq to Rs. 8000/- challan. If
quetiapine.100 (Original) confirmed, then
mg 14-5-2013 Chairman, RB will
4.anti Rs.12,000/- permit issuance of
psychotic, (Photo copy) registration letter.
dibenzothiaze
pine)
Specs:
NabiQasim
144. -do- 1.Bepcor 1.Form5D 1. It is a me too FDA: Tracleer Approved.
2.Tablet 2.Routine 2. At the time of Reference will be
3.Each film 3. Rs. filing application, sent to B & A
coated tablet 30,000/10’s the drug was new. Division, DRAP for
contains: 4.16/09/2010 The firm submitted verification of
Bosentan (as Dy. No. 1690 Form 5-D with fee photocopy of fee
monohydrate) Rs. 15000/- Rs. 15,000/-. Now challan. If
…………...12 (Original) the drug has confirmed, then
5mg 14-5-2013 become registered. Chairman, RB will

4.Pulmonary Rs.5000/- The firm has permit issuance of
arterial (Photo copy) submitted the from registration letter.
hypertension) 5.
(PAH),
systemic
sclerosis with
ongoing
digital ulcer
disease
Specs:
NabiQasim
145. -do- 1.Qrist 1. Form 5 1.Me too status FDA : Khedezla Approved.
2.Tablets 2.Routine confirmed Reference will be
3.Each 3. 10’s, 14’s, Denla XR sent to B & A
extended / 50mg&100mg of Division, DRAP for
release tablet As per PRC M/s Semos verification of
contains: 4.16/09/2010 Pharma, photocopy of fee
Desvenlafaxin Dy. No. 1689 (Reg.No.070433&0 challan. If
e succinate eq Rs. 8000/- 70434) confirmed, then
to (Original) 2.The firm has Chairman, RB will
desvenlafaxine 14-5-2013 submitted the permit issuance of
……….50mg Rs.12,000/- undertaking registration letter.
4.Antidepressa (Photo copy) regarding
nt submission of
Specs: comparative
NabiQasim dissolution profile
before marketing of
the product
146. -do- 1.Qrist 1. Form 5 1.Me too status FDA: Kheedezla Approved.
2.Tablets 2.Routine confirmed Reference will be
3.Each 3. Denla XR sent to B & A
extended 10’s,14’s/As 50mg&100mg of Division, DRAP for
release tablet per PRC M/s Semos verification of
contains: 4.16/09/2010 Pharma, photocopy of fee
Desvenlafaxin Dy. No. 1693 (Reg.No.070433&0 challan. If
e succinate eq Rs. 8000/- 70434) confirmed, then
to (Original) 2.The firm has Chairman, RB will
desvenlafaxine 14-5-2013 submitted the permit issuance of
………..….10 Rs.12,000/- undertaking registration letter.
0mg (Photo copy) regarding
4.antidepressa submission of
nt comparative
Specs: dissolution profile
NabiQasim before marketing of
the product
147. -do- 1.Qutex 1. Form 5 Me too status FDA: Seroquel Approved.
2.Tablet 2.Routine confirmed Reference will be
3.Each film 3. sent to B & A
coated tablet 10’s,30’s/As Division, DRAP for

contains: per PRC verification of
Quetiapine 4.16/09/2010 photocopy of fee
fumarate eq to Dy. No. 1698 challan. If
quetiapine..25 Rs. 8000/- confirmed, then
mg (Original) Chairman, RB will
4.anti 14-5-2013 permit issuance of
psychotic, Rs.12,000/- registration letter.
dibenzothiaze (Photo copy)
pine
Specs:
NabiQasim
148. -do- 1. Form 5 Me too status FDA: Seroquel Approved.
2.Routine confirmed Reference will be
3. 10’s, 30’s / sent to B & A
As per PRC Division, DRAP for
1.Qutex
4.16/09/2010 verification of
2.Tablet
Dy. No. 1695 photocopy of fee
3.Each film
Rs. 8000/- challan. If
coated tablet
(Original) confirmed, then
contains:
14-5-2013 Chairman, RB will
Quetiapine
Rs.12,000/- permit issuance of
fumarate eq to
(Photo copy) registration letter.
quetiapine.200
mg
4.anti
psychotic,
dibenzothiaze
pine
Specs:
NabiQasim
149. -do- 1.Bepcor 1. Form 5 1. It is a me too. FDA: Tracleer Approved.

2.Tablet 2.Routine Reference will be
3.Each film 3. Rs. 2. The firm has sent to B & A
coated tablet 19000/10’s now submitted Division, DRAP for
contains: 4.16/09/2010 form 5. verification of
Bosentan (as Dy. No. 1696 photocopy of fee
monohydrate) Rs. 15000/- challan. If
……..62.5mg (Original) confirmed, then
4.Pulmonary 14-5-2013 Chairman, RB will
arterial Rs.5000/- permit issuance of
hypertension (Photo copy) registration letter.
(PAH)
Specs:
NabiQasim

Registration-V
150. M/s Care 1.Sinocare 1.Form5 Reply has been FDA: Generic Deferred for
Pharmaceuticals, 2.Cream 2.Routine received. (Taro) confirmation of
8Km, Thokor 3.Each gm 3.Rs.50/15g steroidal section.
Raiwind Road, contains: m,
Lahore Fluocinolone Rs.90/30gm
acetonide..2.5 4.30-09-2010
mg Dy.No.4032
4.Corticosteroi Rs.8000/-
d Rs.12,000/-
13-5-2013
151. -do- 1.Fusidcare 1.Form5 Reply is still BNF: Fucidin Last reminder will be
2.Cream 2.Routine awaited. (Leo) issued to the firm for
3.Each gm 3.Rs.65/5gn, The firm was rectification opf
contains: Rs.165/15gm communicated shortcomings.
Fusidic Acid 4.30-09-2010 twice. They have
(2%)…….20 Dy.No.4033 stated that they are
mg Rs.8000/- no more interested
4.Antibacterial 15-05-2013 in the product
Rs.12,000/- registration.
152. -do- 1.Clomezole 1.Form5 Reply is still FDA: Generic Last reminder will be
2.Cream 2.Routine awaited. (Taro) issued to the firm for
3.Each gm 3. The firm was rectification opf
contains: Rs.41/10gn, communicated shortcomings.
Clotrimazole Rs.70/20gm twice. They have
………….10 4.30-09-2010 stated that they are
mg Dy.No.4029 no more interested
4.Antifungal Rs.8000/- in the product
15-05-2013 registration.
Rs.12,000/-
153. M/s CCL 1.Cip 1.Form5 FDA: Cipro Deferred for review
Pharmaceuticals, 2.Suspension 2.Routine (Different of formulation by
Pvt. Ltd. 3.Each 5ml 3.60ml/ Price formulation) Review Committee.
62-Industrial contains: not
Estate, Kot Ciprofloxacin mentioned The originator’s
Lakhpat, Lahore hydrochloride 4.06-09-2010 (M/s Bayer)
eq. to Rs.8000/- formulation
ciprofloxacin (Photo copy) contains
…..................1 20-05-2013 ciprofloxacin in
25mg 20-05-2013 base form,
4.Antibiotic. Rs.12,000/- however the
(Original) firm has
submitted that a
number of
products in

Pakistan are
registered in
which
ciprofloxacin is
present in HCl
form. The firm
has also
provided
labeling and
outer packaging
of Novidate
(product of Sami
pharmaceuticals,
Karachi) which
confirms the
stance of the
firm.
154. M/s Schazoo 1.Cavrex 1.Form5 Tacavair of M/s FDA: Baraclude Approved.
Pharmaceuticals 2.Tablet 2.Routine Consolidated
Laboraories Pvt. 3.Each film 3.Rs.15,000/ chemical Lab. Me too status
Ltd. Kaolawala coated tablet 30’s confirmed
Stop, 20, KM contains: 4.24-09-2010
Jaranwala Road, Entecavir as Rs.8000/-
District monohydrate (Original)
Shehikhupura. (M.S)……1 28-05-2013
mg Rs.12,000/-
4.Anti viral. (Original)
155. -do- 1.Ceretek 1.Form5 FDA: Generic Deferred for

2.Injection 2.Routine (Sagent Pharms) confirmation of
3.Each 1ml 3.Rs.300/(2x Me too status installation and
contains: 5) 1ml confirmed
operational
Haloperidol as Ampoule
lactate…5mg 4.24-09-2010 qualification of TOC
4.Anti Rs.8000/- analyser & Liquid
Psychotic (Original) Particle Counter by
28-05-2013 area FID.
Rs.12,000/-
(Original)
156. -do- 1.Ceretek 1.Form5D 1. It is new drug. FDA: Generic Deferred for
2.Tablet 2.Routine 2. Differential fee (Sandoz) submission of
3.Each tablet 3.Rs.300/3x1 of Rs. 30,000/- is differential fee,
contains: 0’s required to be The firm has assessment of
Haloperidol 4.24-09-2010 deposited by the been asked for stability studies &
Usp……….20 Rs.8000/- applicant. submission of opinion by the
mg (Original) fee. Her experts.
4. Anti 28-05-2013 responses still
Psychotic Rs.12,000/- awaited.
(Original)

Registration – II
157. M/s Genix Diphos Dry 1.Form5 Me too confirmed Int. avail not Deferred for views
Pharma (Pvt.) Suspension 2.Routine confirmed in of recommendations
Ltd; Each 5ml 3. 30 ml Rs. Stringent DRAs. of WHO.
44, 45-B,
contains: 250/-
Korangi Creek The firm has
Road, Dihydroartemi 60 ml Rs. submitted
Karachi sinin………15 500/- reference of Me
mg 80 ml Rs. too as Poart
Piperaquine 667/- susp. of Neutro
Phosphate… 4.14-09-2010 pharma (62770)
…...…120mg 5.Dy. No.72
Rs.8,000/-
Rs.12,000/-
21-05-2013
158. -do- Diphos DS 1.Form5 1. Me too status Int. avail not Deferred for views
Sachet 2. Routine needs confirmation confirmed in Str of recommendations
30/240mg 3. per sachet DRAs. of WHO.
Each Sachet Rs. 45/-
contains: 10’s Rs.450/-
Dihydroartemi 16’s Rs.
sinin 720/-
(Ph.I)….30mg 4.14-09-2010
Piperaquine 5.Dy. No.64
Phosphate Rs.8,000/-
Anhydrous… Rs.12,000/-
….….. 240mg (21-5-2013)
159. -do- 1.Diphos 1.Form5-D 1. Me too status Int. avail not Deferred for views
2. Syrup 2. Routine needs confirmation confirmed in Str of recommendations
3.Each 5ml 3. 30 ml Rs. DRAs. of WHO.
contains: 250/-
Dihydroartemi 60 ml Rs.
sinin……..15 500/-
mg 80 ml Rs.
Piperaquin 667/-
Phosphate 4.14-09-2010
………120mg Dy. No.73
4.Anti Rs.8,000/-
Malarial Rs.12,000/-
(21-5-2013)

160. -do- 1.Diapil 1.Form5D Gliplyza 5mg FDA: Onglyza Approved
2.Tabs 2.Routine Tablet, Regn
3.Each film 3. Rs. no.076316, M/s
Macter int, Karachi
coated tablet 4500/10’s
contains: Rs. 9000/20’s
Saxagliptin Rs.
HCl e.q to 13500/30’s
Saxagliptin… 4.14/09/2010
…….…5mg Dy. No. 1684
4.Anti Diabetc Rs. 15000/-
Rs.12,000/-
21-5-2013
161. -do- 1.Diapil 1.Form5D Gliplyza 2.5mg FDA: Onglyza Approved
2.Tablet 2.Routine Tablet, Regn
3.Each film 3. Rs. no.076316, M/s
Macter int,
coated tablet 2500/10’s
Karachi.
contains: Rs. 5000/20’s
Saxagliptin Rs. 7500/30’s
HCl e.q to 4.14/09/2010
Saxagliptin… Dy. No. 1681
……..……2.5 Rs. 15000/-
mg Rs.12,000/-
4. Anti 21-5-2013
Diabetc
162. -do- 1.Diphos DS 1.Form-5 D Me too status needs Int. avail not Deferred for views
2.Tablet 2.Routine confirmation. confirmed in Str of recommendations
3.Each Tablet 3. Rs.800/8’s DRAs. of WHO.
contains: 4.14/09/2010
Dihydroartemi Dy. No. 67
sinin (Moh)
(Ph.I)…….80 Rs. 8000/-
mg Rs.12,000/-
Piperaquine 21-5-2013
Phosphate
(M.S) 640mg
4.Anti
Malarial

163. -do- 1.Diphos DS 1.Form-5 Me too status needs Int. avail not Deferred for views
2.Suspension 2.Routine confirmation. confirmed in Str of recommendations
3.Each 5ml 3. Rs. DRAs. of WHO.
contains: 450/10’s
Dihydroartemi Rs. 720/16’s
sinin 4.16/09/2010
(PhI)….30mg Dy. No. 69
Piperaquine (Moh)
Phosphate Rs. 8000/-
Anhydrous… Rs.12,000/-
……..…240m 21-5-2013
g
4.Anti
Malarial
164. M/s Noa Hemis Loxicam 4mg Form-5 The formulation Approved (as found
Pharmaceuticals, Tablet found to be EMA approved by EMA).
Plot No. 154, 30-7-2010 approved but Reference will be sent
Sector-23, Korangi Each film coated appeared as not to B & A Division,
tablet contains: Dy.No.1507
Industrial Area, confirmed in the DRAP for verification
Karachi-74900 Lornoxicam Rs.8000/-+Rs. agenda erroneously. of photocopy of fee
…………4 mg 12000/- (10-05- challan. If confirmed,
13) Xefast (Pharmevo) then Chairman, RB
(NSAID) Good (09-06-2014) will permit issuance of
Rs.1200/-/10’s registration letter.
(Manufacturer’s 2. Verification of
Spec.s) photocopy of fee
of Rs. 8000/- is
required.
3. International
availability in
stringent DRA,s
not confirmed.
165. -do- Loxicam-DS 8mg Form-5 The formulation Approved (as found
Tablet found to be EMA approved by EMA).
30-7-2010 approved but Reference will be sent
Each film coated appeared as not to B & A Division,
tablet contains: Dy.No.1505
confirmed in the DRAP for verification
Lornoxicam Rs.8000/- agenda erroneously. of photocopy of fee
…………8 mg challan. If confirmed,
+Rs. 12000/- Xefast (Pharmevo) then Chairman, RB
will permit issuance of

(NSAID) (10-05-13) Good (09-06-2014) registration letter.
(Manufacturer’s Rs.2300/-/10’s 1. Verification of

of Rs. 8000/- is
required.
2. International
availability in
stringent DRA,s
not confirmed.
166. -do- Resipa 1mg Tablet Form-5 BNF : Risperdal Approved. Reference
will be sent to B & A
Each film coated 30-7-2010 (Janssen) Division, DRAP for
tablet contains: verification of
Dy.No.1500 Risperdal
Risperidone …1 photocopy of fee
mg Rs.8000/-+Rs. (Janssen) challan. If confirmed,
12000/- (14-05- then Chairman, RB
(Antipsychotic) 13) Good (09-06-2014) will permit issuance of
(Manufacturer’s As per PRC 1. Verification of
of Rs. 8000/- is
required.
167. -do- Resipa 2mg Tablet Form-5 BNF : Risperdal Approved Reference
Risperidone…2 mg photocopy of fee
Rs.8000/-+Rs. (Janssen) challan. If confirmed,
(Antipsychotic) 12000/- (14-05- then Chairman, RB
13) will permit issuance of
(Manufacturer’s Good (09-06-2014) registration letter.
Spec.s) As per PRC
1. Verification of
photocopy of fee
of Rs. 8000/- is
required.
168. -do- Resipa 3mg Tablet Form-5 BNF : Risperdal Approved Reference
Risperidone ...3 mg photocopy of fee
Rs.8000/-+Rs. challan. If confirmed,

(Antipsychotic) 12000/- (14-05- (Janssen) then Chairman, RB
13) will permit issuance of
(Manufacturer’s Good (09-06-2014) registration letter.
Spec.s) As per PRC
1. Verification of
photocopy of fee
of Rs. 8000/- is
required.
169. -do- Gasiton 50mg Form-5 Not confirmed Deferred for review
Tablet of formulation by
30-7-2010 GANATON Review Committee.
Each tablet (ABBOTT)
contains: Dy.No.1508
Good (09-06-2014)
Itopride Rs.8000/-+Rs.
Hydrochloride…… 12000/- (10-05- 1. Verification of
13) photocopy of fee
…….50 mg
of Rs. 8000/- is
(Gastroprokinetic) As per PRC required.
2. International
(Manufacturer’s availability in
Spec.s) stringent DRA,s
not confirmed.
3. Formulation is
under review by
the review
committee.
170. -do- Etecav 0.5 mg Form-5 BNF : Baraclude Deferred for product
Tablet (Bristol-Myers specific inspection by
30-7-2010 Squibb) panel comprising of
Each film coated Director DTL Karachi,
tablet contains: Dy.No.1506 Centauru S DDG (E & M) & area
(Ferozsons) FID.
Entecavir (as Rs.8000/-+Rs.
monohydrate)…… 12000/- (10-05-
13) Good (09-06-2014)
……...0.5 mg
As per PRC 1. Verification of
(Anti Viral)
photocopy of fee
(Manufacturer’s of Rs. 8000/- is
Spec.s) required.
2. Amount of active
drug is very less
(500mcg), may be
considered for
Product specific

inspection.
171. -do- Proxat 20mg Tablet Form-5 BNF : Seroxat (GSK) Approved. Reference
Each film coated 30-7-2010 Seroxat (GSK) Division, DRAP for
Dy.No.1504
Paroxetine (as Good (09-06-2014) photocopy of fee
HCl)…..…20 mg Rs.8000/-+Rs. challan. If confirmed,
12000/- (10-05- 1. Verification of then Chairman, RB
(Antidepressant, 13) photocopy of fee will permit issuance of
selective serotonin of Rs. 8000/- is registration letter.
reuptake inhibitor) As per PRC required.
(B.P Spec.s)
172. -do- Muscolex 4mg Form-5 Not confirmed Deferred for review of
Capsule formulation by
30-7-2010 Muscoril (Searle) Review Committee.
Each capsule
contains: Dy.No.1502
Good (09-06-2014)
Thiocolchicoside… Rs.8000/-+Rs.
…..4 mg 12000/- (10-05- 1. Verification of
13) photocopy of fee
(Muscle relaxant) of Rs. 8000/- is
As per PRC required.
(Manufacturer’s 2. International
Spec.s) availability in
stringent DRA,s
not confirmed.
3. Formulation is
under review by
the review
committee.
173. -do- Gabagyl 200mg Form-5 Gebapentin in 200mg Deferred for
Capsule strength Not found in confirmation of
30-7-2010 FDA & UK approval in reference
Each capsule Stringeny Regulatory
contains: Dy.No.1510 Gabin of PharmEvo Agencies.
Gabapentin……… Rs.8000/-+Rs.
……...200 mg 12000/- (10-05- Good (09-06-2014)
13)
(Anticonvulsant) 1. Verification of
As per PRC photocopy of fee
(Manufacturer’s of Rs. 8000/- is

Spec.s) required.
2. International
availability in
stringent DRA,s
not confirmed.
174. -do- Zofen 0.25mg/5ml Form-5 BNF : Sanomigran Rejected on the
Syrup (Novartis) grounds that the
30-7-2010 applicant applied the
Each 5ml contains: Not confirmed formulation for wrong
Dy.No.1501
Pizotifen( as pharmacological
Good (09-06-2014)
Hydrogen Rs.8000/-+Rs. indication.
Maleate)………… 12000/- (10-05- 1. Verification of
………………..0.2 13) photocopy of fee
5 mg of Rs. 8000/- is
As per PRC required.
(Appetite 2. The firm has
stimulant) applied the
formulation as
(Manufacturer’s appetite stimulant
Spec.s) which is not
rational.

2. Veterinary applications
S/N Name of Name of Drug(s) / Price/Pack Shelf Life Date of Decision

Applicant Composition Size application
receiving.
175. M/s. Nawan Pameron Injection Decontrolled 2 years 24-12-2010 Deferred for confirmation
Laboratories 10ml of installation and
(Pvt) Ltd., Each ml contains:- 50ml Rs.8000 + Rs. operational qualification of
Karachi. 100ml 12000 = TOC analyser and Liquid
Methampyrone… Particla Counter, Me-too
…………100mg Rs.20,000/- status & GMP status of the
Chlorpheniramine firm.
Maleate…..1mg
Caffeine……10mg
(Antipyretic and
Analgesic).
176. M/s. Mallard Shina Gold Drench Decontrolled 2 years 15-12-2010 Deferred for name change,
Pharmaceutic Me-too & GMP status of
als (Pvt) Ltd., Each ml contains:- 100ml Rs.8000 + Rs. the firm.
Multan. 12000 =
Oxyclozanide…… 250ml
….…..62.50mg Rs.20,000/-
500ml
Oxfendazole……
…….…25mg 1000ml
Cobalt 2.5 Liter

Sulphate…..2mg
Sodium
Selenite……0.5mg
(Anthelmentic).
177. M/s. Mallard Shinazan Plus Decontrolled 2 years 15-12-2010 Deferred for name change,
Pharmaceutic Drench Me-too & GMP status of
als (Pvt) Ltd., 100ml Rs.8000 + Rs. the firm.
Multan. Each ml contains:- 12000 =
150ml
Oxyclozanide…… Rs.20,000/-
……...30mg 250ml
Levamisole 500ml

HCI………...15mg 1000ml
Cobalt 2.5 Liter

Sulphate………....
0.75mg
Sodium
Selenite……..…..0
.35mg
Vitamin
K……………....3
mg
(Anthelmentic).
178. M/s. Mallard Shina Fax Liquid Decontrolled 2 years 15-12-2010 Deferred for name change,
Pharmaceutic Me-too & GMP status of
als (Pvt) Ltd., Each ml contains:- 100ml Rs.8000 + Rs. the firm.
Multan. 12000 =
Oxfendazole…… 250ml
…..22.65mg Rs.20,000/-
450ml
Zinc
Sulphate………2.6 500ml
mg
1000ml
(Anthelmentic).
2.5 Liter
179. M/s. Mallard Shina Zole 12.5% Decontrolled 2 years 15-12-2010 Deferred for name change,
Pharmaceutic SC Liquid Me-too & GMP status of
als (Pvt) Ltd., 30ml Rs.8000 + Rs. the firm.
Multan. Each ml contains:- 12000 =
100ml
Albendazole…… Rs.20,000/-
………..125mg 250ml
Sodium Selenite 500ml

………..1.67mg
1000ml
Cobalt
Sulphate………… 2.5 Liter
0.50mg
(Anthelmentic).

180. M/s. Sanna Sanoxicam Decontrolled 2 years 30-12-2010 Deferred for Me-too &
Laboratories, Injection 10ml GMP status of the firm.
Faisalabad. 30ml Rs.8000 + Rs.
Each ml contains:- 50ml 12000 =
100ml
Meloxicam...7.5mg Rs.20,000/-
(Analgesic).
181. M/s. Sanna SCS-Forte Decontrolled 2 years 30-12-2010 Deferred for Me-too &
Laboratories, Injection 50ml GMP status of the firm.
Faisalabad. Each ml contains:- 100ml Rs.8000 + Rs.
Colistin 12000 =
Sulphate……...1
MIU Rs.20,000/-
(Polymyxin
Antibiotic).
182. M/s. Sanna Sanacol-50 Water Decontrolled 2 years 30-12-2010 Deferred for Me-too &
Laboratories, Soluble Powder 100gm GMP status of the firm.
Faisalabad. Each gram 300gm Rs.8000 + Rs.
contains:- 500gm 12000 =
Colistin 1 Kg
Sulphate…….50,0 Rs.20,000/-
0,000 IU
(Polymyxin
Antibiotic).
183. M/s. Sanna ECS-150 Oral Decontrolled 2 years 30-12-2010 Deferred for Me-too &
Laboratories, Liquid 100ml GMP status of the firm.
Faisalabad. Each 100ml 500ml Rs.8000 + Rs.
contains:- 1 Liter 12000 =
Enrofloxacin
…………10gm Rs.20,000/-
Colistin
Sulphate…50,000,
000 IU
(Antibiotic).

Evaluator – I
S. N Name and Brand Name Type of Form International Remarks / Decision

address of (Proprietary status in Observations
Manufacturer / name + Dosage Initial date, stringent
Applicant form + Strength) diary. regulatory
agencies
differential fee Me-too status
Pharmacological
Group Demanded GMP status as
Price / Pack depicted in
Finished product size inspection
specification report (dated)
184. M/s Ray Pharma Raylox Tablet Form 5 LEVAQUIN Approved.

(Pvt.) Ltd, S-58, 750mg Film
S.I.T.E. Film Coated 10’s /Rs.299/- coated tablet
Extension Tablet US FDA
Hawksbay Dy. No. Not
Road, Karachi Each Film Coated mentioned LEFLOX
Tablet Contains. (Duplicate 750mg
Dossier) Getz
Levofloxacin as Dossier dated
Hemihydrate Inspection report
29-06-2010 dated 06/05/2014
..........750mg Rs.8000/- (17- good level of
(Quinolone group 05-2010) GMP compliance
reported.
Antibacterial)
Dy. No. Not
Manufacturers mentioned
Specifications Rs.12,000/-
dated 26-09-
2013 (Fee
challans are
duplicate)
Total
Rs.20,000/-
185. M/s Ray Pharma Rayart DS Tablet Form 5 ARTHEGET Approved

(Pvt.) Ltd, S-58, 40/240mg tablet
S.I.T.E. Tablet 8’s /Rs.264/- Getz
Extension
Hawksbay Each Tablet Dy. No. Not
Road, Karachi Contains. mentioned Inspection report
(Duplicate dated 06/05/2014
good level of

Artemether Dossier) GMP compliance
……….40mg Dossier dated reported.
Lumefantrine…… 29-06-2010
.240mg Rs.8000/- (17-
05-2010)
(Anti Malarial) Dy. No. Not

Specifications Rs.12,000/-
dated 26-09-
2013 (Fee
challans are
duplicate)
Total
Rs.20,000/-
186. M/s Ray Pharma Rayart Tablet Form 5 ARTHEGET Approved.

(Pvt.) Ltd, S-58, 80/480mg tablet
S.I.T.E. Tablet 4’s /Rs.220/- Getz
Extension
Hawksbay Each Tablet Dy. No. Not Inspection report
Road, Karachi Contains. mentioned dated 06/05/2014
(Duplicate good level of
Artemether Dossier) GMP compliance
……….80mg reported.
Dossier dated
Lumefantrine…… 19-07-2010
.480mg Rs.8000/- (17-
(Anti Malarial) 05-2010)
Dy. No. Not

mentioned
Manufacturers Rs.12,000/-
Specifications dated 26-09-
2013 (Fee
challans are
duplicate)
Total
Rs.20,000/-
187. M/s Ray Pharma Rayaz Tablet Form 5 ZITHROMAX Approved.

(Pvt.) Ltd, S-58, 3’s /Rs.160/- 500mg tablets
S.I.T.E. Dy. No. Not US FDA

Extension Tablet mentioned
Hawksbay (Duplicate AZOMAX
Road, Karachi Each Film Coated Dossier) 500mg tablet
Tablet Contains. Novartis
Dossier dated
Azithromycin as 29-06-2010 Inspection report
dihydrate Rs.8000/- (17- dated 06/05/2014
…………………. 05-2010) good level of
Dy. No. Not GMP compliance
500mg
mentioned reported.
(Macrolide Rs.12,000/-
Antibiotic) dated 26-09-
2013 (Fee
Manufacturers challans are
Specifications duplicate)
Total
Rs.20,000/-
188. M/s Macter Micam Form 5 VICTRA Approved.

International 4mg tablet
(Pvt.) Ltd. F- Tablet 5’s and 10’s/As Scitech
216, S.I.T.E., Per PRC
Karachi Each film coated Lornoxicam
tablet Contains:- Dy No 255 R&I 4mg f/c tablet
dated 23-07- EMA
Lornoxicam 2010 Rs.8000/-
…..4mg Inspection report
Rs.12,000/- dated 10-04-2014
(Analgesic and 22-05-2013 considered to be
anti- operating at
inflammatory) satisfactory level
of GMP.
Capsule section
mentioned in
inspection report.
189. M/s Bosch Falgan Form 5-D PERFALGAN 1. Copy of Deferred for
Pharmaceutical, 500mg/50ml 10mg/ml (50ml cashiers’ cheque rectification of
221, Bosch 1,s /Rs.60/- Vial) amounting to following
House, Sector MHRA 168,000/- (Rs. shortcomings
Infusion
Dy in the dossier:
23, Korangi 12,000/- each for
1. Copy of
Industrial Area, Each Vial No.1386/R&I Injectable Liquid 14 products,
cashiers’
Karachi. Contains. dated 22-07- section granted including Falgan
cheque
2010/ vide letter No. F. 500mg/50ml).
amounting to
Paracetamol 2-4/91-Lic (Vol- However, the
Rs.15,000/- 168,000/-
….(B.P) II) (M-196). cheque or the
(Rs. 12,000/-
500mg/50ml covering is not
each for 14
Routine GMP endorsed by STO

Copy of cashiers inspection report and is also not the products,
cheque dated 12-08-2014 prescribed fee for including
(Analgesics and cGMP level rated Form-5D Falgan
amounting to
Antipyretics) as good. applications. 500mg/50ml)
168,000/- (Rs.
2. Pyrogen free . The cheque
(Manufacturer’s 12,000/- each distilled water has or the
Specs) for 14 products, been mentioned in covering is
including Falgan the master not endorsed
500mg/50ml). formulation by STO and
However, the whereas, the is also not the
cheque or the reference brand prescribed
contains WFI for fee for Form-
covering is not
which evidence of 5D
endorsed by TOC analyzer and applications.
STO and is also liquid particle 2. Pyrogen
not the counter is required. free distilled
prescribed fee However, firm has water has
for Form-5D provided copies of been
applications. operator’s manual mentioned in
of particle counter the master
only, as evidence. formulation
3. Stability whereas, the
summary at 30 C reference
and 65% RH for brand
only one batch of contains WFI
3,000/- vials for which
submitted. evidence of
TOC
analyzer and
liquid
particle
counter is
required.
However,
firm has
provided
copies of
operator’s
manual of
particle
counter only,
as evidence.
Confirmation
from FID is
required for
the
Installational
& Operation
Qualification

of liquid
particle
counter &
TOC
analyzer.
3. Stability
summary at
30 C and
65% RH for
only one
batch of
3,000/- vials
submitted.
Which is
required to be
as per WHO
guidelines.
190. M/s Pakistan Pioglit 15mg + Form 5 Glibetic Evidence of Deferred for
Pharmaceutical 2mg Tablet 15/2mg approval of same confirmation
Products (Pvt) Dy. No. Not ICI formulation by of approval
Ltd. D-122, Tablet mentioned / R&I stringent regulatory in reference
Sindh Industrial date not authority e.g., Stringent
Trading Estate, Each Tablet mentioned Inspection report FDA, TGA, Regulatory
Karachi Contains. dated 13-02-2013 MHLW, EMA and Agencies.
(Covering letter
and 03-06-2014 Health Canada
Pioglitazone.. dated considered to be required.
…..…. 15mg 07/07/2010) operating at
Rs.8000/- satisfactory level
Glimepiride.. (19/07/2010) of GMP.
…….. 2mg Rs.12,000/-
(15/05/2013) fee
(Anti- challans are
Hyperglycemic) duplicate
Total
Rs.20,000/-
14’s / Rs. 10 per

tablet
191. M/s Pakistan Glitter 4mg Tablet Form 5 Amaryl Approved.

Pharmaceutical MHRA
Products (Pvt) Tablet Dy. No Not
Ltd. D-122, mentioned / R&I Amaryl
Sindh Industrial Each Tablet dated not Sanofi-Aventis
Trading Estate, Contains. mentioned
Karachi
Glimepiride …….. (Covering letter
Inspection report

4mg dated dated 13-02-2013
20/07/2010) and 03-06-2014
(Anti- considered to be
Hyperglycemic) operating at
Rs.8000/-
satisfactory level
(22/07/2010) of GMP.
Rs.12,000/-
(15/05/2013)
fee challans are
duplicate
Total
Rs.20,000/-
20’s As per PRC

Pharmaceutical MHRA
Products (Pvt) Tablet Dy. No. Not
Karachi
Glimepiride …….. (Dossier dated
3mg 20/07/2010) Inspection report
dated 13-02-2013
(Anti- Rs.8000/- and 03-06-2014
Hyperglycemic) (22/07/2010) considered to be
Rs.12,000/- operating at
satisfactory level
(15/05/2013)
of GMP.
fee challans are
duplicate
Total
Rs.20,000/-
20’s / As per
PRC

Pharmaceutical MHRA
Karachi
Inspection report
2mg 20/07/2010) dated 13-02-2013
and 03-06-2014

(Anti- Rs.8000/- considered to be
Hyperglycemic) (22/07/2010) operating at
Rs.12,000/- satisfactory level
of GMP.
(15/05/2013)
fee challans are
duplicate
Total
Rs.20,000/-
20’s / As per
PRC

Pharmaceutical MHRA
Karachi Inspection report
dated 13-02-2013
1mg 20/07/2010) and 03-06-2014
considered to be
(Anti- Rs.8000/- operating at
Hyperglycemic) (22/07/2010) satisfactory level
Rs.12,000/- of GMP.
(15/05/2013)
fee challans are
duplicate
Total
Rs.20,000/-
20’s / As per
PRC

6. Routine drug registration applications
Evaluator – II
S.No Name and Brand Name Type of Form Remarks on the Decision
manufacturer / Dosage Form + Strength) Initial date, diary including
Applicant International status in
Composition Fee including stringent drug
differential fee regulatory agencies /
Pharmacological Group authorities
Demanded Price /
Finished product Pack size Me-too status
Specification
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
195. M/s Macter Affient 5mg Tablet Form 5 BNF: Efient(Lilly) Approved.
International Each film coated tablet Reference will
(Pvt) Ltd. F-216, contains: 05‐7‐2010(54) Prasu (Amson) be sent to B &
S.I.T.E, Karachi. Prasugrel HCl eq. to Rs.15000/‐ A Division,
Prasugrel…………….5 22‐5‐2013 Satisfactory level of DRAP for
mg Rs.5,000/‐ GMP compliance. (10- verification of
(Inhibitor of platelet 04-14) photocopy of
activation and Rs. 8.42/Tab fee challan. If
aggregation) Rs. 118/14’s 1. Verification of confirmed,
(Manufacturer’s Spec.s) Rs.236/28’s then Chairman,
photocopy of
differential fee (Rs. RB will permit
issuance of
5000/-) paid is
registration
required. letter.
2. The Firm had
applied on Form 5-
D initially but has
now submitted
Form 5.
3. Approval of section
/ manufacturing
facility of applied
drug from licensing
section is required.
The Firm has
submitted GMP
insp. Report dated
10-04-14 which

mentions Tablet
(General) Section.
196. -do- Affient 10mg Tablet Form 5 BNF: Efient(Lilly) Approved.
Each film coated tablet Reference will
contains: 05‐7‐2010(46) Prasu (Amson) be sent to B &
Prasugrel HCl eq. to Rs.15000/‐ A Division,
Prasugrel…………….10 22‐5‐2013 Satisfactory level of DRAP for
mg Rs.5,000/‐ GMP compliance. (10- verification of
(Inhibitor of platelet 04-14) photocopy of
activation and Rs. 14/Tab fee challan. If
aggregation) Rs. 96/14’s 1. Verification of confirmed,
(Manufacturer’s Spec.s) Rs.392/28’s photocopy of then Chairman,
differential fee (Rs. RB will permit
5000/-) paid is issuance of
required. registration
2. The Firm had letter.
applied on Form 5-
D initially but has
now submitted
Form 5.
197. -do- Tamsyl Tablets Form 5 Not confirmed Deferred for
Each Tablet contains: confirmation
Etamsylate 05‐7‐2010(N/A) Not confirmed of me too
(B.P)….250mg Rs.15000/‐ status &
(Antifibrinolytic, synthetic 22‐5‐2013 Satisfactory level of approval in
antihaemorrhagic and Rs.5,000/‐ GMP compliance. (10- reference
angioprotective) 04-14) Stringent
(Manufacturer’s Spec.s) Rs. 7.5/Tab Regulatory
Rs. 75/10’s 1. Verification of Agencies.
Rs.150/20’s
photocopies of fee Reference will
(Rs. 15000/- + Rs. be sent to B &
A Division,
5000/-) paid is
DRAP for
required. verification of
2. The Firm had photocopy of
applied on Form 5- fee challan.
D initially but has
now submitted
Form 5.
3. International
availability not
confirmed in same
strength.
4. Me-too status given
as Dicynone of
French
Pharmaceuticals

Group (Reg. No.
004229) needs
confirmation.
198. -do- Tamsyl Tablets Form 5 BNF: Dicynene Deferred for
Each Tablet contains: (Sanofi-Aventis) confirmation
Etamsylate 05‐7‐2010(N/A) of me too
(B.P)….500mg Rs.15000/‐ Cytoplex of M/s AGP status.
(Antifibrinolytic, synthetic 22‐5‐2013 Reg. No. 061420 Reference will
antihaemorrhagic and Rs.5,000/‐ (Me too status appeared be sent to B &
angioprotective) in agenda as not A Division,
(Manufacturer’s Spec.s) Rs. 15/Tab confirmed erroneously) DRAP for
Rs. 150/10’s verification of
Rs.300/20’s Satisfactory level of photocopy of
GMP compliance. (10- fee challan.
04-14)
1. Verification of
photocopies of fee
(Rs. 15000/- + Rs.
5000/-) paid is
required.
2. The Firm had
applied on Form 5-
D initially but has
now submitted
Form 5.
199. -do- Valsitan Tablets Form 5 BNF: Exforge Approved.
Each film coated tablet (Novartis) Reference will
contains: 06‐7‐2010(N/A) be sent to B &
Amlodipine (as Rs.8000/‐ Exforge A Division,
besilate)…5mg 22‐5‐2013 (Novartis) DRAP for
Valsartan….160mg Rs.12,000/‐ verification of
(Calcium Antagonist) Satisfactory level of photocopy of
(Manufacturer’s Spec.s) AS per PRC GMP compliance. (10- fee challan. If
04-14) confirmed,
then Chairman,
1. Verification of RB will permit
photocopies of fee issuance of
(Rs. 8000/- + Rs. registration
letter.
12000/-) paid is
required.
200. -do- Valsitan Plus Tablets Form 5 BNF: Exforge Approved with
Each tablet contains: (Novartis) change in
Amlodipine (as 06‐7‐2010(N/A) brand name.
besilate)…10mg Rs.8000/‐ Exforge Reference wil
Valsartan….160mg 22‐5‐2013 (Novartis) be sent to B &
(Calcium Antagonist) Rs.12,000/‐

(Manufacturer’s Spec.s) A Division,
AS per PRC Satisfactory level of DRAP for
GMP compliance. (10- verification of
04-14) photocopy of
fee challan. If
1. Verification of confirmed,
photocopies of fee then Chairman,
(Rs. 8000/- + Rs. RB will permit
issuance of
12000/-) paid is
registration
required. letter.
201. -do- Alozin Tablets Form 5 FDA: Ranexa (Gilead) Approved.
Each film coated extended Reference will
release tablet 06‐7‐2010(N/A) Ranola (Highnoon) be sent to B &
contains: Rs.8000/‐ A Division,
Ranolazine…1000mg 22‐5‐2013 Satisfactory level of DRAP for
(anti‐ischemic And Rs.12,000/‐ GMP compliance. (10- verification of
antianginal) 04-14) photocopy of
(Manufacturer’s Spec.s) AS per PRC fee challan. If
1. Verification of confirmed,
photocopies of fee then Chairman,
(Rs. 8000/- + Rs. RB will permit
issuance of
12000/-) paid is
registration
required. letter.
202. -do- Tamsyl 2ml Injection Form 5-D Not confirmed Deferred for
Each 2ml ampoule confirmation
contains: 06‐7‐2010(N/A) Cytoplex of M/s AGP of followings:
Etamsylate……….250 mg Rs.15,000/‐ Reg. No. 061419 1. Installation
(Antifibrinolytic synthetic 22‐5‐2013 (Me too status appeared and
antihaemorrhagic and Rs.5,000/‐ in agenda as not performance
angioprotective) confirmed at that time) qualifications
(Manufacturer’s Spec.s) AS per PRC/4’s, of TOC
100’s Satisfactory level of analyser &
GMP compliance. (10- Liquid Particle
04-14) Counter by
area FID.
1. Verification of 2. Approval in
photocopies of fee reference
(Rs. 15000/- + Rs. Stringent
Regulatory
5000/-) paid is
Agencies.
required. Reference will
2. The Firm had be sent to B &
applied on Form 5- A Division,
D initially but has DRAP for
now submitted verification of
Form 5. photocopy of
fee challan.

3. Approval of section
/ manufacturing
facility of applied
drug from licensing
The Firm has
submitted GMP
insp. Report dated
10-04-14 which
mentions Sterile
Products (Liquid
injections,
Opthalmic/Otic
drops).
4. International
availability not
confirmed.
5. Verification of
Total Organic
Testing Facility is
required.
203. M/s. WelMark Rismek 3mg Tablets Form 5 BNF. Risperdal Approved.
Pharmaceuticals Each film coated tablet (Janssen)
Plot # 122, contains:- 12-07-2010 (17)
Risperidone(USP)….3mg Rs.8,000/ Benzisox (Highnoon)
Block-B, Phase-
(Antipsychotic) +Rs. 12000 (09-
V Industrial (USP Spec.s) No conclusion of
Estate Hattar. 05-2013)
inspection report,
recommendations of
As Per PRC
some corrections (24-
05-14 routine GMP
inspection)
The Board considered
the above inspection
report & satisfied with
the same.
204. -do- Welfam 40mg Tablets Form 5 BNF: Famotidine (Non- Approved in
Each tablet contains:- proprietary) uncoated
Famotidine (USP)…40mg 12-07-2010 (16) Tablets.
(H2 receptor Blocker, Rs.8,000/ Acicon (Barrett
Antipeptic ulcerate) +Rs. 12000 (09- Hodgson)
(USP Spec.s)
05-2013)

No conclusion of
As Per PRC/10’s inspection report,
recommendations of
some corrections (24-
05-14 routine GMP
inspection)
the same.
1. BNF describes the

product as uncoated
while the Firm has
applied for the film
coated formulation.
205. M/s Atco Combinol-D Sugar Free Form 5 Not confirmed Deferred for
Laboratories Syrup review of
Limited B-18, Each 5ml contains:- 06-07-2010 Combinol-D Syrup formulation by
Rs.8,000/ (N/A) (Atco Laboratories) Review
S.I.T.E, Karachi. Dextromethorphan
+Rs. 12000 (22- Committee.
Hydrobromide Good level of GMP
(B.P)…10mg 05-2013)
(18-06-2014)
Ephedrine Hydrochloride
(B.P)…7.5mg Rs. 38/- Per 120ml 1. Verification of
bottle photocopies of fee
Chlorphenamine Maleate
(B.P)…4mg (Rs. 8000/- + Rs.
Terpin Hydrate (USP)… 12000/-) paid is
3.5 mg required.
Ammonium Chloride 2. Approval of section
(B.P)…90mg / manufacturing
facility of applied
(Bronchodilator) drug from licensing
(Manufacturer’s Spec.s) section was asked.
The Firm has
submitted GMP
insp. Report dated
18-06-14 which
mentions Oral
Liquid
(Syrup/Suspension)
section Non
Antibiotic.
3. International

availability of
formulation in
SRA’s not
confirmed.
4. Formulation
contains Ephedrine
Hydrochloride, a
controlled drug
substance.
206. M/s Nenza NenKast 5mg Tablets Form 5 BNF: Singulair (MSD) Approved.
Pharmaceuticals, Each Chewable Tablet
33 A Industrial contains:- 16-07-2010 Montiget (Getz)
Estate Montulekast Sodium Rs.8,000/ (80)
+Rs. 12000 (23- No conclusion
Hayatabad Equivalent to regarding GMP of the
Peshawar Montelukast(B.P)…5mg 05-2013)
Firm, some minor
(Antiasthmatic) observations at which
(Manufacturer’s Spec.s) As Per SRO/- 14’s the management was
agreed to rectify.
(routine GMP 10-04-
2014)
the same.
207. -do- Nenmether DS Tablets Form 5 WHO approved Approved.
Each Tablet contains:- formulation
Artemether…40mg 16-07-2010
Rs.8,000/ (79) A-Fantrine 40/240 by
Lumefantrine…240mg
+Rs. 12000 (23- M/s Atco
(Antimalarial)
(USP Salmous Spec.s) 05-2013)
No conclusion
regarding GMP of the
As Per SRO/- 8’s Firm, some minor
observations at which
the management was
agreed to rectify.
(routine GMP 10-04-
2014)
the same.

208. M/s PharmEvo Evorox 1.5g Injection Form 5 BNF: Zinacef (GSK) Approved.
(Private Limited (Powder for reconstitution) 06-07-2010, Rs. Reference will
Plot #A-29, Each Vial contains:- 8000/- + Rs. Zecef (Bosch) be sent to B &
12,000 (22-05- A Division,
North West Cefuroxime Sodium
2013) Good, GMP compliance DRAP for
Industrial Zone, equivalent to Cefuroxime (01-04-14) Provincial verification of
Port Qasim, (USP) …1.5g As per PRC Drug Inspector. photocopy of
Karachi-75020 (Antibiotic) The firm later on fee challan. If
(USP Spec.s) submitted inspection confirmed,
report dated 20.03.2013 then Chairman,
conducted by DRAP. RB will permit
The Board considered issuance of
the above inspection registration
report & satisfied with letter.
the same.
1. Verification of
copies of fee
challans is required.
2. Evidence of
approval of
technical staff from
licensing section is
required.
(The firm
provided the
technical staff
approval but
missed
erroneously in
agenda).
3. Firm has submitted
inspection report of
provincial drug
inspector and has
informed that they
will submitt latest
inspection report of
FID when
inspection report
would be received.
209. M/s Maple Defrinac Plus Tablets Form 5-D Form 5-D Deferred for
Pharmaceuticals Each film coated tablet 01-07- last reminder
(Pvt.) Ltd., contains:- 2010(11)Rs.8,000/- for correction
Dexibuprofen Overall cGMP
147/23, Korangi +Rs. 12,000 (25- in form 5-D

Industrial Area, (M.S)…300mg 07-2013)+Rs. measures are followed alongwith
Karachi. Pseudoephidrine 30,000/- (01-12- in the Firm (31-03- stability
Hydrochloride(B.P)…60mg 2014) 2014) studies.
(NSAID+Decongestant)
Rs. As per PRC Reference will
(Manufacturer’s Spec.s) 1. The Firm had
/3×10’s be sent to B &
applied on Form 5,
A Division,
but after evaluation
DRAP for
the Firm has
verification of
deposited
photocopy of
differential fee for
fee challan.
application on Form
5-D. Form 5-D is
incorrect.
2. Verification of fee
of Rs. 12000/- is
required.
3. Formulation
contains controlled
drug substance.
210. -do- Fastofen Tablets Form-5 Form 5-D Deferred for
Each film coated tablet 05-07- last reminder
contains:- 2010(44)Rs.8,000/- Overall cGMP for correction
Ibuprofen lysinate…342mg measures are followed
+Rs. 12,000 (14- in form 5-D
(NSAID) in the Firm (31-03-
(Manufacturer’s Spec.s) 05-2013) Rs. 2014) alongwith
30,000/- (01-12- stability
2014) 1. The Firm had studies.
Rs. As per PAC applied on Form 5, Reference will
/30’s but after evaluation be sent to B &
the Firm has A Division,
deposited DRAP for
differential fee for verification of
application on Form photocopy of
5-D. Form 5-D is fee challan.
incorrect.
2. Verification of fee
of Rs. 12000/- is
required.
211. M/s Nabiqasim Misocot 50 mg Tablets Form 5 BNF: Arthrotec Deferred for
Industries (Pvt) Each tablet contains:- (Pharmacia) Product specific
Ltd. 17/24, Diclofenac Sodium 01/07/10(Nil) inspection by
Korangi (B.P)…50mg Rs.8000/- Arthrotec (Pfizer) panel
Industrial Area, Misoprostol…200mcg +Rs.12000/- comprising of
Karachi. (NSAIDs) (14/05/13) Good GMP compliance Director DTL,
(Manufacturer’s Spec.s) (18-12-13) Karachi, DDG

As per PRC (E&M) and
/10’s,20’s 1. Verification of area FID.
photocopies of fee Reference
submitted is will be sent to
required. B & A
2. Other strength of Division,
the product Misocot DRAP for
75 mg Tablets has
verification
of photocopy
already been
of fee
deferred for Product
challan.
specific inspection
by panel
comprising of
Director DTL,
DDG (E&M) and
area FID
Evaluator – II
Applications checked by Evaluator IV (human)
manufacturer / Dosage Form + Strength) Initial date, including
Applicant diary International status
Composition in stringent drug
Pharmacological Group differential authorities
fee
Finished product Me-too status
Specification Demanded
Price / Pack GMP status as
size depicted in latest
inspection report
(with date) by the
Evaluator
212. M/s Pfizer Zetamax Tablet Form 5 International: BNF: Approved.

Pakistan Limited. Each film coated tablet 23-07-2010 Azithromycin (Non-
B-2, S.I.T.E., contains Dy. No. 264 proprietary)
Karachi Azithromycin Dihydrate eq Rs. 8000 + Local:
to Azithromycin USP 12000 Azitor of Macter Int
……….500mg Rs 340/ 6’s Pvt Limited Karachi
Antibiotic
According to

Finished product inspection report
specifications are USP dated 16-05-2012,
factory premises and
manufacturing
operations were found
in line and good with
GMP compliance
standards at time of
inspection.
Latest inspection
report is required. The
firm later on
submitted inspection
report dated
09.09.2014 conducted
by DRAP.
report & satisfied
with the same.
According to BNF
Azithromycin has
been approved in UK
as Azithromycin
monohydrate hemi-
ethanolate in Tablet
dosage form.
213. -do- Zetamax Tablet Form 5 International: BNF: Approved.
Each film coated tablet 05-07-2010 Azithromycin (Non-
contains Dy. No. 37 proprietary)
Azithromycin Dihydrate eq Rs. 8000 + Local:
to Azithromycin USP 12000 Azitor of Macter Int
……….250mg Rs 240/ 6’s Pvt Limited Karachi
Antibiotic
According to
Finished product inspection report
specifications are USP dated 16-05-2012,
factory premises and
manufacturing
operations were found
in line and good with
GMP compliance
standards at time of
inspection.
Latest inspection
report is required. The
firm later on
submitted inspection

report dated
09.09.2014 conducted
by DRAP. The Board
considered the above
inspection report &
satisfied with the
same.
According to BNF
Azithromycin has
been approved in UK
as Azithromycin
monohydrate hemi-
ethanolate in Tablet
dosage form.
214. M/s Genome Ovulin Tablet Form 5 BNF: Clomid Deferred till
Pharmaceuticals Each tablet contains 17-08-2010 (Sanofi-Aventis) decision on the
(Pvt) Limited., Clomiphene Citrate USP Rs 20,000/- manufacturing
Plot No. 16/I- …… 50mg As per PRC Ovi-F (Merck) requirement for this
Phase IV, Anti estrogen product.
Industrial Estate, Grant of GMP for
Hattar Finished product Export recommended
specifications are USP (27-12-13)
215. M/s Rotexmedica Texpami Capsule Form 5 Not confirmed Deferred for
Pakistan (Pvt) Each capsule contains 19-05-2010 confirmation of
Ltd., Pamidronate as disodium Rs 8000 + Aminomux Cap approval in
Plot no 206 & USP ………..100 mg 12000 100mg by M/s reference Stringent
207, Industrial (bone Resorption Inhibitor) 10’s as per Seignior Regulatory Agencies
triangle, SRO & latest GMP report.
Kahuta Road, Finished product A compliance report
Islamabad specifications are was asked to be
Manufacturer submitted for follow
up inspection. (13-02-
14)
Firm has not given

international
availability. It is
required as it is part
of Form 5. Firm has
replied reference of
argentina.
Latest satisfactory
GMP inspection
report is required. A

compliance report
was asked to be
submitted for follow
up inspection. (13-02-
14)
216. M/s Macter Zincasa Syrup 10 mg/ 5 ml Form 5 Me too Zegen Syrup Approved with USP
International Each 5 ml contains 20-08-2010 10 mg/5ml by Genera specification (as
(Pvt.) Limited. F- Zinc Sulphate Monohydrate Dy. No. 151 International formulation is WHO
216, S.I.T.E., USP eq to elemental Rs. 8000 + available in India, recommended).
Karachi. Zinc……10 mg 12000 China, Bangladesh
Antidiarrheal As per PRC According to
inspection report
Finished Product dated 10-04-2014,
Specifications are firm was considered
Manufacturer to be operating at
satisfactory level of
compliance with
GMP guidelines.
International
availability in SRA’s
not confirmed. USP
mentions the
formulation as Oral
Solution with pH of
2.5to 4.5 while
Manuf. Spec.s for this
formulation has pH of
5 to 6.
217. M/s Macter Mclevo Infusion 250mg Form 5 FDA has not Deferred for
International approved strength of approval in
(Pvt.) Limited. F- Each 100 ml contains 21-07-2010 2.5mg/ml. FDA reference Stringent
216, S.I.T.E., Levofloxacin USP 250 mg Dy. No. 1371 approved 5ml/ml with Regulatory Agencies
Karachi. Dextrose5%. in same strength &
Broad Spectrum Rs. 8000 + volume along with
Antibacterial Agent 12000 Firm has not confirmation of
submitted undertaking installation and
Finished Product operational
Specifications are (The firm had
qualifications of
Manufacturer Rs 500 submitted the above
TOC analyser &
undertaking but was
Liquid Particle
erroneously missed
Counter by area
in the agenda)
FID.
According to

inspection report
dated 10-04-2014,
firm was considered
to be operating at
compliance with
GMP guidelines.
International: FDA
has not approved 2.5
mg/ml
Local: Bexus Inf

250mg/100ml by M/s
Shaigan
218. M/s Macter Mclevo Infusion 250mg Form 5 Firm has not Deferred for
International submitted undertaking confirmation of
(Pvt.) Limited. F- Each 50 ml contains 21-07-2010 installation and
216, S.I.T.E., (The firm had operational
Levofloxacin 250 mg Dy. No. 1371 submitted the above qualifications
Karachi. of
Broad Spectrum Rs. 8000 + undertaking but was TOC analyser &
Antibacterial Agent 12000 erroneously missed Liquid Particle
in the agenda) Counter by area
Finished Product
Specifications are According to FID.
Manufacturer Rs 400/ 50 ml inspection report
dated 10-04-2014,
firm was considered
to be operating at
compliance with
GMP guidelines.
International:
Levaquine 250mg/50
ml (FDA)
Local: Xeflox Inf

250mg/50ml by M/s
Helix
International submitted undertaking approval in
(Pvt.) Limited. F- Each 100 ml contains 21-07-2010 reference Stringent

216, S.I.T.E., Levofloxacin 750 mg Dy. No. 1371 (The firm had Regulatory Agencies
Karachi. submitted the above in same strength &
Broad Spectrum Rs. 8000 + undertaking but was volume along with
Antibacterial Agent 12000 erroneously missed confirmation of
Finished Product in the agenda) installation and
Specifications are operational
Rs 800/ 100 ml According to qualification of TOC
Manufacturer inspection report analyser & Liquid
dated 10-04-2014, Particle Counter by
firm was considered area FID.
to be operating at
compliance with
GMP guidelines.
International: FDA
has not approved 7.5
mg/ml
Local: Bexus Inf

750mg/100ml by M/s
Shaigan
International submitted undertaking verification of me
(Pvt.) Limited. F- Each 20 ml contains 21-07-2010 too status along with
216, S.I.T.E., (The firm had confirmation of
Levofloxacin 500 mg Dy. No. 1373 submitted the above installation
Karachi. and
Broad Spectrum Rs. 8000 + undertaking but was operational
Antibacterial Agent 12000 erroneously missed qualification of TOC
in the agenda) analyser & Liquid
Finished Product
Specifications are According to Particle Counter by
Manufacturer Rs 500/ 20 ml inspection report area FID.
dated 10-04-2014,
firm was considered
to be operating at
compliance with
GMP guidelines.
International:
Levaquine 500mg/20
ml (FDA)

Local: Me too status
needs confirmation
221. M/s Macter Kirin Tablet Form 5 Me too Co-Kiren Approved.

International Tablet by Tabros
(Pvt.) Limited. Each film coated tablet 30-08-2010 Pharma
contains
F-216, S.I.T.E., Dy. No. 191 International
Karachi. Aliskirin hemifumarate Tekturna HCT tablet
MS……150 mg Rs. 8000
(USA)
Hydrochlorothiazide USP As per PRC
According to
…..12.5 mg 1 × 14’s inspection report
Non peptide, direct rennin dated 10-04-2014,
inhibitor firm was considered
to be operating at
Finished Product satisfactory level of
Specifications are compliance with
Manufacturer GMP guidelines.
Firm has not

submitted
undertaking.
(The firm had

submitted the above
undertaking but was
erroneously missed in
the agenda)
222. M/s Macter Mimin Tablet 200 mg Form 5 Me too Xerifax Approved.
International Tablet 200 mg
(Pvt.) Limited. Each film coated tablet 30-08-2010
contains International
F-216, S.I.T.E., Dy. No. 196 Xifaxan Tablet 200
Karachi. Rifaximin……..200 mg mg (FDA)
Rs. 8000
Non systemic Antibiotic According to
As per PRC
Finished Product inspection report
Specifications are 1 × 10’s dated 10-04-2014,
Manufacturer firm was considered
to be operating at
compliance with

GMP guidelines.
Firm has not

submitted
undertaking.
(The firm had

submitted the above
undertaking but was
erroneously missed
in the agenda)
223. M/s Macter Mirin Capsule 50 mg Form 5 Me too Diora Capsule Deferred for review
International 50 mg by Getz of formulation by
(Pvt.) Limited. Each capsule contains 30-08-2010 Review Committee.
International
F-216, S.I.T.E., Diacerein MS …..50 mg Dy. No. 198 Diacerein Capsule 50
Karachi. Antirheumatics/ Pain Rs. 8000 + mg available in India.
Management 12000 EMA approved
Diacerein for rare
Finished Product As per PRC disease
Specifications are (epidermolysis
Manufacturer bullosa).
According to
inspection report
dated 10-04-2014,
firm was considered
to be operating at
compliance with
GMP guidelines.
Firm has not

submitted
undertaking.
(The firm had

submitted the above
undertaking but was
erroneously missed in
the agenda)
Firm has given assay

limit for finished

product as 288-368
mg/capsule.
Firm has given assay

for tablets while
applied product is
capsule.
The firm has

submitted the correct
assay method with
correct limits.
224. M/s Macter Micam Injection 8 mg Form 5 Firm has not provided Deferred for
International reference of confirmation of
(Pvt.) Limited. Each vial contains 30-08-2010 specifications of installation and
Lornoxicam…….8 mg Dy. No. 200 finished product. operational
F-216, S.I.T.E., qualification of TOC
Karachi. Analgesic & Anti Rs. 8000 + The firm submitted analyser & Liquid
inflammatory 12000 Finished Product Particle Counter by
Specification as area FID.
Finished Product As per PRC Manufacturer’s
Specifications are specifications
Firm has written

Glenmark as
reference to
specifications of
active raw material
for description,
identification,
solubility and Aydin/
Turkey for assay of
active raw material.
QC tests for injections

have not been
provided.
Me too Xefast tablet

8 mg by PharmEvo
International Xefo
powder for injection 8

mg (EMA)
225. -do- Zincasa DS Syrup 20 mg/ 5 Form 5 Me too Zegen Syrup Approved with USP
ml 20-08-2010 10 mg/5ml by Genera specification as
Each 5 ml contains Dy. No. 151 International formulation is WHO
Zinc Sulphate Monohydrate Rs. 8000 + available in India, recommended.
USP eq to elemental 12000 China, Bangladesh
Zinc……20 mg As per PRC According to
Antidiarrheal inspection report
dated 10-04-2014,
Finished Product firm was considered
Specifications are to be operating at
Manufacturer satisfactory level of
compliance with
GMP guidelines.
International
availability in SRA’s
not confirmed. USP
mentions the
formulation as Oral
Solution with pH of
2.5to 4.5 while
Manuf. Spec.s for this
formulation has pH of
5 to 6.
226. M/s Pharmatec Alptec 0.25mg Tablet Form 5 International: Deferred for
Pakistan (Pvt.) Alprazolam 0.25mg confirmation of
Ltd. Each tablet contains 31-05-2013 (FDA) segregated
Alprazolam USP Rs 60,000/- manufacturing
D- 86/A., S.I.T.E., Me too: Alloram 0.25 facility for Narcotic
Karachi. ….0.25mg mg by M/s Global
3 × 10 Drugs and
Anxiolytic According to Psychotropic
Finished product inspection report substances.

specifications are USP dated 23-10- 2013,
firm was considered
to be operating at
good level of
compliance with
GMP guidelines.
227. M/s Benson Moxi Tablet Form 5 BNF: Avelox (Bayer) Deferred for
Pharmaceuticals. Each film coated tablet 09-06-2010 provision of assay
Plot No 119, street contains Rs 8000 + Local: Morax tab method of Finished
No 8, I-10/3, Moxifloxacin (as 12000 400mg by M/s Global Product.
Industrial area hydrochloride) 5’s as per SRO
Islamabad. (USP...400mg Firm is operating at

(Fluroquinolone) satisfactory level of
(Manufacturer’s Spec.s) GMP compliance (15-
04-14)
Assay method had not

been given in
Finished Product
specifications.
228. -do- Piclo Tablet Form 5 BNF: Deferred for

Each film coated tablet 09-06-2010 Brexidol(Chiesi) correction in coating
contains Rs 8000 + & speficication of
Piroxicam (as beta 12000 Local: Brexidol cap active material &
cyclodextrin)……………20 5’s as per SRO 20mg by M/s Genome finished product.
mg
(NSAID) Firm is operating at
(Manufacturer’s Spec.s) satisfactory level of
GMP compliance (15-
04-14)
Originator’s
formulation is
uncoated while the
Firm has applied Film
coated formulation.
Firm has not given

active raw material
specifications.
Finished product
specifications are
incomplete and
without reference.
Assay, identification,
dissolution methods
have not been
provided.
229. M/s WnsFeild Venlax tablet 37.5 mg Form 5 BNF: Venlafaxine Approved with
Pharmaceuticals Each extended release film 04-08-2010 (Non-proprietary) change in brand
Plot no. 122, coated tablet contains Rs 20,000/- name.
Block B, Phase V, Venlafaxine (as HCl) Pack of 20’s Local: Zaxine (Araf
Industrial Estate, ……..37.5 mg As fixed by Pharma)
Hattar (Anti depressant) Govt
(B.P Spec.s) Grant of GMP
Certificate for Export
recommended (04-09-
14)
230. -do- Venlax tablet 75mg Form 5 BNF: Venlafaxine Approved with

Each extended release film 04-08-2010 (Non-proprietary) change in brand
coated tablet contains Rs 20,000/- name.
Venlafaxine (as HCl) Pack of 2 × 7’s Local: Zaxine (Araf
……..75 mg As fixed by Pharma)
(Anti depressant) Govt
(B.P Spec.s) Grant of GMP
Certificate for Export
recommended (04-09-
14)
231. -do- Venlax tablet Form 5 FDA: Venlafaxine (as Approved with
Each film coated tablet 04-08-2010 HCl) by Teva change in brand
contains Rs 20,000/- name.
Venlafaxine (as HCl) Pack of 20’s Amfax (Amson)
(USP)……..50 mg As fixed by
(Anti depressant) Govt Grant of GMP
(BP Spec.s) Certificate for Export
recommended (04-09-
14)
232. -do- Artidoxin DS co-blister Form 5 International: Not Deferred for
Tablet 04-08-2010 confirmed. confirmation of co-
(i) 3Tablets of which Each Rs 20,000/- (Formulation is blister facility by
coblister tablet contains 2 × 10’s tab found WHO area FID.
Sulphadoxin USP …….. As fixed by approved)
500mg Govt
Pyrimethamine USP Local:Fansi Plus
……..25mg (Wilshire)
(USP Spec.s)
(ii) 6Tablets of which Each Grant of GMP
tablet contains Certificate for Export
Artisunate……100mg recommended (04-09-
(Antimalarial) 14)
Finished product
specifications are International
(Manufacturer’s Spec.s) availability in SRA’s
not confirmed. Firm
has provided
reference from China.
For verification of
Facility (Co-blister
Machine etc) Firm
has submitted that
they possesses the
Chinese made blister
machine which has
the capability of
blistering different
size of tablets
together I to one

blister. The machie is
convertible from Alu
Alu to Alu PVC and
vice versa. The have
given undertaking
that they will procure
the specific dye for
the purpose if the
product is registered.
233. -do- Artidoxin co-blister Tablet Form 5 International: Not Deferred for
(i) 3Tablets of which Each 04-08-2010 confirmed. confirmation WHO
coblister tablet contains Rs 20,000/- recommended
Sulphadoxin USP …….. 2 × 10’s tab Local: Arteka of formulation / Pack
500mg As fixed by Hemis & verification of co-
Pyrimethamine USP Govt Grant of GMP blister facility by
……..25mg Certificate for Export area FID.
(USP Spec.s) recommended (04-09-
(ii) 6Tablets of which Each 14)
tablet contains
Artisunate……50mg International
(Antimalarial) availability in SRA’s
Finished product not confirmed. Firm
specifications has provided
are(Manufacturer’s Spec.s) reference from China.
Me-too status needs
confirmation. (Arteka
of Hemis), Pricing of
formulation has been
fixed in 19th PRC.
For verification of
Facility (Co-blister
Machine etc) Firm
has submitted that
they possesses the
Chinese made blister
machine which has
the capability of
blistering different
size of tablets
together I to one
blister. The machie is
convertible from Alu
Alu to Alu PVC and
vice versa. The have
given undertaking
that they will procure
the specific dye for
the purpose if the
product is registered.

234. -do- Winprid Tablet Form 5 International: Deferred for review
Each film coated tablet 04-08-2010 Ganaton of formulation by
contains:- Rs 20,000/- Local:Ganaton Review Committee.
Itopride HCl…..50mg 1 × 10’s tab (Abbot)
Gastroprokinetic As fixed by Grant of GMP
(Manufacturer’s Spec.s) Govt Certificate for Export
recommended (04-09-
14)
Formulation is under
review by the review
committee.
235. M/s Qintar HEMA Chewable (Sugar Form 5 International: Not Deferred for
Pharmaceuticals, Free) Tablets 27-03-2010 confirmed confirmation of
14-A P.S.I.E., Each chewable tablet Rs 8000 + Local: Hicobal approval of same
Lahore road, contains 12000 500mcg by M/s dosage form in
Sargodha Mecobalamin (J.P)…500 Rs 178 for Himont reference Stringent
mcg 20’s Renewal of DML Regulatory Agencies
(Co enzyme type vitamin Rs 267 for recommended (08-10- and clarification of
B12) 30’s 12) formulation as not
(Manufacturer’s Spec.s) Rs 890 for International given for applied
100’s availability not chewable dosage
confirmed in SRAs. form and submission
Firm has given of latest GMP
reference of inspection report.
international
availability from
India.
Formulation given is
not of chewable
Tablets
Latest inspection
report is required.
236. -do- Gexin Tablets Form 5 International: FDA Deferred for

Each film coated tablet 27-03-2010 Factive submission of latest
contains:- Rs 8000 + Local: Actigem tab GMP inspection
Gemifloxacin as 12000 320mg by M/s report.
mesylate………… 320 mg Rs 625 for 7’s Ferozsons
(Fluroquinolone)
Renewal of DML
(Manufacturer’s Spec.s) recommended (08-10-
12)
Latest inspection
report is required.
237. -do- Smart XR Tablets Form 5 International:ALLEGRA- Deferred for

Each film coated XR tablet 27-03-2010 D 12 HOUR ALLERGY AND submission of latest
CONGESTION (Sanofi)
contains Rs 8000 + GMP inspection
Fexofenadine HCL (USP) 12000 Local: Fexet D by report & product
as immediate Layer…..60 Rs 120 for M/s Getz specific inspection
mg 10’s by panel comprising
Pseudoephedrine HCL Renewal of DML of DDG, Lahore and
(USP) as extended recommended (08-10- area FID for
release….. 120 mg 12) verification of
(Histamine H1 receptor manufacturing &
antagonist & adrenergic Formulations is testing facilities of
vasoconstrictor) specialized dosage the applied
Finished product form, Product specific formulation.
specifications are USP inspection may be
carried out for the
product for
verification of facility
etc.
Confirmation of
Latest inspection
report is required.
238. -do- Rovax Tablet Form 5 BNF: Crestor Deferred for
Each film coated tablet 27-03-2010 (AstraZeneca) submission of latest
Rosuvastatin Calcium eq to 12000 Local: Rast 5mg by report.
Rosuvastatin….. ……..5mg Rs 100 for M/s Tabros
(Hypolipidaemics) 10’s
(Manufacturer’s Spec.s) Renewal of DML
recommended (08-10-
12)
Latest inspection
report is required.
239. -do- Rovax Tablet Form 5 BNF: Crestor Deferred for

Each film coated tablet 27-03-2010 (AstraZeneca) submission of latest
Rosuvastatin Calcium eq to 12000 Local: Rast 5mg by report.
Rosuvastatin….. Rs 180 for M/s Tabros
……..10mg 10’s
(Hypolipidaemics) Renewal of DML
(Manufacturer’s Spec.s) recommended (08-10-
12)
Latest inspection
report is required.
240. M/s Nenza Flotin Tablet 20 mg Form 5 Me too Floxac tablet Approved.
Pharmaceuticals, Each tablet contains 15-07-2010 20 mg by Schazo

Plot No. 33 A, Fluoxetin HCl USP eq to 8000 + 12000
Phase- V, Fluoxetin…. As fixed by International
Industrial Estate, 20 mg govt Selfemra tablet 20 mg
Hayatabad, (Antidepressant) 1 × 10 pack (FDA)
Peshawar.
Finished product No conclusion
specifications are USP regarding GMP of the
Firm, some minor
observations at which
the management was
agreed to rectify.
(Routine GMP 10-04-
2014).
The Board
considered the above
inspection report &
satisfied with the
same.
241. M/s Genix Triptan Tablet Form 5 D International:Frova Deferred for
Pharma (Pvt.) Ltd. Each film coated tablet 10-08- Tablet 2.5 mg (FDA) rectification of
44, 45- B, Korangi contains 2010(52) following
Creek Road, Frovatriptan (as Succinate Rs 15000/-+ Local: Form 5-D observations in the
Karachi. monohydrate)….. …2.5 mg Rs. 12000/- dossier:
Anti migraine (21-05- Good GMP (30-04- 1. Reference will be
13)+Rs. 2014) sent to B & A
Finished product 23000/- 21-11- Division, DRAP for
specifications are 2014 Verification of copy verification of
Manufacturer. Rs. 200 per of Rs.12000/- fee photocopy of fee
tablet challan is required. challan.
Pack of 10’s
for Rs 2000/- No authentic 2. No authentic
reference to clinical reference to clinical
use & doses given in use & doses given in
clinical part of dossier clinical part of
dossier
Stability studies
conducted under Zone 3. Stability studies
IV A conditions as conducted under
per ICH/ WHO Zone IV A
guidelines, Clinical conditions as per
ICH/
data/ clinical trials are WHO
required. guidelines, Clinical
data/ clinical trials
Reference of are required.
specifications/testing
methods of finished 4. Reference of
product is required. specifications/testing
methods of finished

product is required.
242. M/s Genix Eltram Tablet Form 5-D International: Deferred for
Pharma (Pvt.) Ltd. Each film coated tablet 10-08-2010 Promacta Tablet 50 rectification of
44, 45- B, Korangi contains Rs 15000/-+ mg (FDA) following
Creek Road, Eltrambopag (as Rs. 12000/- Local: Not observation in the
Karachi. olamine)….. …50 mg (21-05-13) confirmed. dossier:
Haematopoietic Rs. 200 per Good GMP (30-04- 1. Reference will be
tablet 2014) sent to B & A
Finished product Pack of 10’s Division, DRAP for
specifications are for Rs 2000/- verification of
Manufacturer. Pack of 20’s Verification of copy photocopy of fee
for Rs 4000/- of Rs.12000/- fee challan.
challan is required.
2. Form 5 is
Firm has requested to required.
change Form 5-D to
Form 5 as at the time 3. Evidence of Me-
of initial application, too status is
the product was new required.
but now it has
become me-too.
Form 5 is required.
Evidence of Me-too
status is required.
243. M/s Genix Eltram Tablet Form 5 D International: Deferred for
Pharma (Pvt.) Ltd. Each film coated tablet 10-08-2010 Promacta Tablet 50 rectification of
44, 45- B, Korangi contains Rs 15000/-/-+ mg (FDA) following
Creek Road, Eltrambopag (as Rs. 12000/- Local: observation in the
Karachi. olamine)….. …25 mg (21-05-13) Good GMP (30-04- dossier:
Haematopoietic Rs. 150 per 2014) 1. Reference will be
tablet sent to B & A
Finished product Pack of 10’s Verification of copy Division, DRAP for
specifications are for Rs 1500/- of Rs.12000/- fee verification of
Manufacturer. Pack of 20’s challan is required. photocopy of fee
for Rs 3000/- challan
Firm has requested to
change Form 5-D to 2. Form 5 is
Form 5 as at the time required.
of initial application,
the product was new 3. Evidence of Me-
but now it has too status is
become me-too. required.
Form 5 is required.
Evidence of Me-too
status is required.

244. M/s Genix Art-M Tablet Form 5 D International: Deferred for
Pharma (Pvt.) Ltd. Each tablet contains 10-08- rectification of
44, 45- B, Korangi Artesunate …….60 mg 2010(52) Local: Form 5-D following
Creek Road, Pyronaridine Phosphate eq Rs 15000/-+ observation in the
Karachi. to Pyronaridine…180 mg Rs. 12000/- Good GMP (30-04- dossier:
Anti malarial (21-05- 2014)
13)+Rs. Verification of copy 1. Reference will be
Finished product 23000/- 21-11- of Rs.12000/- fee sent to B & A
specifications are 2014 challan is required. Division, DRAP for
Manufacturer. Rs. 300 per verification of
tablet No authentic photocopy of fee
Pack of 10’s reference to clinical challan.
for Rs 3000/- use & doses given in
Pack of 20’s clinical part of dossier 2. No authentic
for Rs 6000/- reference to clinical
Pack of 30’s Stability studies use & doses given in
for Rs 9000/- conducted under Zone clinical part of
IV A conditions as dossier
per ICH/ WHO
guidelines, Clinical 3. Stability studies
data/ clinical trials are conducted under
required. Zone IV A
conditions as per
Reference of ICH/ WHO
specifications/testing guidelines, Clinical
methods of finished data/ clinical trials
product is required. are required.
Evidence of 4. Reference of
Availability in specifications/testing
Stringent SRA’s is methods of finished
required. product is required.
5. Evidence of
Availability in
Stringent SRA’s is
required.
245. M/s Helix Pharma Primavera/ Omni Plus/ Form 5 International: Deferred for review
(Pvt) Ltd., Ristor/ Omnita Omitag/ 30-08-2010 Zegerid (FDA) of formulation by
Hakimsons OSB Capsule Dy No 203 Local: Rapid (global) Review Committee.
House, A/ 56, Each capsule contains Rs 8000+Rs. Satisfactory GMP
S.I.T.E., Karachi Omeprazole…..20mg 12000/- (22- compliance (11-08-
Sodium Bicarbonate 07-13) 14)
…….1100mg MRP of 10 Verification of copy
(Strength has been capsules as per of Rs.12000/- fee
corrected as 1100 mg which PRC challan is required.
was typed as 110mg in the
agenda copy)
Proton Pump Inhibitor &

Antacid
246. M/s AGP Maxna Injection Form 5 International: Deferred for
(Private) Limited. Each ml contains 30-08-2010 Local: rectification of
B-23, S.I.T.E., Tranexamic acid BP Rs. 8000 + Satisfactory GMP following
Karachi ……….100mg 12000 compliance (26-11- observations in the
Anti Fibrinolytic Agent As fixed by 13) dossier:
DPC 1. Reference will be
Finished product 5 × 10 ml Verification of copy sent to B & A
specifications are BP ampoules of fee challans is Division, DRAP for
required. verification of
Verification of TOC photocopy of fee
analyzer & liquid challan.
particle counter is 2. confirmation of
required. installation and
operational
Confirmation of Me qualification for
too status in 1g/10ml TOC analyzer &
is required. liquid particle
counter by area FID.
Letter of approval of 3. Confirmation of
injection section is Me too status in
required. Inspection 1g/10ml is required.
report dated 26-09- 4. Letter of approval
2012 mentions of injection section
Injectable (Antibiotic, is required.
Analgesic,
Spasmolytics etc)
Section.
247. M/s Bloom Surfen Plus Tablet Form 5 International: Deferred for
pharmaceuticals Each film coated tablet 05-08-2010 rectification of
(Pvt) Ltd. Phase I Contains: Rs 20,000/- Local: Buscopan following
& II Industrial Hyoscine N 10 × 10’s tab Plus Tablets observations in the
Estate, Hattar Butylbromide BP………… As per SRO dossier:
10 mg NO conclusion , 1. International
Paracetamol BP…… routine GMP availability (in
500mg inspection , Stringent Regulatory
Anticholinergic & Shortcomings have Agencies) required
Analgesic been improved (25- as part of Form 5.
07-14) 2. Reference to
(B.P Spec.s) finished product
International specifications has
availability has not been given as B.P
been written. It is while the
required as it is part formulation is not
of Form 5. included in B.P.
Reference to finished
product specifications 3. Undertaking on
has been given as B.P desired format has

while the formulation not been submitted.
is not included in B.P.
Undertaking on
desired format has not
been submitted.
248. M/s Bloom Amalar Suspension Form 5 International: Deferred for
Pharmaceuticals Each 5 ml contains 05-08-2010 rectification of
(Pvt) Ltd. Phase Artemether…..15mg Rs 20,000/- Local: Buscopan following
I & II Industrial Lumefantrine…..90mg As per SRO Plus Tablets observations in the
Estate, Hattar Antimalarial 30 ml & 60 ml dossier:
NO conclusion , 1. International
Finished product routine GMP availability has not
specifications are inspection , been submitted.
Manufacturer. Shortcomings have 2. Active raw
been improved (25- material
07-14) specifications have
been given as B.P
Firm has written that while these are not
“we will surrender included in B.P.
our already registered 3. Undertaking on
product Benol desired format has
Capsule Reg No. not been submitted.
022525 in case of fast
track registration of
our this product
Amalar Suspension.”
No clarification has
been given in reply.
International
availability has not
been written. It is
required as it is part
of Form 5.
Active raw material
specifications have
been given as B.P
while these are not
included in B.P.
Undertaking on
desired format has not
been submitted.
249. Rogen Olirag 10 mg Tablet Form 5 International: Approved.
Pharmaceuticals. Olanzapine 52 mg
Each film coated tablet 19-07-2010 (FDA)
Plot No. 30, St contains:
No. S-4 20,000 Me too: Amprex
Olanzapine 10 mg tablet 5 mg by
National Industrial As per SRO

Zone (RCCI), (Tranquilizers, Sedative, for 10’s Amarant
Rawat, Islamabad. Hypnotics)
The firm has rectified
USP Specifications the short-comings
conveyed to him.
250. Rogen Olirag 5 mg Tablet Form 5 International: Approved.

Pharmaceuticals. Olanzapine 5 mg
Each tablet contains: 19-07-2010 (FDA)
Plot No. 30, St
No. S-4 Olanzapine 5 mg 20,000 Me too: Amprex
(Tranquilizers, Sedative, As per SRO tablet 5 mg by
National Industrial Amarant
Zone (RCCI), Hypnotics) for 10’s
Rawat, Islamabad. USP Specifications
251. Rogen Rocep 250 mg Capsule Form 5 International: Not Deferred for review
Pharmaceuticals. approved by reference of formualation by
Each capsule contains: 19-07-2010 DRAs Review Committee.
Plot No. 30, St
No. S-4 Ciprofloxacin HCL USP 20,000 Local: Ciprocin cap
250 mg 250mg by M/s
(Quinolone) for 10’s Miracle
Zone (RCCI),
Rawat, Islamabad. Finished product
specifications are
Manufacturer
252. Rogen Rocep 500 mg Capsule Form 5 International: Not Deferred for review
Each capsule contains: 19-07-2010 DRAs Review Committee.
Plot No. 30, St
No. S-4 Ciprofloxacin HCL 500 20,000 Local: Ciprocin cap
mg 250mg by M/s
(Quinolone) for 10’s Miracle
Zone (RCCI),
specifications are
Manufacturer
253. Rogen Sulrog Tablet 25 mg Form 5 International: Not Deferred for review
Each tablet contains: 19-07-2010 DRAs Review Committee.
Plot No. 30, St
Levosulpride 25 mg 20,000 Local: levopraid

No. S-4 (Antidepressant/ As per SRO tablet 25mg by M/s
Gastroprokinetic) for 20’s Pacific
National Industrial
Zone (RCCI), Finished product
Rawat, Islamabad. specifications are
Manufacturer
Plot No. 30, St
No. S-4 Levosulpride 50 mg 20,000 Local: levopraid
(Antidepressant/ As per SRO tablet 50mg by M/s
National Industrial Pacific
Zone (RCCI), Gastroprokinetic) for 20’s
specifications are
Manufacturer.
Plot No. 30, St
No. S-4 Levosulpride 100 mg 20,000 Local: levopraid
(Antidepressant/ As per SRO tablet 100mg by M/s
National Industrial Pacific
Zone (RCCI), Gastroprokinetic) for 20’s
specifications are
Manufacturer
256. Rogen Mecrogen 500 mcg Tablet Form 5 International: Approved with sugar
Pharmaceuticals. Methycobal tablet coating.
Each film coated tablet 19-07-2010 (Japan)
Plot No. 30, St contains
No. S-4 20,000 Local: levopraid
Macobalamin……..500 tablet 100mg by M/s
National Industrial mcg As per SRO
for 30’s Pacific
Zone (RCCI),
Rawat, Islamabad. Vitamin B12
Finished product
specifications are
Manufacturer

Evaluator – II
Applications of impot checked by Evaluator – IV
S.No Name and address of Brand Name Type of Form Remarks on the Decision
manufacturer / (Proprietary name + formulation (if any)
Applicant Dosage Form + Strength) Initial date, including
diary International status in
Composition stringent drug
Pharmacological Group differential authorities
fee
Price / Pack GMP status as
size depicted in latest
inspection report (with
date) by the Evaluator
257. M/s. Novartis Pharma Sebivo Oral Solution Form 5-A FDA: Tyzeka (Novartis) Approved
(Pvt) Ltd, Karachi. / 20mg/ml `(The firm submitted
Product License Each ml of oral solution 11-11-2009 New Application the relevant portion
Holder:- contains: - Diary No. 659 of CTD showing the
M/s. Novartis Pharma Telbivudine…………20mg Rs.15000/- N/A Process validation,
Schweiz Ltd (Hepatitis B) 12-02-2014 validation of
Monbijoustrasse Bern, Rs.35000/- Following objections analytical method &
Switzerland. Total were raised on the chromatograms of
Manufacturing Site:- Rs.50,000/- applications: sample and standard
M/s. Novartis Pharma 1. Firm has not of :
SAS, rue la Chapelle, Demanded provided Studies like (i) API
Huningue, France. Price/Pack process validation, (ii) Benzoic acid
Size pharmaceutical (iii) Degradation
Rs.3915/300ml development studies, products.
validation of analytical The referred CTD
methods. mentions same the
2.Firm has not provided manufacturing site
chromatographs for as applied).
sample and reference of
active ingredient,
benzoic acid,
degradation products in
analytical procedures
and stability studies.
3.Clinical trial data/
clinical data
Firm had objected on

these observations and
regarding limited time

period provided for
reply of these objections
but now has submitted
the reply of these
observations.
Assessment of reply
reveals that the Firm has
not submitted the
validation reports
regarding process and
analytical methods in a
prescribed manner viz.
without contents like
specificity, linearity,
precision, accuracy,
limit of detection,
Range , Robustness etc.
Further, the Firm has
also not submitted the
chromatograms of
sample and standard of :
(i) API
(ii) Benzoic Acid
(iii) Degradation
products.
258. Applicant: FD Injection IV Form 5-A International: Deferred for
M/s. Mehran Dental, Each 1.8ml ampoule 17-02-2009 Local: rectification of
Karachi. contains: - Diary No.153 Sole agency agreement following
M No. Al Noor Lidocaine HCl…36.0mg Rs.15000/- has been expired. observations in the
Centre Randle Road, Epinephrine…0.018mg 18-06-2013 GMP certificate of dossier:
ADJ- Local Anesthetic Rs.85000/- manufacturer has been 1. Sole agency
ANKLESeriaHospital, /Adrenergic agonist Rs.1200 / expired. agreement has been
Karachi 1 x 10 Firm has not provided expired.
Manufacturer: cartridge in original & legalized 2. GMP certificate
M/s. Laboratorios Finished product each blister Certificate of of manufacturer has
Zeyco S.A. DE C.V. specifications are USP Total 5 blister Pharmaceutical Product been expired.
CAMINO A SANTA in packet with english translation. 3. Firm has not
ANA TEPETITLAN Total 50 Firm has not provided provided original &
NO. 2230 COLONIA Pieces of long term stability legalized Certificate
SANTA ANA cartridges in studies under zone IV A of Pharmaceutical
TEPETITLAN 45230 Packet conditions are ICH/ Product with english
ZAPOPAN WHO guidelines. translation.
JALISCO, Mexico. Chromatograms in 4. Firm has not
analytical methods & provided long term
stability studies have stability studies
not been provided along under zone IV A
with data. conditions are ICH/
Firm gave reference of WHO guidelines.
USP for finished 5. Chromatograms in

product specifications analytical methods
while given & stability studies
assay
method is not as same have not been
as given in USP 35. provided along with
Firm has not provided data.
active raw material 6. Firm gave
specifications. reference of USP for
Firm has not provided finished product
specifications specifications while
of
primary packaginggiven assay method
material (glass vial). is not as same as
Undertaking on desired given in USP 35.
format has not been 7. Firm has not
submitted. provided active raw
material
specifications.
8. Firm has not
provided
specifications of
primary packaging
material (glass vial).
9. Undertaking on
desired format has
not been submitted.
259. Applicant: Mydriaticum Stulln UD Form 5-A Reply of the Firm needs Deferred for
M/s. Haroon Brothers, Eye Drops 30-04-2009 further evaluation. evaluation of replies
1/ A, Each ml contains: - Rs.15000 + submitted by the
KarimjeeBuilding, Tropicamide Ph. Eur. Rs.85000 = firm.
Opposite HBL Napier ….…5mg Rs.100000/
Rd Branch, Near Ophthalmic Preparation / Rs.30/ Per Vial
Denso Hall, Mydriatic & Cycloplegic (0.4ml),
Karachi. depending on
pack size
Manufacturer: Finished product
M/s. Pharma Stulln specifications are
GmbH Werksstrasse
3, D-92551 Stulln,
Germany.
260. Applicant: Blupan UD Eye Drops Form 5-A Reply of the Firm needs Deferred for
M/s. Haroon Brothers, Each ml contains: - 30-04-2009 further evaluation. evaluation of replies
1/ A, Sodium Rs.15000 + submitted by the
KarimjeeBuilding, Hyaluronate Ph. Eur. Rs.85000 = firm.
Opposite HBL Napier …1.5057mg Rs.100000/
Rd Branch, Near Dexpanthenol (Vitamin Rs.36/ per vial
Denso Hall, B5) USP….20.0000 mg (0.5ml)
Karachi. Ophthalmic Preparation
Manufacturer:
M/s. Penta

Arzneimittel GmbH Finished product
Werksstrasse 3, specifications are
Germany.
Evaluator – III

address of (Proprietary name Form the by the Evaluator
manufacturer / + Dosage Form + formulation (if
Applicant Strength) Initial any) including
date, diary International
Composition status in
Fee stringent drug
Pharmacological Group including regulatory
differential agencies /
Finished product fee authorities
Specification
Demanded Me-too status
Price /
Pack size GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator
261. M/s Atco ADVOCORT Fatty Form-5 Advantan Fatty Firm has submitted Deferred for
Laboratories Ointment 0.1% Ointment of that they are in confirmation
(Pvt) Limited Dy. No: CSL Limited process of of
Karachi. Each gram contains: 126 dated (TGA establishing the manufacturing
Methylprednisolone 14th Approved) steroidal section facility for
aceponate…….1mg October facility. The firm steroids.
2010 Advantan of has also submitted
Synthetic corticosteroid Bayer Pakistan letter regarding
8,000/- Karachi. approval of
Manufacturer proposed layout
Rs. 95/- per Inspection of plan for Ointment
5gm tube the firm was (Steroid) and Oral
Rs. 176/- conducted on Liquid Section
per 10gm 18-06-14 by the (General).
tube area FID and
Rs. 250/- GMP
per 15gm Compliance
tube was found
good.

262. -do- ADVOCORT Ointment Form-5 Advantan Deferred for
0.1% Ointment of confirmation
Dy. No: CSL Limited of
Each gram contains: 125 dated (TGA manufacturing
Methylprednisolone 14th Approved) facility for
aceponate…….1mg October steroids.
2010 Advantan of
Synthetic corticosteroid Bayer Pakistan
8,000/- Karachi
Manufacturer
Rs. 95/- per
5gm tube
Rs. 176/-
per 10gm
tube
Rs. 250/-
per 15gm
tube
263. -do- ADVOCORT Lotion 0.1% Form-5D Advantan a. Stability studies Deferred for
Lotion of CSL needs to be followings:
Each ml contains: Dy. No: Limited (TGA submitted as per 1.
Methylprednisolone 127 dated Approved) ICH/ WHO Confirmation
aceponate…….1mg 14th guidelines. of
October Inspection of b. Clinical trial manufacturing
Synthetic corticosteroid 2010 the firm was data is required facility for
conducted on along with steroids.
Manufacturer 15,000/- 18-06-14 by the clinical 2. Stability
dated 14- area FID and justification. studies as per
10-10 GMP ICH/ WHO
35000/- Compliance guidelines.
dated 05- was found 3. Clinical
12-13 good. trial data
along with
Rs. 225/- clinical
30ml justification.
Rs. 330/-
per 60ml

264. M/s Linear PYRETIC Effervescent Form-5 Paracetamol Approved.
Pharma, Rawat Tablets 500mg effervescent
Islamabad. 06-10-2010 tablet of Accord
Each tablet contains: Dy. Health Care
Paracetamol….500mg No.9220 UK.
8,000/-
Analgesic/ Antipyretic Acetosol of
28-02-2014 Shigan Pharma
Manufacturer Dy. No.595 Islamabad.
12000/-
Inspection of
As per the firm was
SRO/ conducted by
Pack of the area FID on
100’s 13-11-14 and
the was
complying the
GMP
265. -do- MEFQUINE Tablets 250mg Form-5 Lariam Tablet Approved.
of Roche UK
Each tablet contains: 06-10-2010
Mefloquine Dy. Meflogen of
Hydrochloride…..250mg No.9226 Genome
8,000/- Pharmaceuticals
Antimalarial
28-02-2014
Manufacturer Dy. No.594
12000/-
As per
SRO/
Pack of
25’s
266. -do- PENTO Capsule 40mg Form-5 Not available in Deferred for
SRA’s review of
Each capsule contains: 06-10-2010 formulation.
Pantoprazole sodium 22.5 Dy. Pentoloc of
% pellets equivalent to No.9226 Aeries Pharma
Pantoprazole…..40mg 8,000/-
PPI 28-02-2014
Dy. No.596
Manufacturer 12000/-
Source: Vision As per

Pharmaceuticals Islamabad. SRO/
Pack of
14’s

267. M/s Innvotek LETRO Tablets Form-5 Femara of Deferred till
Pharmaceuticals Novartis decision on
Islamabad. Each film coated tablet Dy. No: the
contains: 1037/ 20- Femara of manufacturing
Letrozole……2.5mg 10-10 Novartis requirement
Karachi for this
Non steroidal aromatase 20,000/- product.
Inhibitor Inspection of
As per the firm was
USP PRC/ Pack conducted on
of 10’s 04-07-14 by the
area FID and
GMP
compliance was
found
satisfactory.
268. -do- MILTEFO Capsules Form-5 Impavido of Approved.
Knight Theraps
Each capsule contains: Dy. No: (USFDA)
Miltefosine…..50mg 1036/ 20-
10-10 Fosin Capsules
Antiprotozoal of Nimral Labs
20,000/-
Manufacturer
As per
PRC/ Pack
of 8x7’s
269. M/s Fedro RANIDOL Tablets 150mg Form-5 Ranitidine a. Evidence of Deferred till
Pharmaceutical tablets of approval of rectifications
Labs. Peshawar Each film coated tablet 20-09-2010 Aurobindo section from of
contains: Dy. No. Pharma. Drug Licensing shortcomings
Ranitidine as 1148 division is not as mentioned
hydrochloride……150mg Zantac of GSK submitted. in GMP
20,000/- b. Inspection of the inspection
H2 Blocker Firm was report dated
As per conducted by 23.07.2014.
BP SRO the area FID on
1x10’s 23-07-14 and
certain
shortcomings
were found,
which are
discussed with
the management
of which they
agreed to
rectify.

(“drainage line
found not
cleaned properly
in tablet section,
three blistering
and one
stripping
machines found
kept in one
room without
segregation and
advised to
provided
partition and AC
facilities to
control
temperature and
humidity.”)
270. -do- RANIDOL Tablets 300mg Form-5 Ranitidine Deferred till
tablets of rectifications
Each film coated tablet 20-09-2010 Aurobindo of
contains: Dy. No. Pharma. shortcomings
Ranitidine as 1137 as mentioned
hydrochloride……300mg Zantac of GSK in GMP
20,000/- inspection
H2 Blocker report dated
As per 23.07.2014.
BP SRO
1x10’s
271. -do- FEKAST Tablets 4mg Form-5 Not found in Deferred till
SRA’s, (applied rectifications
Each film coated tablet 20-09-2010 strength is of
contains: Dy. No. approved as shortcomings
Montelukast as 1138 chewable as mentioned
sodium……4mg tablet.) in GMP
20,000/- inspection
Leukotriene Receptor Me too status report dated
Antagonist As per needs 23.07.2014.
SRO confirmation
Manufacturer 2x7’s
272. -do- FEKAST Tablets 5mg Form-5 Not found in Deferred till
SRA’s, applied rectifications
Each film coated tablet 20-09-2010 strength is of
contains: Dy. No. approved as shortcomings
Montelukast as 1146 chewable tablet. as mentioned
sodium……5mg in GMP
20,000/- Me too status inspection
Leukotriene Receptor needs report dated
Antagonist As per confirmation 23.07.2014.

SRO
273. -do- FEKAST Tablets 10mg Form-5 Motelukast of Deferred till
Accord rectifications
Each film coated tablet 20-09-2010 Healthcare of
contains: Dy. No. shortcomings
Montelukast as 1143 Aerokast of as mentioned
sodium……10mg Barrett & in GMP
20,000/- Hodgson (Pvt) inspection
Leukotriene Receptor Limited report dated
Antagonist As per Karachi 23.07.2014.
SRO
274. -do- FINFLEX-S Tablets 50mg Form-5 Voltral of Master formulation Deferred till
Novartis submitted is of film rectifications
Each enteric coated tablet 20-09-2010 coated tablets of
contains: Dy. No. Fastaid of however applied shortcomings
Diclofenac Sodium 1147 Platinum product is enteric as mentioned
BP…….50mg Pharma Karachi coated. in GMP
20,000/- inspection
Antirehumatic report dated
As per 23.07.2014 &
BP SRO rectification
2x10’s of following
observation:
Master
formulation is
of film coated
tablets while
applied
product
should be
enteric coated.
275. -do- FINFLEX-S Tablets 75mg Form-5 Diclofenac Master formulation Deferred till
sodium of submitted is of film rectifications
Each enteric coated tablet 20-09-2010 Sandoz coated tablets of
contains: Dy. No. (USFDA) however applied shortcomings
Diclofenac Sodium 1142 product is enteric as mentioned
BP…….75mg Fastaid of coated. in GMP
20,000/- Platinum inspection
Antirehumatic Pharma Karachi report dated
As per 23.07.2014 &
BP SRO rectification
observation:
Master
formulation is
of film coated
tablets while

applied
product
should be
enteric coated.
276. -do- FEDRACAM-BCD Tablets Form-5 Brexidol of Master formulation Deferred till
20mg Chesi (BNF) needs rectification rectifications
20-09-2010 regarding quantity of
Each tablet contains: Dy. No. Brexin of of API. shortcomings
Piroxicam as Beta 1140 Chiesi Karachi. as mentioned
Cyclodextrin……20mg in GMP
20,000/- inspection
NSAID report dated
As per 23.07.2014 &
Manufacturer SRO rectification
observation:
Master
formulation
needs
rectification
regarding
quantity of
API.
277. -do- CERIGEX-L Tablet 5mg Form-5 Levocetirizine Deferred till
of Actavis UK rectifications
Each film coated tablet 20-09-2010 of
contains: Dy. No. Alergocit of
shortcomings
Levocetirizine as 1139 Global Pharma
dihydrochloride…..5mg Islamabad. as mentioned
20,000/- in GMP
Antihistamine inspection
Manufacturer As per report dated
SRO 23.07.2014
Pack of
10’s
278. -do- DI- METHER Tablets Form-5 WHO Deferred till
recommended rectifications
Each tablet contains: 20-09-2010 Formulation of
Artemether ……40mg Dy. No.
shortcomings
Lumefantrine….240mg 1145 Artem DS of
Hilton as mentioned
Antimalarial 20,000/- in GMP
inspection

USP (Salmus) As per report dated
SRO 23.07.2014
Pack of
10’s
279. M/s Asian FEVEREN 6 Plus Form-5 Calpol 6 Plus Approved.

Continental Suspension (BNF)
(Pvt) Limited, Dated: 08-
Karachi Each 5ml contains: 10-2010 Calpol 6 Plus
Paracetamol……..250mg 8,000/- GSK Karachi
Analgesic and AntipyreticDated: 31- Inspection of

07-2013 the firm was
USP 12000/- conducted on
09-09-14 by the
As per area FID and
SRO/ concluded that
Pack of 1’s the firm is
90ml bottle working at
acceptable level
of GMP
compliance.
280. -do- ATIZA Syrup 2.5mg/ 5ml Form-5 Xyzal Oral Approved.
Solution
Each 5ml contains Dated: 12- (USFDA)
Levocetirizine 10-2010
dihydrochloride……..2.5mg 8,000/- T-Day of
Novartis
Antihistamine Dated: 31- Karachi
07-2013
Manufacturer 12000/-
As per
SRO/
Pack of 1’s
90ml bottle
281. -do- FEVEREN Tablet 500mg Form-5 Panadol GSK Approved.
USA
Each tablet contains: Dy. No:
Pracetamol……500mg 1916/ 29- Panadol GSK
10-10 Karachi
Analgesic
8,000/-
Manufacturer
As per

PRC
282. -do- FEVEREN Extra Tablet Form-5 Panadol Extra Approved.

500mg GSK USA
Dy. No:
Each tablet contains: Not Panadol Extra
Pracetamol……500mg provided GSK Karachi.
Caffiene…….65mg
8,000/-
Analgesic dated 27-
10-10
As per
PRC
283. M/s Linear FACAL Tablet Form-5 Not available in Deferred for
Pharma, Rawat SRA’s confirmation
Islamabad Each tablet contains: Dy. No: of approval in
Alfacalcidol….0.25mg 9229 dated Me too status reference
06-10-10 needs Stringent
Elemental confirmation. Regulatory
Calcium…..50mg 20,000/- Agencies &
Inspection of me too status.
Vitamin D supplement As per the firm was
SRO/ Pack conducted by
Manufacturer of 10’s the area FID on
13-11-14 and
the was
complying the
GMP
284. -do- ALEND Tablets Form-5 Alendronic acid Approved.

of Accord
Each tablet contains: Dy. No: HealthCare UK
Alendronate as 1139 dated
sodium…..10mg 03-11-10 Alendrate of
Global Pharma
Biphosphonates 20,000/-
Manufacturer As per
SRO/ Pack
of 10’s

285. -do- DOMELATE-C Tablet Form-5 Not available in Deferred for
SRA’s review of
Each tablet contains: Dy. No: formulation
Domperidone as 1148 dated Me too status by Review
meleate….15mg 03-11-10 needs Committee.
Cinnarizine……25mg confirmation
20,000/-
Antidopaminergic/
Antihistamine As per
SRO/ Pack
Manufacturer of 2x10’s
286. -do- DIVAL Tablets Form-5 Depakote of Approved.
Abbive
Each delayed release tablet Dy. No:
contains: 1147 dated Divarex of
Divalproex 03-11-10 Medera Pharma
sodium…….500mg
20,000/-
Antiepileptic
As per
USP SRO/ Pack
of 10x10’s
287. -do- DIVAL Tablets Form-5 Depakote of Approved.
Abbive
Each delayed release tablet Dy. No:
contains: 1146 dated Divarex of
Divalproex 03-11-10 Medera Pharma
sodium…….250mg
20,000/-
Antiepileptic
As per
USP SRO/ Pack
of 10x10’s
288. -do- LINQUE Tablets Form-5 Seroquel of Approved.
AstraZeneca
Each film coated tablet Dy. No: (USFDA)
contains: 1151 dated
Quetiapine Fumarate 03-11-10 Dequit of
equivalent to Shaheen
Quetiapine….200mg 20,000/- Pharma
Hypnotic As per
SRO/ Pack
of 3x10’s
289. -do- LINQUE Tablets Form-5 Seroquel of Approved.
AstraZeneca
Quetiapine Fumarate 03-11-10 Dequit of

equivalent to Shaheen
Quetiapine….400mg 20,000/- Pharma
Hypnotic As per
SRO/ Pack
Manufacturer of 10’s
290. -do- ALMOVAL Tablets Form-5 Exforge of Approved.
Novartis
Amlodipine as 03-11-10 Exforge of
besylate……5mg Novartis
Valsartan….80mg 20,000/- Karachi
Antihypertensive As per
SRO/ Pack
291. -do- AMEASAID Tablets Form-5 Froben Tablet Approved (As
of Abbot sugar coated
Each sugar coated tablet Dy. No: HealthCare UK approved in
contains: 1152 dated UK).
Flurbiprofen….100mg 03-11-10 Ansaid of Pfizer
Karachi
Antirheumatic 20,000/-
Manufacturer As per
SRO/ Pack
of 30’s
292. -do- ALDONATE Tablet Form-5 Aldomet of Approved.
Aspen UK
Each film coated tablet Dy. No:
contains: 1155 dated Aldomet of
Methyldopa….250mg 03-11-10 MSD
Antihypertensive 20,000/-
Manufacturer As per
SRO/ Pack
of 100’s
293. -do- LINESTIN Tablet Form-5 Aerius of Approved.
Dermagen
Each film coated tablet Dy. No: Pharma
contains: 1149 dated Islamabad
Ebastine……10mg 03-11-10
Antihistamine 20,000/-
As per
SRO/ Pack

of 10’s
294. -do- L-FENAC Capsule Form-5 Acitretin Approved.

Capsules of
Each capsule contains: Dy. No: Genus
Acitretin…..10mg 1136 dated Pharmaceuticals
03-11-10 UK
Vitamin A Derivative
20,000/- Neotigason of
Roche Karachi
As per
SRO/ Pack
of 3x10’s
295. -do- TOLFERID Tablet Form-5 Detrusitol Approved.
Tablet of Pfizer
Each film coated tablet Dy. No: UK
Tolterodine tartrate…..2mg 03-11-10 Detrusitol
Tablet of Pfizer
Urinary antispasmodic 20,000/- Karachi
Manufacturer As per
SRO/ Pack
of 28’s
296. -do- OFLOX Tablet Form-5 Terivid of Approved.
Sanofi UK
contains: 9221 dated Treivid of
Ofloxacin……200mg 06-10-10 Sanofi Karachi
Fluoroquinolone 20,000/-
Manufacturer As per
SRO/ Pack
of 10’s

297. -do- CITAL Tablet Form-5 Not available in Deferred for
SRA’s approval in
Each chewable tablet Dy. No: reference
contains: 9228 dated Me too status Stringent
Escitalopram as 06-10-10 needs Regulatory
oxalate……10mg confirmation Agencies &
20,000/- me too status.
Antidepressant
As per
Manufacturer SRO/ Pack
of 10’s
298. -do- LEVRINE Tablets Form-5 Not available in Deferred for
SRA’s approval in
Each film coated tablet Dy. No: reference
contains: 1140 dated Me too status Stringent
Alverine Citrate…..60mg 03-11-10 needs Regulatory
Simethicone….300mg confirmation. Agencies &
20,000/- me too status.
Antispasmodic
As per
of 2x10’s
299. -do- TAMSIN Capsule Form-5 Flomax MR Approved.
Capsules of
Each capsule contains: Dy. No: Boehringer
Tamsulosin HCL as 1154 dated Inghelheim UK
modified release pellets 03-11-10
(0.2%) equivalent to Tamsolin of
Tamsulosin……0.4mg 20,000/- Getz Karachi
Alpha-1 Blocker As per

SRO/ Pack
Source: Vision
Pharmaceuticals Islamabad
300. -do- LINAKSAT Tablets Form-5 Singulair of Approved.
MSD
contains: 9222 dated Montiget of
Montelukast as 06-10-10 Getz Karachi
sodium……10mg
20,000/-
Antihistamine
As per
of 30’s

301. -do- GEMNILOX Tablets Form-5 Factive of LG Approved.
Life Sciences
Gemifloxacin as 03-11-10 Factiflox of
mesylate…..320mg Envoy Pharma
20,000/-
Quinolone
As per
of 7’s
302. -do- LINPRIDE Tablets Form-5 Solian Tablet Approved.
Each tablet contains: Dy. No: Solian Tablet of

Amisulpride…..50mg 1141 dated Sanofi Karachi
03-11-10
Antipsycotic
20,000/-
Manufacturer
As per
SRO/ Pack
of 2x10’s
303. -do- DOB-C Capsules Form-5 Not available Deferred for
in SRA’s review of
Each capsule contains: Dy. No: formulation
Calcium 1138 dated Doxium of by the Review
dobisilate….500mg 03-11-10 AGP Karachi Committee.
Vasotherapeutic 20,000/-
As per
SRO/ Pack
of 2x10’s
304. M/s Caraway ONDENLES Injection 8mg Form-5 Zofran of GSK a. Evidence of Deferred for
Pharmaceuticals, availability of the
Islamabad. Each ml contains: Dy. No: Zofran of GSK, TOC and liquid followings:
Ondansetron hydrochloride 9773 dated Karachi particle counter 1.
dihydrate equivalent to 18th is not provided Confirmation
Ondansetron……2mg October The inspection by the firm. of installation
2010 of the firm was b. Latest and
5HT-3 Antagonist conducted on inspection operational
20,000/- 24-09-12 by the report is qualifications
USP panel of required. of TOC
As per inspectors and analyser and
SRO they concluded liquid particle
that the firm is counter by
operating at FID.
good level of 2. Latest
GMP inspection

compliance. report is
required.
305. -do- ONDENLES Tablet 8mg Form-5 Zofran of GSK

Latest inspection Deferred for
report is required. latest GMP
Each film coated tablet Dy. No: Zofran of GSK, status of the
contains: 9774 dated Karachi firm.
Ondansetron hydrochloride 18th
dihydrate equivalent to October
Ondansetron……8mg 2010
5HT-3 Antagonist 20,000/-
USP As per
SRO
306. M/s Genix GRANI Tablet Form-5 Kytril Tablet of Approved.
Pharma (Pvt) Roche
Limited, Each film coated tablet Dy. No:
Karachi. contains: 1899 dated Kytril Tablets
Granisetron HCL equivalent 29-10-10 of Roche
to Granisetron…….1mg Karachi
8,000/-
Antiemetic Inspection of
Rs. 3250/- the firm was
Manufacturer Pack of conducted on
10’s 30-04-14 by the
Rs. 6500/- area FID and
Pack of GMP
20’s compliance is
rated as GOOD
307. -do- GRANI Syrup Form-5 Kytril Syrup of Approved.
Roche
Each 5ml contains: Dy. No:
Granisetron HCL equivalent 1907 dated Graniset Syrup
to Granisetron…….1mg 29-10-10 of SJ & G Fazul
Elahi Karachi
Antiemetic 8,000/-
Manufacturer Rs. 210/-

Pack of
30ml
Rs. 420/-
Pack of
60ml

Evaluator – III (Veterinary Cases)
S/N Name and Brand Name Type of Form Remarks on the Recommendat Decision
address of (Proprietary name formulation (if ions by the
manufacturer / + Dosage Form + Initial date, any) including Evaluators
Applicant Strength) diary International
status in
differential fee regulatory
Pharmacological agencies /
Group Demanded authorities
Price / Pack
Finished product size Me-too status
Specification
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
308. M/s Noble NOBI-LINCOL Form-5 Vety Lincon Approved.

Pharma, Mirpur Powder Powder of Leads
Azad Kashmir Dy. No: 05 Pharma Karachi.
Each 1gm contains: dated 02-10-10
Lincomycin
Sulphate…..100mg 20,000/-
Colistin
Sulphate……8,00,0 Decontrolled/
00IU 100gm, 500gm
and 1kg
Antibacterial
Manufacturer
309. -do- TRIDOX-TD Oral Form-5 Pulmotin Water Approved.
Powder Soluble Powder of
Dy. No: 85 Attabak Pharma
Each 1000gm dated 08th Islmabad.
contains: November 2010
Doxycycline
HCL……200gm 20,000/-
Tylosin
Tartrate…..100gm Decontrolled/
Bromohexine 100gm, 500gm,
HCL…..5ogm and 1Kg
Colistin
sulphate…..48MIU

Evaluator – III (Import applications)
S/N Name and Brand Name Type of Form Remarks on Recommendatio Decision
address of (Proprietary name the ns by the
manufacturer + Dosage Form + Initial date, formulation Evaluators
/ Applicant Strength) diary (if any)
including
Composition Fee including International
differential fee status in
Pharmacological stringent
Group Demanded drug
Price / Pack regulatory
Finished product size agencies /
Specification authorities
Me-too status
GMP status
as depicted in
latest
inspection
report (with
date) by the
Evaluator
310. Applicant Famous Brand Form-5A a. Evidence of Deferred for the
M/s Bajwa Single Blood Bags Balance fee is followings:
Sons, 129 Dy No: Not not submitted. 1. Evidence of
Circular Road, provided b. Stability studies Balance fee is
Lohari Lahore Each 100ml of as per Zone-IV- not submitted.
CPDA (Citrate 15000/- dated A conditions as 2. Stability
Manufacturer Phosphate Dextrose 08-10-10 per ICH/ WHO studies as per
Shanghai Adenine Solution, guidelines need Zone-IV-A
Transfusion Anticoagulant) Rs 150/ Blood to be submitted. conditions as
Technology contains: Bag of 250ml c. Original per ICH/ WHO
Co. Ltd. Citric acid Rs 150/ Blood Legalized and guidelines need
Add: No.500 monohydrate……0 Bag of 450ml valid COPP as to be submitted.
You Dong .299g Rs 160/ Blood per WHO 3. Original
Road, Sodium citrate Bag of 500ml format or Legalized and
Minhang, dihydrate………… original and valid COPP as
Shanghai, 2.63g legalized GMP per WHO
201100, P.R of Sodium certificate format or
China biphosphate along with Free original and
monohydrate……0 sale certificate legalized GMP
.222g from regulatory certificate
Dextrose body of country along with Free
monohydrate…….. of origin, needs sale certificate
3.19g to be submitted. from regulatory
Adenine……….0.0 d. Clinical trial body of country
275g data is not of origin, needs

Water for submitted. to be submitted.
Injection….Qs e. Packaging 4. Clinical trial
material data is not
Disposable specification submitted.
are not 5. Packaging
provided material
specification
has not been
provided
M/s Bajwa Double Blood Bags Balance fee is followings:
Sons, 129 Dy No: 29 dated not submitted. 1. Evidence of
Circular Road, Each 100ml of 08-10-10 b. Stability studies Balance fee is
Lohari Lahore CPDA (Citrate as per Zone-IV- not submitted.
Phosphate Dextrose 15000/- dated A conditions as 2. Stability
Manufacturer Adenine Solution, 08-10-10 per ICH/ WHO studies as per
Shanghai Anticoagulant) guidelines need Zone-IV-A
Transfusion contains: Rs 300/ Blood to be submitted. conditions as
Technology Citric acid Bag of 450ml c. Original per ICH/ WHO
Co. Ltd. monohydrate……0 Rs 315/ Blood Legalized and guidelines need
Add: No.500 .299g Bag of 500ml valid COPP as to be submitted.
You Dong Sodium citrate per WHO 3. Original
Road, dihydrate………… format or Legalized and
Minhang, 2.63g original and valid COPP as
Shanghai, Sodium legalized GMP per WHO
201100, P.R of biphosphate certificate format or
China monohydrate……0 along with Free original and
.222g sale certificate legalized GMP
Dextrose from regulatory certificate
monohydrate…….. body of country along with Free
3.19g of origin, needs sale certificate
Adenine……….0.0 to be submitted. from regulatory
275g d. Clinical trial body of country
Water for data is not of origin, needs
Injection….Qs submitted. to be submitted.
e. Packaging 4. Clinical trial
Disposable material data is not
specification submitted.
are not 5. Packaging
provided material
specification has
not been provided
M/s Bajwa triple Blood Bags Balance fee is followings:
Sons, 129 Dy No: Not not submitted. 1. Evidence of
Circular Road, Each 100ml of provided b. Stability Balance fee is
Lohari Lahore CPD (Citrate studies as per not submitted.
Phosphate Dextrose 15000/- dated Zone-IV-A 2. Stability
Manufacturer Solution, 08-10-10 conditions as studies as per

Shanghai Anticoagulant) per ICH/ Zone-IV-A
Transfusion contains: Rs 510/ Blood WHO conditions as
Technology Citric acid Bag of 450ml guidelines per ICH/ WHO
Co. Ltd. monohydrate……0 Rs 525/ Blood need to be guidelines need
Add: No.500 .299g Bag of 500ml submitted. to be submitted.
You Dong Sodium citrate c. Original 3. Original
Road, dihydrate………… Legalized and Legalized and
Minhang, 2.63g valid COPP as valid COPP as
Shanghai, Sodium per WHO per WHO
201100, P.R of biphosphate format or format or
China monohydrate……0 original and original and
.222g legalized GMP legalized GMP
Dextrose certificate certificate
monohydrate…….. along with along with Free
3.19g Free sale sale certificate
Water for certificate from regulatory
Injection….Qs to from body of country
100ml regulatory of origin, needs
body of to be submitted.
Each 100ml of country of 4. Clinical trial
SAGM (Saline origin, needs data is not
Adenine Glucose to be submitted.
Mannitol, Red submitted. 5. Packaging
Blood Cell d. Clinical trial material
Preservative) data is not specification has
contains: submitted. not been
Dextrose e. Packaging provided
monohydrate…..0. material
900g specification
Sodium are not
chloride…..0.877g provided
Adenine…….0.016
9g
D-
Mannitol…….0.52
5g
Water for
Injection….qs to
100ml
Disposable
M/s Bajwa Quadruple Double Balance fee is followings:
Sons, 129 Blood Bags Dy No: Not not submitted. 1. Evidence of
Circular Road, provided b. Stability Balance fee is
Lohari Lahore Each 100ml of studies as per not submitted.
CPD (Citrate 15000/- dated Zone-IV-A 2. Stability
Manufacturer Phosphate Dextrose 08-10-10 conditions as studies as per
Shanghai Solution, per ICH/ Zone-IV-A

Transfusion Anticoagulant) Rs 440/ Blood WHO conditions as
Technology contains: Bag of 450ml guidelines per ICH/ WHO
Co. Ltd. Citric acid Rs 445/ Blood need to be guidelines need
Add: No.500 monohydrate……0 Bag of 500ml submitted. to be submitted.
You Dong .299g c. Original 3. Original
Road, Sodium citrate Legalized and Legalized and
Minhang, dihydrate………… valid COPP as valid COPP as
Shanghai, 2.63g per WHO per WHO
201100, P.R of Sodium format or format or
China biphosphate original and original and
monohydrate……0 legalized GMP legalized GMP
.222g certificate certificate
Dextrose along with along with Free
monohydrate…….. Free sale sale certificate
3.19g certificate from regulatory
Water for from body of country
Injection….Qs to regulatory of origin, needs
100ml body of to be submitted.
country of 4. Clinical trial
Each 100ml of origin, needs data is not
SAGM (Saline to be submitted.
Adenine Glucose submitted. 5. Packaging
Mannitol, Red d. Clinical trial material
Blood Cell data is not specification has
Preservative) submitted. not been provided
contains: e. Packaging
Dextrose material
monohydrate…..0. specification
900g are not
Sodium provided
chloride…..0.877g
Adenine…….0.016
9g
D-
Mannitol…….0.52
5g
Water for
Injection….qs to
100ml
Disposable

Case No.07. Remaining drug registration applications of previously approved new sections
Evaluator – I
M/s Stallion Pharmaceuticals (Pvt) Ltd, Lahore have informed that their 04 products were deferred in
244th meeting of Registration Board held on 8th and 9th May, 2014 due to confirmation of manufacturing
facility and that they are now under process of developing a dedicated Carbapenem facility and that the
04 deferred products may be considered of their approved manufacturing facility. The firm has requested
consideration of the following 04 products on priority basis (according to 10 products per section policy).
S. Name and address Brand Name Type of Form International Remarks / Decision
N of Manufacturer / (Proprietary status in Observations
Applicant name + Dosage Initial date, stringent
form + Strength) diary. regulatory
agencies
Pharmacological
Group Demanded Price GMP status as
/ Pack size depicted in
Finished product inspection
314. M/s. Stallion Fluclox Injection Form-5 FLOXAPEN Approved.

Pharmaceuticals 500mg Injection 500mg
(Pvt) Ltd, 581- 27-10-2014 MHRA UK
Sunder Industrial Dry Powder 1336 R&I
Estate, Lahore Injection
New License Rs. 20,000/-
1.Capsule.(Penicillin Each vial A-FLOX
) contains:- 500mg Injection
2.Dry Powder Flucloxacillin Pack of one Rs. Laderly
Suspension Sodium (B.P) eq. 90/-
(Penicillin) to Flucloxacillin Pack of 5 Rs.
3.Dry Powder ……………….. 450/- N/A (New
Injection (Penicillin) 500mg Pack of 10 Rs. License)
900/-
(Penicillin)
Vide letter No. F. 1-
33/2009 – Lic dated BP Specifications
6th February, 2014
315. -do- Staclox Injection Form-5 AMPICLOX Approved.
250/250mg
Dry Powder 27-10-2014 Injection
Injection 1337 R&I MHRA

Each vial Rs. 20,000/-
contains:- AMPICLOX
Ampicillin 500mg Injection
Sodium (B.P) eq. Pack of one Rs. Gsk
to Ampicillin 70/-
……………….. Pack of 5 Rs.
250mg 350/- N/A (New
Cloxacillin Pack of 10 Rs. License)
Sodium (B.P) eq. 700/-
to Cloxacillin
250mg
(Penicillin)
Manufacturers
Specifications
316. -do- Flustal Injection Form-5 FLUMOX 1) Evidence of Deferred
250/250mg Injapproval of for
Dry Powder 27-10-2014 EIPICO, Egyptsame confirmatio
Injection 1338 R&I formulation in n of
Egypt has been approval in
Each vial Rs. 20,000/- Biflocin provided reference
contains:- 500mg Inj instead of Stringent
Amoxicillin Zam Zam Corp stringent Reulatory
Sodium (B.P) eq. Pack of one Rs. regulatory Agencies.
to 144/- N/A (New authority e.g.,
Amoxicillin…….. Pack of 5 Rs. License) FDA, TGA,
….. 250mg 720/- MHLW, EMA
Flucloxacillin Pack of 10 Rs. and Health
Sodium (B.P) eq. 1440/- Canada.
to Flucloxacillin
…………………
250mg
(Penicillin)
Manufacturers
Specifications
317. -do- Amoxi Injection Form-5 Amoxil 500 mg Approved.
500mg (BP) Vial
Dry Powder 25-10-2013 MHRA
Injection 643 R&I
Each Vial Amoxil 500 mg
Contains: Rs. 20,000/- GSK, Pakistan
Amoxicillin
Sodium ( BP) eq. Rs. 90.0 / 1’s, N/A (New

to Rs. 900.0 / 10’s License)
Amoxicillin ……
500mg
(Penicillin)
BP Specifications
Evaluator – II
The Registration Board has been granting 10 products per section to newly approved sections. Following
are the remaining products of the applicants as per above policy.
S/ Name and Brand Name Type of Form Remarks on the Decision

N address of formulation (if any)
manufacturer / (Proprietary name + Initial date, diary including International
Applicant Dosage Form + status in stringent drug
differential fee regulatory agencies /
Composition authorities
Demanded Price /
Pharmacological Pack size Me-too status
Group GMP status as depicted
Finished product in latest inspection
Specification report (with date) by
the Evaluator
318. M/s Rogen Efrog 13.9%Cream Form 5 BNF: Vaniqa (Almirall), Approved in
Pharmaceuticals Each gram contains:- but in 11.5% strength 11.5 % strength.
Plot No. 30 Street Eflornithine (as 26/11/2014 Dy. No.
No. # S-4 National eflornithine 1907 Rs. 20000/- Vanika (Crystollite) 13.9
Industrial Zone Hydrochloride % , Depilus Cream (Atco)
Rawat Islamabad. …139mg As per SRO in 11.5% strength but no
Semi Solid (Enzyme Inhibitor) pricing
(Cream/Ointment) (Manufacturer’s
General Section Spec.s) The company may be
(No. F. 1-27/2009- issued cGMP Certificate
Lic Dated 19-07-10 for export purpose. (09-
) 06-2014)
1. The product is
available in 11.5 %

strength as per BNF.
In Pakistan product is
available in both
13.9% and 11.5 %
strengths but pricing
of 11.5 % strength
could not be traced.
The Firm has
submitted master
formulation of both
strength after
evaluation of initial
dossier and has
requested to grant
them registration of
any one strength.
319. M/s Faas Antisec Sachet Form 5 BNF: Hidrasec (Abbott Deferred for
Pharmaceuticals Each Sachet Healthcare) confirmation of
(Pvt.) Limited F- contains:- 29/10/2014 Dy. No. me too status
784/L S.I.T.E. Racecadotril 117 Rs. 20000/- Not confirmed otherwise the
Karachi (B.P)…10mg firm shall apply
(Anti-Diarrheal) As per SRO/1×10’s Satisfactory level of GMP on form 5-D
Sachet Section: (Manufacturer’s compliance(18-03-14) with fee & other
F. 2-2/2009-Lic Spec.s) codal
dated 15-02-2013 1. Me-too status needs formalities.
confirmation.
320. -do- Antisec Sachet Form 5 Not confirmed Deferred for
Each Sachet confirmation of
contains:- 29/10/2014 Dy. No. Not confirmed approval in
Racecadotril 116 Rs. 20000/- reference
(B.P)…15mg Satisfactory level of GMP Stringent
(Anti-Diarrheal) As per SRO/1×10’s compliance(18-03-14) Regulatory
(Manufacturer’s Agencies & me
Spec.s) 1. International too status.
availability of
formulation in SRA’s
not confirmed.
2. Me-too status needs
confirmation.

321. -do- Antisec Sachet Form 5 BNF: Hidrasec (Abbott Deferred for
Each Sachet Healthcare) confirmation of
contains:- 29/10/2014 Dy. No. me too status
Racecadotril 115 Rs. 20000/- Not confirmed otherwise the
(B.P)…30mg firm shall apply
(Anti-Diarrheal) As per SRO/1×10’s Satisfactory level of GMP on form 5-D
(Manufacturer’s compliance(18-03-14) with fee & other
Spec.s) codal
1. Me-too status needs formalities.
confirmation.
322. -do- Uronol Sachet 3G Form 5 Health Canada: Monurol Deferred for
Each Sachet (Triton Pharma Inc.) confirmation of
contains:- 29/10/2014 Dy. No. me too status
Fosfomycin (as 114 Rs. 20000/- Not confirmed otherwise the
Tromethamine firm shall apply
…3gm As per SRO/1×10’s Satisfactory level of GMP on form 5-D
(Anti-bacterial) compliance (18-03-14) with fee & other
(Manufacturer’s codal
Spec.s) 1. Me-too status needs formalities.
confirmation.
323. -do- Ostrolife Sachet Form 5 Not confirmed Deferred for
Each Sachet confirmation of
contains:- 29/10/2014 Dy. No. Not confirmed approval in
Cholecalciferol 276 Rs. 20000/- reference
(USP)…60,000IU Satisfactory level of GMP Stringent
(Vitamin) As per SRO/1×10’s compliance(18-03-14) Regulatory
(Manufacturer’s Agencies & me
Spec.s) 1. International too status.
availability of
not confirmed.
2. Me-too status needs
confirmation.
324. -do- Oraltral Sachet Form 5 Not confirmed Approved as the
(Orange Flavor) formulation is
Each Sachet 29/10/2014 Dy. No. Peditral (Searle) WHO approved.
contains:- 271 Rs. 20000/-
Sodium Satisfactory level of GMP
Chloride…3.5g As per SRO/1×20’s compliance(18-03-14)
Sodium Citrate
Dihydrate…2.9g 1. International
Potassium availability of
Chloride…1.5 formulation in SRA’s
Glucose
not confirmed. WHO
Anhydrous…20g
(Electrolytes) formulation is sodium
(Manufacturer’s chloride 2.6 g,

Spec.s) potassium chloride
1.5 g, sodium citrate
2.9 g, anhydrous
glucose 13.5 g
325. -do- Oraltral Sachet Form 5 Not confirmed Approved as the
(Lemon and Lime formulation is
Flavor) 17/09/2014 Dy. No. Peditral (Searle) WHO approved.
Each Sachet 274 Rs. 20000/-
contains:- Satisfactory level of GMP
Sodium As per SRO/1×20’s compliance(18-03-14)
Chloride…3.5g
Sodium Citrate 1. International
Dihydrate…2.9g availability of
Potassium formulation in SRA’s
Chloride…1.5
not confirmed. WHO
Glucose
Anhydrous…20g formulation is sodium
(Anti-Malarial) chloride 2.6 g,
(B.P Spec.s) potassium chloride
1.5 g, sodium citrate
2.9 g, anhydrous
glucose 13.5 g.
326. -do- Neomecta Sachet Form 5 Not confirmed Deferred for
Each Sachet review of
contains:- 17/09/2014 Dy. No. Smecta (Atco) formulation by
Dioctahedral 275 Rs. 20000/- Review
Smectite…3000mg Satisfactory level of GMP Committee.
(Anti-diarrhioeals) As per SRO/1×30’s compliance(18-03-14)
(Manufacturer’s
Spec.s) 1. International
availability of
not confirmed.
327. -do- Itometic Capsule Form 5 Not confirmed Deferred for
Capsule Section: Each capsule review of
F. 2-2/2009-Lic contains: 17/09/2014 Dy. No. Ganaton OD (Abbott) formulation
dated 15-02-2013 270 Rs. 20000/- alongwith the
Itopride
Satisfactory level of GMP rectification of
hydrochloride…150 As per SRO/1×10’s compliance(18-03-14) following
mg observations:
(as sustained release 1. Formulation is under 1. Fee for
pellets) review by the Review import of
(Gastoprokinetic / Committee. pellets,
antiemetic) Legalized Copy
2. Fee for import of
of Valid GMP
(Manufacturer’s pellets, Legalized certificate of
Spec.s) Copy of Valid GMP manufacturer of

(Source of Pellets: certificate of Pellets;
M/s Titan manufacturer of 2. stability
Laboratories Private Pellets; stability studies
Limited Plot No. according to
studies according to
zone of Pakistan
E27/1, E27/2, MIDC, zone of Pakistan of of Pellets are
Mahad Village Jite Pellets are required. required.
District, Raigad, .
Maharashtra, India)
328. -do- Azobact Capsule Form 5 BNF : Zithromax Approved.
250mg (Pfizer)
Each capsule 17/09/2014 Dy. No.
266 Rs. 20000/- Azomax (Novartis)
contains:
Azithromycine (As As per SRO/1×10’s Satisfactory level of GMP
dihydrate) compliance(18-03-14)
(USP)..250mg
(Anti-Infective)
(USP Spec.s)
329. -do- Pirotrin 20mg Form 5 BNF : Feldene (Pfizer) Approved.
Capsule
Each capsule 17/09/2014 Dy. No. Pirobet (Highnoon)
267 Rs. 20000/-
contains:
Satisfactory level of GMP
Piroxicam beta As per SRO/1×10’s compliance(18-03-14)
cyclodextrin eq. to
Piroxicam……..20
mg
(Analgesic / anti-
rheumatic/ anti
pyretic)
(Manufacturer’s
Spec.s)
330. -do- Tamsol 0.4mg Form 5 BNF: Tamsulosin Approved. Firm
Capsule hydrochloride (Non- will provide
Each capsule 17/09/2014 Dy. No. proprietary) Certificate of
268 Rs. 20000/- Analysis and
contains:-
Tamsolin (Getz) stability studies
Tamsulosin As per SRO/1×10’s of pellets
hydrochloride(as Satisfactory level of GMP according to
modified release compliance (18-03-14) zone IV A and
pellets)…….0.4 mg Chairman, RB
(Anti BPH) 1. Certificate of will permit
(USP Spec.s) Analysis, stability issuance of
studies according to registration
{Source: M/s Vision
letter.
Pharmaceuticals, Plot zone of Pakistan of
No 224, Street No. Pellets are required.

01, I-10/3 , Industrial
area, Islamabad}
Evaluator – III

manufacturer / Dosage Form + formulation
Applicant Strength) Initial date, (if any)
diary including
Composition International
Fee status in
Pharmacological including stringent drug
Group differential regulatory
fee agencies /
Finished product authorities
Price / Pack Me-too status
size
GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator
331. M/s Wenovo CLARITHREM Form-5 Klaricid of Approved.

Pharmaceuticals, Injection Abbott UK
Taxila Dy No: 864 (Lyophilized
Each vial contains: dated 24-09- Powder)
(Dry Powder Vial Clarithromycin 2014
Injectable) ….….500mg Clariset of
20,000/- Mediate
Macrolide Pharma
As fixed by
BP Govt.
Pack of 1’s
332. -do- LANSOP Injection Form-5 Prevacid of Approved.
30mg Takeds Pharm
Dy No: 863 (USFDA)
Each vial contains: dated 24-09- Lyophilized
Lansoprazole……30mg 2014 Powder
PPI 20,000/- Lansit of SJ &

G Fazul Elhahi
Manufacturer As fixed by Karachi
Govt.

Pack of 1’s
333. -do- PANTOWEN Injection Form-5 Protonix of Approved.

Wyeth
Each vial contains: Dy No: 862 (USFDA)
Pantoprazole as dated 24-09- Lyophilized
sodium…..40mg 2014 powder
PPI 20,000/- Lesprot of

Nabiqasim
Manufacturer As fixed by Karachi
Govt.
Pack of 1’s
334. -do- AZINOV Injection Form-5 Zithromax of Approved.
Pfizer
Each vial contains: Dy No: 862 (USFDA)
Azithromycin….500mg dated 24-09- Lyophilized
2014 Powder
Macrolide
20,000/- Azimycin of
Manufacturer Medicina
As fixed by Pharma Lahore
Govt.
Pack of 1’s
335. -do- WENOLOX Capsule Form-5 Cymbalta of Approved.
(Capsule General) EliLilly
Each capsule contains: Dy No: 1277 Netherlands
Duloxetine as HCL dated 24-10-
enteric coated pellets 2014 Duxafit of
(17%) eq. to Wnsfield
Duloxetine…..30mg 20,000/- Hattar
Antidepressant As per policy

of MOH
Source: Vision Pharma

Islamabad

336. -do- WENOLOX Capsule Form-5 Cymbalta of Approved.
Eli Lilly
Each capsule contains: Dy No: 1276 Netherlands
Duloxetine as HCL dated 24-10-
enteric coated pellets 2014 Duxafit of
(17%) eq. to Wnsfield
Duloxetine…..60mg 20,000/- Hattar
Antidepressant As per policy

of MOH
337. -do- GABANOV Capsules Form-5 Gabapentin Approved.
Capsules of
Each capsule contains: Dy No: 1274 Sandoz UK
Gabapentin…..300mg dated 24-10-
2014 Nerogabin of
Anticonvulsant Merck
20,000/-
USP
As per policy
of MOH
1x10’s
338. -do- GABANOV Capsules Form-5 Gabapentin Approved
Arrow 400mg
Each capsule contains: Dy No: 1275 Hard Capsules
Gabapentin…..400mg dated 24-10- of Actavis UK
2014
Anticonvulsant Nerogabin of
20,000/- Merck
USP
As per policy
of MOH
1x10’s
339. -do- TRAMANOV Injection Form-5 Tramdol Evidence of Deferred for
(Liquid Ampoule Injection of availability of TOC confirmation
SVP) Each 2ml ampoule Dy No: 1273 Beacon analyzer and liquid of
contains: dated 23-10- Pharma UK particle counter is installation
Tramadol 2014 required. and
HCL……100mg Lamadol of operational
20,000/- Brooks qualifications
Synthetic opiate Karachi of TOC
analogue As per policy analyser &
of MOH liquid
Manufacturer Pack of 5’s Particle
& 10’s Counter by
Area FID.

340. -do- WENOFEN Injection Form-5 Availability in Evidence of Deferred for
SRA’s needs availability of TOC confirmation
Each 2ml of amber Dy No: 1272 confirmation analyzer and liquid of
glass ampoule contains: dated 23-10- particle counter is installation
Diclofenac 2014 Dinopen of required. and
Sodium…..75mg Global operational
Lidocaine 20,000/- Pharma, qualifications
HCl…..20mg Islamabad. of TOC
As per policy analyser &
Analgesic, Local of MOH liquid
anesthetic Pack of 5’s Particle
& 10’s Counter by
Manufacturer Area FID.
Evaluator – III (Veterinary applications)
S/N Name and Brand Name Type of Form Remarks on Remarks by the Decision
address of (Proprietary name + the formulation Evaluator
manufacturer / Dosage Form + Initial date, (if any)
Applicant Strength) diary including
International
Composition Fee including status in
differential stringent drug
Pharmacological fee regulatory
Group agencies /
Finished product Price / Pack
Specification size Me-too status
GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator
341. M/s Noble Nobivec Injection 2% Form-5 Elvomec D/S of Deferred for
Pharma, Mirpur Elko Karachi confirmation
Azad Kashmir Each ml contains: Dy. No: 65 of
Ivermectin……..20mg dated 20-07-14 Inspection of the installation
Liquid Injection firm was and
Section Antiparasitic 20,000/- conducted by operational
(Veterinary) the area FID and qualifications
Approved vide BP Decontrolled/ firm was found of liquid
letter No. F.5- Pack of 50ml GMP compliant. Particle
2/207 Lic Counter by
dated: 18-02-13 Area FID.

342. -do- Nobivec Injection 1% Form-5 Actimec Deferred for
Injection of confirmation
Each ml contains: Dy. No: 66 Selmore of
Ivermectin……..10mg dated 20-07-14 Pharmaceuticals installation
Lahore. and
Antiparasitic 20,000/- operational
qualifications
BP Decontrolled/ of liquid
Pack of 50ml Particle
Counter by
Area FID.
Case No.08. Registration applications of Pregabalin deferred in previous meetings of

Registration Board
Evaluator - I
Sr. Name and address Brand Name Type of Form International Remarks / Decision
No. of Manufacturer / (Proprietary name status in Observations
Applicant + Dosage form + Initial date, stringent
Strength) diary. regulatory
agencies
Pharmacological
Group Demanded GMP status as
Price / Pack depicted in
Finished product size inspection
343. M/S CCL Achlin Capsule Form 5 LYRICA Approved.

Pharmaceutical 25mg Capsules (25, 50,
(Pvt.) Ltd. 62- 14-11-2005 75, 100,
Industrial Estate , Capsule Rs.8000/- 150,200, 225 and
Kot Lakhpat, Each Capsule Dy. No. Not 300mg)
Lahore. Contains: mentioned US FDA
Pregabalin……25
mg 14-02-2014 ZEEGAP
Dy. No.596 Capsules (25, 50,
(Antiepileptics, Rs.12000/- 75, 100 and
other antiepileptics) 150mg)
14’s/ As Per Hilton
Manufacturers Brand Leader
specifications Panel inspection
for the grant of
GMP certificate

conducted on
06/11/2013,
12/12/2013 &
18/12/2013.
Capsule
(General) section
mentioned in
Issuance of /
Revalidation of
DML vide letter
No. F. 1-8/84-Lic
(Vol. II)
(Pvt.) Ltd. 62- 14-11-2005 75, 100,
Pregabalin……50
for the grant of
GMP certificate
conducted on
06/11/2013,
12/12/2013 &
18/12/2013.
Capsule
(General) section
mentioned in
Issuance of /
Revalidation of
DML vide letter
No. F. 1-8/84-Lic
(Vol. II)
(Pvt.) Ltd. 62- 14-11-2005 75, 100,
Pregabalin……100

for the grant of
GMP certificate
conducted on
06/11/2013,
12/12/2013 &
18/12/2013.
Capsule
(General) section
mentioned in
Issuance of /
Revalidation of
DML vide letter
No. F. 1-8/84-Lic
(Vol. II)
346. M/S NabiQasim Preka Capsule Form 5 LYRICA Approved.
(Pvt) Ltd. 17/24, 150mg Capsules (25, 50,
Korangi Industrial Capsule 24-04-2008 75, 100,
Area, Karachi- Rs.8000/- 150,200, 225 and
Pakistan. Each Capsule Dy. No. Not 300mg)
Contains: mentioned US FDA
Pregabalin……150
Rs.12000/- Capsules (25, 50,
(Anticonvulsant) Dy. No. not 75, 100 and
mentioned 150mg)
Manufacturers duplicate dossier Hilton
Specifications /
Inspection report
10’s, / Rs. 288/- dated 18-12-
20’s / Rs. 547/- 2013. Capsule
30’s / 799/- section
mentioned in
report and cGMP
certificate.


Pregabalin……75
Rs.12000/- Capsules (25, 50,
mentioned 150mg)
Specifications /
Inspection report
10’s / Rs.160/- dated 18-12-
20’s / Rs. 304/- 2013. Capsule
30’s / Rs. 444/- section
mentioned in
report and cGMP
certificate.
Pregabalin……50
Rs.12000/- Capsules (25, 50,
mentioned 150mg)
Specifications /
Inspection report
10’s / Rs.144/- dated 18-12-
20’s / Rs. 273/- 2013. Capsule
mentioned in
report and cGMP
certificate.
Pregabalin……100
Rs.12000/- Capsules (25, 50,
mentioned 150mg)
Specifications /

Inspection report
10’s / Rs.201/- dated 18-12-
20’s / Rs. 382/- 2013. Capsule
mentioned in
report and cGMP
certificate.
350. M/S Linz Pegab 300mg Form 5 LYRICA Approved.
Pharmaceuticals Capsule Capsules (25, 50,
(Pvt) Ltd., 31-G/H, Capsule Covering letter 75, 100,
Sector 15 Korangi not attached. 150,200, 225 and
Industrial Area, Each Capsule Rs.8000/- Jul, 300mg)
Karachi-Pakistan. Contains: 2008 US FDA
Pregabalin……300 Dy. No. Not
mg mentioned GABICA
Capsules (50, 75,
(Anticonvulsant 28-05-2014 100, 150 and
Agent) Rs.12000/- 300mg)
Dy. No. 802 Getz
Manufacturers duplicate dossier
specifications /
Panel inspection
14’s/ Rs.390/- dated 27-05-
2014. Capsule
section
mentioned. Panel
recommended
grant of renewal.
Pregabalin……100
mg Dy. No. Not GABICA
mentioned Capsules (50, 75,
Agent) Rs.12000/- 300mg)
Dy. No. Not Getz
14’s/ Rs.291/- dated 27-05-
2014. Capsule
section
mentioned. Panel
recommended
grant of renewal.

mg mentioned GABICA
Capsules (50, 75,
Agent) Rs.12000/- 300mg)
Dy. No. Not Getz
14’s/ Rs.237/- dated 27-05-
2014. Capsule
section
mentioned. Panel
recommended
grant of renewal.
353. M/S Bosch 221, Gablin 100mg Form 5 LYRICA Approved.

Bosch House , Capsule Capsules (25, 50,
Sector 23, Korangi Capsule Covering letter 75, 100,
Industrial not attached. 150,200, 225 and
Area,Karachi. Each Capsule June, 2008 300mg)
Contains: Rs.8000/- US FDA
mg mentioned ZEEGAP
Capsules (25, 50,
Agent) Rs.12000/- 150mg)
803 R&I Hilton
Manufacturers
specifications 14’s / Rs.291/- Inspection report
dated 12-08-
2014. Capsule
section approved
mg mentioned ZEEGAP
Capsules (25, 50,
Agent) Rs.12000/- 150mg)

803 R&I Hilton
Manufacturers
specifications 14’s/ Rs.237/- Inspection report
dated 12-08-
2014. Capsule
section approved
Pregabalin……300 Dy. No. 803
mg ZEEGAP
28-05-2014 Capsules (25, 50,
(Anticonvulsant Rs.12000/- 75, 100 and
Agent) 803 R&I 150mg)
Hilton
Manufacturers 14’s/ Rs.390/-
specifications Inspection report
dated 12-08-
2014. Capsule
section approved
356. M/S Sami Pregy 50mg Form 5 LYRICA Approved.
Pharmaceutical Capsule Capsules (25, 50,
Pvt., Limited F-95, Capsule Rs.8000/- 75, 100,
S.I.T.E. Karachi. 22-12-2009 150,200, 225 and
Each Capsule Dy. No. not 300mg)
Pregabalin……50
mg GABICA
Rs.12000/- fee Capsules (50, 75,
(Anticonvulsant) challan is 100, 150 and
missing 300mg)
Manufacturer Getz
Specifications As per PRC
Panel inspection
duplicate dossier report dated 24-
06-2014. Panel
recommended
grant of
additional
sections. Capsule
section
mentioned.
22-12-2009 150,200, 225 and

S.I.T.E. Karachi. Each Capsule Dy. No. not 300mg)
Pregabalin……75
mg Rs.12000/- GABICA
29-07-2013 Capsules (50, 75,
(Anticonvulsant) Dy. No. Not 100, 150 and
mentioned 300mg)
Manufacturer Getz
Specifications As per PRC
duplicate dossier Panel inspection
report dated 24-
06-2014. Panel
recommended
grant of
additional
sections. Capsule
section
mentioned.
S.I.T.E. Karachi. 22-12-2009 150,200, 225 and
Pregabalin……100
29-07-2013 Capsules (50, 75,
(Anticonvulsant) Dy. No. Not 100, 150 and
mentioned 300mg)
Manufacturers Getz
specifications As per PRC
Duplicate Panel inspection
dossier report dated 24-
06-2014. Panel
recommended
grant of
additional
sections. Capsule
section
mentioned.
Pharmaceutical Capsule Rs.8000/- Capsules (25, 50,
Pvt., Limited F-95, Capsule 22-12-2009 75, 100,
S.I.T.E. Karachi. Dy. No. not 150,200, 225 and
Each Capsule mentioned 300mg)
Pregabalin……150 29-07-2013
mg Dy. No. Not GABICA
mentioned Capsules (50, 75,

(Anticonvulsant) 100, 150 and
As per PRC 300mg)
Manufacturers Duplicate Getz
specifications dossier
Panel inspection
report dated 24-
06-2014. Panel
recommended
grant of
additional
sections. Capsule
section
mentioned.
360. M/S AGP (Private) Hi-Gab Capsules Form 5 LYRICA Approved.
Limited, B-23, 75mg Capsules (25, 50,
S.I.T.E., Karachi Capsule Rs.8000/- 75, 100,
17-07-2009 150,200, 225 and
Pregabalin……75
19-03-2014 Capsules (50, 75,
(Anti-Epileptic) Dy. No. Not 100, 150 and
mentioned 300mg)
Manufacturers Getz
specifications 14’s / Rs.565/-
Duplicate Inspection report
dossier dated
26/11/2013.
Capsule section
mentioned in FID
report.
361. M/S AGP (Private) Hi-Gab Capsules Form 5 Approved.
Limited, B-23, 50mg LYRICA
S.I.T.E., Karachi Capsule Rs.8000/- Capsules (25, 50,
17-07-2009 75, 100,
Each Capsule Dy. No. not 150,200, 225 and
Contains: mentioned 300mg)
Pregabalin……50 US FDA
mg Rs.12000/-
19-03-2014 GABICA
(Anti-Epileptic) Dy. No. Not Capsules (50, 75,
mentioned 100, 150 and
Manufacturers 300mg)
specifications 14’s / Rs.450/- Getz
duplicate dossier
Inspection report
dated
26/11/2013.

Capsule section
mentioned in FID
report.
17-07-2009 150,200, 225 and
Pregabalin……200
mg Rs.12000/- SYNGAB
19-03-2014 Capsules 200mg
(Anti-Epileptic) Dy. No. Not Atco
mentioned
Manufacturers Inspection report
specifications 14’s / Rs.1225/- dated
duplicate dossier 26/11/2013.
Capsule section
mentioned in FID
report.
363. M/S AGP (Private) Hi-Gab Capsules Form 5 LYRICA 1) Evidence Deferred for
Limited, B-23, 225mg Capsules (25, 50, of me too confirmation of
S.I.T.E., Karachi Capsule Rs.8000/- 75, 100, status me too status.
17-07-2009 150,200, 225 and required.
Pregabalin……225
mg Rs.12000/- Evidence of Me
19-03-2014 too status
(Anti-Epileptic) Dy. No. Not required
mentioned
Manufacturers Inspection report
specifications 14’s / Rs.1370/- dated
duplicate dossier 26/11/2013.
Capsule section
mentioned in FID
report.
17-07-2009 150,200, 225 and
Pregabalin ……
300mg Rs.12000/- GABICA
19-03-2014 Capsules (50, 75,
mentioned 300mg)
Manufacturers Getz

specifications 14’s/Rs.1560/-
duplicate dossier Inspection report
dated
26/11/2013.
Capsule section
mentioned in FID
report.
17-07-2009 150,200, 225 and
Pregabalin……100
19-03-2014 Capsules (50, 75,
mentioned 300mg)
Manufacturers Getz
dated
26/11/2013.
Capsule section
mentioned in FID
report.
17-07-2009 150,200, 225 and
Pregabalin……25
mg Rs.12000/- ZEEGAP
19-03-2014 Capsules (25, 50,
mentioned 150mg)
Manufacturers Hilton
specifications 14’s / Rs.270/-
dated
26/11/2013.
Capsule section
mentioned in FID
report.
17-07-2009 150,200, 225 and

Pregabalin……150
19-03-2014 Capsules (50, 75,
mentioned 300mg)
Manufacturers Getz
dated
26/11/2013.
Capsule section
mentioned in FID
report.
368. M/s Neutro Pharma Gabin Capsules Form 5 LYRICA Approved.
(Pvt) Ltd., 9.5 Km, 300mg Capsules (25, 50,
Sheikhupura Road, Capsule Rs.8000/- 75, 100,
Lahore 17-08-2009 150,200, 225 and
Pregabalin……300
07-07-2014 Capsules (50, 75,
(GABA Analogue) Dy. No. 66 100, 150 and
300mg)
Manufacturers As per PRC Getz
Specifications
Panel inspection
to check GMP
compliance
conducted on
6th& 7th January,
2014.
369. M/s Atco Syngab Form 5 LYRICA Approved.
Laboratories Capsules75mg Capsules (25, 50,
Limited, B-18, Capsule Rs.8000/- 75, 100,
S.I.T.E., Karachi 29-04-2008 150,200, 225 and
Pregabalin……75
08-04-2014 Capsules (50, 75,
(Anti Epileptic) Dy. No. not 100, 150 and
mentioned 300mg)
Manufacturers Getz
Specifications As per leader
price per 14’s Inspection report
dated 18-06-2014

370. M/s Atco Syngab Capsules Form 5 LYRICA Approved.
Laboratories 150mg Capsules (25, 50,
S.I.T.E., Karachi 29-04-2008 150,200, 225 and
Pregabalin……150
08-04-2014 Capsules (50, 75,
mentioned 300mg)
Manufacturers Getz
dated 18-06-2014
371. M/s Atco Syngab Capsules Form 5 LYRICA Approved.
Laboratories 300mg Capsules (25, 50,
S.I.T.E., Karachi 22-04-2008 150,200, 225 and
Pregabalin……300
08-04-2014 Capsules (50, 75,
mentioned 300mg)
Manufacturers Getz
dated 18-06-2014
372. M/S Tabros Grelin Capsule Form 5 LYRICA Approved.
Pharma 75mg Capsules (25, 50,
Capsule Rs.8000/- 75, 100,
L-20/B, F.B. 30-06-2008 150,200, 225 and
Industrial Area, Each Capsule Dy. No. Not 300mg)
Karachi. Contains: mentioned US FDA
Pregabalin……75
Dated 20-03- Capsules (50, 75,
(Anti-Epileptic.) 2014 100, 150 and
Dy. No. not 300mg)
Manufacturers mentioned Getz
specifications
14’s / Rs.1100/- Inspection report
(Rs. 78.57 per dated
capsule) 11/03/2014.
(duplicate Overall
dossier) conditions noted
improved as

compared to last
visit.
Capsule Rs.8000/- 75, 100,
L-20/B, F.B. 30-06-2008 150,200, 225 and
Pregabalin……100
Dated.20-03- Capsules (50, 75,
Dy. No. not 300mg)
specifications
14’s/Rs.1300/- Inspection report
(duplicate dated
dossier) 11/03/2014.
Overall
conditions noted
improved as
compared to last
visit.
Capsule Rs.8000/- 75, 100,
L-20/B, F.B. 30-06-2008 150,200, 225 and
Pregabalin……150
Dy. No. not 300mg)
specifications
(duplicate dated
dossier) 11/03/2014.
Overall
conditions noted
improved as
compared to last
visit.
Capsule Rs.8000/- 75, 100,
L-20/B, F.B. 30-06-2008 150,200, 225 and

Pregabalin……300
Dy. No. not 300mg)
specifications
(duplicate dated
dossier) 11/03/2014.
Overall
conditions noted
improved as
compared to last
visit.
376. M/S Scotmann Foxril Capsule Form 5 LYRICA Approved.
Pharmaceuticals, 5- 75mg Capsules (25, 50,
D, I-10/3, Industrial Capsule Rs.8000/- 75, 100,
Area Islamabad. 15-07-2008 150,200, 225 and
Each Capsule Dy. No. 186 300mg)
Contains: US FDA
Pregabalin……75 Rs.12000/-
mg Dated.08-07- GABICA
2014 Capsules (50, 75,
(Anticonvulsant.) Dy. No. 1244 100, 150 and
300mg)
Manufacturers 14’s / Rs. 16.95 Getz
specifications / Capsule
Inspection report
dated 12-04-
2013. Good
compliance.
Capsule section
mentioned in
panel inspection
report dated 02-
12-2008.
Each Capsule Dy. No.176 300mg)
Contains: US FDA
2014 Capsules (50, 75,
300mg)

Manufacturers 14’s/Rs.20.85/C Getz
specifications apsule
Inspection report
dated 12-04-
2013. Good
compliance.
Capsule section
mentioned in
panel inspection
report dated 02-
12-2008.

Each Capsule Dy No.181 300mg)
Contains: US FDA
2014 Capsules (50, 75,
300mg)
Manufacturers Rs.33.90/Capsul Getz
specifications e
14’s Inspection report
dated 12-04-
2013. Good
compliance.
Capsule section
mentioned in
panel inspection
report dated 02-
12-2008.
379. M/S OBS Pakistan Pregalin Capsule Form 5 LYRICA Approved.
(Pvt.) Ltd. C-14, Capsule Capsules (25, 50,
S.I.T.E., Rs.8000/- 75, 100,
Manghopir Road Each Capsule 18-10-2008 150,200, 225 and
Karachi-75700 Contains: Not mentioned 300mg)
mg Rs.12000/-
Dated.29-07- GABICA
(Antiepileptics) 2013 duplicate Capsules (50, 75,
dossier 100, 150 and
specifications Dy. No. not Getz
mentioned
dated 06-03-

2014. GMP
satisfactory and
capsule section
mentioned in
report.
S.I.T.E., Rs.8000/- 75, 100,
mg Rs.12000/-
Dated.29-07- GABICA
mentioned
dated 06-03-
2014. GMP
satisfactory and
capsule section
mentioned in
report.
S.I.T.E., Rs.8000/- 75, 100,
mg Rs.12000/-
Dated.29-07- GABICA
mentioned
dated 06-03-
2014. GMP
satisfactory and
capsule section
mentioned in
report.
382. M/S Glitz Pharma P-Gab 75 Form 5 Inspection report 1) Firm had The request of
(Pvt.) Ltd; 265- Tablet dated 18-03- initially the firm has
Industrial Triangle, Rs.8000/- 2013. applied on not been
Kahuta Road Each film coated 31-12-2008 Satisfactory GMP Form 5 for acceded to by

Islamabad. tablet Contains: Dy. No.561 and tablet section registration of the Board &
Pregabalin……75 mentioned. Pregabalin the Board
mg Rs.12000/- 75mg tablet. rejected the
Dated.08-07- Since the application of
(Antiepileptics) 2014 product is not P-Gab 75
Dy. No. 1239 me too, firm Tablet
Manufacturers was asked to
specifications 10x2=20’s /As provide me
Per SRO too reference
or application
on Form 5D.
Now, firm
has requested
to change the
particulars of
the file to
Pregabalin
Oral Solution
20mg/ml.
Firm has also
submitted that
additional fee
if any, will be
deposited.
383. M/S Glitz Pharma P-Gab 100 Form 5 Inspection report 1) Firm had The request of
Kahuta Road Each tablet 31-12-2008 Satisfactory GMP Form 5 for acceded to by
Islamabad. Contains: Dy. No.562 and tablet and registration of the Board &
Pregabalin……100 capsule section Pregabalin the Board
mg Rs.12000/- mentioned. 100mg tablet. rejected the
Dated.08-07- Since the application P-
(Antiepileptics) 2014 product is not Gab 100,
specifications 10x2=20’s & provide me
14’s /As Per too reference
SRO or application
on Form 5D.
Now, firm
has requested
to change the
particulars of
the file to
Pregabalin
300mg
capsules.
Firm has also

submitted that
additional fee
if any, will be
deposited.
384. M/S Glitz Pharma P-Gab 50 Form 5 1) Firm had The request of
(Pvt.) Ltd; 265- Tablet Inspection report initially the firm has
Industrial Triangle, Rs.8000/- dated 18-03- applied on not been
Kahuta Road Each tablet 31-12-2008 2013. Form 5 for acceded to by
Islamabad. Contains: Dy. No. 560 Satisfactory GMP registration of the Board &
Pregabalin……50 and tablet section Pregabalin the Board
mg Rs.12000/- mentioned. 100mg tablet. rejected the
Dated.08-07- Since the application of
(Antiepileptics) 2014 product is not P-Gab 50,
specifications 10x2=20’s /As provide me
Per SRO too reference
or application
on Form 5D.
Now, firm
has requested
to change the
particulars of
the file to
Pregabalin
200mg
capsules.
Firm has also
submitted that
additional fee
if any, will be
deposited.
385. M/S Glitz Pharma P-Gab 150mg Form 5 Inspection report 1) Firm had The request of
Kahuta Road 31-12-2008 Satisfactory GMP Form 5 for acceded to by
Islamabad. Each film coated Dy. No.563 and tablet section registration of the Board &
tablet Contains: mentioned. Pregabalin the Board
Rs.12000/- 100mg tablet. rejected the
Pregabalin……150 Dated.08-07- Since the application of
mg 2014 product is not P-Gab 150mg
(Antiepileptics) was asked to
10x2=20’s/As provide me
Manufacturers Per SRO too reference
specifications or application
on Form 5D.

Now, firm
has requested
to change the
particulars of
the file to
Pregabalin
150mg
capsules.
Firm has also
submitted that
additional fee
if any, will be
deposited.
386. M/S Glitz Pharma P-Gab 100 Form 5 LYRICA Approved.

(Pvt.) Ltd; 265- Capsule Capsules (25, 50,
Industrial Triangle, Rs.8000/- 75, 100,
Kahuta Road Each capsule 31-12-2008 150,200, 225 and
Islamabad. Contains: Dy. No.559 300mg)
mg Rs.12000/-
Dated.08-07- GABICA
(Antiepileptics) 2014 Capsules (50, 75,
Dy. No. 1236 100, 150 and
specifications 10x2=20’s & Getz
14’s /As Per
SRO and Rs. Inspection report
625/- per 20’s dated 18-03-
2013.
Satisfactory GMP
and tablet section
mentioned.
mg Rs.12000/-
Dated.08-07- GABICA
Dy. No. 1238 100, 150 and
14’s/As Per
SRO and Rs. Inspection report
345/- per 20’s dated 18-03-
2013.

Satisfactory GMP
and tablet section
mentioned.

mg Rs.12000/-
Dated.08-07- GABICA
Dy. No. 1237 100, 150 and
14’s/As Per
SRO Inspection report
dated 18-03-
2013.
Satisfactory GMP
and tablet section
mentioned.
389. M/S Global Pert 50 mg Form 5 LYRICA 1) Rs. 8,000/- Approved.
Pharmaceuticals Capsules Capsules (25, 50, fee challan Reference will
(Pvt.) Ltd., Plot No. Capsule Rs.8000/- fee 75, 100, (duly be sent to B &
204-205, Industrial challan not 150,200, 225 and endorsed by A Division for
Triangle, Kahuta Each capsule attached 300mg) Statistical verification of
Road, Islamabad. Contains: US FDA Officer) has fee challan. In
Pregabalin……50 not been acse of non-
mg Rs.12000/- GABICA provided. confirmation,
Dated.05-06- Capsules (50, 75, However, firm will
(Anticonvulsant) 2014 100, 150 and copy of deposit the fee
Dy. No. 566 300mg) extracts from (Rs.8000/-)
Manufacturers R&I Getz 214th meeting and Chairman,
Specifications of RB will permit
14’s As Per cGMP certificate Registration for issuance of
SRO dated 21-11- Board as registration
2014. evidence of letter.
Capsule section fee
mentioned in submission.
inspection report
and GMP
certificate dated
31-05-2012 and
21-11-2014.
390. M/S Global Pert 75 mg Form 5 LYRICA 1) Rs. 8,000/- Approved.
Pharmaceuticals Capsules Capsules (25, 50, fee challan Reference will
(Pvt.) Ltd., Plot No. Capsule Rs.8000/- fee 75, 100, (duly be sent to B &

204-205, Industrial challan not 150,200, 225 and endorsed by A Division for
Triangle, Kahuta Each capsule attached 300mg) Statistical verification of
Road, Islamabad. Contains: US FDA Officer) has fee challan. In
Pregabalin……75 not been acse of non-
mg Rs.12000/- GABICA provided. confirmation,
Dated.05-06- Capsules (50, 75, However, firm will
(Anticonvulsant) 2014 100, 150 and copy of deposit the fee
Dy. No. 565 300mg) extracts from (Rs.8000/-)
Manufacturers R&I Getz 214th meeting and Chairman,
Specifications of RB will permit
14’s As Per cGMP certificate Registration for issuance of
SRO dated 21-11- Board as registration
2014. evidence of letter.
Capsule section fee
mentioned in submission.
inspection report
and GMP
certificate dated
31-05-2012 and
21-11-2014.
391. M/S Genome Pregabanome-150 Form 5 LYRICA Approved.
Private Limted, Capsule Rs.8000/- 75, 100,
Factory 16/1-Phase 09-08-2008 150,200, 225 and
IV, Industrial Each Capsule Dy. No.287 300mg)
Estate, Hattar. Contains: US FDA
Dy. No. 258 Capsules (25, 50,
(Gaba Analogue) 75, 100 and
As Per SRO 150mg)
Manufacturers 2x7’s (14) Hilton
specifications
Panel inspection
for grant of GMP
dated 27-12-
2013.
Capsule General /
Antibiotic
mentioned.


As Per SRO 150mg)
specifications
Panel inspection
for grant of GMP
dated 27-12-
2013.
Capsule General /
Antibiotic
mentioned.
IV, Industrial Each Capsule Dy. No. 289 300mg)
Pregabalin……50 Rs. 12000/-
As Per SRO 150mg)
specifications
Panel inspection
for grant of GMP
dated 27-12-
2013.
Capsule General /
Antibiotic
mentioned.
394. M/S Genome Pregabanome- Form 5 LYRICA Approved.
Pharmaceutical 100Capsule Capsules (25, 50,
As Per SRO 150mg)
specifications
Panel inspection
for grant of GMP
dated 27-12-
2013.

Capsule General /
Antibiotic
mentioned.
395. M/s Noa Hemis Gabatil-75mg Form 5 LYRICA Approved.
Plot No.154, Rs.8000/- 75, 100,
Sector-23, Korangi Each Capsule 22-07-2008 150,200, 225 and
Industrial Contains: Dy. No. not 300mg)
Area,Karachi Pregabalin mentioned US FDA
……75mg
Rs.12000/- GABICA
(Anti epileptic) 19-06-2014 Capsules (50, 75,
1609 R&I 100, 150 and
specifications 10’s, 14’s/15% Getz
less then brand
leader DDG and FID
inspection report
dated 09-06-2014
GMP compliance
considered good.
Capsule section
mentioned in
GMP inspection
reports.
Plot No.154, Rs.8000/- 75, 100,
……150mg
Rs.12000/- GABICA
1609 R&I 100, 150 and
specifications 10’s, 14’s / 15% Getz
less then brand
leader DDG and FID
inspection report
dated 09-06-2014
GMP compliance
considered good.
Capsule section
mentioned in
GMP inspection
reports.

Plot No.154, Rs.8000/- 75, 100,
……300mg
Rs.12000/- GABICA
1609 R&I 100, 150 and
specifications 10’s, 14’s / 15% Getz
less then brand
leader DDG and FID
inspection report
dated 09-06-2014
GMP compliance
considered good.
Capsule section
mentioned in
GMP inspection
reports.
398. M/S Sharooq Gabmor Capsule Form 5 LYRICA Approved.
(Pvt) Ltd. 21-KM Rs.8000/- 75, 100,
Ferozepur Road, Each Capsule 19-01-2009 150,200, 225 and
Lahore. Contains: Not mentioned 300mg)
US FDA
2014 duplicate Capsules (50, 75,
(Antiepileptic) dossier 100, 150 and
Dy. No. 1286 300mg)
Manufacturers Getz
specifications 14’s/As per PRC
Panel inspection
after non-
compliance
report and grant
of GMP
certificate dated
28-03-2014.
GMP issued and
capsule section
mentioned.
(Pvt) Ltd. 21-KM Rs.8000/- 75, 100,
Contains: Not mentioned 300mg)

Lahore. Pregabalin……75 US FDA
mg Rs.12000/-
Dated.19-06- GABICA
(Antiepileptic) 2014 duplicate Capsules (50, 75,
Manufacturers Dy. No. 1281 300mg)
specifications Getz
14’s,10’s/As per
PRC Panel inspection
after non-
compliance
report and grant
of GMP
certificate dated
28-03-2014.
GMP issued and
capsule section
mentioned.
(Pvt) Ltd. 21-KM Rs.8000/- 75, 100,
Lahore. Contains: Not mentioned 300mg)
Pregabalin……… US FDA
………..…150mg Rs.12000/-
Dated.19-06- GABICA
(Antiepileptic) 2014 duplicate Capsules (50, 75,
Manufacturers Dy. No. 1282 300mg)
specifications Getz
14’s, 10’s/As
per PRC Panel inspection
after non-
compliance
report and grant
of GMP
certificate dated
28-03-2014.
GMP issued and
capsule section
mentioned.
401. M/s Rasco Pharma, Pregab Capsule Form 5 LYRICA Approved.
5.5Km Raiwind 300mg Capsules (25, 50,
Road Lahore. Capsule Rs.8000/- 75, 100,
25-07-2009 150,200, 225 and
Each Capsule Dy. No. Not 300mg)
Pregabalin
….……300mg Rs.12000/- GABICA

20-06-2014 Capsules (50, 75,
(Anticonvulsant) Dy. No. 1296 100, 150 and
300mg)
Manufacturers Rs.630/-, 1x14 Getz
specifications
Panel inspection
dated 03-06-2014
where panel
recommended
grant of renewal
of DML. Capsule
section
mentioned in said
report.

25-07-2009 150,200, 225 and
Pregabalin
……150mg Rs.12000/- GABICA
20-06-2014 Capsules (50, 75,
300mg)
specifications
Panel inspection
dated 03-06-2014
where panel
recommended
grant of renewal
of DML. Capsule
section
mentioned in said
report.
25-07-2009 150,200, 225 and
Pregabalin
20-06-2014 Capsules (50, 75,
300mg)

specifications
Panel inspection
dated 03-06-2014
where panel
recommended
grant of renewal
of DML. Capsule
section
mentioned in said
report.
404. M/s WnsFeild Lyricowin 75 Form 5 LYRICA Approved.
Pharmaceuticals, Capsule Capsules (25, 50, Reference will
Plot#122, Block-A, Rs.8000/- 75, 100, be sent to B &
Phase-V, Industrial Each capsule 19-04-2009 150,200, 225 and A Division for
Estate, Hattar Contains: Dy. No. Not 300mg) verification of
Pregabalin mentioned US FDA fee challan for
……75mg capsule dosage
Rs.12000/- GABICA form. If
(Anticonvulsants) 19-06-2014 Capsules (50, 75, confirmed,
Dy. No. 259 100, 150 and then Chairman,
Manufacturer’s 300mg) RB will permit
specifications As per SRO Getz for issuance of
registration
In agenda, Panel report letter.
erroneously dated 04-09- Otherwise case
dosage form with 2014. Panel will be placed
brand name recommends before the
written as Tablet grant of GMP Board for
instead of and capsule decision.
Capsule. The firm section
actually mentioned.
mentioned dosage
form as capsule in
form 5.
405. M/s Pakistan Gablin 150mg Form 5 LYRICA Approved.
Products (Pvt) Ltd. Capsule Rs.8000/- 75, 100,
D-122, Sindh 17-06-2009 150,200, 225 and
Industrial Trading Each capsule (Challan 300mg)
Estate, Karachi. Contains: submission date) US FDA
Pregabalin Dy. No. Not
……150mg mentioned GABICA
Capsules (50, 75,
(Anticonvulsants) Rs.12000/- 100, 150 and
26-07-2013 300mg)
Dy. No. not Getz
mentioned
Covering letter Inspection report

is not attached dated 13-02-2013
and 03-06-2014
Rs.25/Capsule considered to be
/not mentioned operating at
satisfactory level
of GMP.
D-122, Sindh 17-06-2009 150,200, 225 and
Industrial Trading Each capsule Dy. No. Not 300mg)
Estate, Karachi. Contains: mentioned US FDA
Pregabalin
26-07-2013 Capsules (50, 75,
(Anticonvulsants) Dy. No. not 100, 150 and
mentioned 300mg)
Covering letter Getz
is not
attached Inspection report
dated 13-02-2013
Rs.25/Capsule and 03-06-2014
/not mentioned considered to be
operating at
satisfactory level
of GMP.
D-122, Sindh 17-06-2009 150,200, 225 and
Industrial Trading Each capsule Dy. No. Not 300mg)
Estate, Karachi. Contains: mentioned US FDA
Pregabalin
26-07-2013 Capsules (50, 75,
(Anticonvulsants) Dy. No. not 100, 150 and
mentioned 300mg)
Covering letter Getz
is not attached
Inspection report
Rs.25/Capsule dated 13-02-2013
/not mentioned and 03-06-2014
considered to be
operating at
satisfactory level
of GMP.
408. M/s Danas Gabfast Form 5 LYRICA Approved.
Pharmaceuticals Capsule300mg Capsules (25, 50,
(Private) Limited, Capsule Rs.8000/- 75, 100,

Islamabad. 08-12-2009 150,200, 225 and
Each capsule Dy. No. 57 300mg)
Contains: US FDA
Pregabalin Rs.12000/-
……300mg 05-06-2014 GABICA
(Gaba analogue) 100, 150 and
10’s/As Per 300mg)
SRO Getz
cGMP certificate
dated 28-01-
2014. Capsule
section
mentioned.
Islamabad. 08-12-2009 150,200, 225 and
Contains: US FDA
……75mg 05-06-2014 GABICA
SRO Getz
cGMP certificate
dated 28-01-
2014. Capsule
section
mentioned.
Islamabad. 08-12-2009 150,200, 225 and
Contains: US FDA
……150mg 05-06-2014 GABICA
SRO Getz
cGMP certificate
dated 28-01-
2014. Capsule

section
mentioned.
S.I.T.E. Karachi. 07-09-2010 150,200, 225 and
Pregabalin……25
10-05-2013 Capsules (25, 50,
(Anticonvulsant) duplicate dossier 75, 100 and
Dy. No. Not 150mg)
Manufacturer mentioned Hilton
Specifications
As per PRC Panel inspection
report dated 24-
06-2014. Panel
recommended
grant of
additional
sections. Capsule
section
mentioned.
412. M/S Weather Folds Gabalin 50mg Cap Form 5 LYRICA Approved.
Pharmaceuticals, Capsule Capsules (25, 50,
Plot No.69/2, Rs.8000/- 75, 100,
Phase-II, Industrial Each Capsule 29-12-2010 150,200, 225 and
Area, Hattar, KPK Contains: Dy. No. Not 300mg)
Pregabalin……50 mentioned US FDA
mg
Rs.12000/- ZEEGAP
(Analgesic / Dated.11-07- Capsules (25, 50,
Anticonvulsant 2014 75, 100 and
Activity) Dy. No. 323 150mg)
Hilton
Manufacturers As per SRO
report dated 04-
09-2014. Panel
recommended
grant of GMP
certificate.
Capsule section
approved.
413. M/S Weather Folds Gabalin 100mg Form 5 LYRICA Approved.

Pharmaceuticals, Cap Capsules (25, 50,
Plot No.69/2, Capsule Rs.8000/- 75, 100,

Phase-II, Industrial 29-12-2010 150,200, 225 and
Area, Hattar, KPK Each Capsule Dy. No. Not 300mg)
Pregabalin……100
(Analgesic / 2014 75, 100 and
Anticonvulsant Dy. No. not 150mg)
Activity) mentioned Hilton
Manufacturers As per SRO Panel inspection

specifications report dated 04-
09-2014. Panel
recommended
grant of GMP
certificate.
Capsule section
approved.
414. M/S Lowitt Pharma P-Gablin Form 5 LYRICA 1) Balance Approved.

(pvt.) Ltd. 24- 150Capsule Capsules (25, 50, fee Rs. Reference will
Hayatabad Oral Capsule Rs.8000/- 75, 100, 12,000/- has be sent to B &
Industrial Estate 22-03-2010 150,200, 225 and been A Division for
Peshawar. Each Capsule (Endorsement 300mg) submitted for verification of
Contains: date) US FDA tablet dosage fee challan for
Pregabalin……150 Dy. No. Not form. capsule dosage
mg mentioned ZEEGAP form. In acse
Capsules (25, 50, of non-
(Gaba Analogue, Rs.12000/- (for 75, 100 and confirmation,
Anticonvulsant.An tablet) 150mg) firm will
algasic) Dated 22-05- Hilton deposit the fee
2014 (Rs.12000/-)
Manufacturers Dy. No. Not Inspection report and Chairman,
specifications mentioned dated 21-08- RB will permit
2014. Overall for issuance of
Both pack size firm in good registration
and price as Per working letter.
SRO condition.
Duplicate Capsule section
Dossier mentioned in
inspection report
and revised
layout plan
approval dated
13-12-2013.
415. M/S Lowitt Pharma P-Gablin Form 5 LYRICA Approved.
(pvt.) Ltd. 24- 50Capsule Capsules (25, 50,
Hayatabad Oral Capsule Rs.8000/- 75, 100,
Industrial Estate 22-03-2010 150,200, 225 and

Peshawar. Each Capsule (Endorsement 300mg)
Contains: date) US FDA
mg mentioned ZEEGAP
Capsules (25, 50,
(Gaba Analogue, Rs.12000/- 75, 100 and
Anticonvulsant.An Dated. 22-05- 150mg)
algasic) 2014 Hilton
Dy. No. Not
Manufacturers mentioned Inspection report
specifications dated 21-08-
Both pack size 2014. Overall
and price as Per firm in good
SRO working
Duplicate condition.
Dossier Capsule section
mentioned in
inspection report
and revised
layout plan
approval dated
13-12-2013.
416. M/S Lowitt Pharma P-Gablin Form 5 LYRICA Approved.
(pvt.) Ltd. 24- 100Capsule Capsules (25, 50,
Hayatabad Oral Capsule Rs.8000/- 75, 100,
Industrial Estate 22-03-2010 150,200, 225 and
Peshawar. Each Capsule (Endorsement 300mg)
Contains: date) US FDA
mg mentioned ZEEGAP
Capsules (25, 50,
(Gaba Analogue, Rs.12000/- 75, 100 and
Anticonvulsant.An Dated.21-05- 150mg)
algasic) 2014 Hilton
Dy. No. Not
Manufacturers mentioned Inspection report
specifications dated 21-08-
Both pack size 2014. Overall
and price as Per firm in good
SRO working
Duplicate condition.
Dossier Capsule section
mentioned in
inspection report
and revised
layout plan
approval dated
13-12-2013.
417. M/s Rogen P-Roglin 75mg Form 5 LYRICA Approved.

Plot#30, S-4, Capsule Rs.8000/- 75, 100,
National Industrial 02-06-2010 150,200, 225 and
Zone, Rawat, Each capsule Dy. No. 4754 300mg)
Islamabad. Contains: US FDA
Pregabalin Rs. 12000/-
……75mg 16-06-2014 GABICA
(Anti-epileptic) 100, 150 and
Manufacturers SRO Getz
specifications
Panel inspection
report dated 09-
06-2014. Tablet /
capsule section
mentioned.
General Capsule
section
mentioned on the
report.
418. M/s Focus & Rulz Pregab 75mg Form 5 LYRICA Approved.
Pharmaceuticals Capsule Capsules (25, 50, Firm will
(Pvt) Ltd. Plot Capsule Rs.8000/- 75, 100, provide
No.4, Industrial 61 R&I 150,200, 225 and verified challan
Triangle, Kahuta Each capsule 28-06-2010 300mg) of Rs.12000/-
Road, Islamabad. Contains: US FDA and Chairman
Pregabalin Fee Rs.12000/- will authorize
……75mg challans form is GABICA issuance of
missing Capsules (50, 75, registration
(Analgesic and 100, 150 and letter.
Anticonvulsant) 14’s/As Per 300mg)
SRO Getz
Manufacturers
report dated 27-
03-2014. Capsule
section approved.
419. M/s Focus & Rulz Pregab 50mg Form 5 LYRICA Approved.
Pharmaceuticals Capsule Capsules (25, 50, Firm will
(Pvt) Ltd. Plot Capsule Rs.8000/- 75, 100, provide
No.4, Industrial 62 R&I 150,200, 225 and verified challan
Triangle, Kahuta Each capsule 28-06-2010 300mg) of Rs.12000/-
Road, Islamabad. Contains: US FDA and Chairman
Pregabalin Fee Rs.12000/- will authorize
……50mg challans form is GABICA issuance of
missing Capsules (50, 75, registration
(Analgesic and 100, 150 and letter.

Anticonvulsant) 14’s/As Per 300mg)
SRO Getz
Manufacturers
report dated 27-
03-2014. Capsule
section approved.
420. M/s Amarant Gabalin Capsule Form 5 LYRICA Approved.
Pharmaceuticals 50mg Capsules (25, 50,
(Pvt) LTD 158-D, Capsule Rs.8000/- 75, 100,
Toro Gadap Road, 22-11-2010 150,200, 225 and
Super highway, Each filled Capsule Dy. No. not 300mg)
Pregabalin……50
mg Rs.52,000/- GABICA
(fast track) Capsules (50, 75,
(Anticonvulsant) 19-11-2012 100, 150 and
Dy. No. Not 300mg)
specifications
Rs.36/- capsule Inspection report
duplicate dossier dated 08-08-2014
observed that
management is
taking serious
measures to
rearrange and
upgrade their
whole
manufacturing,
quality control
and storage
facilities as per
approved layout
plan.
Pregabalin……75
Dy. No. Not 300mg)
specifications

observed that
management is
taking serious
measures to
rearrange and
upgrade their
whole
manufacturing,
quality control
and storage
facilities as per
approved layout
plan.
Pregabalin……100
Dy. No. Not 300mg)
specifications
observed that
management is
taking serious
measures to
rearrange and
upgrade their
whole
manufacturing,
quality control
and storage
facilities as per
approved layout
plan.
Pregabalin……150

Dy. No. Not 300mg)
specifications
observed that
management is
taking serious
measures to
rearrange and
upgrade their
whole
manufacturing,
quality control
and storage
facilities as per
approved layout
plan.
9. Contract manufacturing applications
Evaluator – II (Application checked by Evaluator - IV)
address of (Proprietary formulation (if
manufacturer / name + Dosage Initial date, any) including
Applicant Form + Strength) diary International
status in stringent
Composition Fee including drug regulatory
Pharmacological fee authorities
Group
Specification size GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
424. M/s Safe Impulse Injection Form 5 International: Deferred for rectification of
Pharmaceuticals 500 mcg/ml Not mentioned Methycobal Inj by following observation in the
(Pvt.) Ltd. Each 1 ml Rs 150,000 M/s Eisai Co., Ltd. dossier:
Plot No. C-1-20, ampoule contains 1 ml × 10’s Tokyo

Sector 6-B, Mecobalamin Me too:Elgin Inj by 1. Reference will be sent to B &
North Karachi (J.P)…..500 mcg M/s Novartis A Division for verification of
Industrial Area, (Co-enzyme type According to challan.
Karachi Vitamin B12) inspection report
For (Manufacturer’s dated 20-08-2014 of 2. Confirmation of installation
M/s Amarant Spec.s) M/s Safe and operational qualifications
Pharmaceuticals Pharmaceuticals; for TOC analyzer and liquid
(Pvt.) Ltd. GMP compliance particle counter by the area FID.
158, D. Tore, level of firm is rated
Gadap Road, as good.
Super Highway,
Karachi. Only Form 5 of the
application has been
evaluated. Rest of
the conditions of
policy matters have
not been evaluated .
Verification fee
Evidence of TOC
analyzer and liquid
particle counter is
required. Firm has
replied that these are
under the process of
procurement.
425. -do- Moxina Infusion Form 5 International: Deferred for rectification of
400 mg/ 250 ml Not mentioned Avelox Inf (FDA) following observation in the
Each vial (250 ml) Rs 150,000 Me too: Moxiget dossier:
contains As per PAC Inf 400mg/250ml
Moxifloxacin (as According to 1. Reference will be sent to B &
HCl) (USP)…. inspection report A Division for verification of
400 mg dated 20-08-2014 of challan.
Quinolone M/s Safe
(Manufacturer’s Pharmaceuticals; 2. Confirmation of installation
Spec.s) GMP compliance and operational qualifications
level of firm is rated for TOC analyzer and liquid
as good. particle counter by the area FID.
Only Form 5 of the

evaluated. Rest of
the conditions of
policy matters have
Verification fee

Evidence of TOC
analyzer and liquid
particle counter is
required. Firm has
procurement.
426. -do- Quvoxin Injection Form 5 International: Deferred for rectification of
500 mg/ 100 ml Not mentioned Levaquine following observation in the
Each vial (100ml) Rs 150,000 500mg/100ml dossier:
contains As per PAC (FDA)
Levofloxacin Me too: Raylox Inf 1. Reference will be sent to B &
(USP)…. 500 mg 500mg/100ml by A Division for verification of
Quinolone M/s Ray challan.
(Manufacturer’s According to
Spec.s) inspection report 2. Confirmation of installation
dated 20-08-2014 of and operational qualifications
M/s Safe for TOC analyzer and liquid
Pharmaceuticals; particle counter by the area FID.
GMP compliance
level of firm is rated
as good.
Only Form 5 of the

evaluated. Rest of
the conditions of
policy matters have
Verification fee
Evidence of TOC
analyzer and liquid
particle counter is
required. Firm has
procurement.
427. -do- Amadrol Injection Form 5 International: Deferred for rectification of
100 mg/ 2 ml Not mentioned Zamadol Inj following observation in the
Each 2 ml Rs 150,000 50mg/ml (100mg dossier:
contains 2 ml × 5’s ampoule) in UK
Tramadol HCl As per PAC Me too: Tramadol 1. Reference will be sent to B &
(B.P) …..100 mg Inj 50mg/ml by M/s A Division for verification of
Non Narcotic Highnoon challan.
analgesic Latest GMP
(Manufacturer’s inspection report of 2. Confirmation of installation
Spec.s) contract giver is and operational qualifications
required. for TOC analyzer and liquid

According to particle counter by the area FID.
inspection report
dated 20-08-2014 of
M/s Safe
Pharmaceuticals;
GMP compliance
level of firm is rated
as good.
Only Form 5 of the

evaluated. Rest of
the conditions of
policy matters have
Verification fee
Evidence of TOC
analyzer and liquid
particle counter is
required. Firm has
procurement.
428. -do- Amblum Injection Form 5 International: Deferred in the light of
Each ml ampoule Not mentioned Artem Inj in China recommendation of National
contains Rs 150,000 Me too: Artem Inj Malaaria Control programme &
Artemether……80 1 × 5 ampoule by M/s Hilton for rectification of following
mg As per PAC According to observation in the dossier:
(Anti malarial) inspection report
(Manufacturer’s dated 20-08-2014 of 1. Reference will be sent to B &
Spec.s) M/s Safe A Division for verification of
Pharmaceuticals; challan.
GMP compliance
level of firm is rated 2. Confirmation of installation
as good. and operational qualifications
Only Form 5 of the for TOC analyzer and liquid
application has been particle counter by the area FID.
evaluated. Rest of
the conditions of
policy matters have
Verification fee
Formulation was
Deferred in the light
of recommendations
by Malaria Control
Programme in M-

245 of DRB.
429. M/s Caraway Amant- D Form 5 International: Deferred for rectification of
Pharmaceuticals Injection Not mentioned Required following observation in the
Plot No. 12, Each ml contains Rs 150,000 Me too: Calciferol dossier:
street # N-3, Cholecalciferol As per PAC Inj by M/s Global
National BP …..5 mg Good level of GMP 1. Reference will be sent to B &
Industrial Zone, Vitamin compliance (24-09- A Division for verification of
Rawat, 2012) challan.
Islamabad. Finished product Only Form 5 of the
For specifications are application has been 2. Confirmation of installation
M/s Amarant B.P evaluated. Rest of and operational qualifications
Pharmaceuticals the conditions of for TOC analyzer and liquid
(Pvt.) Ltd. policy matters have particle counter by the area FID.
158, D. Tore, not been evaluated .
Gadap Road, Verification fee 3. Evidence of approval in
Super Highway, challan is required. reference Stringent Regulatory
Karachi. International Agencies.
availability not
confirmed in SRA’s. 4. Approval of manufacturing
Letter of approval of facility by Licensing section.
injection section is
required. Inspection 5. Correction in labeling as
report dated 24-09- submitted label mentions the
12 mentions use of formulation in malaria.
Ampoule and Vial
sections.
Labeling
information has
been given for
malaria.
430. -do- Amta- Rose Form 5 International: Deferred for rectification of
Injection Not mentioned Venofer Inj (FDA) following observation in the
Each ampoule Rs 150,000 Me too: Merofer dossier:
(5ml) contains As per PAC JInj by M/s Bosch
Iron Sucrose 420 Good level of GMP 1. Reference will be sent to B &
mg eq to compliance (24-09- A Division for verification of
elemental Iron ….. 2012) challan.
100mg
Haematinic Only Form 5 of the 2. Confirmation of installation
application has been and operational qualifications
Finished product evaluated. Rest of for TOC analyzer and liquid
specifications are the conditions of particle counter by the area FID.
USP policy matters have
Verification fee 3. Initially on Form 5, firm
challan is required. mentioned quantity of active as
Initially on Form 5, 420 mg/ ampoule, in reply firm
firm mentioned mentioned it as 1873 mg/
quantity of active as ampoule. Clarification is

420 mg/ ampoule, in required. No clarification is
reply firm provided in second reply.
mentioned it as
1873 mg/ ampoule. 4. Letter of approval of
Clarification is injection section is required.
required. No Not provided in second reply.
clarification is Inspection report dated 24-09-
provided in second 12 mentions Ampoule and Vial
reply. sections.
Letter of approval of
injection section is
required. Not
provided in second
reply. Inspection
report dated 24-09-
12 mentions
Ampoule and Vial
sections.
Evidence of TOC
analyzer and liquid
particle counter is
required. Not
provided in replies.
Evaluator – III
S/N Name and Brand Name Type ofRemarks on Recommendations Decision

manufacturer / Dosage Form + formulation (if
Applicant Strength) Initial any) including
date, diary International
Composition status in
Fee stringent drug
Pharmacological Group including regulatory
Finished product fee authorities
Specification
Price /
Pack size GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator

431. Contract Giver OD-CEF Injection 500mg Form-5 Inspection of The applications Approved.
M/s Dyson M/s McColson have been Firm will
Research Labs, Each vial contains: Dy No: Research Labs evaluated as per provide
Lahore. Ceftriaxone sodium 2437 dated: conducted on Form-5. However undertakings
equivalent to 15-04-2013 26-08-14 and the formalities as & agreement
Contract Ceftriaxone…..500mg 11-09-14 by the per contract as per
Acceptor 1,42,000/- panel of manufacturing approved
M/s McOlson Cephalosporin dated 15- inspectors and policy may be contract
Research 04-13 recommends fulfilled by the policy and
Laboratories, USP 8,000/- the grant of concerned section Chairman will
Sheikhupura. dated 18- renewal of before issuance of permit
05-09 DML to the registration letter. issuance of
firm registration
As per letter.
SRO Permission
Pack of 1’s will be valid
till
30.06.2015).
432. Contract Giver AZIBAC Suspension Form-5 Inspection of Approved.
M/s McOlson 200mg the M/s Dyson Firm will
Research Dy No: Research Labs provide
Laboratories, Each 5ml after 2430 dated: Sheikhupura undertakings
Sheikhupura. reconstitution contains: 15-04-2013 was conducted & agreement
Azithromycin dihydrate on 26-09-14 by as per
Contract equivalent to 50,000/- the area FID approved
Acceptor Azithromycin dated 15- and overall contract
M/s Dyson USP…..200mg 04-13 hygiene and policy and
Research Labs, 1,00,000/- condition is Chairman will
Lahore. Macrolide Antibiotic dated 14- found good. permit
05-13 issuance of
USP registration
As per letter.
SRO Permission
will be valid
till
30.06.2015).
433. Contract Giver M-XIME Suspension Form-5 Inspection of Approved.

M/s Masfa 100mg/5ml M/s McColson Firm will
Industries (Pvt) Dy No: Research Labs provide
Limited, Lahore Each 5ml contains: 2430 dated: conducted on undertakings
Cefixime trihydraye 15-04-2013 26-08-14 and & agreement
Contract equivalent to 11-09-14 by the as per
Acceptor Cefixime…..100mg 1,50,000/- panel of approved
M/s McOlson inspectors and contract
Research Cephalosporin As per recommends policy and
Laboratories, SRO the grant of Chairman will
Sheikhupura. USP renewal of permit
DML to the issuance of

firm registration
letter.
Permission
will be valid
till
30.06.2015).
434. Contract Giver M-XIME Capsule 400mg Form-5 Inspection of Approved.

M/s Masfa M/s McColson Firm will
Industries (Pvt) Each capsule contains: Dy No: Research Labs provide
Limited, Lahore Cefixime as 2405 dated: conducted on undertakings
Trihydrate…..400mg 15-04-2013 26-08-14 and & agreement
Contract 11-09-14 by the as per
Acceptor Cephalosporin 1,50,000/- panel of approved
M/s McOlson inspectors and contract
Research USP As per recommends policy and
Laboratories, SRO the grant of Chairman will
Sheikhupura. Pack of 5’s renewal of permit
DML to the issuance of
firm registration
letter.
Permission
will be valid
till
30.06.2015).
435. Contract Giver MECOFOL Injection Inspection

Form-5 of Evidence of Deferred for
M/s Arsons M/s Friends availability of confirmation
Pharmaceutical Each1ml ampoule Dy No: Pharma Lahore TOC and liquid of
Industries, contains: 2383 dated was conducted particle counter installation
Lahore. Mecobalamin……500mcg 12-04-13 by the panel of is not provided. and
inspectors on operational
Contract Co-Enzyme Vitamin B-12 1,50,000/- 21-05-14 qualifications
Acceptor concluded the for TOC
M/s Friends IP As per firm GMP analyser &
Pharma (Pvt) SRO compliant. Liquid
Limited, Lahore Pack of 1’s Particle
for Liquid Injection Counter by
(general) Area FID.
section
approval vided
letter No. F.1-
18/ 93-Lic
(Vol-II) (M-
227) dated 17-
06-11.

436. Contract Giver ESUN Injection 40mg Form-5 Nexium of a. Quantity of API Deferred for
M/s M/s Unison AstraZeneca in master rectification
Chemical Each vial contains: Dy No: formulation of following
Works Lahore. Sterilized Esomeprazole 3160 dated Nexium of needs observations:
Sodium lyophilized 17-05-13 BMS rectification. 1. Quantity
Contract equivalent to b. Latest GMP of API in
Acceptor Esomeprazole…..40mg 1,50,000/- The inspection Inspection master
M/s English M/s English report of M/s formulation
Pharmaceuticals PPI As per Pharmaceuticals English Pharma needs
Lahore SRO Lahore was is required. rectification.
Manufacturer conducted on 2. Latest
14-11-2012 and GMP
15-11-2012 by Inspection
the area FID report of M/s
and found GMP English
complaint Pharma is
required.
437. Contract Giver U-MIP Injection 40mg Form-5 Losec Infusion a. Quantity of Deferred for
M/s M/s Unison of AstraZeneca API in master rectification
Chemical Each vial contains: Dy No: formulation of following
Works Lahore. Sterilized Omeprazole 3161 dated Risek of Getz needs observations:
Sodium lyophilized 17-05-13 Pharma rectification 1. Quantity
Contract equivalent to b. Latest GMP of API in
Acceptor Omeprazole…..40mg 1,50,000/- The inspection Inspection master
M/s English M/s English report of M/s formulation
Pharmaceuticals PPI As per Pharmaceuticals English needs
Lahore SRO Lahore was Pharma is rectification.
Manufacturer conducted on required. 2. Latest
14-11-2012 and GMP
15-11-2012 by Inspection
the area FID report of M/s
and found GMP English
complaint Pharma is
required.
438. Contract Giver BEMOX Infusion Form-5 Avelox of a. Specifications Deferred for
M/s Dyson Bayer of API needs to rectification
Research Labs, Each 250ml contains: Dy No: HealthCare Inc be submitted. of following
Lahore. Moxifloxacin as 2417 dated: b. Under finished observations:
hydrochloride…….400mg 15-04-2013 Molox Infusion product 1.
Contract of CCL Pharma specifications Specifications
Acceptor Fluoroquinolone 1,50,000/- assay method of API needs
M/s English needs to be to be
Pharmaceuticals Manufacturer As per submitted. submitted.
Lahore SRO c. Evidence of 2. Under
facility of TOC finished
analyzer and product
particle counter specifications
needs to be assay method
submitted. needs to be

d. Latest GMP submitted.
Inspection 3.
report of M/s Confirmation
English Pharma of installation
is required. and
operational
qualifications
for TOC
analyzer and
particle
counter.
4. Latest
GMP
Inspection
report of M/s
English
Pharma is
required.
439. Contract Giver DYPENEM Injection Form-5 Meronem of a. Evidence of Deferred for
M/s Dyson 500mg AstraZeneca approval of rectification
Research Labs, Dy No: manufacturing of following
Lahore. Each vial contains: 2411 dated: Demonem of facility for observations:
Meropenem trihydrate 15-04-2013 Rotex Medica applied product 1. Evidence of
Contract equivalent to needs to be approval of
Acceptor Meropenem……500mg 50,000/- submitted manufacturing
M/s English dated 15- b. Latest GMP facility for
Pharmaceuticals Penicillin Antibiotic 04-13 Inspection applied
Lahore 100,000 report of M/s product needs
Manufacturer dated 14- English Pharma to be
05-13 is required. submitted
2. Latest
As per GMP
SRO Inspection
report of M/s
English
Pharma is
required.
440. Contract Giver DYPENEM Injection 1g Form-5 Meronem of a. Evidence of Deferred for
M/s Dyson AstraZeneca approval of rectification
Research Labs, Each vial contains: Dy No: manufacturing of following
Lahore. Meropenem trihydrate 2412 dated: Demonem of facility for observations:
equivalent to 15-04-2013 Rotex Medica applied product 1. Evidence of
Contract Meropenem……1g needs to be approval of
Acceptor 50,000/- submitted manufacturing
M/s English Penicillin Antibiotic dated 15-04 b. Latest GMP facility for
Pharmaceuticals -13 Inspection applied
Lahore Manufacturer 100,000 report of M/s product needs
dated 14- English Pharma to be

05-13 is required. submitted
As per 2. Latest
SRO GMP
Inspection
report of M/s
English
Pharma is
required.
Case No.10. Replies of deferred applications
Evaluator – I
Case No. a: -
The following two products, namely Effiflox 125mg/5ml and Effiflox 250mg/5ml, of M/s
Sami Pharmaceuticals (Pvt) Ltd., Karachi were deferred in the 242nd meeting of the Registration
Board held on 24th – 25th February, 2014 for confirmation of approved dosage form (dry powder
suspension or solution) by stringent regulatory bodies.
2. The firm has now submitted that they have prepared the drugs against LEVAQUIN of
M/s Janssen Pharma – USA as oral solution and in parallel conducted accelerated stability
studies. The firm has also submitted revised Form – 5 and requested the Board to grant
registration as oral solution.
3. It is pertinent to mention that evidence of approval of 250mg / 5ml strength by stringent
regulatory agencies was not submitted by the firm instead comments of some local prescribers in
favor of the same have been submitted.
S/N Name and 1. Brand Name 1.Type of 1.Finished Decision in 242nd Decision
address of 2. Dosage Form Form Product Meeting of
manufacturer / 3. Composition 2. Type of Specification Registration
Applicant 4. application 2. Facility where Board
Pharmacologic 3. Demanded drug has to be
al group Price / Pack manufactured
size with status
4. Initial date, whether
diary. approved by
5. Date on CLB or not
which fee 3. Last GMP
becomes inspection
complete report with date
according to & status.
type of
application
/or Form

441. M/s Sami 1. EFFIFLOX 1. Form-5 1. Manufacturers Deferred for The Board did not
Pharmaceuticals 125 mg/5ml 2. Fast track specification. confirmation of accede the request
(Pvt) Ltd., F-95, 2. Dry powder 3. As per 2. Dry powder approved dosage of firm for change
Off. Hub River suspension 3. PAC, 60ml. suspension form (dry powder in dosage form &
Road, S.I.T.E., Each 5ml of 4. 20/04/2011,General suspension or deferred the
Karachi. reconstituted 264 (R&I) Antibiotic solution) by instant application
suspension 5. 24/04/2013 available as per stringent for review of
contains: Rs.60,000/- inspection report regulatory bodies. formulation by
Levofloxacin dated 02/05.2013. Incharge, PEC..
Hemihydrate 3. cGMP report
MS eq. to dated 02/05/2013
Levofloxacin is provided
…………….. wherein good
125mg level of GMP
4. compliance is
Fluroquinolone. reported.
442. M/s Sami 1. EFFIFLOX 1. Form-5 1. Manufacturers Deferred for The Board did not
Pharmaceuticals 250 mg/5ml 2. Fast track specification. confirmation of acceed the request
(Pvt) Ltd., F-95, 2. Dry powder 3. As per 2. Dry powder approved dosage of firm for change
Off. Hub River suspension PAC, 60ml. 4. suspension form (dry powder in dosage form &
Road, S.I.T.E., 3. Each 5ml of 20/04/2011, General suspension or deferred the
Karachi. reconstituted 263 (R&I) Antibiotic solution) by instant application
suspension 5. 24/04/2013 available as per stringent for review of
contains: Rs.60,000/- inspection report regulatory bodies. formulation by
Levofloxacin dated 02/05.2013. Incharge, PEC.
Hemihydrate 3. cGMP report
MS eq. to dated 02/05/2013
Levofloxacin is provided
…………….. wherein good
250mg level of GMP
4. compliance is
Fluroquinolone. reported.

Case No. b:
Following registration application of M/s Arson Pharmaceutical Industries (Pvt) Ltd., Lahore was
deferred in the 243rd meeting of the Registration Board for status of license in light of inspection report
dated 15-04-2013.
2. The firm has now submitted copy of panel inspection report dated 08/05/2014 for renewal of
Drug Manufacturing License and Grant of additional section (Tablet Psychotropic). The panel in its
aforesaid report reached on the following recommendations:
a. Recommend the renewal of Drug Manufacturing License of the firm M/s Arson
Pharmaceutical Industries (Pvt) Ltd., Multan Road Lahore.
b. Recommend the grant of license to the additional tablet Psychotropic Section.
3. The firm has also submitted a copy of certificate of current Good Manufacturing Practices dated
19-08-2014 wherein it is reported that firm is found complying with cGMP in terms of process control,
maintenance of equipment and area, documentation etc. as per provisions of Drugs Act, 1976 and rules
framed there under.
443. M/s Arsons DOXICYCLINE As Per Form-5 Vibramycin Deferred for

Pharmaceutical 100mg Capsules SRO 10 x 100mg status of lisence
Industries (Pvt) Ltd. 10’s 28-09-2012 Capsules in light of
22 Km Multan Capsule 2280 R&I US FDA inspection report
Road off 4 Km dated 15-04-2013
Defence Road, Each Capsule Rs.20,000/- DOTUR
Lahore contains:- 100mg
Doxycycline as Capsule
Anomaly Case: Hyclate…..100 mg Novartis
Capsule (General
Antibiotic) Tetracycline
Vide letter No. F. 1-

14/95 – Lic (Vol I)
(M – 227) dated
13th June, 2011
Decision: The Board approved the registration of application.

Case No. c: -
Following registration application of M/s A’raf (Pvt) Ltd., Lahore was deferred in the 242nd
meeting of the Registration Board for expert opinion of Dr.Rizwan Taj, PIMS and Brig Jehangeer
Saleem. Now, the firm has informed that same product is already registered in the 214th meeting of the
Registration Board having registration No. 062765 to the firm M/s Schazoo Zaka.
2. In light of above, firm has requested for registration of their product and to change it to XR.
444. M/s A’RAF (Pvt) 1. Zaxine SR 1. Form-5 D 1. B.P. specifications. Deferred for expert
Ltd. (Former M/s 150mg tablets 2. 2. Fast track 2. General Tablet opinion of
Remedy Sustained release 3. Rs. 1100/- section available as Dr.Rizwan Taj,
Pharmaceutical Pvt film coated tablet per 14’s 4. per inspection report PIMS; Brig
Limited), 23 Km 3. Each tablet 30/07/2013, dated 19/01/2012. Jehangeer Saleem
Raiwind Road contains: 9209 (R&I) 3. GMP report dated
Lahore. Venlafaxine as 5. Rs.60,000/- 19/01/2012 attached.
Hydrochloride Rs. 90,000/-
……. 150mg The formulation is
4. Serotonin and found available in
Noradrenaline UK
Reuptake
Inhibitors.
Decision: The Board approved the registration of the product & acceded to the request of
the firm for change in nomenclature from SR to XR.

Evaluator - I
S/ Name and address Brand Name Type of Form Decision of Remarks on the Decision
N of manufacturer / Previous formulation (if
Applicant (Proprietary Initial date, Meeting any) including
Form + Strength) status in
Fee including
Composition differential fee stringent drug
regulatory
Pharmacological Demanded agencies /
Group Price / Pack authorities
size
Specification
GMP status as
depicted in
latest inspection
report (with
date) by the
Evaluator
445. M/s. P.D.H. Pyrox-B Tablets Form-5 Deferred for Brexidol, Cheisi, Approved.
Pharmaceuticals, Fast Track final reminder BNF
Lahore Each tablet 28/8/2013 9991 for completion
contains:- R&I of Form 5 Brexin 20mg,
Piroxicam Beta 28/8/2013 1. An Cheisi
Cyclodextrin (Rs. 60,000/-) undertaking /
equivalent to Rs.265.22 per commitment Inspection report
Piroxicam …. 2x10’s regarding the dated 30/09/2014
20mg submission of provided. Firm
following, as
showed
per decision of
(NSAID) improvement
the
Registration
regarding
Manufacturers Board, may be previous
specifications submitted: shortcomings /
a) Label claim observations.
and prescribing
information
being same as
approved by
reference drug
agencies e.g.,
FDA, TGA,
MHLW, EMA
and Health
Canada.

2. Several
observations
have been
made by the
area FID in the
inspection
report dated
05/03/2014
regarding
validation of
HVAC,
frequency of In
Process testing,
differential
pressure
maintenance,
old machinery
like fluid bed
dryer, mixer,
granulator to
be replaced
with latest
version etc.
446. M/s. P.D.H Giostatin 10mg Form 5 Deferred for Crestor 10mg, Approved.
Pharmaceuticals Tablets Fast Track final reminder FDA
(Pvt) Ltd., 19 Km, 12/4/2013 798 for completion
Ferozpur Road, Each film coated R&I of Form 5 Rosutrol 10mg,
Lahore. tablet contains:- 13/11/2013 1. An Pfizer
Rosuvastatin (Rs. 60,000/-) undertaking /
Calcium Rs.250/10’s commitment Inspection report
equivalent to regarding the dated 30/09/2014
Rosuvastatin submission of provided. Firm
following, as
…………….. showed
per decision of
10mg improvement
the
Registration
regarding
Statins Board, may be previous
submitted: shortcomings /
Manufacturers a) Label claim observations.
specifications and prescribing
information
being same as
approved by
reference drug
agencies e.g.,
FDA, TGA,
MHLW, EMA
and Health
Canada.
2. Several
observations

have been
made by the
area FID in the
inspection
report dated
05/03/2014
regarding
validation of
HVAC,
frequency of In
Process testing,
differential
pressure
maintenance,
old machinery
like fluid bed
dryer, mixer,
granulator to
be replaced
with latest
version etc.
447. M/s. P.D.H Esogerd 20mg Form 5 Deferred for Nexium 20mg Approved.
Pharmaceuticals Capsule Fast Track final reminder Capsules, FDA
Ferozpur Road, Enteric coated R&I of Form 5
Lahore. pellets 12/11/2013 1. An Nexum 20mg,
Each capsule (Rs. 60,000/-) undertaking / Capsules
contains:- Rs.231/ 2x7’s commitment
Esomeprazole regarding the
Magnesium submission of Inspection report
trihydrate enteric following, as dated 30/09/2014
coated pellets per decision of provided. Firm
equivalent to the showed
Esomeprazole Registration improvement
…………..… Board, may be regarding
20mg submitted: previous
a) Label claim shortcomings /
Anti-ulcer and observations.
prescribing FID mentioned
Manufacturers information that automatic
specifications being same as capsule filling
approved by machine should
reference drug be provided in
Source: M/s agencies e.g., capsule filling
Vision FDA, TGA, area.
Pharmaceuticals, MHLW, EMA
Islamabad and Health
Canada.
2. Several
observations

have been
made by the
area FID in
the inspection
report dated
05/03/2014
regarding
validation of
HVAC,
frequency of
In Process
testing,
differential
pressuremaint
enance, old
machinery like
fluid bed
dryer, mixer,
granulator to
be replaced
with latest
version etc.
448. M/s. P.D.H Esogerd 40mg Form 5 Deferred for Nexium 40mg Approved.
Pharmaceuticals Capsule Fast Track final reminder Capsules, FDA
Ferozpur Road, Enteric coated R&I of Form 5
Lahore. pellets 12/11/2013 Nexum 40mg,
Each capsule (Rs. 60,000/-) Capsules
contains:- Rs.360/ 2x7’s 1. An
Esomeprazole undertaking / Inspection report
Magnesium commitment dated 30/09/2014
trihydrate enteric regarding the provided. Firm
coated pellets submission of showed
equivalent to following, as improvement
Esomeprazole per decision of regarding
the
……………… previous
Registration
40mg shortcomings /
Board, may be
submitted:
observations.
Anti-ulcer a) Label claim
and prescribing FID mentioned
Manufacturers information that automatic
specifications being same as capsule filling
approved by machine should
Source: M/s reference drug be provided in
Vision agencies e.g., capsule filling
Pharmaceuticals, FDA, TGA, area.
Islamabad MHLW, EMA
and Health
Canada.

2. Several
observations
have been
made by the
area FID in the
inspection
report dated
05/03/2014
regarding
validation of
HVAC,
frequency of In
Process testing,
differential
pressure
maintenance,
old machinery
like fluid bed
dryer, mixer,
granulator to
be replaced
with latest
version etc.
449. M/s Zanctok Genelor Form5 Deferred for Firm has Approved.
Pharmaceutical Syrup Routine confirmation informed that due
Laboratories, F/5 of me too to typographic
S.I.T.E Area,
Each 5ml 23/07/2010 status error the strength
Hyderabad
Contains: Dy. No. 1411 was typed as
Desloratadine…… Rs. 8000/- 5mg/10ml and
………….2.5mg that they have
13-05-2013 corrected the
Antihistamine Rs. 12000/- strength to
2.5mg/5ml. A
Manufacturers 60ml,120ml/As revised Form-5
specifications per PRC has been
submitted by the
firm.
Clarinex
0.5mg/ml, Syrup,
FDA
Desora 0.5mg/ml
Syrup,
Continental
Pharma

450. M/s Hiranis Relevo Sachet Form-5D Deferred for BREXIN Deferred for
Pharmaceuticals 20mg evidence of PULVER evaluation of
(Pvt) Ltd., Plot No. New License approval of 20mg powder stability data
E-145 – E-149, Each sachet same Torrex-Chiesi & expert
North Western contains: 28-05-2014 formulation by Pharma,Austria opinion by the
Industrial Zone, 810 R&I reference drug following:
Port Qasim, Piroxicam beta- agencies e.g., BREXIN 1. Dr.Abid
Karachi. cyclodextrin 191.2 Rs. 150 / per FDA, TGA, 20mg granules Farooki, PIMS
mg eq. to 10’s MHLW, EMA for oral solution 2.Brig.Mushta
Piroxicam and Health q, MH
(Sachet)
………… 20mg Rs. 50,000/- Canada. 3.Dr.fareedull
Promedica, Italy ah Zimri,
(Manufacturer’s NIRM
Specs)
NSAIDs
451. M/s Hiranis Gastocon Liquid Form-5D Deferred for: Now following Deferred for
Pharmaceuticals Sachet 1) Evidence of reference in evaluation of
(Pvt) Ltd., Plot No. New License approval of terms of evidence stability data
E-145 – E-149, Each 10ml sachet same of international & expert
North Western contains: 28-05-2014 formulation by availability has opinion by the
Industrial Zone, 809 R&I reference drug been submitted: following:
Port Qasim, Sodium alginate agencies e.g., GAVISCON 1.Brig.Amjad
Karachi. (BP) 500 mg Rs. 100 / per FDA, TGA, Liquid Sachet Salamat
10’s MHLW, EMA MHRA 2.Dr.Najam,
Sodium bicarbonate
and Health Shifa
(BP) 267mg Rs. 50,000/- Canada. 3.Prof.Umer,
2) Stability RMC
Calcium carbonate
data.
(BP)…. 160 mg
(BP Specifications)
Reflux suppressant
/ Antacid
452. M/s Panadol Sinus Form 5-D (Fast Registration BENYLIN Deferred for
GlaxoSmithKline Caplets Track) Board referred COLD & SINUS evaluation of
Pakistan limted, F- Panadol sinus 500/5mg stability data
268 S.I.T.E., Caplets Rs.8,000/- Caplets to Health Canada which should
Karachi 09-12-2010 Pharmaceutica be performed
Each Caplet Dy. No. not l Evaluation Inspection dated at the
Contains: mentioned Cell for 07-01-2014, 21- applicant’s
Paracetamol…500 scrutinization 01-2014 & 19- site & expert
mg Rs.60,000/- in light of 02-2014. Well opinion by the
Phenylephrine 20-03-2013 check list maintained / following:
Hcl. 5.00mg Dy. No. not approved by retained unit 1.Brig.Aslam

mentioned Registration reported. Tablet 2.Dr.Shazli
Board. section Manzor
Rs.82,000/- mentioned in 3.Dr.Rehana
19-11-2013 report. Kauser, PIMS
Dy. No. not
mentioned 1. In terms of
Prescribing
Rs.300/-100’s information (PI),
Patient
Information
Leaflet (PIL) and
Summary of
product
characteristics
(SmPC) as
approved by
Drug regulatory
agencies or
authorities of
country of origin
or FDA, EMA,
TGA, etc., firm
has submitted
international data
sheet for the
product.
2. Data of
stability studies
conducted on
three pilot
batches at
25C/60%RH,
30C/60%RH,
30C/75%RH and
40C/75%RH.
However, it is
pertinent to
mention that the
batches were
manufactured in
Sydney, Australia
as the raw
material and
pharmaceutical
development was
carried out in
firms R&D
center in
Australia.

Evaluator – II
Form + status in
differential fee stringent drug
Composition regulatory
Demanded agencies /
Pharmacologic Price / Pack authorities
al Group size
Me-too status
Finished
product GMP status as
Specification depicted in
latest
inspection
report (with
date) by the
Evaluator
453. M/s Herbion Pakistan LacNovex / Form 5 Deferred for BNF 61 Approved.
(Pvt) Ltd., Kahuta LaxNovex / confirmation of (Lactulose Firm will
Road, industrial ConstiNovex 26-02-2014 1. Source & (Non- provide
Triangle, Humak, 3.35g Syrup Dy.No.208
Fee. proprietary) legalized
Rawalpindi- Each 5ml Rs.20,000+
Islamabad. contains:- 2. Testing GMP of
Rs.80,000/-(05-
Lactulose facility by DDG DUPHALAC(H source of
09-2014) DRAP and FID
(BP)………3.35 IGHNOON lactulose and
g (M-243)
LABORATORI Chairman,
(Laxative) Rs.170.00/
120ml ES LTD.) RB will
(B.P Spec.s) permit
{Source of Grant of DML issuance of
Lactulose: M/s recommended registration
Fresenius Kabi th
(23-24 January letter.
Austria GmbH 2014)
EstermannstraB
e 17 4020 Linz}

1. The firm has
deposited fee
of Rs.
80,000/- and
requested for
fixation of
source i.e.
M/s Fresenius
Kabi Austria
GmbH
Estermannstr
aBe 17 4020
Linz.
2. Valid and
legalized
GMP
Certificate of
Source, COA
and stability
studies
according to
zone IV-a of
lactulose are
required.
(The firm has
submitted
COA &
Stability
studies)
3. Confirmation
of testing
facility by
DDG DRAP
and FID.
(The
inspection
report by
area FID &
DDG dated
02.12.2014
confirms the
testing
facility).

454. -do- MonteNovex / Form 5 Deferred for BNF 61: Approved.
AzmaNovex / correction in (Singulair
LeukoNovex 24-02-2014 master (MSD)
5mg Chewable Dy.No.201
formulation.
Tablets
Each chewable Rs.20,000 Aerokast
tablet contains:- (Barrett
Montelukast Rs.400.00/ Hodgson)
Sodium BP eq. 14’s
to Grant of DML
Montelukast…5 recommended
mg
(23-24th January
(Antiasthmatic
Agent 2014)
(Leukotriene
Receptor 1. The firm has
antagonist) corrected
(Manufacturer’s master
Spec.s) formulation.
455. -do- MonteNovex / Form 5 Deferred for Not confirmed Rejected on

AzmaNovex / correction in the grounds
LeukoNovex 24-02-2014 master Aerokast that the
10mg Chewable Dy.No.197 (Barrett
formulation and efficacy &
Tablets Rs.20,000 hodgson) not in safety of the
Each chewable confirmation of
chewable
tablet contains:- Rs.460.00/ international said
dosage form
Montelukast 14’s availability formulation
Sodium BP eq.
Grant of DML has not been
to established in
Montelukast… recommended
…….10mg (23-24th January chewable
2014) dosage form.
(Antiasthmatic
Agent
(Leukotriene 1. The firm has
Receptor corrected
antagonist)
master
(Manufacturer’s
Spec.s) formulation.
2. Reference of
International
availability
has been
given from
India and
Bangladesh.
3. Reference of

5mg
chewable
tablets has
been given
from Health
Canada.
Formulation
is in film
coated
dosage form
in Health
Canada.
456. -do- Neemplast Form 5 Deferred for Not confirmed Deferred for
Plaster 17-03-2014 confirmation of verification
Contains:- Dy.No.251 me too status Saniplast that the said
Acrinol……… Rs.20,000
and international (Uniferoz formulation
…10.4%
(Disinfectant Rs. 25/ availability. Karachi) is registered
and Antiseptic) 19×72mm (10 in which
(Manufacturer’s strips) Grant of DML category in
) Rs. recommended the reference
35/19×72mm th
(23-24 January Stringent
(20 strips) 2014) Regulatory
Rs.
Agencies
160/19×72mm
(100 strips) 1. The firm has whether as an
Rs. provided OTC or
720/19×72mm reference of Pharmaceutic
(500 strips) Saniplast of al.
Uniferoz for
both
international
availability
and me-too
status.
2. International
availability
not
confirmed in
stringent
DRS’s.
3. Discussion
is requested
from
honorable

Drug
Registration
Board about
the status of
formulation
that whether
it is a drug
or HOTC
product.
Form + status in
differential fee stringent drug
Composition regulatory
Demanded agencies /
Pharmacologic Price / Pack authorities
al Group size
Me-too status
Finished
product GMP status as
Specification depicted in
latest inspection
report (with
date) by the
Evaluator
457. M/s. Simz Ibusim DS Form-5 Deferred for Health Canada: Approved.
Pharmaceuticals (Pvt) 200mg confirmation Advil Pediatric
Ltd, 574-575 Sundar Liquid Rs.20,000/-10- of Drops
Suspension 2-2014 international
Industrial Estate,
Each 5ml availability. Brufen DS
Raiwind Road contains:- Rs.60.00/90ml (M-244) (Abbot)
Lahore. Ibuprofen
(B.P)…..200mg GMP compliant
(Antirheumatic, (22-11-2013)
anti-
inflammatory)
1. The product
(B.P Spec.s)
was deferred
because the Firm
had not provided

the International
availability
especially in
FDA, EMA,
Health Canada,
TGA & MHLW
for same generic,
dosage form &
strength with
reference is
required. Firm
had provided
Dolan Fp Forte
from Phillipine.
Later on same
formulation was
approved in M-
245 for M/s
Titles Pharma
Karachi because
international
availability was
confirmed. The
Firm has
requested to
consider their
application for
registration.
458. M/s. Cibex (Private) Batema-F Syrup Form-5 Deferred for Not confirmed Approved
Ltd. F-405, SITE, Each 15ml 30-04-2014 confirmation
Karachi contains: (611) of Me-Too & Sucrofer-F
International
Iron Protein Rs.20,000/- Syrup
(especially in
Succinylate As per Stringent (Nexpharm)
800mg SRO/60ml, Regulatory
equivalent to 120ml Agencies) Grant of DML
elemental registration recommended
iron…40mg Status. (22-10-2013)
Folic
(M-245) 1. The Firm has
Acid…5mg
(Anti-Anaemic) submitted
(Manufacturer’s that the
Spec.s) product is
already
available
locally
manufactured

by CCL
under the
license of
Nexpharm
and the
product is
although not
available in
SRA,s but
DRAP has
granted
registration
to several
companies.
The Firm has
requested for
product
registration.
459. -do- Cimora 20mg Form-5 Deferred for BNF: Nexium Approved
Capsule 30-04-2014 rectification (AstraZeneca)
Each Capsule (625) of following C-ESO (Crown
contains: Rs.20,000/- observation: Pharmaceuticals
Esomeprazole As per )
Magnesium SRO/14 1. Fee for
Trihydrate Capsules import. Grant of DML
enteric coated 2. Legalized recommended
pellets equivalent and Valid (22-10-2013)
to GMP 1. The Firm has
Esomeprazole… 3. Certificate submitted
20mg of Analysis documents
(Anti-Ulcerant) 4. Stability for source of
(Manufacturer’s Studies pellets, M/s
Spec.s) according to Surge Lab
zone assigned
(Pvt. ) Ltd.
to Pakistan.
10th K.M
(M-245) Faisalabad
Road ,
Sheikhupura.
2. cGMP
certificate
has been
issued to M/s
Surge for

Enteric
coated
Pellets/Granu
les and Taste
Masked
Granules/
Pellets.
3. Approval by
CLB for
manufacturin
g of
Esomeprazol
e enteric
coated pellets
by M/s Surge
submitted.
Evaluator – III
Cases deferred in M-245 meeting
S/N Name and Brand Name Type of Form Decision in Remarks on Decision
address of (Proprietary name 245th of the
manufacturer / + Dosage Form + Initial date, diary Registration formulation (if
Applicant Strength) Board. any) including
Fee including International
Composition differential fee status in
stringent drug
Pharmacological Demanded Price regulatory
Group / Pack size agencies /
authorities
Finished product
Specification Me-too status
GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator

460. M/s Cibex (Pvt) KATAFEN Rapid Form-5 Deferred for The firm has Approved.
Limited Karachi. Gel 1% submission of submitted the
Dated 30/04/14 finished finished
Each gram contains:- Dy No: 602 product product
Diclofenac specifications specifications
diethylamine….10mg 20,000/- of applied
product.
Anti-Rheumatic Pack of 1’s, 20gm
& 50gm/ As per
Manufacturer PRC
461. -do- MYBINA Plus Form-5 Deferred for The firm has Approved.
Ointment rectification ofsubmitted the
Dated 30/04/14 following assay method
Each gram contains:- Dy No: 605 observations: under finished
Polymyxin B product
sulphate….5000IU 20,000/- Under finished specifications
Bacitracin…500IU product of applied
Neomycin…3.5mg Pack of 1’s, 20gm specifications product.
Lidocaine….40mg tube/ As per PRC assay method
is not
Antibacterial submitted.
Manufacturer
462. M/s.Shawan DEXPRO Tablet Form 5 Deferred for Seractil of Approved.
Pharmaceuticals, 300mg review Genus (BNF-61)
Plot #37, Road: Fast Track committee for
NS-1, National Each film coated review of Dexib of Tabros
Industrial Zone, Tablet contains: Dy. No.5246 formulation Pharma Karachi
Rawat Islamabad. Dexibuprofen ….. dated 16-08-2013
300mg Inspection of the
Rs.60,000/- firm was
NSAID conducted on 23
As per SRO July 2013 and
Manufacturer Pack of 10’s GMP
compliance is
found GOOD
Cases deferred in M-242 meeting

S/N Name and Brand Name Type of Form Decision in 242nd Remarks on the Decision
address of (Proprietary name of Registration formulation (if
manufacturer / + Dosage Form + Initial date, diary Board. any) including
Applicant Strength) International
Fee including status in
Composition differential fee stringent drug
regulatory
Pharmacological Demanded Price agencies /
Group / Pack size authorities

Specification
GMP status as
depicted in
latest inspection
report (with
date) by the
Evaluator
463. M/s Medwell BETADINE Scrub Form-5 Deferred as the Pyodine of Approved.
Pharmaceuticals, firm has not Brookes Pharma
Lawrencepur Each 5ml contains: Dy.No: 6382 completed the Karachi
Povidone- dated: 07-10-2013 requisite
Iodine…….7.5% documentation per The inspection of
60,000/- Form-5 firm was carried
Disinfectant out on 01-04-
As per SRO/ 2014 by the area
BP 50ml, 60ml and FID and GMP
450ml bottle compliance was
found good.

Veterinary cases
S/N Name and Brand Name Type of Form Decision in 242nd Remarks on Decision
address of (Proprietary name of Registration the
manufacturer / + Dosage Form + Initial date, Board. formulation (if
Applicant Strength) diary any) including
International
Composition Fee including status in
differential stringent drug
Pharmacological fee regulatory
Group agencies /
Specification size Me-too status
GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator
464. M/s Jfrin JF COLAMINE Form-5 Deferred as the Broncofas of Rejected as

Pharmaceuticals, Oral Powder firm has not Zakfas the
Lasbella Dy.No: 866 completed the Pharmaceuticals formulation
Balochistan Each 100gm dated: 24-07- requisite contains
contains: 2013 documentation banned drug
per Form-5 that is Phenyl
Tylosin 60,000/- Butazone.
Tartrate…..100mg
Doxycycline Decontrolled/
HCL…..200mg Jar of 100,
Phenyl 500, 1000gm
Butazone….12gm
Bromohexine
HCL….05gm
Colistin
Sulphate…..500MIU
Antibiotic
Manufacturer

Case No. 11. NEW APPLICATIONS IN LEIU OF REJECTED ONES
Evaluator - III
Two products of M/s Hiranis Pharmaceuticals are rejected in the 243rd meeting of Registration Board as
the safety and efficacy has not been established in the stringent SRA’s. The firm has submitted new
applications in lieu of the rejected products. The detail is tabulated below:
Sr. Products Discussed in M- Decision in M-243 New Products applied

No. 243
1. Acebro Capsule Rejected as safety and Fungisaf Capsule
(Acebrophylline 100mg) efficacy of formulation has (Fluconazole 150mg)
not been established in
stringent regulatory
authorities.
2. Acebro syrup Rejected as safety and Levopearl oral suspension
(Acebrophylline 50mg/ efficacy of formulation has 125mg/5ml (Levofloxacin)
5ml) not been established in
stringent regulatory
authorities.

The detail of new products is follows:
S/N Name and Brand Name Type of Form Remarks on the Recommendations Decision
address of (Proprietary name + formulation (if by the Evaluator
manufacturer / Dosage Form + Initial date, any) including
Applicant Strength) diary International
status in
differential fee regulatory
Pharmacological agencies /
Group Demanded Price authorities
/ Pack size
Specification
GMP status as
depicted in
latest inspection
report (with
date) by the
Evaluator
465. M/s Hiranis FUNGISAF Capsule Form-5 Diflucan Pfizer Approved.

Pharmaceuticals 150mg Inc
Karachi Dy No: 807 dated
Each capsule contains 28-07-14 Diflucan of
Fluconazole…..150mg Pfizer Karachi
20,000/-
Triazole Antifungal
As per PRC
Manufacturer
466. -do- LEVOPEARL Oral Form-5 Levaquin Oral The product was The Board
Solution Solution of initially considered did not
Dy. No: 2067 Janssen as dry oral accede to
Each 5ml contains: dated:16-12-2013 (USFDA) suspension in 243rd the request
Levofloxacin meeting of of firm for
(USP)….125mg/ 5ml 20,000/- Registration Board change in
and deferred with dosage
Quinolone As per PRC following decision: form &
“Deferred for deferred
Manufacturer confirmation of the instant
formulation” application
The firm then for review
revised the of
formulation as Oral formulation
Solution which was by
product again Incharge,

considered in 244th PEC.
meeting of
Registration Board
and deferred with
decision:
“Deferred as the
Registration Board
has already granted
ten products in
liquid syrup section
(general)”
The firm has now
requested to
consider applied
formulation in lieu
of the rejected
product (Acebro
syrup
(Acebrophylline
50mg/ 5ml) in
243rd meeting of
RB

Item No. VI Miscellaneous Cases - Pharmaceutical Evaluation & Registration Division.
Registration-I
Case No.01. Drugs deferred by Registration Board for expert opinion.
a. Strefen Lozenges - M/s. Reckitt Benckiser Healthcare International, Karachi.
Following drugs deferred for expert opinion. Accordingly product was referred to expert
for views. Comments are as under:-
S. No. Name of Indenter/ Name of drug (s)/ Demanded Shelf Life Date of
Manufacturer Composition Price/Pack application
& Therapeutic Group receiving
& fee.
1. M/s. Reckitt Benckiser Strefen Lozenge Price not 03 years 04-06-2012
Healthcare Each one lozenge mentioned. Rs.15000 +
International, contains:- Rs.35000 =
Karachi. / Flurbiprofen Rs.50,000/-
M/s. Notting Site, BP……………..8.75mg
Nottingham,
Nottinghamshire,
United Kingdom.
Dr. M.Ehsan-ul-Haq, Prof. Dr. Ejaz Hussain Brig. (R) Prof. Dr.
MBBS, DTCD, FCPS, Malik, Muzammil Hasan Najmi,
(Physician (Medicine), Nishtar Medical Institution, Chairman, Department of
Federal Govt. Services Multan. Pharmacology/Associate
Hospital, Islamabad. Dean, Basic Sciences
Division, Foundation
University, Medical College,
Rawalpindi.
The drug Strefen Lozenge I have gone through the literature Awaited.
containing flurbiprofen BP 8.75 of Flurbiprofen. The only is good
can be useful addition to the list and sample and recommended
of pharmaceutical available in for registration.
the country. Since the amount of
the active principle is quite small.
It is les likely to cause untoward
dose-related side effects. The
lozenge formulation of this
compound is already in use in the
world market. However the
therapeutic efficacy and the

social acceptance in our
population can only be accessed
when it is used in our country.
The drug is intended for local use
and has small amount of the
active principle and thus is
expected to be cost effective.
Decision: Registration Board approved registration of Strefen Lozenge as per detail

mentioned in the case. The approval is subject to inspection of manufacturer abroad as per
import policy, verification of storage facilities and price fixation / calculation by the pricing
Division etc.
b. AminoFluid ® Infusion Solution 1000ml - M/s Otsuka Pakistan Ltd., Distt. Lasbella
Registration Board in its 238th meeting deferred following products for expert opinion.
Accordingly products were referred for views. Comments are as under:-
S. Name of Name of drug (s)/ Demanded Shelf Date of

No. Indenter/ Composition Price/Pack Life application
Manufacturer & Therapeutic Group receiving
& fee.
1. M/s Otsuka AminoFluid ® Infusion Solution Rs.4201/Per 02 27-09-2012
Pakistan Ltd., 1000ml 1000ml Soft years Rs.50,000/-
Distt. Lasbella. / Each 150ml contains:- bags.
M/s. PT. Otsuka L-Leucine…...………………2.100g
Indonesia, L-Isoleucine……………...…1.200g
Lawang, Malang. L-Valine..………………...…1.200g
Indonesia. L-Lysine hydrochloride…….1.965g
(L-Lysine Equivalent)….....(1.573g)
L-Threonine...........................0.855g
L-Tryptophen……………….0.300g
L-Methionine.………………0.585g
L-Cystoine………………….0.150g
L-Phenylalanine…………….1.050g
L-Tyrosine..………………...0.075g
L-Arginine………………….1.575g
L-Histidine………………….0.750g
L-Alanine…………………...1.200g
L-Proline….………………...0.750g
LSerine ……………………..0.450g
Gylcine……...........................0.885g

L-Aspartic acid……………..0.150g
L-Glutamic acid….................0.150g
Dipostassium phosphate…....0.458g
Water for injection ad….........150ml
(Clinical Parrenteral Nutrition).
2. M/s Otsuka Kidmin ® Injection Rs.1708/ 02 18-10-2012

Pakistan Ltd., Each 1000ml contains:- Per 200ml years Rs.15000 +
Distt. Lasbella. / L-Leucine………………….…14.0g bag Rs.35000 =
M/s. PT. Otsuka L-Isoleucine………………...…9.0g Rs.50,000/-
Indonesia, L-Valine……………………...10.0g
Lawang, Malang. L-Lysine acetate………………7.1g
Indonesia. (free base)…………………..(5.05g)
L-Threonine…...........................3.5g
L-Tryptophan……………….....2.5g
L-MEthionine…………………3.0g
L-Phenylalanine…………….....5.0g
L-Cysteine….…………………1.0g
L-Tyrosin……………………...0.5g
L-Arginine…..………………...4.5g
L-Histidine………………...…..3.5g
L-Alanine………………...……2.5g
L-Proline…………………...….3.0g
L-Serine……………………….3.0g
L-Aspartic acid..........................1.0g
L-Glutamic acid……………….1.0g
(Clinical Parentertal Nutrition).
3. M/s Otsuka Amiparen ® Injection Rs.2512/ 02 24-09-2012
Pakistan Ltd., Each 500ml contains:- Per 500ml years Rs.15000 +
Distt. Lasbella. / L-Leucine…...………………..7.00g Bag Rs.35000 =
M/s. PT. Otsuka L-Isoleucine……………….....4.00g Rs.50,000/-
Indonesia, L-Valine……………………...4.00g
Lawang, Malang. Lysine Acetate……………….7.40g
Indonesia. (L-Lysine equivalent)…....…(5.25g)
L-Threonine………………….2.85g
L-Tryptophan...........................1.00g
L-Methionine...........................1.95g
L-Phenylalanine……………...3.50g
L-Cysteine…………………...0.50g
Total free amino acids……50.00g
Essential amino acids (E)…..29.55g
Nonessential amino acids (N)20.45g
Total nitrogen………………..7.84g
L-Tyrosine…...........................0.25g
L-Arginine...…………………5.25g
L-Histidine…………………...2.50g
L-Alanine…………………….4.00g
L-Proline…..…………………2.50g

L-Serine…...…………………1.50g
Aminoacetic acid………….…2.95g
L-Aspartic Acid.......................0.50g
L-Glutamic acid.......................0.50g
Water for injection……ad 500mL
(Clinical Parenteral Nutrition).
In charge Intensive Care Unit In charge Intensive Care Unit

(ICU), (ICU),
Pakistan Institute of Medical Sciences, Military Hospital,
Islamabad. Rawalpindi.
I have evaluated the data provided by Otsuka Pakistan Awaited

Limited concerning AminoFluid ® 1000ml dual
chamber soft bags, Kidmin ® Injection 200ml soft bag
and Amiparen ® Injection 500ml soft bag. I have
found that the scientific data supports the therapeutic
efficacy and favorable safety profile. I recommended
that this drug be registered according to the drug
authority regulations.
Decision: Brig. Aslam Khan, Member Registration Board / Incharge Intensive Care
Unit (ICU), Military Hospital, Rawalpindi also recommended the appled formulations.
Thus Registration Board approved registration of AminoFluid ® Infusion Solution 1000ml,
Kidmin ® Injection and Amiparen ® Injection as per detail mentioned in the case. The
approval is subject to inspection of manufacturer abroad as per import policy, verification
of storage facilities and price fixation / calculation by the pricing Division etc.
c. Propilen Surgical Suture with Needle - M/s. Nishat Surgical Hyderabad
Registration Board in its 243rd meeting deferred following products for expert opinion.

Manufacturer & Therapeutic Group receiving &
fee.
1. M/s. Nishat Propilen Surgical Suture with As per PRC 05 26-03-2012
Surgical Needle years Rs.100,000/-
Hyderabad Sindh
Pakistan
manufactured by
M/s. Dogsan

Tibbi Malzeme
Sanayi A.S.
Trabzon Turkey.
2. -do- Silk Non Absorbable Surgical As per PRC 05 26-03-2012
Sutures years Rs.100,000/-
3. -do- Pegelak and Pegelak Rapid As per PRC 05 26-03-2012

Synthetic Absorbable years Rs.100,000/-
Surgical Sutures with Needle
4. -do- Tektel Non Absorbable As per PRC 05 26-03-2012
Surgical Sutures with Needle years Rs.100,000/-
5. -do- Pedesente Synthetic As per PRC 05 26-03-2012

Absorbable Surgical Sutures years Rs.100,000/-
with Needle
6. -do- Pegesorb and Pegesorb Rapid As per PRC 05 26-03-2012
Synthetic Absorbable years Rs.100,000/-
Surgical Sutures with Needle
Professor Tanwir Khaliq, Dr. I.U Baig, FCPS FRCS, Lt. Col. Dr. Farhan Ahmad
Professor of Surgery, Consultant Surgeon & HOD, Majeed, Surgeon, Combined
Department of General Federal Government Military Hospital,
Surgery, Pakistan Institute Polyclinic, Islamabad. Rawalpindi
of Medical Sciences,
Islamabad.
We have used the surgical Samples of sutures supplied Surgical sutures of M/s.
sutures in our procedures. The by M/s. Nishat Surgical Nishat Surgical Hyderabad
tissue penetration, needle, Hyderabad Sindh Pakistan Sindh Pakistan are of
suture strength, pliability and manufactured by M/s. Dogsan unsatisfactory quality,
knotting quality have been Tibbi Malzeme Sanayi A.S. specially size of needle is
found satisfactory. Trabzon Turkey were dispropertmat with thread size
used/tested by me and by my (dia).
surgeons at FGPC and our
observations regarding the
surgical sutures are :
1.Sterile packing is good.
2.Tensile strength of sutures
of their appropriate types and
sizes is good.
3.Needle anchorage is fine.
4.Needle quality is good.
5.Tissue reaction to sutures is
according to standard.

6.No allergic reaction to
suture material.
7.No postoperative infections
nooted.
In light of above observations
I recommend sutures namely;
Propilen, Silk, Pegalak and
Pegalak Rapi, Tektel,
Pedesente and Pegesorb and
Pegesorb Rapid.
Decision: Registration Board deferred the case due to the comments of Lt. Col. Dr.
Farhan Ahmad Majeed, Surgeon, Combined Military Hospital, Rawalpindi as he
mentioned “unsatisfactory quality, specially size of needle is dispropertmat with thread size
(dia)”. The Board decided to send these observations of Lt. Col. Dr. Farhan Ahmad Majeed
to the following experts for further pratical evaluation:
 Col. Dr.Bilal Umair, Surgeon, CMH.

 Dr.Mamoon Rasheed, Surgeon, Shifa Int Hospital, Islamabad.
d. Azarga Eye Drop Suspension 5ml - M/s. Ali Gohar & Co. (Pvt) Ltd., Karachi

Manufacturer & Therapeutic Group receiving &
fee.
1. Applicant: Azarga Eye Drop Suspension Rs.1400/ 24 02-03-2010
M/s. Ali Gohar & 5ml 5ml Eye months Rs.50, 000/-
Co. (Pvt) Ltd., Each ml contains:- Drops packs
Karachi. / Brinzolamide......10mg
Manufacturer: Timolol...............4mg
M/s. S.A. Alcon- (Beta Blocking agents).
Couvreur N.V. Finished product
Rijksweg 14, specifications are
2870 Puurs, Manufacturer.
Belgium.

Prof. Dr. M. Daud Khan, Prof.Dr. Ali Raza, Maj. Gen. Mazhar Ishaq,
Principal & Dean, Head of Eye Department, Commandant,
Pak International Medical RMC and Allied Hospitals, Armed Forces Institute of
College, Hayatabad, Rawalpindi. Opthalmology,
Peshawar. The Mall, Rawalpindi.
Alcon International is the I have reviewed the literature Azarga (Brinzolamide,

leading international& references relating to the Timolol) is already being used
pharmaceutical company above mentioned product with internationally for the
dealing with Ophthalmic regard to its safety, efficacy & management of Glaucoma &
drugs and devices. Alcon cost effectiveness. Azarga all references given by them
drugs are known for quality, (Brinzolamide, Timolol) is have been published in peer
safety and efficacy. Azarga most comfortable Eye Drops reviewed international
Eye Drops, which is a preferred by patient then Medical Journals on regular
combination of a beta blocker Dorzolomide/Timolol basis. It has a very good
and carbonic anhydrase combination. I have gone efficacy and is well tolerated
inhibitor. It is registered by through all references which by the patients.
FDA and has many studies in have been published in
support of its safety, efficacyrenowned International Therefore in the light of data
and effectiveness. The price Medical Journals on regular provided I recommend this
seems to be reasonably intervals. As you all know that drug for registration in
comparable to other anti- Glaucoma is a second leading Pakistan.
glaucoma drugs. I therefore cause of irreversible blindness
recommend that the drug may worldwide & as well as in
kindly be registered in Pakistan & patient has to use
Pakistan. lifelong. So it needs excellent
tolerability & efficacy both.
We need this product in
Pakistan for the preservation
of sight and prevention of
blindness with Glaucoma. I
always trust the quality of
innovative products & Brands.
I highly recommend this drug
for registration & made
available in Pakistan.
Decision: Registration Board approved registration of Azarga Eye Drop Suspension
5ml as per detail mentioned in the case. The approval is subject to inspection of
manufacturer abroad as per import policy, verification of storage facilities and price
fixation / calculation by the pricing Division etc.

e. Hidrasec 10mg, 30mg Sachet and and Hidrasec Capsule 100mg
S. Name of Indenter/ Name of drug (s)/ Demanded Shelf Date of

No. Manufacturer Composition Price/Pack Life application
& Therapeutic Group receiving &
fee.
1. M/s. Abbott Hidrasec 10mg Sachet Rs.1046.30/Per 24 29-04-2013
Laboratories Each sachet contains:- 16 Sachets months Rs.100,000/-
(Pakistan) Limited, Racecadotril……10mg
Karachi. / (Anti-Diarrheal).
M/s. Laboratoires
SOPHARTEX 21
Rue du Pressoir
Vernouillet,
France.
2. M/s. Abbott Hidrasec 30mg Sachet Rs.1046.30/Per 24 29-04-2013
Laboratories (Pakistan) Each sachet contains:- 16 Sachets
Limited,
months Rs.100,000/-
Karachi. /
Racecadotril….30mg
M/s. Laboratoires (Anti-Diarrheal).
SOPHARTEX 21 Rue
du Pressoir
Vernouillet, France.
3. M/s. Abbott Hidrasec 100mg Rs.654/ 24 29-04-2013
Laboratories Capsules Per 10 months Rs.100,000/-
(Pakistan) Limited, Each capsule contains:- Capsules
Karachi. / Racecadotril….100mg
M/s. Laboratoires (Anti-Diarrheal).
SOPHARTEX 21
Rue du Pressoir
Vernouillet,
France.
Prof.Dr. Rauf Niazi, Prof.Dr. Syed Irfan Ahmed, Brig.Amjad Salamat,

Head of Unit-2 Professor of Medicine, Military Hospital,
Pakistan Institute of Medical RMC & Allied Hospitals, Rawalpindi.
Sciences, Benazir Bhutto Hospital,
Islamabad. Murree Road, Rawalpindi.
I strongly recommend Hidrasec is recommended for Awaited.
registration of that Raceadotril registration for the treatment
(acetorphan), Capsules and

Sachets, however if the price of diarrhea in conjunction with
of the drug can be brought ORS. However it should not
down, keeping in mind the be used to treat infections.
economic status of our
Even in Cholera, which
population these drugs would
be very useful addition, to requires antibiotics and
present drugs, available to intravenous saline, it should
treat acute secretory diarrhea be used with caution as severe
and reduce morbidity of this fluid depletion can be a “Pre-
common condition. I highly renal” cause of renal failure.
recommend registration of the Hidrasec has a renal mode
drug, on fast track basis.
excretion. Also no studies
have been conducted
comparing its safety profile
with Zinc or probiotics. Hence
it can not be claimed superior
to these modes of treatment.
Decision: Registration Board deferred the case for evaluation of clinical data by the
following experts:
 Brig.Amjad Salamat MH, Rawalpindi.

 Prof.Syed Irfan, BBH.
 Prof.Rauf Niazi, PIMS.
Case No. 02. Registration of solvents for Oncodex (Docetaxel) Injection - M/s. PharmEvo
(Pvt) Ltd, Karachi.
Drug Registration Board in 236th meeting held on 20th November, 2012 approved the
registration of following drugs in the name of M/s. PharmEvo (Pvt) Ltd, Karachi manufactured
by M/s. Jiangsu Aosaikang Pharmaceutical Co., Ltd., 699-Kejian Road, Jiangning Science Park,
Nanjing, China subject to inspection of manufacturer abroad:-
S. No. Name of drug (s) & composition.

1. Oncodex 20mg Injection.
Each vial contains:-
Docetaxel……………20mg.

4. Oncotaxel 100mg Injection.
Paclitaxel……………100mg.
In compliance of Drug Registration Board’s decision, inspection of the manufacturer

M/s. Jiangsu Aosaikang Pharmaceutical Co., Ltd., 699-Kejian Road, Jiangning Science Park,
Nanjing, China has been carried out by the nominated panel comprising Dr. Obaidullah, Deputy
Director General (Registration) and Mr. Abdullah, Deputy Drugs Controller (RRR), Drug
Regulatory Authority of Pakistan. M/s. PharmEvo (Pvt) Ltd, Karachi was advised to submit
separate solvent application for each product. The panel of inspector has recommended the
registration of the above said products. The storage facility of the importer has already been
verified by the area FID.
In response to our latter M/s. PharmEvo (Pvt) Ltd, Karachi have informed that same
solvent with same composition is being used in all three strengths of docetaxel range with final
concentration of the diluted solution equivalent to 10mg/ml. Below is a self-explanatory chart
depicting the fill range, approximate extractable volume and final concentration of the product
i.e. 10mg/ml:-
PRODCUT DILUENT 13% APPROXIMATE CONCENTRATION

NAME (W/W) EXTRACTABLE OF THE INITIAL
ETHANOL IN VOLUME OF DILUTED
WATER FOR DILUENT WHEN SOLUTION
INJECTION ENTIRE (MG/ML
FILL RANGE CONTENTS ARE DOCETAXEL)
(ML) WITHDRAWN
(ML)
DOCETAXEL 3.88 – 3.08 ml 1.8 ml 10mg/ml
20MG INJECTION
40MG INJECTION
80MG INJECTION

M/s. PharmEvo (Pvt) Ltd, Karachi was again advised to submit separate solvent
application for each strength. In response, M/s. PharmEvo (Pvt) Ltd, Karachi has submitted
separate solvent application for each three strengths.
Decision: Registration Board approved the request of the firm for registration of the
solvents for already registered Docetaxel range of products.
Case No.03. Drugs deferred by Registration Board for submission of documents.
a. Caflam 50mg Sachets - M/s. Novartis Pharma, Karachi.
Drug Registration Board deferred the following applications for registration of drugs in
its 243rd meeting and decided as mentioned against each. Accordingly, firm was advised to
provide the same information and the firm has submitted the required information as follows:-
S.# Name of Name of Drug (s) Demanded Shelf Decision Reply of

Manufacturer / Composition & Life the firm.
Price &
Importer. Therapeutic
Pack Size.
Group.
1. M/s. Novartis Pharma Caflam 50mg Sachets Rs.198/ 02 Deferred for The firm has
(Pakistan) Limited, Each sachet contains:- Per packs years submission provided
Karachi / Diclofenac of 9’s of COPP COPP of
M/s. Mipharm S.p.A., potassium……50mg Rs.22/Per from Italy attested
Milan, Italy. (Non-steroidal anti- Sachet regulatory by Pakistan
inflammatory drug authority of Embassy.
(NSAID) Analgesic. Italy
Decision: Registration Board approved registration of Caflam 50mg Sachets as per

detail mentioned in the case. The approval is subject to inspection of manufacturer abroad
as per import policy, verification of storage facilities and price fixation / calculation by the
pricing Division etc.

b. Fluimucil A 600mg Effervescent Tablets - M/s. Angelini Pharmaceuticals (Pvt) Ltd.,
Lahore.
Drug Registration Board in its 244th meeting held on 22-23rd July, 2014 considered and
deferred the application of “Fluimucil A 600mg Effervescent Tablets (Acetylcysteine
600mg)” applied by M/s. Angelini Pharmaceuticals (Pvt) Ltd., Lahore imported from M/s.
Zambon Switzerland Ltd., Cadempino, Switzerland for submission of safety and efficacy data of
the drug along with complete clinical trial data of the formulation.
Name of Importer / Name of Drug (s) Demanded Shelf Life

Manufacturer. Composition & Therapeutic
Group. Price & Pack Size.
M/s. Angelini Fluimucil A 600mg Rs.561.41/Per 03 years

Pharmaceuticals (Pvt) Effervescent Tablets. packs of 10
Ltd., Lahore / Each tablets contains:- effervescent
Acetylcysteine........600mg.
tablets.
M/s. Zambon Switzerland (Mucolytics).
Ltd., Cadempino, Rs.56.14/Per
Switzerland. effervescent
tablets.
Accordingly, M/s. Angelini Pharmaceuticals (Pvt) Ltd., Lahore was advised to provide
the same. The firm has submitted the documents safety and efficacy data, which needs
deliberation by the Board.
Decision: Registration Board deferred the case for evaluation of clinical data by the
following experts:
 Brig. Aslam Khan, Member registration Board
 Abdul Lateef Shaikh, Director Pharmacy, AKUH, Karachi.
 Dr.Shazli Manzoor, Pulmonologist, Quaid-e-Azam Int Hospital, Islamabad.

Case No. 04. Registration of imported – Inspections of manufacturing units abroad
thereof.
a. Withdrawal of registration applications - M/s. Barrett Hodgson Pakistan (Private)

Limited, Karachi.
Drug Registration Board in its 228th meeting held on 12th - 13th October, 2010 approved
the registration of following drugs in the name of M/s. Barrett Hodgson Pakistan (Private)
Limited, Karachi manufactured by M/s. Yangtze River Pharmaceutical (Group) Jiangsu, China,
subject to inspection of manufacturer abroad:-
S. No. Name of Drug (s) Composition.

1. PacliBar Injection 30mg.
Each 5ml vial contains:-
Paclitaxel………30mg USP Specs.
2. PacliBar Injection 100mg.
Each 16.7ml vial contains:-
Paclitaxel………100mg USP Specs.
Dr. Muhammad Khalid Khan, Director, DTL, KPK / Member Drug Registration Board
and Mrs. Rohi Obaid, DDC, DRAP, Karachi was nominated for inspection of M/s. Yangtze
River Pharmaceutical (Group) Jiangsu, China. Accordingly, M/s. Barrett Hodgson Pakistan
(Private) Limited, Karachi was informed for arranging the inspection.
In response, M/s. Barrett Hodgson Pakistan (Private) Limited, Karachi have informed
that their principal M/s. Yangtze River Pharmaceutical (Group) Jiangsu, China is no more
interested in getting these products registered in Pakistan due to much delay in the process.
Therefore, the firm has requested for withdrawing the cases for registration of the above
mentioned products.
Decision: Registration Board acceded to request of the firm about withdrawl of above
registration applications.

b. Registration of imported drugs – Comments of panel of inspectors.
Drug Registration Board in its 236th meeting held on 20th November, 2012 approved the
registration of following drugs for import in the name of M/s. Sind Medical Stores, Karachi
manufactured by M/s. Boryung Pharmaceutical Co. Ltd., Singil-dong, Wonnam-dong, Chongro-
ku, Seoul, Korea, subject to inspection of manufacturer abroad:-
S. No. Name of Drug (s) & Fee Price approved by the Price
Composition. deposited. Advisory Committee.
1. A.D. Mycin Injection 10mg. Rs.100,000 Rs.430.00/Per vial.

Doxorubicin HCI…….10mg.
2. A.D. Mycin Injection 50mg. Rs.100,000 Rs.1716.00/Per vial.

3. E.P. Mycin Injection 10mg. Rs.100,000 Rs.670.00Per vial.

Epirubicin HCI……10mg.
4. E.P. Mycin Injection 50mg. Rs.100,000 Rs.2500.00/Per vial.

Epirubicin HCI…....50mg.
5. Neotabine Injection 1gm. Rs.100,000 Rs.8330.00/Per vial.
Gemcitabine HCI….1.14gm.
6. Neotabine Injection 200mg. Rs.100,000 Rs.1675.00/Per vial.

Gemcitabine HCI….228mg.
In compliance, inspection of the manufacturer abroad M/s. Boryung Pharmaceutical Co. Ltd.,
Singil-dong, Wonnam-dong, Chongro-ku, Seoul, Korea, has been carried out by the nominated
panel comprising Dr. Saifur-Rehman Khattak, Director, CDL, Karachi and Mr. Salateen Waseem
Philip, ADC (Licensing), Drug Regulatory Authority of Pakistan, Islamabad.

The panel of inspectors has recommended the registration of the above said products with the
remarks that registration of the applied products is recommended however import to Pakistan
should be allowed only after confirmation of successful execution of the desired improvement.
The storage facility of the importer has already been verified by the Area FID.
With reference to the inspection report Dr. Saifur-Rehman Khattak, Director, CDL, Karachi
and Mr. Salateen Waseem Philip, ADC (Licensing), Drug Regulatory Authority of Pakistan,
Islamabad were requested to inform about type of short coming pointed out whether these are
critical in nature affecting the quality of the product or suggestive / advisory nature for further
processing the case.
In response, Dr. Saifur-Rehman Khattak, Director, CDL, Karachi have informed that the firm
was thoroughly inspected for facilities regarding the production, quality control and storage of
their products (Anti-Cancer Injections) intended for registration in Pakistan. The risk based
assessment of the facilities of the firm identified a number of critical, major and minor
observations which can adversely affect the quality of the products intended for registration in
Pakistan. They has further clarified that the observation No.1,2,4,6 and 10 are the critical
observations which need be rectified in any stance along with the other stated observations
before importing these products in Pakistan.
The panel informed that the certain observations are very critical and can affect the quality of
the product which is very serious threat for the patients to whom use these products. It should be
the duty of the panel of experts should gave the clear recommendation in light of observation, in
light of these serious observations the panel also recommended these products in final
recommendation, which is not understandable.
Decision: Registration Board discussed the inspection report in detail and keeping in
view nature of the observations being critical rejected the following applications of M/s.
Sind Medical Stores, Karachi manufactured by M/s. Boryung Pharmaceutical Co. Ltd.,
Singil-dong, Wonnam-dong, Chongro-ku, Seoul, Korea;
S. No. Name of Drug (s) &

Composition.

1. A.D. Mycin Injection 10mg.
2. A.D. Mycin Injection 50mg.
3. E.P. Mycin Injection 10mg.
Epirubicin HCI……10mg.
4. E.P. Mycin Injection 50mg.
Epirubicin HCI…....50mg.
5. Neotabine Injection 1gm.
Gemcitabine HCI….1.14gm.
6. Neotabine Injection 200mg.
Gemcitabine HCI….228mg.
c. Registration of imported drug – Issuance of registration letter after inspection of

manufacturer abroad.
i. M/s. Laderly Bio-Tech Pharma, Karachi
Drug Registration Board in its 244th meeting held on 22-23rd July, 2014 approved the
registration of following drugs in the name of M/s. Laderly Bio-Tech Pharma, Karachi,
manufactured by M/s. CSPC Pharmaceutical Co., Ltd., No. 188 Gongnong Road, Shijiazhuang
City, P R China, subject to inspection of manufacturer abroad, verification of storage facilities
and price fixation / calculation etc as per policy:-
S.# Name of drug (s)/Composition. Fee deposited. Prices approved by
the Price
Recommendatory
Committee
1. Meropeon Injection 0.5gm. Rs.100000 Rs.600/Per vial
Each vial contains: -
Meropenem USP…… 0.5gm.
2. Meropeon Injection 1gm. Rs.100000 Rs.1100/Per vial.

Each vial contains: -
Meropenem USP …… 1gm.

Inspection of the manufacturer abroad M/s. CSPC Zhongnuo Pharmaceutical
(Shijiazhuang) Co., Ltd., 188 Gongnong Road, Shijiazhuang City, Hebei Province, China has
already been carried out by the nominated panel comprising Dr. Obaidullah, Deputy Director
General (Registration) and Mr. Abdullah, Deputy Drugs Controller (RRR), Drug Regulatory
Authority of Pakistan. The panel of inspectors has recommended the registration of the above
said products.
Decision: Registration Board considered the inspection report of the panel and
approved the registration of above products.
ii. M/s. Pak China International, Karachi.

Drug Registration Board in its 245th meeting held on 29-30th September, 2014 approved
the registration of following drug in the name of M/s. Pak China International, Karachi
manufacture by M/s. Zheijing Chimin Pharmaceutical Co. Ltd, 888 Beiyuan Road, Huangyan,
Zhejiang, P.R. China and exported by M/s. Ningbo Tisun Biochemi Company Ltd. Ningbo,
China subject to inspection of manufacturer abroad, verification of storage facilities and price
fixation / calculation etc as per policy:-
S.# Name of drug (s)/Composition.
1. Sodium Ringer Lactate Injection.

Each 500ml bottle contains:-
Sodium Chloride….......................3.0gm.
Sodium Lactate, Anhydrous……1.55gm.
Potassium Chloride .....................0.15gm.
Calcium Chloride............................0.1gm.
Inspection of the manufacturer abroad M/s. Zheijing Chimin Pharmaceutical Co. Ltd, 888
Beiyuan Road, Huangyan, Zhejiang, P.R. China has already been carried out by the nominated
panel comprising Dr. Obaidullah, Deputy Director General (Registration) and Mr. Abdullah,
Deputy Drugs Controller (RRR), Drug Regulatory Authority of Pakistan. The panel of inspectors
has recommended the registration of the above said product.

Decision: Registration Board considered the inspection report of the panel and
approved the registration of above products.
Case No. 05. Change of manufacturing site of imported registered drug.

a. Duac Gel (Reg. No.043090) - M/s. GlaxoSmithKline Pakistan Limited, Karachi.
M/s. GlaxoSmithKline Pakistan Limited, Karachi have requested to approve the change
of source of manufacturing & supply of their registered imported drug “Duac Gel (Reg.
No.043090)” from M/s. Stiefel Laboratories, Ireland to M/s. Glaxo Operations UK Limited,
Barnard Castle, UK.
The firm has deposited fee Rs.50000/- and submitted following supporting documents:-
i) Original legalized CPP from new source.

ii) Supporting letter from endorsing source change.
iii) Copy of initial registration letter.
iv) Copy of transfer of registration letter in the name of M/s. GSK Pakistan Ltd.,
Karachi.
M/s. GlaxoSmithKline Pakistan Limited, Karachi was advised to submit the balance fee
as per revised “Schedule-F” for change of source of Duac Gel (Reg. No.043090) and status of
registration with EMA, US-FDA, Japan & Australia.
In response, M/s. GlaxoSmithKline Pakistan Limited, Karachi has submitted required fee
as per revised fee structure given in SRO 1117 (I) 2012.
The firm M/s. GlaxoSmithKline Pakistan Limited, Karachi has submitted legalized
Certificate of Pharmaceutical Product of “Duac Gel” issued by Australian Regulatory Authority.
The firm has submitted the all document and required fee as per approved policy of the
Drug Registration Board.
Decision: Registration Board approved request of M/s. GlaxoSmithKline Pakistan
Limited, Karachi for change in manufacturing site of Duac Gel (Reg. No.043090) from M/s.
Stiefel Laboratories, Ireland to M/s. Glaxo Operations UK Limited, Barnard Castle, UK.

Case No.06 Transfer of registered drugs.
a. M/s. Getz Pharma (Pvt) Limited, Karachi.
M/s. Getz Pharma (Pvt) Limited, Karachi have requested for transfer of registration of the
under-mentioned registered imported drugs from the name of previous importer M/s. Abbott
Laboratories (Pakistan) Limited, Karachi to their name as a result of agreement between M/s.
AbbVie Inc & M/s. Getz Pharma (Pvt) Limited, Karachi: -
S. No. Reg. No. Name of Drugs. Name of Manufacturer.
1. 015532 Survanta Suspension 8ml. M/s. Abbvie Inc., North Chicago, IL 60064,
USA.
2. 059025 Survanta Suspension 4ml. -do-
3. 011081 Forane Liquid for Inhalation Manufactured by:-

100ml. M/s. Aescia Queenborough Limited, U.K.
Marketing Authorization Holder:-
M/s. Abbvie Limited, U.K.
4. 027374 Sevorane Volatile Liquid for -do-
Inhalation 250ml.
M/s. Getz Pharma (Pvt) Limited, Karachi have deposited required fee
Rs.100000x4=400000/- and submitted the following documents:-
i) Legalized CoPP / GMP Certificate of Survanta Suspension 4ml.
ii) Legalized CoPP of Forane Liquid for Inhalation 100ml.
iii) Legalized GMP Certificate of Forane Liquid for Inhalation 100ml.
iv) Legalized CoPP of Sevorane Volatile Liquid for Inhalation 250ml.
v) Legalized GMP Certificate of Sevorane Volatile Liquid for Inhalation 250ml.
vi) Legalized Termination letter from M/s. AbbVie.
vii) Legalized Authorization letter from M/s. AbbVie
viii) No Objection Certificate from M/s. Abbott Laboratories (Pakistan) Limited,
Karachi.
ix) Registration applications on Form-5-A.
x) Copy of NOC for CRF.
Decision: Registration Board decided as follows:

 Cancellation of above registrations from M/s. Abbott Laboratories (Pakistan)
Limited, Karachi.
 Grant of above registrations in name of M/s. Getz Pharma (Pvt) Limited, Karachi.
Chairman, Registration Board will permit issuance of registration letter after
evaluation / completion of Form 5A as per check list approved by Registration

Board, comments of Cost & Pricing Division about MRP of the drug and
compliance of Import Policy for Finished Drugs.
b. Xenetix 350mg/ml Solution for Injection - M/s. A & Z Health Services, Rawalpindi
M/s. A & Z Health Services, Rawalpindi have requested for transfer of registration of a
registered drug “Xenetix 350mg/ml Solution for Injection (Reg. No.027353)” manufactured by
M/s. Guerbet France from the name of previous agent M/s. Digital Imaging Systems (Pvt) Ltd.,
Lahore to their name for finish import. They have deposited fee Rs.15000/- and submitted their
distribution agreement and previous agent dismissal notice. Since NOC of the former agent M/s.
Digital Imaging Systems (Pvt) Ltd., Lahore was not available. Therefore, as per practice in
vogue M/s. Digital Imaging Systems (Pvt) Ltd., Lahore were asked on 25th May 2009 either to
submit their NOC in this regard or provide their fresh agency agreement (if any) with the
manufacturer abroad. Thereafter a reminder was issued on 01-07-2009 but they did not respond.
Then a show cause notice was issued to them on 29th July 2009 to submit reply within 15 days
but they did not respond at all. Copy of this notice was also endorsed to DDG (E&M) Lahore to
ensure delivery to M/s. Digital Imaging Systems (Pvt) Ltd., Lahore. In response, Federal
Inspector of Drugs, Lahore, Mr. Asim Rauf has informed that despite personal visit of Drugs
Controller Officers to M/s. Digital Imaging Systems (Pvt) Ltd., Lahore on 03-03-2010 and
written reminder thereafter, the firm did not respond to the queries sought.
M/s. A & Z Health Services, Rawalpindi was advised to deposit balance fee as per
revised fee Schedule-F. In response, the firm have deposited the balance fee Rs.35000/-.
The firm has applied for the renewal neither on time nor after the expiry of the time till to
date. Therefore, the registration is not valid and cannot be transferred.
Decision: Registration Board did not accede to request of firm as registration of the
drug is not valid.
Case No. 07. Transfer of registrations and change of manufacturing site - M/s. Abbott
Laboratories (Pakistan) Limited, Karachi
M/s. Abbott Laboratories (Pakistan) Limited, Karachi have requested for transfer of
registration of the under-mentioned registered imported drugs from the name of previous
importer M/s. Highnoon Laboratories Ltd., Lahore to their name due to an International

Acquisition of the Pharmaceutical Section of Solvay with all associated companies has been
acquired by the Abbott group since February 15, 2010: -
S# Reg. No. Name of Drugs. Existing Name of New Name of

Manufacturer. Manufacturer.
1. 018552 Physiotens 0.2mg M/s. Eli Lilly S.A., Manufactured by:
Tablets. Spain. M/s. Rottendrof Pharma
GmbH, Germany.
Packed by: -
M/s. Abbott Healthcare
SAS, France.
2. 018551 Physiotens 0.3mg -do- -do-
Tablets.
3. 018550 Physiotens 0.4mg -do- -do-

Tablets.
They have deposited required fee and following supporting documents: -

i) Original NOC of the previous importer M/s. Highnoon Laboratories Ltd., Lahore.
ii) Copy of the acknowledgement of last renewal of registration of the products
applied by the previous importer M/s. Highnoon Laboratories Ltd., Lahore.
iii) Copies of acknowledgement of receipt issued by the German National authority
BfArM & a notification submitted by the Solvay to the Germany authority for the
change in manufacturer name to M/s. Rottendrof Pharma GmbH, Germany.
iv) Copy of NOC for CRF.
Drug Registration Board in its 239th meeting held on 12th September, 2013 approved the
transfer of registration of Physiotens Tablet from M/s. Highnoon to M/s. Abbott Laboratories
(Pakistan) Ltd. Karachi along-with the change in manufacturing site from M/s. Eli Lilly S.A.,
Spain to M/s. Rottendrof Pharma GmbH, Germany, while the packaging site of the finished
products will be M/s. Abbott Healthcare SAS, France. The Board advised to provide site master
file of both sites and panel will inspect the manufacturing sites as well to comply the provisions
of import policy. The Board authorized its chairman to accord approval for issuance of letter
after compliance of aforementioned provisions.
As per decision of the Drug Registration Board M/s. Abbott Laboratories (Pakistan)
Limited, Karachi have submitted site master files of both sites attested by an authorized person
of the company.

M/s. Abbott Laboratories (Pakistan) Limited, Karachi was again advised to submit the
Form-5 (A), legalized CoPP’s of both Germany and French sources.
In response, M/s. Abbott Laboratories (Pakistan) Limited, Karachi have submitted Form
5(A) and following documents for an intermediate International Change of Manufacturing from
M/s. Rottendrof Pharma GmbH, Germany to M/s. Abbott Healthcare SAS, France:-
i) CoPP of the M/s. Abbott Healthcare SAS, France legalized by Pakistan Embassy.
ii) GMP of the regulatory authority for the manufacturing site legalized by Pakistan
Embassy.
iii) Justification of Change.
M/s. Abbott Laboratories (Pakistan) Limited, Karachi have also submitted that both
manufacturing and release site will be M/s. Abbott Healthcare SAS, France.
This case was discussed in 239th meeting of the Drug Registration Board for the change
of manufacturing site from M/s. Eli Lilly S.A., Spain to M/s. Rottendrof Pharma GmbH,
Germany & packaging at M/s. Abbott Healthcare SAS, France. Meanwhile the firm requested
that all the manufacturing and packaging steps will be carried out at “M/s. Abbott Healthcare
SAS, France” and for which they have submitted documents as per SOP. Under the Drugs Act,
1976 there is no provision for transfer of registration from one company to another.
Decision: Registration Board referred above formulations for c onsideration of Review
Committee.
Case No.08 Change in name of manufacturer.

a. Rocaltrol Capsules 0.25mcg and 0.5mcg - M/s. Martin Dow Limited, Karachi.
M/s. Martin Dow Limited, Karachi has requested to approve the change of
manufacturer name of their following registered imported drugs as follows:-
S# Reg. No. Name of Drug (s) Current Name of New Proposed Name
Manufacturer. of Manufacturer.
1. 015557 Rocaltrol Capsules M/s. R.P Scherer GmbH, M/s. Catalent
0.25mcg. Germany. Germany Eberbach
GmbH,

Gammelsbacher
Strasse 2
69412 Eberbach /
Baden, Germany.
2. 015556 Rocaltrol Capsules -do- -do-
0.5mcg.
The firm have deposited required fee Rs.100000x2=200000/- and submitted following
supporting documents:-
i) Copy of registration letter.
ii) Copy of transfer of registration letter.
iii) Copy of change in manufacturing site.
iv) Copy of NOC for CRF clearance.
v) Original and legalized CoPP as per WHO format.
M/s. Martin Dow Limited, Karachi was advised to provide CoPP issued from German
authority as the above said products are being manufactured in Germany and Certificate of Swiss
Medica is irrelevant.
In response, M/s. Martin Dow Limited, Karachi have submitted that Rocaltrol Capsules
0.25mcg & 0.5mcg are imported in finished form from M/s. F. Hoffmann-La Roche Ltd.,
Switzerland, under contract manufacturing arrangement with M/s. R.P Scherer GmbH,
Germany. M/s. F. Hoffmann-La Roche Ltd., Switzerland holds marketing authorization for
Rocaltrol range and M/s. R.P Scherer GmbH, Germany is just a contract manufacturer of
Rocaltrol. M/s. R.P Scherer GmbH, Germany does not hold marketing authorization of Rocaltrol
in Germany as such German authorities cannot issue CoPP for the product not marketed by the
company in Germany.
The firm has further submitted that they have submitted CoPP of Rocaltrol Capsules
0.25mcg & 0.5mcg issued from Swiss authorities, as the finish product is supplied from
Switzerland which indicates M/s. R.P Scherer (new name Catalaent) as manufacturing site.
The firm has also informed that only the name of manufacturer of Rocaltrol Capsules is
changed from “R.P. Scherer GmbH & Co. KG” to “Catalent Germany Eberbach GmbH”. The
physical address of the facility, the manufacturing process and quality controls for the capsules
as well as the personnel producing & testing of the capsules remains unchanged.

The manufacturing site of the product “Rocaltrol Capsules” is located in Germany but the
firm has submitted CoPP of Swiss Medica and not of German Authorities. The same was asked
them but they have not provided the same. The CoPP of country of origin is mandatory for such
approval.
Decision: The Board deferred the case and advised the firm to submit the legalized
document issued by German regulatory authorities for following confirmations:
 Above referred products are being contract manufactured at Catalent Germany
Eberbach GmbH.
 It is only change of title / name of the firm and rest of facilities including address is
same as of previous manufacturer.
Case No.09 Exemption from the Drugs (Labeling & Packing) Rules, 1976.
a. Kytril (Granisetron) Ampoule 3mg/3ml, Reg. No.020691 - M/s. Roche Pakistan
Limited, Karachi.
M/s. Roche Pakistan Limited, Karachi have informed that “Kytril Ampoule 3mg/3ml
(Reg. No.020691)” was registered in the name of M/s. SmithKline & French Pakistan Limited,
Karachi on February 10, 1998 and the registration was subsequently transferred to M/s. Roche
Pakistan Limited, Karachi on July 25, 2001 after the global acquisition of this brand by their
principal M/s. F. Hoffmann La-Roche Basel, Switzerland. Due to the low volumes of the imports
/ sales, (approx 2000 packs / anum) M/s. Roche Pakistan Limited had applied for exemption
from the Drugs (Labeling & Packing) Rules 1986 and the exemption was granted on November
10, 2004. Furthermore, for necessary compliance to the Drugs (Labeling & Packing) Rules 1986,
i.e. (after imports of the consignment) the information, i.e. Pak Reg. No., Price and Urdu
instructions are being overprinted on the secondary carton using an ink-jet printer.
Recently M/s. Roche Pakistan Limited, Karachi have imported a consignment of “Kytril
Ampoules” in Islamabad, (1000 packs) and have been advised by the concerned ADC to paste
stickers for compliance to the Drugs (Labeling & Packing) Rules 1986 on the individual
ampoules of the 5’s pack. Following find few facts which would reveal that individual ampoule
sticker pasting would be detrimental to the 5’s pack and the product:-

i) It’s a Neo-top secondary carton, (5’s pack) with perforated seal, and if open once the
temper evident seal / integrity of the pack would be compromised.
ii) Pasting of stickers is not possible due to the limited space available on the 3ml
ampoule as the sticker would mask the primary label, hiding the critical information
on the primary label, (ampoule photo attached).
iii) There would be high risk of ampoule breakage during the excessive handling of the
pack after opening it and while carrying out the manual process of sticker pasting.
Considering the above mentioned facts M/s. Roche Pakistan Limited, Karachi have
requested for an exemption of overprinting of the primary label (ampoule), since the secondary
label (carton) is being duly complied with the requirement of the Drugs (Labeling & Packing)
Rules 1986 by ink-jet printing.
M/s. Roche Pakistan Limited, Karachi have deposited required fee Rs.5000/- and
submitted following supporting documents:-
i) Copy of transfer of registration letter.

ii) Copy of initial registration letter.
iii) Copy of letter exemption from Drugs (Labeling & Packing) Rules 1986.
iv) Copy of last renewal status.
v) Copy of labels.
Kytril Ampoules (Reg. No.020691) is an 5HT3-antagonist used as antienetic, available in

3ml ampoule, which cannot be allowed to sell without complying full requirement of the Drugs
(Labeling & Packing) Rules 1986.
Decision: The Board after detailed deliberations decided that M/s Roche Pakistan Ltd,
Karachi may be permitted for ink-ject printing of Urdu version only of the ampules of
Kytril Ampoules (Reg. No. 020691) in any licensed manufacturing unit having facility for
this purpose. The firm will provide NOC of any licensed manufacturing unit and case will
be processed for approval for issuance of letter. The firm will comply the rest of the
labeling requirements under the Drugs (Labeling & Packaging) Rules, 1986 before import.

Case No.10 Extension in shelf life of registered drugs.
a. Alimta 100mg Injection, Regn. No.066174 and Alimta 500mg Injection, Regn.
No.043068.
M/s. Eli-Lilly Pakistan (Private) Limited, Karachi have requested to approve the
extension of shelf life of their following registered imported drugs from 24 months to 36 months.
As the current stability studies conducted on this product confirms that the product is well stable
when tested at 36 months time interval:-
S. No. Reg. No. Name of Product.
1. 066174 Alimta 100mg Injection.
2. 043068 Alimta 500mg Injection.
The firm has deposited required fee Rs.5000x2=10,000/- and submitted following
supporting documents:-
i) Copy of registration letter of Alimta 100mg Injection.

ii) Original CoPP of Alimta 100mg Injection attested by Pakistan Embassy having
approved shelf life of 36 months.
iii) Copy of registration letter of Alimta 500mg Injection.

iv) Copy of the acknowledgement of last renewal of registration of Alimta 500mg
Injection.
v) Original CoPP of Alimta 500mg Injection attested by Pakistan Embassy having
approved shelf life of 36 months.
vi) Copies of Stability Studies.
M/s. Eli-Lilly Pakistan (Private) Limited, Karachi was advised to clarify whether
stability data conducted for Zone-IV is approved by US-FDA or otherwise. In response, M/s. Eli-
Lilly Pakistan (Private) Limited, Karachi have submitted that previously provided stability data
was conducted for Zone-IV and approved by FDA. They have further submitted that original
CPPs issued by the FDA mentioning 36 months shelf life. These CPPs issued by the FDA
specifically for Pakistan for Alimta 100mg & 500mg on the basis of submitted Zone-IV stability
data. Therefore, Zone IV stability data should be considered as approved by the FDA.
As per practice in vogue views of following experts regarding extension of shelf lives of
the products has been obtained:-

S. No. Name of Expert. Opinion
1. Prof. Dr. Zafar Iqbal, Recommended

Chairman, Department of Pharmacy,
University of Peshawar,
Peshawar.
2. Dr. Farzana Chowdhary, Extension in shelf-lives is recommended
Director, Department of Pharmacy, on condition that they will be available
University of Veterinary & Animal only in hospitals / institutions specialized
Sciences, Lahore. for the treatment of cancer.
3. Jamil Anwar, Recommended

Director,
Drugs Testing Laboratory,
Punjab, Lahore.
M/s. Eli-Lilly Pakistan (Private) Limited, Karachi was advised to clarify as these
“Pemetrexed” containing products are meant for malignant pleural mesotheliona, which indicate
it is a specialized product for tertiary care institution. The one of the expert indicate these
products should be available only in hospitals / institutions specialized for the treatment of
cancer. Therefore, you are advice to inform this office about mode of sale whether it is selling to
institution / hospitals or also available in retail out lets as well.
In response, M/s. Eli-Lilly Pakistan (Private) Limited, Karachi have confirm that Alimta
(pemetrexed) is indicated for Nonsquamous Non-Small Cell Lung Cancer-NSCLC and
malignant Pleural Mesothelioma. Alimta 500mg and 100mg formulations are registered in
Pakistan since 2006 and 2010 respectively. They would like to inform that at the time of
registration, no restrictions were imposed on the availability of Alimta. They have authorized
their distributor to provide Alimta to hospitals / institutions specialized for the treatment of
Cancer based on tenders / orders and to the very selective licensed outlets in Pakistan.
Decision: Registration Board after deliberations approved the request of the firm for
increase in shelf life.

Case No.11. Resemblance of brand name – Personal hearing thereof.
M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore have informed about resemblance of
brand name of imported drug “OZOL-40 Infusion (Reg. No.044854)” imported by M/s. United
International, Karachi with the brand name of their already registered locally manufactured drug
“O-Zole Capsules 40mg (Reg. No.043642)”. M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore
submitted that they are facing problems in marketing the product, time and again, and it will be
even more aggravated if the situation continues. Therefore they have humbly requested to take a
check on the situation and to strictly instruct M/s. United International, Karachi to change their
brand name as early as possible, so that they could continue marketing their product smoothly
and without apprehensions.
Accordingly, M/s. United International, Karachi was advised to propose at least three
distinguished alternate names of their drug other than the existing name. Also, submit an
undertaking that the new proposed brands do not have resemblance with any already registered
drug.
In response, M/s. United International, Karachi have submitted that they had been
granted the registration of product “OZOL-40 Infusion (Reg. No.044854)” on 9th February,
2007, i.e. more than seven years before and the said product is already being marketed by them
for more than seven years, therefore, their product is strongly recognized and accepted by their
prevailing customers in the market with the said name since they have incurred substantial
marketing expenditures to create awareness among the customers about the product with the said
brand name. They have therefore requested to consider the additional fact that the nature of the
products being traded by them and that by M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore is
different, meaning that the product traded by them is an Injection whereas the product traded by
M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore is a capsule. M/s. United International,
Karachi has requested to continue trading of the said product with the same brand name, keeping
in view the these facts.
Registration Board took serious note of firm for not complying the instructions for
change of brand name. The Board decided to suspend the import of “OZOL-40 Infusion (Reg.
No.044854)” imported by M/s. United International, Karachi immediately and call the firm’s
representative in next meeting for personal hearing.

Accordingly, the importer M/s. United International, Karachi has been advised to suspend
the import of “OZOL-40 Infusion (Reg. No.044854)” imported by them immediately, till the
change of name of the product and called for personal hearing in this meeting.
Decision: The representative of the firm did not appear before the Board and informed
that they are willing to change the name of their product in light of the directions of the
Board. The Board accepts the request of the firm and authorized its Chairman for decision
on the change of name request of the firm.
Case No.12. Veterinary drugs deferred by Registration Board for expert opinion.
Registration Board in its 243rd meeting held on 08th -09th May, 2014 referred all
veterinary applications to a committed comprises of Dr. Muhammad Arshad, Member
Registration Board, Dr. Muhammad Ashraf, UVAS, Lahore and Head of Pharmacology
Department Arid University Rawalpindi for expert opinion. The recommendations of expert are
as under:-
S. No. Name of Importer/ Name of Drug (s)/Composition. Recommendatio Recommendations Recommend

Manufacturer. ns of Dr. of Dr. Muhammad ations of
Muhammad Arshad, Member Head of
Ashraf, UVAS, R.B Pharmacolog
Lahore y Department
Arid
University
Rawalpindi
1. M/s. Ghazi Brothers, Metri-CEF 3 Intrauterine Recommended He endorsed the Dr. Mazhar
Karachi-75350 / Suspension recommendations ul Haq
Product License Each 30ml contains:- of Dr. Wrote to
Holder:- Cephalexin monohydrate Muhammad this office
M/s. Agrovet Market (Base)……………….....600mg Ashraf. “I am
S.A., San Luis, Lima, Neomycin sulfate unable to
Peru. (Base)…………………1.02gm put my
Manufacturer Under Cloxacillin opinion on
Product License benzathine...1.50gm said drugs
Holder:- Vitamin A……….....30.000 IU due to
M/s. Pharmadix Corp. certain
S.A.C. Urbanizacion La unavoidable
Aurora-Ate Lima 3- reasons.
Peru.

2. M/s. Ghazi Brothers, Catofos B9 + B12 Injectable Recommended
Karachi-75350 / Solution
Product License Each ml contains:-
Holder:- Butaphosphan…………100mg
M/s. Agrovet Market Vitamin B9 (Folic Acid)..15mg
S.A., San Luis, Lima, Vitamin B12
Peru. (Cyanocobalamin)…….0.05mg
Manufacturer Under (Vitamin and Mineral).
Product License
Holder:-
M/s. Pharmadix Corp.
S.A.C. Urbanizacion La
Aurora-Ate Lima 3-
Peru.
3. M/s. Ghazi Brothers, Ketoxilen Injection Recommended

Karachi. / Each 100ml contains:-
M/s. Vetanco S.A. Oxytetracycline………...20gm
Buenos Aires, Ketoprofen………………3gm
Argentina. (Antibiotic/Anti-
inflammatory).
4. M/s. Ghazi Brothers, Geslong Injection Recommended
Karachi. / Each ml of solution contains:-
M/s. Cheilbio Co. Ltd., Metoclopramide HCI……5mg
Moknae-Dong, Ansan- (Antiemetic/ Gastroprokinetic).
Si, Gyeonggi-Do,
Korea.
5. M/s. Ghazi Brothers, Cheil Tonocomp Injection Recommended
M/s. Cheilbio Co. Ltd., Toldimfos sodium……200mg
Moknae-Dong, Ansan-
Si, Gyeonggi-Do,
Korea.
6. M/s. Ghazi Brothers, Seletoco Injection Recommended
M/s. Cheilbio Co. Ltd., Vitamin E acetate……..100mg
Moknae-Dong, Ansan- Sodium Selenite…………1mg
Si, Gyeonggi-Do, (Nutritional additive).
Korea.
7. M/s. Ghazi Brothers, Procillin-LA Injection Recommended
Karachi. / Each ml contains:-
M/s. Cheilbio Co. Ltd., Pencillin G

Moknae-Dong, Ansan- Benzathine ………1,00,000 IU
Si, Gyeonggi-Do, Penicillin G
Korea. Procaine…………1,00,000 IU
Dihydrostreptomycin
sulfate…200mg
(Antibacterial).
8. M/s. Ghazi Brothers, Oxyneo Powder Potential of

Karachi. / Each 1 Kg contains:- misuse on feed
M/s. Cheilbio Co. Oxytetracycline Quaternary additive & drug
Ltd.Gyeonggi-Do, Ammonium Salts………110gm interaction.
Korea. Neomycin sulfate…...…110gm
(Antibiotic).
9. M/s. Ghazi Brothers, Oxyone Powder Potential of
Karachi. / Each 1 Kg contains:- misuse on feed
M/s. Cheilbio Co. Oxytetracycline Quaternary additive & drug
Ltd.Gyeonggi-Do, Ammonium Salts……….200g interaction.
Korea. (Antibiotic).
10. M/s. Ghazi Brothers, Cefquin Suspension for Recommended
Karachi. / Injection
M/s. Hebei Yuanzheng Each ml contains:-
Pharmaceutical Co. Cefquinome (as sulfate)..25mg
Ltd., Shijiazhuang City, (Antibiotic).
Hebei Province, China.
11. M/s. Ghazi Brothers, Isomedium Powder for Recommended
Karachi. / parental administration
M/s. Hebei Yuanzheng Each sachet contains:-
Pharmaceutical Co. Isometamedium chloride
Ltd., Shijiazhuang City, hydrochloride…………..…1g
Hebei Province, China. (Antiprotozoal).
12. M/s. Ghazi Brothers, Oxybiotic LA 30% Solution Recommended
Karachi. / for Injection
Pharmaceutical Co. Oxytetracycline (as
Ltd., Shijiazhuang City, dihydrate)…………….300mg
Hebei Province, China. (Antibiotic).
13. M/s. Ghazi Brothers, Bupaquone Solution for Recommended
Karachi. / Injection
Pharmaceutical Co. Buparvaqone…………...50mg
Ltd., Shijiazhuang City, (Antiprotozoal).
Hebei Province, China.
14. M/s. Orient Animal Unimox LA Injection Recommended -
Health (Pvt) Ltd., Each ml contains:-
Karachi. / Amoxicillin (as Amoxicillin
M/s. Univet Ireland Trihydrate) Ph. Eur…...150mg
Ltd. Tullyvin, Cootehill, (Antibacterial).
Co. Cavan, Ireland.

15. M/s. Orient Animal Unicycline LA Injection Recommended (Stability
Health (Pvt) Ltd., Each ml contains:- Study of
Karachi. / Oxytetracycline (as zone IV not
M/s. Univet Ireland Oxytetracycline Dihydrate Ph. provided)
Ltd. Tullyvin, Cootehill, Eur)…………………...200mg
Co. Cavan, Ireland. (Antibacterial).
16. M/s. Orient Animal Multivit Injection Recommended COPP of

Health (Pvt) Ltd., Each 1 ml contains:- Ireland not
Karachi. / Vitamin B1…………….10mg provided.
M/s. Univet Ireland Vitamin B2………...……5mg
Vitamin B6…….………..3mg
Ltd. Tullyvin, Cootehill,
Co. Cavan, Ireland. Vitamin B12………....0.05mg
Nicotinamide………..…35mg
D-Panthenol…….……...25mg
Vitamin A…………15,000 IU
Vitamin D3………....1,000 IU
Vitamin E…………........10mg
(Multivitamins).
17. M/s. Orient Animal Promycin-1000 Injectable Recommended (Mnf. In
Health (Pvt) Ltd. Solution France then
Karachi. / Each ml contains:- packaging in
M/s. V.M.D. N.V, Colistin Belgium;
Hoge Mauw, Arendonk- Sulphate………..1,000,000 IU COPP of
Belgium. (Polypeptide Antibiotic). France)
18. M/s. Orient Animal Promycin-4800 Water Soluble Recommended (Mnf. In

Health (Pvt) Ltd., Powder France then
Karachi. / Each gram contains:- packaging in
M/s. V.M.D. N.V, Colistin Sulphate…4,800,000 Belgium;
Hoge Mauw, Arendonk- IU COPP of
Belgium. (Polypeptide Antibiotic). France)
19. M/s. Marush (Pvt) Ltd., Ubroloxin ® Intramammary Recommended

Lahore. / Suspension
M/s. Univet Ltd. Each 1 injector with 10g
Tullyvin, Cootehill, Co. (12ml) contains:-
Cavan, Ireland. Cefalexin
monohydrate...................200mg
Kanamycin
monosulfate……………133mg
(Corresponds to 100,000 I.U).
(Pharmaceuticals).
20. M/s. U.M. Enterprises, Flumeglu 5gm Injection Recommended

Karachi-74900/ Each 100ml contains:-
M/s. Qilu Animal Flunixin Meglumine equivalent
Health Products Co. to 5.0g of Flunixin.
Ltd., Jinan, Shandong, (Non-steriod, Ant-

China. inflammatory drug).
21. M/s. U.M. Enterprises, Cefent 1gm Injection Recommended

Karachi-74900/ Each 25ml vial contains:-
M/s. Qilu Animal Health Ceftiofur Sodium equivalent to
Products Co. Ltd., Jinan, 1.0g Ceftiofur.
Shandong, China.
(B.Lactum Antibiotics).
22. M/s. U.M. Enterprises, Cefent 4gm Injection Recommended
Karachi-74900/ Each 100ml vial contains:-
M/s. Qilu Animal Ceftiofur Sodium equivalent to
Health Products Co. 4.0g Ceftiofur.
Ltd., Jinan, Shandong, (B.Lactum Antibiotics).
China.
23. M/s. U.M. Enterprises, Ceftihyde 5gm Injection Recommended
Karachi-74900/ Each 100ml contains:-
M/s. Qilu Animal Ceftiofur Hydrochloride
Health Products Co. equivalent to 5.0g Ceftiofur.
Ltd., Jinan, Shandong, (B.Lactum Antibiotics).
China.
24. M/s. Siddiqui Pharma Ciroxin 10% Oral Solution Recommended
(Pvt) Ltd., Multan. / Each Liter contains:-
M/s. KBNP, INC, Ciprofloxacin…………100g
Dugok-ri, Sinam, (Antibiotics).
Yesan, Chungnam,
Korea.
25. M/s. Siddiqui Pharma Kenoxin 10% Oral Solution Recommended

M/s. KBNP, INC, Enrofloxacin……100g
Yesan, Chungnam,
Korea.
26. M/s. Siddiqui Pharma Noroxin 200 Oral Solution Recommended

M/s. KBNP, INC, Norfloxacin…………200g
Yesan, Chungnam,
Korea.
27. M/s. Mustafa Brothers Cefalexine Injectable Recommended
Faisalabad. / Suspension 15%
M/s. Laboratorio Each 10ml contains: -
Centrovet Santiago, Cefalexine ….150/ml
Chile. (Beta lactam Antibiotic)
28. M/s. Mustafa Brothers Ceftiofur Hydrochloride Recommended
Faisalabad. / Injectable Suspension 5%
M/s. Laboratorio Contains:
Centrovet Santiago, Ceftiofur
Chile. Hydrochloride…………...50mg

(Antibiotic)
29. M/s. Ghazi Brothers, Sulfyvit Water Soluble Powder More chances
Karachi. / Each 100gm contains:- of their misuse,
M/s. CEVASA S.A. Sodium drug interaction
Buenos Aires, sulfaquinoxaline………..15gm and
Argentina. Sodium development of
sulfamethazine………….14gm resistance. It is
Sodium better to have
sulfadimethoxine………...2gm separate
Trimethoprim …………...6gm products for
Prednisolone………...0.004gm specific
Vitamin A……....…300,000IU purpose. Need
Vitamin E……………..200 IU experimental
Vitamin D3……..…..60.000IU verification for
Vitamin C……………….2gm such
Vitamin K3……………..1gm combination,
Excipients……..…………..q.s
(Antibiotic, steroids Vitamin).
30. M/s. Fartal Ivermic M.O. Injectable More chances

Pharmaceuticals, Suspension of their misuse,
Karachi. / Each ml contains:- drug interaction
M/s. Laboratorios Ivermectin………..……1,000g and
Microsules Uruguay Zinc Sulphate 7H20…...0,043g development of
S.A. Canelones, Magnesum Chloride resistance. It is
Uruguay. 6H20…………………...0,650g better to have
Copper Chloride separate
2H20…………………...0,004g products for
Magnesium Hypophosphite specific
6H20…………………..2,670g purpose.
Potassium Iodide……...0.030g
Vitamin B12…………..0,010g
Histidine HCI…………0,420g
Valine……….………..0,420g
Arginine HCI………….0,510g
Methionine……………0,420g
Threonine……………..0,500g
Sodium monobasic
glutamate……………....0,840g
(Endectocide, organic
31. M/s. International CTC Plus Water Soluble More chances

Chempharma (Pakistan) Powder of their misuse,
Lahore. / Contains:- drug

M/s. Biopharmachemie Chlortetracycline……5500mg interaction and
Co Ltd TangNhon Phu Vitamin A……………2400IU development
Vietnam. Potassium Chloride…..760mg of resistance. It
Vitamin B12………...280mcg is better to
Lysine…………………60mg have separate
(Antibiotic) products for
specific
purpose.
32. M/s. Better Traders Thiacol 10% Oral Solution Recommended
International, Each ml contains:-
Faisalabad. / Thiamphenicol……….100mg
M/s. Kepro B.V. (Broad Spectrum
Maagdenburgstraat, Antimicrobial Agent).
Holland.
33. M/s. Ani Cure Nemovit Water Soluble More chances
Veterinary Services, Powder of their misuse,
Rawalpindi. / Each gm contains: - drug
M/s. Interchemie Neomycin interaction and
Werken ”De Adelaar” Sulpahte……………..…40mg development
B.V. Metaalweg, CG Oxytetracycline HCl…...60mg of resistance. It
Venray, Holland. Vitamin A……………7500IU is better to
Vitamin D3, have separate
Cholecalciferol………..1500IU products for
Vitamin E, a-tocopherol specific
acetate…………………....5mg purpose.
Vitamin B1….thiamine
hydrochloride……….....…1mg
Vitamin B2,
riboflavine………….….....2mg
Vitamin B6, pyridoxine
hydrochloride………….....2mg
Vitamin B12,
cyanocobalamin……….....7.5µ
Vitamin C, Ascorbic
acid..25mg
Ca-pantothenate……….7.5mg
Vitamin K3, menadione
sodium bisulfite………….5mg
Nicotinamide…………….5mg
Folic Acid…………..…300µg
DL-Methionine…………30mg
L-Lysine
hydrochloride…………...50mg
34. M/s. Ani Cure Aliseryl Water Soluble Powder More chances
Veterinary Services, Each gm contains: - of their misuse,
Rawalpindi. / Erythromycin drug
M/s. Interchemie thiocyanate…………..…35mg interaction and
Werken ”De Adelaar” Oxytetracycline HCl…...50mg development
B.V. Metaalweg, CG Streptomycin Sulphate…35mg of resistance. It

Venray, Holland. Colistin is better to
Sulphate……….…..200,000IU have separate
Vitamin A, retinol products for
acetate…………………3000IU specific
Vitamin D3, purpose.
cholecalciferol………1500IU
Vitamin E, a-tocopherol
acetate…….……………..2mg
Vitamin B1, thiamine
hydrochloride…………….2mg
Vitamin B2,
riboflavine…..4mg
Vitamin B6, pyridoxine
hydrochloride…………….2mg
Vitamin B12,
cyanocobalamin………..10µg
Vitamin C, Ascorbic
Acid..20mg
Ca-
pantothenate…………10mg
Vitamin K3, menadione
sodium
bisulfite…………………..2mg
Nicotinamide……….…..20mg
Inositol……………….….1mg
35. M/s. Seignior Pharma Ceftiofur LPU Injectable Recommended
Karachi./ Each 100ml vial contains: -
M/s. Instituto Ceftiofur HCL…………50mg
Rosenbusch S.A. de Excipients…………..…100ml
Biologia Experimental (Antibiotic)
Agropecuaria, San Jose
1469 (1136) Buenos
Aires, Argentina.
36. M/s. Seignior Pharma, Florfenicol 30% Rosenbusch Recommended

Karachi. / Injectable
M/s. Instituto Each 100ml vial contains:-
Rosenbusch S.A. de Florfenicol………...…...30gm
Biologia Experimental Excipients q.s……....…100ml
Agropecuaria, San Jose (Antibiotic)
1469 (1136) Buenos
Aires, Argentina.
37. M/s. Bio-Labs (Pvt) Bio-Enrocol-A Liquid Contains

Ltd., Islamabad. Each 100ml contains:- “Amantadine”
Enrofloxacin………...…..10% which is antiviral
Colistin Sulphate………..3.5% drug for flu and
may have drug
Amantadine…………….....4%
interaction and

(Antibiotic, Anti-viral). resistance
problem so
should not be
used in these
combinations.
38. M/s. Bio-Labs (Pvt) Coliflox 20% Liquid Recommended

Ltd., Islamabad. Each 100ml contains:-
Enrofloxacin……………20gm
Colistin Sulphate…50,000,000
i.u.
(Quinolones).
39. M/s. Leads Pharma Virex CRD Powder Contains

(Pvt) Ltd., Islamabad. Contains:- “Amantadine”
Tylosin Tartrate……….....10% which is
Doxycycline HCI…….…..22% antiviral drug
Colistin Sulphate……….…4% for flu and may
Amantadine HCI………….3% have drug
(Antibiotic). interaction and
resistance
problem so
should not be
used in these
combinations.
40. M/s. Elko Organization Fe-Zole SC 5% Oral Recommended

(Pvt) Ltd., Karachi. Suspension
Each ml contains:-
Fenbendazole………..….50mg
Elemental Selenium…....1.6mg
Elemental Cobalt.............10mg
(Anthelmintic).
41. Noble Pharma Mirpur ENTRO-5 Powder Drug which are

Azad Kashmir. Each 1000gm contains:- “Me too” like
Tylosin Tartrate BP……..10% drugs with
Doxycycline Hyclate USP20% minor
Colistin Sulphate…...450 MIU modifications
Bromhexine HCI………0.5% which may or
Neomycin SO4…………3.6% may not be
(Antibacterial). considered.
42. M/s. Mallard Centrum Liquid Drug which are

Pharmaceuticals (Pvt) Each 100ml contains:- “Me too” like

Ltd., Multan. Enrofloxacin HCI…...7500mg drugs with
Sulphamethoxypyridazine…… minor
……………………7500mg modifications
Sulphamethazine……5000mg which may or
Trimethoprim………2500mg may not be
(Antibiotic). considered.
43. M/s. Intervac (Pvt) Ltd, Tilmodox Liquid Tissue

Sheikhupura Road, Each 100ml contains:- resistance.
Sheikhpura. Tilmicosin Phosphate….15gm
Doxycycline HCI………15gm
(Antibiotic).
44. M/s. Intervac (Pvt) Amprobit Liquid Recommended

Limited, Lahore. Each liter contains:-
Amprolium HCI………250gm
Ethopabate……………..16gm
(Anticoccidial).
45. M/s. Attabak Tylothrodox Powder Contains

Pharmaceutical, Each 1000gm contains:- “Amantadine”
Islamabad. Doxycycline HCl……..…100g which is
Tylosin tartrate …………..50g antiviral drug
Amantadine HCl ………...40g for flu and may
Erythromycin thiocyanate..60g have drug
(Antibacterial, Antiviral). interaction and
resistance
problem so
should not be
used in these
combinations.
46. M/s. Attabak Spiralinc-B Powder Recommended
Pharmaceutical, Each 100gm powder contains:-
Islamabad. Lincomycin HCI…………..5g
Spectinomycin HCI……..7.5g
Spiramycin adipate...........2.5g
Bromhexine HCI………...0.5g
(Antibacterials).
47. M/s. D-Maarson CRD-555 Water Soluble Drug which are

Pharmaceuticals, Powder “Me too” like
Rawat, Islamabad. Each 1000g contains:- drugs with
Doxycycline HCl ............200g minor
Tylosin tartrate ………....100g modifications
Colistin sulphate……500MIU which may or

Amantadine HCl ………..40g may not be
considered.
48. M/s. Symans SPZ-Plus Feed Additive Oral Recommended

Pharmaceuticals (Pvt) Each 100gm contains:-
Ltd. Lahore. Procaine Penicillin
B.P…1200mg
Streptomycine Sulphate
B.P……………………3600mg
Zinc Bacitracin B.P…5200mg
Colistin Sulphate B.P.500 MIU
(Antimicobial).
49. M/s. Symans Cipro Plus Solution Contains
Pharmaceuticals (Pvt) Each Liter Contains:- “Amantadine”
Ltd. Lahore. Ciprofloxacin…………200gm which is
Colistin Sulphate……400MIU antiviral drug
Amantadine…………….40gm for flu and may
(Antibiotics). have drug
interaction and
resistance
problem so
should not be
used in these
combinations.
50. M/s. Jfrin Jfpidox Oral Powder Drug which are
Pharmaceutical Each Kg contains:- “Me too” like
Laboratories, Hub, Tylosin Tartrate………100gm drugs with
Balochistan. Doxycycline Hcl……...200gm minor
Phyenylbutazone….……12gm modifications
Bromhexine Hcl…...........5gm which may or
Colistine Sulphate….500 MIU may not be
(Antibacterial/Antibiotic). considered.
51. M/s. Biogen Pharma. Amcocin Liquid Contains
8th Km Rawat Chak Beli Each 100ml contains:- “Amantadine”
Road, Rawat. Enrofloxacin………….…10% which is
Colistin Sulphate…………3% antiviral drug
Amantadine HCI…………4% for flu and may
(Antibiotic) have drug
interaction and
resistance
problem so
should not be
used in these
combinations.

52. M/s. Biogen Pharma. Doxytylodine Powder Contains
8th Km Rawat Chak Beli Each 1000gm contains:- “Amantadine”
Road, Rawat. Tylosin Tartrate BP…..200gm which is
Doxycycline HCI BP…100gm antiviral drug for
flu and may
Amantadine HCI……….40gm
have drug
interaction and
resistance
problem so
should not be
used in these
combinations.
53. M/s. Biogen Pharma, Advantage Water Soluble Contains
Rawat. Powder “Amantadine”
Each 1000gm contains:- which is
Tylosin Tartrate BP..…200gm antiviral drug
Doxycycline HCI BP….40gm for flu and may
Amantadine HCI……...100gm have drug
Colistin Sulphate…5000 MIU interaction and
resistance
(Antibiotic/ problem so
Antibacterial/Antiviral). should not be
used in these
combinations.
54. M/s. Wimits Wimtox Injection Recommended

Pharmaceuticals, Each ml of liquid injection
Plot No.129, Sunder contains:-
Industrial Estate (P.I.E) Novaminsulfon………....40mg
Raiwind Road, Lahore. Etilefrin B.P …………...0.2mg
Calcium Gluconate B.P.100mg
Magnesium Gluconate
B.P …………………….10mg
Sodium Salicylate B.P …7mg
Nicotinamide B.P …….0.3mg
Caffeine B.P ………..…10mg
Boric Acid B.P ……..…10mg
(Analgesic and Antipyretic)

Finished product specifications
are Manufacturer.
55. M/s. Wimits Stop Spray Recommended
Pharmaceuticals, Each 100ml of aerosol
Industrial Estate (P.I.E) Deltamethrin BP……...0.500g
Raiwind Road, Lahore.
(Insecticide)
56. M/s. Wimits Defender Spray Recommended
Pharmaceuticals, Each 30g of aerosol contains:-

Plot No.129, Sunder Neomycin Sulfate BP...150mg
Industrial Estate (P.I.E) Clostebol Acetate….....150 mg
Raiwind Road, Lahore. (Antiseptic)
57. M/s. Wimits Methra Spray Recommended
Pharmaceuticals, Each 100ml of aerosol
Industrial Estate (P.I.E) Permethrin ……………..0.5 g
Raiwind Road, Lahore.
(Insecticide)
58. M/s. D-Maarson NOVA DM INJECTION Recommended

Pharmaceuticals, Liquid Injection
Plot # 17, Street # SS-2, Each 100ml contains:-
National Industrial Zone Novaminsulfon………..…..4g
Rawat, Islamabad. Etilefrin………………...0.02g
Calcium Gluconate………10g
Magnesium Gluconate…...1.0g
Sodium salicylate……..0.700g
Nicotinamide…………....0.3g
Caffeine……………….…1.0g
Boric acid………………..1.0g
(Analgesic, Antipyretic)
Decision: Registration Board deferred the case for the recommendations of Expert
Committee on Veterinary Drugs.
Case No.13. Directions from Drug Appellate Board regarding Nitrofurans.

Drugs Appellate Board in its 140th Sitting held on 20-08-2013 in the appeal of M/s.
Selmore Pharmaceuticals (Pvt.) Ltd., Lahore regarding rejection of their product “URO-
Pessaries” decided as follows:-
i) That the said formulation shall be referred to two veterinary experts, by the
defendants, namely: (i) Vice Chancellor, University of Veterinary and Animal
Sciences, Lahore, and (ii) A veterinary expert from Army, to be named by Brig.
Akbar Waheed, Member, Drugs Appellate Board, for their expert opinion.
ii) The Chairman, Drugs Appellate Board was authorized to take decision on the
aforesaid Appeal in the light of the recommendations of the experts.

iii) That the fate of other drug(s) / brand(s) of the same formulation available in the
market shall also be decided by the Registration Board in the light of the
recommendations of the experts and the provisions of law / rules, under
intimation to the Drugs Appellate Board.
Accordingly, opinion of following experts regarding registration of product has been

obtained, which are as follows:-
S. No. Name of Expert. Recommendations.

1. Prof. Dr. Muhammad Ashraf, URO-Pessaries having combination of
Dean, Faculty of Bio-Sciences, Chlorotetracycline, Furazolidone and
University of Veterinary & Metronidazole is not recommended for approval in
Animal Sciences, Lahore animals.
2. Ltd. Col. Iftikhar Ahmad Anjum, In order to proceed further, following steps be
for DGRV&F, QMG Branch taken up before the product is registered:-
RV&F Directorate, GHQ, a) A fair trial on animals after cultural sensitivity
Rawalpindi. test, at least on 50 animals which can be provided
by Military Farms located at Lahore or Okara.
b) Deliberate and authentic recording of readings
and fair evaluation be ensured.
c) Post treatment cultural sensitively in an aseptic
environment.
The Drugs Appellate Board in its 142nd Sitting held on 20-06-2014 keeping in view the
fact that Nitrofurans are recognized by FDA as mutagens / carcinogens, decided to dismiss the
appeal with the directions to the respondent Registration Board to decide the fact of similar
formulations accordingly. As per record, there is only one product “Utacare Pessary” (Reg.
No.035062) is registered in the name of M/s. Nawan Laboratories (Pvt) Ltd., Karachi.
Decision: In compliance to decision of Drugs Appellate Board, Registrstion Board

decided to issue the show cause notice to M/s. Nawan Laboratories (Pvt.) Karachi for
cancellation of registration of Utacare Pessary, (Reg. No.035062). Registration Board
authorized its Chairman for issuance of show cause notice for any other such me too drug.

Case No.14 Registration of imported veterinary drugs - Correction in minutes.
The Drug Registration Board in its 237th meeting held on 26-02-2013 approved the
registration of following imported veterinary drugs in the name of M/s. Mustafa Brothers,
Faisalabad, manufactured by M/s. Veyx-Pharma B.V, Forellenwegm SJ Raamsdonksveer, The
Netherlands, subject to inspection of manufacturer abroad, verification of storage facilities as per
policy. The firm has deposited the required fee;
S# Name of Drug (s) /Composition. Decontrolled / Shelf Life

Pack Size.
1. Masti Veyxym ® Suspension for Tube of 10ml 02 years
Intramammary.
Each 10gm contains:-
All-rac-aTocopheryl acetate (Vitamin E
acetate)……120.00mg.
Vitamin A concentrate 100.000 IU.
Chymotrypsin………2400 FIP-U.
Trypsin……………..240 FIP-U.
Papain…………………6-FIP-U.
2. Veyxyl ® LA 20% Solution. 50ml 03 years

Each 1ml contains:- 100ml
Amoxicillin trihydrate…229.60mg
(equivalent to 200.00mg Amoxicillin).
The applicant M/s. Mustafa Brothers, Faisalabad has requested for issuance of
registration letter of the above said drugs. M/s. Mustafa Brothers, Faisalabad was advised to
provide legalized (CoPP) of M/s. Vexy-Pharma B.V., Forellenweg 16, NL-4941 SJ
Raamsdonksveer, issued by Netherlands as the manufacturing site is located in Netherlands duly
endorsed by the Pakistan Embassy/Consulate office in the country of export.
In response, M/s. Mustafa Brothers, Faisalabad have informed that the production of
“Masti Veyxym ® Suspension for Intramammary & Veyxyl ® LA 20% Solution” is performed
in the Netherlands (as contract manufacturer) by M/s. Vexy-Pharma B.V, the Netherlands for
their principal company M/s. Vexy-Pharma GmbH, Germany. However, this production site only
produces bulk (unlabeled bottles / injections) that is shipped subsequently to their site in

Germany M/s. Vexy-Pharma GmbH for finalization the production. At the German site,
the secondary packaging takes place and final batch release is performed. The firm M/s. Vexy-
Pharma GmbH (Germany) is the marketing authorization holder and consequently responsible
for the overall quality, the safety and the efficacy of the products.
The firm has disclosed that the products referred above are being manufactured in bulk at
“M/s. Vexy-Pharma B.V, The Netherlands” then these will be labeled and packed at M/s. Vexy-
Pharma GmbH, Germany. Now it is clear the firm will import these drugs from Germany.
Therefore, it needs amendment in minutes i.e. name of manufacturer is mentioned from
Netherlands in the minutes of 237th meeting of the Registration Board.
Decision: Registration Board approved correction in minutes of 237th meeting for

name of manufacturer as M/s. Vexy-Pharma GmbH, Germany for the following products.
S# Name of Drug (s) /Composition. Decontrolled / Shelf Life

Pack Size.
1. Masti Veyxym ® Suspension for Tube of 10ml 02 years
Intramammary.
Each 10gm contains:-
All-rac-aTocopheryl acetate (Vitamin E
acetate)……120.00mg.
Vitamin A concentrate 100.000 IU.
Chymotrypsin………2400 FIP-U.
Trypsin……………..240 FIP-U.
Papain…………………6-FIP-U.
2. Veyxyl ® LA 20% Solution. 50ml 03 years

Each 1ml contains:- 100ml
Amoxicillin trihydrate…229.60mg
(equivalent to 200.00mg Amoxicillin).
Case No.15 Registration of veterinary drug.

Drug Registration Board in its 236th meeting held on 20th November, 2012 approved the
registration of following imported veterinary drugs in the name of M/s. Vet Line International,
Lahore manufactured by M/s. Bela-Pharm GmbH & Co.KG Lohner Strasse 19 49377 Vechta,
Germany, subject to inspection of manufacturer abroad, verification of storage facilities as per

policy. The firm has deposited the required fee.
# No. Name of Drug (s) /Composition. Decontrolled / Shelf Life.

Pack Size.
1. Neomycinsulfat Powder. 100gm. 3 years
Each gm powder contains:- 500gm.
Neomycin Sulphate……..1000mg. 1kg.
5kg.
2. Belacol 100% Pulver 100gm. 3 years
Each gm powder contains:- 250gm.
Colistin Sulphate……….1000mg. 1kg. & 2.5kg
The storage facility of the importer has also already been verified by the Area FID. The
applicant M/s. Vet Line International, Lahore has requested for issuance of registration letter of
the above said drugs. During processing of case for issuance of registration letter, it was
observed that these products are 100% API and under the Drug Act 1976 the drugs which are
ready to use are registered under the Section 7 of the Act. Then it was deliberated to get opinion
of experts. Accordingly, views of the following experts regarding use of products above in pure
form “100 API” with special reference to efficacy, safety, toxicity and residual effects in food
producing animal has been obtained, which are as follows:-
S.# Name of Expert. Opinion

1. Dr. Muhammad Ovais Omer, i) Based on the pharmacological properties,
Chairman, Neomycinsulfat is a recommended drug for
Department of Pharmacology & treatment of enteric infections in calves, pigs and
Toxicology, chickens.
University of Veterinary and ii) Based on the pharmacological properties,
Animal Sciences, Lahore. Colistin Sulphate is a recommended drug for
treatment of Salmonella, E. coli, Campylobacter,
Pullorum, Paratyphoid infections, Colibacillosis
and Diarrhoea by E.coli in different animal
species.
2. Brig. Zahid Hussain Abid, As regards efficacy, safety, toxicity and residual
Director Rem & Vet., effects in food producing animal, viz a viz both
QMG Branch RV & F Dte, the products are concerned, in puts of the experts
General Headquarters, from University of Veterinary and Animal

Rawalpindi. Sciences, Lahore would be more valuable and
pertinent. However, it is suggested that a trial
may be conducted at least on 200 animals for
establishment of all above factors. In this regard
Army Veterinary School can be assigned this
task.
3. Dr. Farzana Chowdhary, 1. Neomycinsulfat – this drug contains 100mg

Director, Neomycin Sulphate in 1gm indicating that it is a
Department of Pharmacy, pure API and not a veterinary finished dosage
University of Veterinary & form. According to the Drugs Act, 1976 APIs do
Animal Sciences, not require registration and can only be imported
Lahore. by manufacturers possessing a valid Drug
Manufacturing License (Formulation) and
registration of the finished drug of which it is an
ingredient.
2. Belacol 100% Pulver contains Colistin
Sulphate 1000mg per 1gm (1000mg) powder and
does not contain any adjuvant or excepient
which is indicative of the fact that it is a pure
API and not a finished dosage form for
veterinary use. Only finished dosage forms
require registration under the Drugs Act, 1976,
whereas, APIs can be imported only by those
who hold a valid DML (Formulation) and
registration of finished drug containing that API.
Committee on Veterinary Drugs and list of all such products registered earlier by the
DRAP.
Case No.16. Correction of composition of registered veterinary drug-Neurozoc Injection

Regn. No. 074072.
M/s. Hilton Pharma (Private) Limited, Karachi have requested for correction of
composition of their registered veterinary “Neurozoc Injection (Reg. No.074072)”. They have
informed that they want to apply below composition as “each 1ml contains, pack size of 100ml”
but by typographically mistake it was mentioned in application dossier as “each 100ml contains,
pack size 100ml”. The registration letter received for following composition “each 100ml
contains, pack size 250ml & 500ml”. They have therefore requested for correction of

composition from “each 100ml contains” to “each 1ml contains” and also change in pack size
from 250ml & 500ml to “100ml”:-
Approved composition Revised composition.

Neurozoc Injection. Neurozoc Injection.
Each 100ml contains:- Each ml contains:-
Novaminsulfon …………….. .100mg. Novaminsulfon …………….. .100mg.
Etilefrin……………………. 0.50mg. Etilefrin……………………. 0.50mg.
Calcium gluconate …………250mg. Calcium gluconate …………250mg.
Magnesium gluconate ……… 25mg. Magnesium gluconate ……… 25mg.
Sodium salicylate ………….17.5mg. Sodium salicylate ………….17.5mg.
Nicotinamide ………………0.75mg. Nicotinamide ………………0.75mg.
Caffeine………………………. 25mg. Caffeine………………………. 25mg.
Boric acid………………………25mg. Boric acid………………………25mg.
M/s. Hilton Pharma (Private) Limited, Karachi have deposited required fee Rs.20000/-
and submitted following supporting documents:-
i) Copy of registration letter.
ii) Copy of old Form-5.
iii) New Stability data.
iv) Copy of new Form-5.
Committee on Veterinary Drugs.
Case No. 17. Cancellation of registration of drugs and stoppage of production.
Drug Registration Board in its 240th meeting held on 07-11-2013 considered the
inspection report of M/s. Avicenna Laboratories (Pvt) Ltd.,14 Km, Sheikhupura, Faisalabad
Road, Bikhi, District Sheikhupura dated 04-03-2013 conducted by the area FID, wherein the FID
has reported that the firm has registration of following (10) injectable products including
(Penicillin and Steroids) but the Injectable Section is not approved as yet by Licensing Section
and the Registration Section has granted the registration of the same:-
S. No. Reg. No. Name of Drug (s) / composition.

1. 035001 Gentacen 100 Injectable Solution.
Each ml Contains: -
Gentamycin Sulphate (eq to 100mg

Gentamycin base).
2. 035002 Moxicol Injectable Suspension.
Each ml contains: -
Amoxycillin Trihydrate 100mg.
Colistin Sulphate 250,000 IU.
3. 035003 Avimox Injectable Suspension.
Each ml contains: -
Amoxycillin base (as trihydrate) 150mg.
4. 035004 Tylocen-200 Injectable Solution.
Each ml contains: -
Tylosin Sulphate 200mg.
5. 035005 Avoxy LA Injectable Suspension.
Each ml contains: -
Oxytetracycline HCl…200mg.
6. 035006 Dexon-5 Injectable Solution.
Each ml contains: -
Dexamethasone 5mg.
7. 035127 Oxytocen Injectable Solution.
Each ml contains: -
Oxytocin 10 I.U.
8. 043166 Predexon Injectable Suspension.
Each ml contains:-
Dexamethasone ……… 2.5mg.
Prednisolon ………….. 7.5mg.
9. 043167 Lincospec Injectable Solution.
Each ml contains:-
Spectinomycin Sulphate 100mg base.
Lincomycin Hydrochloride 50mg base.
10. 043168 Avigen-F20 Injectable Solution.

Each ml contains:-
Gentamycin Sulphate ……. 10mg.
Flumequine ……………… 20mg.
The Drug Registration Board decided that the production of the firm for above mentioned
products should immediately be stopped till the complete investigation of the matter and issue a
show cause notice to the firm for explanation of reasons in their defense. Then place the case
before the Board for further deliberations.
Accordingly, a show cause notice was issued to the firm.
In response to the show cause notice the firm has submitted following documents:-

i) Approval of layout plan.
ii) Copies of registration letters.
iii) Copy of layout plan.
M/s. Avicenna Laboratories (Pvt) Ltd., Sheikhupura was again advised to provide proof
of approval of the Injectable Section and also provide proof of renewal of registration of drugs
above said drugs. The firm have submitted copies of the acknowledgement of last renewal of
registration of above said products and also submitted that on April 15, 2014 the panel
constituted by the Director QA, inspected their Oral Powder, Liquid, Vaccine and Injectable
Sections. The report will be submitted in coming board meeting. The firm have further submitted
that they also want to shift all Penicillin products into toll manufacturing.
DDC (RRR) was also requested to confirm renewal status of the above products. DDC
(RRR) have confirmed the renewal of the drugs.
The Chairman, CLB also resumption of production to the firm only in veterinary oral
powder and veterinary oral liquid sections.
Decision: Registration Board after detailed deliberations canceled the registrations of

following products of M/s. Avicenna Laboratories (Pvt) Ltd., Sheikhupura as the firm do
not have the approved manufacturing facility for these products;
S. No. Reg. No. Name of Drug (s) / composition.

1. 035001 Gentacen 100 Injectable Solution.
Each ml Contains: -
Gentamycin Sulphate (eq to 100mg
Gentamycin base).
2. 035002 Moxicol Injectable Suspension.
Each ml contains: -
Amoxycillin Trihydrate 100mg.
Colistin Sulphate 250,000 IU.
3. 035003 Avimox Injectable Suspension.
Each ml contains: -
Amoxycillin base (as trihydrate) 150mg.
4. 035004 Tylocen-200 Injectable Solution.
Each ml contains: -
Tylosin Sulphate 200mg.
5. 035005 Avoxy LA Injectable Suspension.
Each ml contains: -
Oxytetracycline HCl…200mg.

6. 035006 Dexon-5 Injectable Solution.
Each ml contains: -
Dexamethasone 5mg.
7. 035127 Oxytocen Injectable Solution.
Each ml contains: -
Oxytocin 10 I.U.
8. 043166 Predexon Injectable Suspension.
Each ml contains:-
Dexamethasone ……… 2.5mg.
Prednisolon ………….. 7.5mg.
9. 043167 Lincospec Injectable Solution.
Each ml contains:-
Spectinomycin Sulphate 100mg base.
Lincomycin Hydrochloride 50mg base.
10. 043168 Avigen-F20 Injectable Solution.
Each ml contains:-
Gentamycin Sulphate ……. 10mg.
Flumequine ……………… 20mg.
Case No.18. Registration of Magnesium Sulphate 15% in veterinary products.

Drug Registration Board in its 243rd meeting held on 08-09th May, 2014 considered and
approved the registration of following drug for import in the name of M/s. BN Pharmaceuticals,
Lahore manufactured by M/s. Laboratories Chaix et Du Marais Lavoisier Head Quarter Paris
France subject to price fixation / calculation:-
Name of drug (s)/Composition. Demanded Price

/Pack.
Sulphate De Magnesium Lavoisier (1.5G/10ML) 15% Rs.450/Per ampoule.
(I.V) Injectable. Rs.4500/Per 10 ampoules.
Each ampoule contains: -
Magnesium as Sulphate. 1.5g/10ml (15%).
Meanwhile, the firm M/s. BN Pharmaceuticals, Lahore have submitted the references in
support of above mentioned product which is already under process of registration. The firm has
also submitted the list of countries-organizations in which this product is registered / sponsored
at this time along with the report of WHO Drug Information volume-21/2.2007 WHO Geneva.

The Magnesium Sulphate 15% is not approved by any of the reference authorities i.e.
EMA, USFDA, TGA or PDMC, except France.
Decision: Registration Board referred the case to Review Committee for formulation
review.
Registration-II
Case No.19 Registration of drugs deferred by Registration Board.
a. Cases deferred for expert opinions.
i. Lurisa Tablet 40mg and 80mg – M/S Helix Pharma, Karachi.
Registration Board in 242nd meeting deferred following products for expert opinion. Accordingly
products were referred to expert for views. Comments are as under.
S. Name of drug(s) & Composition Proposed Demanded

No Pack size Price
1 Lurisa Tablets 10’s, As per PRC

Each film coated tablet contains: 20’s,
Lurasidone HCl………..….40 mg 30’s
(Antipsychotic for Treatment of Schizophrenia)
2 Lurisa Oral Tablets 10’s, As per PRC
Each tablet contains: 20’s,
Lurasidone HCl…….80 mg 30’s
(Antipsychotic for Treatment of Schizophrenia)
Brig. Saleem Jehangeer Prof. Dr. Rizwan Taj Dr. Nadeem Abbas
Armed Forces Institute of Psychiatrist, Fauji Foundation Medical

Mental Health, Centre,
Pakistan Institute of Medical
Rawalpindi Sciences, Rawalpindi
Islamabad
Brig for Comdt (Farrukh Hayat I have study documents and fee Although Lurasidone salt is not
Khan) stated that Maj. Gen that this medication should be available / introduced in Pakistan,
Salim Jehangir, Commandant of available in Pakistan. In the light of above mentioned
Armed Forces Institute of facts & data provided, the drugs
Mental Health is not avail due It is a new salt which has shown Lurasidone (Lurisa) 40mg &
promising result as compared to

to official commitments other products in the market it Lurasidone (Lurisa) 80mg are
side effect profile is better also. recommended for Registration
Board
I am recommending its
availability in Pakistan
Decision: Registration Board discussed and agreed to above expert opinions. However,
the Board advised firm to provide data for stability studies conducted under zone IV-A
conditions as per ICH / WHO guidelines for consideration of Registration Board.
ii. Roflumilast 500mcg Tablet.
Registration Board in its various meetings deferred registration of Roflumilast 500mcg Tablet of
various firms for expert opinion. Accordingly products were referred to expert for views. Comments are
as under.
S. Name of firm(s) Name of drug(s), Composition & Proposed Demanded

No Registration Board Meeting Pack size Price
1. M/s Macter Milast Tablet Per tab. Rs.17.36/-

International Each film coated tablet contains:
Karachi Roflumilast …………… 500 mcg
(Phosphodiesterase 4 inhibitors)
( M-242 )
2. M/s Hiranis Roflu Tablet 10’s Rs.270/-
Pharma, Karachi Each film coated tablet contains: 14’s Rs.378/-
Roflumilast…………..500mcg
(Inhibitor of the enzyme PDE-4)
( M-243 )
3. M/s Helix Raspro 500mcg Tablet 10’s As per PRC
Pharma, Karachi Each tablet contains:
Roflumilast…………...500 mcg
(Anti-Inflammatory)
( M-243 )
Brig. Dr. Aslam Khan, Dr. Rehana Kauser, Dr. Shazli Manzoor
Consultant Pulmonologist, Consultant Pulmonologist, Quaid-e-Azam International
Military Hospital, Pakistan Institute of Mecial Hospital, Islamabad
Rawalpindi Sciences, Islamabad

Regarding expert opinion on Regarding expert opinion on Regarding expert opinion on
efficacy, safety, quality and efficacy, safety, quality and efficacy, safety, quality and cost
cost effectiveness of cost effectiveness of effectiveness of Roflumilast. In
Roflumilast in the Roflumilast in the management this connection I would
management of COPD of COPD. FDA and EMEA recommend that Roflumilast
Roflumilast is a approved this drug for use in (PDE4 inhibitor), is an FDA and
Phosphodiesterase-4 Enzyme COPD management in severe EMEA approved drug with
Inhibitor. FDA and EMEA has and very severe COPD. This established role in the
approved this drug as an drug reduce Exacerbations rate management of COPD. This has
adjunct to bronchodilator in COPD also included in been proven to reduce COPD
therapy in the maintenance GOLD guidelines exacerbations in various clinical
treatment of severe chronic trials and also included in GOLD
obstructive pulmonary disease However certain studies guidelines 2014. Clinical Studies
(COPD) associated with reported no much beneficial have also demonstrated higher
chronic bronchitis given for the role in the COPD patients. pharmacological activity and
purpose of preventing Clinical Studies have also better tolerability of Roflumilast
exacerbations demonstrated higher as compared to earlier PDE-4
Roflumilast significantly pharmacological activity and inhibitors. Therefore, Roflumilast
improved prebronchodilator better tolerability of as 500mcg orally once a day if made
FEV1 and decreased the rate of compared to earlier PDE-4 available in Pakistan especially
moderate to severe inhibitors. In my honest opinion from Macter platform due to
exacerbations in a 52 week, this drug may be helpful in the quality and cost effectiveness
randomized trial of 3091 management of COPD in concern; it can held in reducing
patients with COPD . combination with other drugs suffering due to exacerbations of
Compared to placebo, so it should be cost effective COPD.
roflumilast decreased and affordable to the patients.
exacerbations (17 percent [95%,
CI 8-25]).
The use of a once daily oral
medication in COPD is
enticing; however, the
medication should be used as a
maintenance therapy to prevent
exacerbations rather than to
improve other COPD outcomes
It is a safe drug which is
contraindicated only in
moderate or severe hepatic
impairment (Child-Pugh class B
or C)
In view of the above I
recommend this drug for
registration at an affordable

price.
Decision: Registration Board discussed and agreed to above expert opinions. However,
the Board advised firm to provide data for stability studies conducted under zone IV-A
iii. Cocard Plus 75/75MG Tablet – M/S Helix Pharma, Karachi.
Registration Board in 237th meeting approved following product of M/s Helix Pharma,
Karachi subject to reason mentioned in last column. Accordingly provided data was referred to
expert for views. Comments are as under.
S. Name of drug(s) & Composition Proposed Demand Decision

No Pack size ed Price
1 Cocard Plus 75/75mg Tablet 10’s As per Approved subject to

Each tablet contains: PRC confirmation of
Clopidogrel bisulfate eq. to Bilayered tablet
clopidogrel……….75 mg manufacturing facility
Aspirin as enteric coated
pellets………….…75 mg
(Anti coagulant anti platelet)
Dr. Amanullah Khan, Mr. Abdul Razzaq, Mr. Muhammad Jamil Anwar,
Director, Drug Testing Director, Drug Testing Director, Drug Testing
Laboratory, Laboratory, Laboratory,
Government of Baluchistan, Government of Sindh, Government of Punjab,
Quetta Karachi Lahore
COCARD PLUS 75/81MG Tablet COCARD PLUS is a COCARD PLUS 75/81MG

TABLET dissolution profile is bilayered film coated TABLET
different from the originator (Antiplatelets) having 02 It is observed that necessary
brand (OGREL PLUS 81 years shelf life is indicated in equipment, particularly Bilayered
TABLET OF M/S BOSCH different kind of CV diseases. Tableting Machine is available for
PHARMA, Karachi) and  The comparative manufacturing of Cocard Plus 75mg
scientifically the dissolution dissolution profile of /81mg Tablet.
method applied is incorrect M/s Helix Pharma The accelerated stability studies for

because they use separate tablet Products “ COCARD the product has been carried out
of Cocard for acid and buffer PLUS Tablets” with with the concluded results of active
stages rather replacing the originator Brand “ ingredient within the limits and also
OGREL PLUS 81
buffer medium from acid to shows that no significant physical
TABLETS” by M/s
buffer stage, hence on scientific Bosch Pharmaceuticals, and chemical change occurred
grounds of dissolution profile Karachi” was thoroughly during accelerated stability study
the product COCARD PLUS checked & evaluated. carried out for six months.
75/81MG TABLET is not  The stability profile The Dissolution Profile of the
recommended. shows that stability product Batch TF001 has been
studies was carried out, studied in acidic and buffer stage
and there was no
and observed satisfactory. The
significant physical and
chemical changes when comparative study with the other
product was kept at 40o brand “Ogrel Plus 81mg Tablets of
C + 2o C /75% RH + M/s Bosch Pharma, Karachi was
5%, provided proof of also carried out with the acceptable
climatic chamber, also results.
complies the other tests In the light of above and as per
performed such as
data / information provide the
weight variation, Assay,
disintegration time, drug “Cocard Plus 75mg /81mg
dissolution and other (Clopidogrel 75mg + Aspirin
aspects that meets the 81mg) Tablet is recommended for
required quality registration.
specifications.
 The data provided
also reflects that
manufacturing method /
equipments / instruments
are properly validated
and calibrated.
 The last panel
inspection was
conducted on 28-06-
2013 & for verification
of bilayered tablets
manufacturing facilities
was conducted 06-12-
2013 wherein they stated
that the firm has good
facilities provided for
manufacturing and
quality control and GMP
Compliance was found
good / satisfactory.
 The data provided is
sufficient regarding raw
material specification &

finished product
specification &
analytical procedures,
labeling, packing is also
available.
 So In the light of
above mentioned facts
& data provided the
drug COCARD PLUS
Tablets is
recommended for
registration.
It is to mention here that following is correct formulation submitted by the firm and same has
been evaluated by experts. However, erroneously wrong formulation has been mentioned in
agenda and minutes of 245th Registration Board meeting:-
Cocard Plus 75/81mg Tablet

Each tablet contains:
Clopidogrel bisulfate eq. to clopidogrel…….75 mg
Aspirin as enteric coated pellets………….…81 mg
(Anti coagulant anti platelet)
Decision: Registration Board decided to forward comments of Director DTL, Quetta to

the manufacturer for clarification.
iv. Dexlansoprazole - M/s OBS Pakistan, Karachi

Registration Board in its 235th meeting deferred following products of M/s OBS Pakistan,
Karachi for reason mentioned in last column.
Name of Drug & Composition Pack Demanded Decision

MRP
Kapdex 30mg Capsule 14’s Rs.840.00 Deferred.
Each capsule contains:- Not me- too
Dexlansoprazole ………..30mg product.
(Anti ulcerants) May be referred to
expert committee
for new molecule

Kapdex 60mg Capsule 14’s Rs.1260.00 Deferred.
Each capsule contains:- Not me- too
Dexlansoprazole ……...60mg product. May be
(Anti ulcerants) referred to expert
committee for new
molecule
Registration Board in 245th meeting discussed same formulation and agreed to expert
opinions and advised the firms to provide data for stability studies conducted under zone IV-A
M/s OBS Pakistan, Karachi has deposited remaining fee (Rs.50000/-) and requested to consider
their above formulations.
Decision: Keeping in view decision of 245th meeting of registration board regarding same
formulation, the advised firm to provide data for stability studies conducted under zone
IV-A conditions as per ICH / WHO guidelines for consideration of Registration Board.
b. Cases for registration of Tramadol.
Registration Board in its 236th meeting held on 20th November, 2012 had decided
that since Nalbuphine and Tramadol are not controlled drugs as per INCB regulation. So the
Board will not consider these cases in light of controlled drug guidelines. However to avoid
misuse potential, their procurement and manufacturing record shall be strictly maintained and
submitted in quadruplicate under Rule 30 (6) of Drugs (Licensing, Registering and Advertising)
Rules, 1976 to the E&M (Evaluation of Monitoring) Department of DRAP.
In light of above decision for registration of Tramadol containing product of

following firm was pending for decision. Firm has deposited the remaining fee @ Rs.12000/- as
per revised schedule for fees. Details are as under:-
S. No. Name of firm Name of Drug(s) Pack MRP Decision
1. M/s Safe Magadol Drops 10ml As per PAC 225th RB

Pharmaceutic Each ml contains:-

als, Karachi Tramadol HCl ………2.5mg Deferred for
(Non Narcotic Analgesic) confirmatio
n of facility
2. -do- Magadol Capsule 1x10’s As per PAC -do-

Each capsule contains:-
Tramadol HCl ………50mg
(Non Narcotic Analgesic)
Decision: Registration Board deferred the case for evaluation of registration

application as per approved check list.
c. Registration of Agomelatine Tablet 25mg.
Registration Board in its 227th meetings deferred following products of M/s Nabiqasim
Industries, Karachi and M/s PharmaEvo, Karachi for confirmation of formulation, application on
Form 5D, fee Rs.15, 000.
M/s Nabiqasim Industries, Karachi
Name of Drug & Composition Pack Demanded

MRP
Modton Tablet 25mg 10’s Rs.1500.00
Each film coated tablet contains:-
Agomelatine ……25mg
(Antidepressant)
M/s PharmEvo, Karachi.

MRP
Agloda 25mg Tablet 10’s Rs.2690/-
Each tablet contains:- 14’s Rs.3750/-
Agomelatine ……..25mg 28’s Rs.7500/-
(Anti depressant)

Later on scrutiny of registration data reveals that the above formulation is already approved by
the Registration Board in its 236th meeting in favour of M/s Servier Research and Pharmaceuticals
(Pakistan) Ltd, Lahore under the brand name “ Valdoxan 25mg Tablets”
M/s PharmEvo has deposited remaining fee @ Rs.5,000/- and M/s Nabiqasim Industries,
Karachi has also deposited fee @ Rs.15,000/- (dated 10-08-2010) + Rs.52,000/- (dated 24-
01-2013) + Rs.5,000/- (dated 06-05-2013)

applications as per approved check list.
d. Kaizen Pharmaceutical (Pvt.) Ltd , Karachi
i. Calcium citrate + Vitamin D.
Registration Board in its 237th meeting deferred following registration application of M/s
Kaizen Pharmaceuticals (Pvt.) Ltd, Karachi for reason mentioned in last column.
Name of drug(s) & Composition Proposed Demanded Date of Decision

Pack size Price application,
Diary No. &
Form
Calvit-D Sachet 10’s As per PRC 28-01-2013 Deferred for
Each sachet contains: 20’s Dy.No.60 submission of
Calcium citrate Form-5 application on
maleate…………..2500mg Rs.20,000/- form-5D with
Vitamin D……….400 IU balance fee
(Calcium and Vitamin
supplement/replacement preparation)
Now firm has stated that same formulation is already registered in favour of M/s Maple
Pharmaceuticals, Karachi with the brand name “Calcivit Sachet” Reg. No.076051 in 234th
meeting of Registration Board.


ii. Alfacalcidol + Calcium carbonate
Registration Board in its 237th meeting deferred following registration application of M/s
Kaizen Pharmaceuticals (Pvt.) Ltd, Karachi for reason mentioned in last column.
Name of drug(s) & Composition Proposed Demanded Date of Decision

Pack size Price application,
Diary No. &
Form
Alfakal Tablet 10’s As per PRC 28-01 -2013 Deferred for
Each tablet contains: 20’s 65 Clarification
Alfacalcidol ………....0.5 mcg 30’s Form-5 regarding dosage
Calcium carbonate….1000 mg Rs.60,000/- of calcium
(Calcium and Vitamin Analogue)
Now firm has stated that same formulation is available / marketed by M/s SchazooZaka
(Pvt.) Ltd, Lahore with the brand name “Bone-Care C Tablet” vide Reg. No.062790.

e. Sodium Polystyrene– M/s PharmaEvo, Karachi.
Registration Board in its 227th meeting deferred following product of M/s PharmaEvo,
Karachi for expert opinion.
S. Name of drug(s) & Composition Proposed Demanded Date of Decision
No Pack size Price application,
Diary No. &
Form
1 Klenar Sachet 15’s Rs.3000.00 02-11-2009 Deferred for
Each sachet contains:- 30’s Rs.6000.00 2229 expert
Sodium Polystyrene Form-5 opinion
Sulphonate …………..…15000mg Rs.8000/-
(Potassium removing resin)
Now M/s PharmEvo have deposited remaining fee @ Rs.42,000/- being new formulation.

application as per approved check list. Moreover, the product will be referred to Prof. Dr.
Ghias Butt, PIMS, Islamabad; Syed Ather Hussain, Head of Nephrology, Agha Khan
University Hospital, Karachi and Uzma Bano, FFH, Rawalpindi for expert opinion.
f. Macter International, Karachi

Following products of M/s Macter International, Karachi was deferred by Registration
Board in 214th meeting for confirmation of atomic absorption spectrophotometer.

MRP
Mactosin Suspension 60ml Rs.100.00
Each 5ml contains:-
Ossien Mineral Complex (Hydroxy Apatite)
800mg equivalent to
Calcium …………. 130mg
Phosphorous …………… 68.8mg
Residual Mineral Salts ….57.5mg
Collagen …………………87.5mg
Other Proteins …………20mg
Trace elements F1,mg,Zn,Fe,Ni,Cu)
Mactosin Tablets Per tablet Rs.5.33
Each tablet contains:-
Ossien Mineral Complex (Hydroxy Apatite)
250mg equivalent to
Calcium ….53.5mg
Phosphorous …….24.8mg
Other Proteins …………
Trace elements F1,Mg,Zn,Fe,Ni,Cu)
Later on scrutiny of registration data reveals typographic error in above formulation.

Correct formulation as applied by the firm are as under:-
Correct Formulation
Mactosin Tablets

Ossien Mineral Complex (Hydroxy Apatite) 800mg
equivalent to
Calcium …………. 130mg
Phosphorous …………… 68.8mg
Other Proteins …………..…20mg
Trace elements F1,mg,Zn,Fe,Ni,Cu)
Mactosin Suspension
Each 5ml contains:-
Ossien Mineral Complex (Hydroxy Apatite) 250mg
equivalent to
Calcium ………….53.5mg
Phosphorous …….24.8mg
Other Proteins ………… 20mg
Trace elements F1,Mg,Zn,Fe,Ni,Cu)
Federal Inspector of Drug, Karachi in inspection dated 27.09.2012 confirmed atomic

absorption in the Quality Control Laboratory of the firm.
Decision: Registration Board approved correct formulation for registration.
g. M/s Bosch Pharmaceuticals, Karachi.

Registration Board in 228th & 244th meeting deferred following products of M/s Bosch
Pharmaceuticals, Karachi reason mentioned in last column.
S. No. Name of drug(s) & Composition Proposed Demanded Decision

Pack size Price
1. Calamox Chewable Tablet 200mg Not Not Deferred for confirmation of
Each chewable tablet contains:- mentioned mentioned international availability &
Amoxycillin as Trihydrate ..200mg expert opinion
Clavulanic Acid as
Potassium ……….….28.50mg

(Antibiotics)
2. Calamox Chewable Tablet 400mg Not Not -Do-
Each chewable tablet contains:- mentioned mentioned
Amoxycillin as Trihydrate ..400mg
Clavulanic Acid as
Potassium ………………….57 mg
(Antibiotics)
3. Calamox Dispersible Tablet 375mg Not Not -Do-
Each Dispersible tablet contains:- mentioned mentioned
Amoxycillin as Trihydrate ..250mg
Clavulanic Acid as
Potassium ………………...125mg
(Antibiotics)
4. Calamox ES Oral Suspension 75ml Rs.225.00 Deferred for confirmation of
Each ml contains: 125ml Rs.375.00 me too status
Amoxycillin as 200ml Rs.600.00
Trihydrate……….600 mg
Clavulanic acid as potassium salt……
42.9 gm
(ntibiotic / antibacterial for microbial
diseases)
5. Calamox-XR Tablet 6’s Rs.180.00 Deferred for confirmation of

Each extended release tablet contains: 14’s Rs.420.00 me too status.
Amoxycillin as 28’s Rs.840.00
trihydrate ……….…...1 gm
Clavulanic acid as
potassium…………… 62.5 mg
(Antibiotic / antibacterial for microbial
diseases)
Now firm has stated as under:-
For products at S. No.1 – 3

 Remaining fee @ Rs.35,000/- for each product
 Application of Form-5-D
For products at S. No.4 – 5

 Remaining fee @ Rs.23,000/- for each product
 Application of Form-5-D
Decision: Registration Board advised firm to provide data for stability studies
conducted under zone IV-A conditions as per ICH / WHO guidelines for consideration of
Registration Board.

Case No.20 De-Registration of registered drugs.
M/s Tabros Pharma, Karachi have requested for de-registration of their registered drugs,
as per following details:-
S. No. Name of drug(s) Reg. No. Reason / Justification

1. Tabromide Capsule 2mg 014296 Due to some unavoidable
Each capsule contains:- circumstances and unfeasibility in the
Loperamide HCl …….2mg market
2. Evac 100mg Tablets 021801 -do-

Each chewable coated tablet
contains:-
Alpha Tocopherol
Acetate J.P ……………100mg

contains:-
Alpha Tocopherol

contains:-
Alpha Tocopherol

contains:-
Alpha Tocopherol
6. Pyrazol 500mg Tablet 014346 -do-

Pyrazolone Magnesium 500mg
Decision: Registration Board deferred the case for presentation before the Board.

Case No.21 Grant of Registration – Mentioning of two MRPs for a formulation.
Registration Board in its 242nd meeting approved following registration in favour of M/s
The Searle Company Ltd, Karachi and accordingly registration letter was issued as per following
details.
S. No Reg. No. Name of Drug(s) & Packing MRP
Composition
1 076280 Peditral-R (Bubble Gum Flavor) 10’s Sachet Rs.100.00
Powder
(Low Osmolar Formulation)
Each sachet contains:-
Pre-cooked Rice Powder…...6g
Sodium Chloride ……….0.35g
Potassium Chloride ……0.30g
Sodium Citrate ………..0.58g
(Manufacturer’s Specifications)
2 076281 Peditral-R (Mango Flavor) 10’s Sachet Rs.100.00
Powder
3 076282 Peditral-R (Orange Flavor) 10’s Sachet Rs.100.00
Powder
Later on firm has stated that basically they have filed for pack size of 10’s in registration
dossier including Costing, pack proposed labeling & design but only in Form-5 pack size 20’s
were also mentioned by mistake. Being brand leader they have demanded the MRP Rs.200/- for
10 sachets. While minutes of meeting 242nd of RB shows only pack size of 20’s instead of
10’s.Firm has also submitted that Drug Pricing Committee in its 15th meeting dated 12-04-2011
has already fixed MRP Rs.140/- for pack size of 10’s for same formulation.

Case was referred to Evaluation Cell and they explained that firm has applied for both
packs / prices i.e Rs.200/20’s & Rs.200/10’s in the same dossier.
Decision: Registration Board referred to Cost & Pricing Division, DRAP for their
opinion on the case.
Case No.22 Transfer of registered drugs:
a. Transfer of registration from import to local manufacturing:
M/s The Searle Company Ltd, Karachi have requested for transfer of registration
of following drugs from import to local manufacturing at their own facility i.e M/s The Searle
Company Ltd, F-319, S.I.T.E, Karachi
S. No. Reg. No. Name of drug (s)
1 010172 Tramal – 100 Injection

(Tramadol)
2. 023317 Tramal SR100mg Tablet
(Tramadol)
As per SOP, supporting documents were sent for expert opinion to three (03) experts and
now two (02) experts out of three (03) has sent their opinion. Details of comments of experts are
as under:-
Prof. Nadeem Irfan Bukhari, Director, Director,

Faculty of Pharmacy, Drug Testing Drug Testing Laboratory,
University of the Punjab, Laboratory, Government of Punjab,
Lahore Government of Lahore
Bluchistan,
Quetta
The report sent for the above After thorough review of Awaited
subject shows the results of the stability data and
ongoing real time stability validation of analytical
studies of Tramal SR Tablets methods of the products of
and Tramal 100mg/2ml Tramal SR Tablets 100mg
Injection. It is understood that and Tramal Injection
the case has been filed for the 100mg/2ml Injection is
transfer of registration from recommended.

import to local manufacturing
at their local facility. My In this regard the
opinion / comments are as undersigned scientifically
follows:- and logically comments as
under:-
The data provided on tablet
formulation indicated that the Stability Studies:
strength (assay) of tramadol
HCl , dissolution test and the The stability studies of
physical characteristics were both Tramal 100 Injection
within the limits and as well as Tramal SR
specifications after the real time 100mg Tablets have been
one year and accelerated carried out against ICH
studies. guidelines.
The data given on the injection The results of ongoing real
formulation showed that the time stability studies
tramadol was stable in this showing all physical
formulation during real time as parameters and assay of
well as in the accelerated Tramadol HCl is well
stability study. within the specified limits.
The data on real time and Also, at accelerated
accelerated study reflected condition the stability data
some variations which were is found satisfactory.
minor and within the acceptable The data given on
limits. Tramadol SR Tablets
The HPLC method developed specified that the
for each formulations was dissolution test, assay of
linear, precise and accurate, Tramadol and physical
through LOQ and LOD was not characteristics of the
provided. Meanwhile the drug formulation is within the
peaks were shown to be limits in ongoing stability
resolved well without studies (real time and
interference. Furthermore, the accelerated).
drug peaks seem to be
responsive to the changes in Validation data
concentrations of the tramadol
HCl in the samples. The validation studies of
both products have been
Keeping the general reflection, evaluated the results are
the data on the stability and found satisfactory.
HPLC method of Tramal SR
Tablets 100mg and Tramal Therefore keeping in view
Injection 100mg/2ml Injetion the present data provided
seem to be appropriate. by the firm for both their
products, the undersigned

is of the opinion to
recommend the
registration of Tramal -100
Injection (Tramadol)
100mg/2ml (Reg.
No.010172 and Tramal SR
100mg Tablets (Tramadol)
(Reg. No.023317) in
favour of the firm.
As per practice in vogue cases for transfer of registration from import to local
manufacturting are considered at same terms and condition including MRP. Cost & Pricing
Divison was also consulted, who confirmed to proceed as per previous practice. Form 5 has
already been evaluated by PEC as per check list approved by Registration Board.
 Cancellation of registrations of Tramal – 100 Injection, Registration No. 010172 and
Tramal SR100mg Tablet, Registration No. 023317 from M/s Serale
Pharmaceuticals, Karcahi.
 Grant of registrations of Tramal – 100 Injection, Registration No. 010172 and
Tramal SR100mg Tablet, Registration No. 023317 in name of M/s The Searle
Company Ltd, F-319, S.I.T.E, Karachi for local manufacturing.
b. Transfer of registrations from M/s Macter International, Karachi to M/s Ray

Pharma, Karachi.
M/s Ray Pharma, Karachi have requested for transfer of registration of following drugs
from M/s Macter International, Karachi to their name. Registration dossiers were evaluated by
Incharge PEC and DDC (R-II) as per check list approved by the Registration Board and firm has
also rectified shortcomings and following recommendations were framed.
S. Reg. No. Name of Drug(s) Recommendations

No.
01 000482 Genticyn Ear / Eye May be approved subject to confirmation
Drops of renewal status
02 004298 Genticyn HC Ear / Referred to Review Committee or may be

Eye Drops discussed in Registration Board due to the
reason that these formulations have not
been found approved in SRA’s (reference
drug agencies)

03 000497 Genticyn Cream May be approved subject to confirmation
0.1% w/w of renewal status
04 000483 Genticyn HC Cream Referred to Review Committee or may be

discussed in Registration Board due to the
reason that these formulations have not
been found approved in SRA’s (reference
drug agencies)
05 010186 Genticyn B Cream -do-
06 007701 Multigesic Cream May be approved subject to confirmation

of renewal status
Renewal status of products are as follows:-

S. Reg. No. Name of Drug(s) Initial date Aplication Renewal
No. receiving status
date
01 000483 Genticyn HC Cream 06-09-2006 Application Registraion
received after is not valid
expiry date and
grace period
24-02-2012
02 010186 Genticyn B Cream -do- -do- -do-
03 007701 Multigesic Cream -do- -do- -do-
04 000482 Genticyn Ear / Eye Drops 24-08-1978 07-06-2012 Registraion
Trasnfer of is valid
regn date upto
18-06-2007 17-06-2017
05 004298 Genticyn HC Ear / Eye -do- -do- -do-
Drops
000497 Genticyn Cream 0.1% 06-09-2006 Application Registraion

06 w/w received after is not valid
expiry date
and grace
period
24-02-2012

 Cancellation of registrations of Genticyn Ear / Eye Drops, Regn No. 010186 from
M/s. Macter International, Karachi.
 Grant of registrations of Genticyn Ear / Eye Drops, Regn No. 010186 in name of
M/s. Ray Pharma, Karachi. Chairman, Registration Board will permit issuance of

registration letter after comments of Cost & Price Division.1
 Genticyn HC Ear / Eye Drops, Registration No. 004298 referred to review
committee as it’s not found approved in SRA’s (reference drug agencies).
 Registrations of Genticyn HC Cream, Genticyn B Cream, Multigesic Cream and
Genticyn Cream 0.1% w/w are not valid.
c. Transfer of registration from M/s Macter Pharmaceutical (Pvt.) Ltd, Karachi to

M/s Macter International (Pvt.) Ltd, Karachi.
M/s Macter International (Pvt.) Ltd, Karachi has requested for transfer of their following
registered drug from previous name i.e M/s Macter Pharmaceutical (Pvt.) Ltd, Karachi to new
name i.e M/s Macter International (Pvt.) Ltd, Karachi.
Sr. Brand Formulation/Generic Date of Renewal

Registration No.
No. Name(s) Name Registration Status
1. Valid up to
Relaxin 06-06-1990
011206 Bromazepam 05-06-2015
Tablets 3mg
Central Licensing Board in its 238th meeting held on 19-11-2014 approved Tablet
(Psychotropic) / Narcotic) Section as segregated section.
Decision: Registration Board approved registration of Relaxin Tablets 3mg in name of

M/s Macter International (Pvt.) Ltd, Karachi.
Case No.23 Change of Contract Manufacturer – M/s B. Braun Pakistan (Pvt.) Ltd, Karachi
M/s B. Braun Pakistan (Pvt.) Ltd, Karachi was granted approval for transfer of
registration from Import to Local manufacturing by contract manufacturing at M/s Mac & Rains
Pharmaceuticals (Pvt.) Ltd, Lahore. Now firm has requested for change of contract
manufacturing from M/s Mac & Rains Pharmaceuticals (Pvt.) Ltd, Lahore to M/s Frontier
Dextrose Ltd, Hattar as the M/s Mac & Rains were unable to manufacture their medicine due to
hiring of their plant by M/s Searle Pakistan.
Applicant Contract Reg. No. Name of drug(s) & Composition Date of Category
manufacturer application,
Diary No. &
Form
1. M/s B. M/s Frontier 053854 B. Braun-RL Infusion 03-06-2014 Import to
Braun Dextrose Ltd, Each 100ml contains:- 537 local

Pakistan Haripur Sodium Chloride …..0.600gm Form-5 contract
(Pvt.) Ltd, Sodium Lactate …..…0.32gm Rs.50,000/-
Karachi Potassium Chloride…0.040gm
Calcium
Chloride 2H2O …...0.027gm
2. -do- -do- 053855 B. Braun-RLD Infusion 03-06-2014 Import to

Each 100ml contains:- 538 local
Sodium Chloride …..0.600gm Form-5 contract
Sodium Lactate …..…0.32gm Rs.50,000/-
Potassium Chloride…0.040gm
Calcium
Chloride 2H2O …...0.027gm
Dextrose Anhydrous for
Parenteral …………5.5gm
3. -do- -do- 053848 B. Braun – Paeds Infusion 03-06-2014 Import to

Dextrose Anhydrous for Rs.50,000/-
Parenteral use………5.0gm
4. -do- -do- 053849 B. Braun – DS ½ Infusion 03-06-2014 Import to

5. -do- -do- 053850 B. Braun – DS Infusion 03-06-2014 Import to

6. -do- -do- 053851 B. Braun – G5 Infusion 03-06-2014 Import to
Dextrose Anhydrous for Form-5 contract
Parenteral use………5.00gm Rs.50,000/-
7. -do- -do- 053852 B. Braun – G10 Infusion 03-06-2014 Import to
Dextrose Anhydrous for Form-5 contract
Parenteral use………10.00gm Rs.50,000/-

8. -do- -do- 053856 B. Braun - Mannitol Infusion 03-06-2014 Import to
Mannitol ………..17.5gm Form-5 contract
Sorbitol for Parenteral Rs.50,000/-
use…………….…2.5gm
9. -do- -do- 053853 B. Braun - NS Infusion 03-06-2014 Import to

Sodium Chloride ……0.90gm Form-5 contract
Rs.50,000/-
The above case was deferred in 245th meeting of Registration Board for confirmation of TOC
analyzer and particle counter in M/s Frontier Dextrose Ltd, Hattar. Federal Inspector of Drugs, DRAP,
Peshawar has reported that that he has checked physically the installation of TOC analyzer and particle
counter in the said firm’s laboratory on 17-11-2014.
Decision: Registration Board acceded to request of M/s B. Braun Pakistan (Pvt.) Ltd,
Karachi for change of contract manufacturer for above products to M/s Frontier Dextrose
Ltd, Hattar at same terms and conditions. This permission will be valid till 30.06.2015.
Case No: 24 Change of contract manufacturer-M/s Excell Health Care Laboratories

(Pvt.) Ltd, Karachi.
Following products of M/s Excell Health Care Laboratories (Pvt.) Ltd, Karachi
were registered for bulk import from M/s ACTAVIS UK Ltd, United Kingdom and local
repacking at M/s Elko Organization, Karachi.
S. No. Name of product(s) Reg. No.

1. Cyclogest Pessaries 200mg 033181
(Progesterone Pessaries)
2. Cyclogest Pessaries 400mg 033182
(Progesterone Pessaries)
Now the firm has requested for change of contract manufacturer for above mentioned
product (bulk import and local repacking) from M/s Elko Organization, Karachi to M/s Apex
Pharmaceuticals (Pvt.) Ltd, D-21-A1, S.I.T.E, Super Highway, Karachi. Firm has deposited fee
@ Rs.10, 0000/- for each product for the purpose.

Registration Board in 241st meeting discussed and decided as under:-
The Board deliberated that reapacking is the part of manufacturing and in this case final
quality control release will be granted by local manufacturer, which will be M/s Apex
Pharmaceuticals (Pvt.) Ltd, D-21-A1, S.I.T.E, Super Highway, Karachi. Thus Board
constituted a panel comprising of Director DTL, Peshawar, Director CDL Karachi and
area FID to inspect the premesis for confirmation of repacking and quality control
facilities of the firm. The Board also advised the panel to confirm that status of imported
products whether in pessaries, blister etc. Registration Board will decide the case in light
of report of the panel.
Accordingly panel inspected the premises of M/s Apex Pharmaceuticals, Karachi

and concluded as under:-
During inspection, it was observed that management has provided adequate facilities for
repacking of above named products and quality control that are being imported from M/s
Actavis, United Kingdom in form of strips and management is intended to repack 15
pessaries in one pack. A room with controlled temperature is also reserved for proper
placement of bulk and repacked products.
Based on the observations made, people met, record reviewed and repacking & QC
facilities provided by the management, panel recommends the transfer of the above name
products from M/s Elko Organization, Karachi to M/s Apex Pharmaceuticals (Pvt.) Ltd,
D-21-A1, S.I.T.E, Super Highway, Karachi
Decision: Registration Board acceded to request of M/s Excell Health Care

Laboratories (Pvt.) Ltd, Karachi for change of contract manufacturer for repacking and
quality control release of above products to M/s Apex Pharmaceuticals (Pvt.) Ltd, D-21-A1,
S.I.T.E, Super Highway, Karachi. However the firm will provide legalized COPP at WHO
format for both products and authorized its Chairman for issuance of letter. Permission is
at the same terms and conditions will be valid till 30.06.2015.
Case No.25 Issuance of duplicate registration letter.
M/s Johnson & Johnson, Karachi have requested for issuance of duplicate registration of
their following drugs:-
S. No. Reg. No. Name of Drug(s)

1. 009078 Daktarin Oral Gel
2. 009084 Daktacort Cream
3. 009083 Sibelium Capsule
4. 009082 Vermox Tablet 500mg

Firm has furnished following documents to support their request:-
a) Copy of entry in roznamcha from concerned policy station

b) Fee @ Rs.5000/- for each product for the purpose.
Decision: Registration Board deferred the case for confirmation of renewal status.
Case No.26 Grant of Registration for export purpose - Contract Manufacturing.
Following firm has requested for registration of drug for export purpose only,
on basis of contract manufacturing.
Contract giver Contract Name of Drug(s) & Composition Date of

manufacturer application,
Diary No. &
Form
M/s Medisure Labs, M/s Cirin Pharma, Rumaclav Tablet 625mg 31-12 -2013
Karachi Hattar Each tablet contains:- Form-5
Amoxicillin as Trihydrate ……500mg Rs.50,000/-
Clavulanic Acid as Potassium…125mg
Decision: Registration Board approved grant of above registration on contract

manufacturing basis for export purpose only. In order to boost export, The Board also
authorized Chairman for grant of registration for export purpose on contract
manufacturing basis excluding controlled drugs and new drug as per contract manufacting
policy.
Case No.27 Grant of Registration for export purpose – Controlled Drug.
M/s Pharmatec Pakistan (Pvt.) Ltd, Karachi has requested for registration of following
drug for export purpose only:-
S. Date of Name of drug(s) & Information required & reply of firm

No. application Composition
Diary No.
& Form
30-09-2014 Flu-Gone C&F  Application on Form 5 with required fee
753 Tablet as per relevant SRO
Form-5 Each tablet contains:-  NOC for CRF clearance
Rs.20,000/- Paracetamol ...600mg  Copy of approved section from CLB
Pseudoephedrine Copy of last inspection report
HCl…………60mg  An undertaking that applied registration

Chlorpheniramine is exclusively for export purpose and
Maleate …….4mg will not be sold in Pakistan.
 If formulation / product is not registered
in Pakistan, then export order from
importing country (Registered in
Pakistan)
Above formulation is registered for local manufacturing as per following details:-
Applied formulations Registered in Pakistan Manufacturer

Flu-Gone C&F Tablet Reltus C&F Tab(Reg. No.024908) M/s Pharmatec
Each tablet contains:- Epinol-CF Tab (Reg. No.023982) M/s CCL, Lahore
Paracetamol …….....600mg
Pseudoephedrine HCl..60mg
Chlorpheniramine Maleate..4mg
Decision: Registration Board discussed that applied drug contains Pseudoephedrine,

which is a precursor chemical and segregated section is required only for Narcotic Drugs
and Psychotropic substances as per Central Licensing Board decision. Thus applied
formulation registered for export purpose only.
Case No.28 Change in flavour – Gastrolyte Rice (Reg.No.070436) –

M/s Sanofi Aventis Pakistan Ltd, Karachi.
M/s Sanofi Aventis Pakistan Ltd, Karachi has informed that their product
Gastrolyte Rice (Reg. No.070436) is registered in Apricot flavor. Now firm has requested for
change of flavor from Apricot to Raspberry.
Firm has submitted for information to support their request.
 O6 months accelerated stability data

 Undertaking
 Specification & Control Method
 Copy of Registration letter
 Fee @ Rs.5,000/- for the purpose.
Decision: Registration Board approved the request. However, Incharge, PEC will
evaluate the stability data and Chairman, Registration Board will authorize issuance of
permission letter on the basis of these recommendations.

Case No.29 Change of manufacturing site from Contract to own facility.
Following products of M/s Medisure Labs (Pvt.) Ltd, Karachi were initially registered for
import as per following details and then permitted for local contract manufacturing from M/s
Indus Pharma, Karachi which are valid till 30.06.2015. Now M/s Medisure Labs (Pvt.) Ltd,
Karachi has informed that they have developed facility for Liquid Injectables (Ampoules &
Vials) at their own premises 17/24, Korangi Industrial Area Karachi and requested to permit
manufacturing of products at this facility.
S. No. Reg. No. Name of Drug(s) Date of Registration
1. 015566 Rosiden Injection 23-08-1994

Each 1ml ampoule contains:-
Piroxicam …………….20mg
2. 014084 Neurocoline 250mg/2ml Injection 01-11-1993
Each 2ml contains:-
Citicoline …………….250mg
Registration dossiers were evaluated by Incharge PEC and DDC (R-II) as per check list
approved by the Registration Board and firm has also rectified shortcomings. It is pertinent to
mention that citicoline is under consideration of Review Committee.
Decision: Registration Board approved request of M/s Medisure Labs (Pvt.) Ltd,
Karachi for manufacturing of Rosiden Injection, Registration No.015566 at its own
premesis. However, request of Neurocoline 250mg/2ml Injection, Registration No.014084
will be considered after recommendation of Review Committee and decision of the Board
on Citicoline.
Case No.30 Correction in Minutes:
a. M/s Amarant Pharma, Karachi
Registration Board in 245th meeting approved following registration in favour

of M/s Amarant Pharma, Karachi. Registration letter could not be issued due to following
mistake in minutes. Existing and correct formulation are as under:-

Name of Drug(s) & Composition Correct Composition
Amprexa-F Tablet 12/25mg Amprexa-F Capsule 12/25mg
Each tablet contains:- Each capsule contains:-
Olanzapine ………..……12mg Olanzapine ……..………12mg
Fluoxetine HCl …….……25mg Fluoxetine HCl ………..…25mg
Decision: Registration Board approved the correction as Amprexa-F Capsule 12/25mg

instead of tablets.
Case No.31 Registration of Drugs for export purpose-Not me too Drugs.
Following firms have requested for registration of following drugs for export
purpose only which are not me-too. Details are as under:-
S. Name of Name of product(s) Date of application, Export Order

No. Company Diary No. & Form
1. M/s Sofos Tablet 23-11-2014 Original Export
Genix Each film coated tablet 769 Order from
Pharma, contains:- Rs.20,000/- Afghanistan
Karachi Sofosbuvir MS ....400mg
2. -do- Sofopas Tablet 23-11-2014 Original Export

Each film coated tablet 770 Order from
contains:- Rs.20,000/- Afghanistan
Ledipasvir MS ……90mg
Sofosbuvir MS .......400mg
3. M/s Vibrenta 400mg Tablet 19-11-2014 Copy of Export
Tabros Each film coated tablet 767 Order from
Pharma, contains:- Rs.20,000/- Afghanistan
Karachi Sofosbuvir MS ....400mg
4. M/s Getz Azvira 400mg Tablet 05-12-2014 Not provided
Pharma, Each film coated tablet 771
Karachi contains:- Rs.20,000/-
Sofosbuvir ....400mg

Decision: Mr.A Q Javed Iqbal, Director QA &LT opined that for export purpose only
those formulations should be registered, which are already registered in Pakistan. For new
formulations (which are not registered in Pakistan), manufacturers should first conduct
stability studies and then registration for export purpose be granted. Prof. Muzammil H
Najmi also endorsed it. Registration Board after deliberation decided that inorder to
facilitate export of quality drugs (non-me too drugs), export registration will be granted
and manufacturer will comply following conditions before export of drug:
 Manufacturer will export the product after complying all the conditions as required
under Drug Act, 1976 including No objection certificate from concerned DRAP
office. Moreover, Federal Inspector of drugs will take sample from each
consignemnet for analysis from CDL, Karachi.
 Manufacturer will also furnish export documents endorsed from custom authorities
in order to ensure the export of the product.
Registration Board approved above products for registration for export purpose only
with aforementioned conditions. These conditions will also be applicable to products
approved for exports (Sofosbuvir) by Chairman, registration Board

Registration-III
Case No.32
Registration Board in its 229th meeting approved the following product of M/s Global
Pharmaceutical, Islamabad.
S.No. Name and Composition of Pack size Demanded

Product Price
1. Tamsol-D Tablets 10’s As Per SRO
Each film coated tablet Fee
contains:- Rs:8,000/=
Tamsulosin Hydrochloride 0.4
mg
(as modified – release tablets)
Dutasteride………………0.5
mg
The Registration Board reconsidered the decision of 229th meeting which is as follows:
“Decision: Registration Board after considering the technical opinion by its
members decided to ask the manufacturer to appear before Registration Board
for presentation of his opinion regarding efficacy of the above drug
formulation. The Board further ordered that till final decision, the registration
of above product would remain suspended under section 7(11) (ad) of Drug
Act, 1976.”
Decision: Registration Board discussed the case and decided to issue show cause notice
to M/s Global Pharmaceutical, Islamabad for cancellation of registration.
Case No.33
M/s. Amgomed, Islamabad has requested to transfer of the following drug from being
imported for local manufacturing on contract basis by M/s. Bio-Lab (Pvt) Limited, Islamabad:-
S.N Reg. Name and Composition of Pack size Demanded

o. No. Product Price
1 053821 Amgozole Injection Per vial As Per SRO

Omeprazole Sodium
≡ Omeprazole……40 mg

(Proton Pump Inhibitor)
The dossier has been submitted along with fee amounting Rs.50,000 and has been evaluated
with the collaboration of the Incharge Evaluation Cell as per check list.
Decision: Registration Board approved request of M/s. Amgomed, Islamabad for
contract manufacturing of Amgozole Injection, Registration No. 053821 from M/s. Bio-Lab
(Pvt) Limited, Islamabad. This permission will be valid till 30.06.2015.
Case No. 34.
M/s. Quaper (Pvt) Limited, Sargodha has requested to transfer the manufacturing site from
M/s. Fassgen Pharmaceuticals, Hattar to M/s. Mediate Pharmaceuticals, Karachi on contract
basis:-
1. From To 054069 Cefein 250 Injection IV

Fassgen Mediat Each vial contains:-
Hattar e Ceftriaxone Sodium
Karachi ≡ Ceftriaxone……..250
mg
(Cephalosporin)
2. Fassgen Mediat 054077 Cefein 500 Injection IV

e Each vial contains:-
Ceftriaxone Sodium
≡ Ceftriaxone……..500
mg
(Cephalosporin)
3. Fassgen Mediat 054073 Cefein 250 Injection IV

e Each vial contains:-
Ceftriaxone Sodium
≡ Ceftriaxone……..1g
(Cephalosporin)
4. Fassgen Mediate 054067 Rayxime 400 mg Capsule

Cefixime Trihydrate
≡ Cefixime…………400
mg
(Cephalosporin)

5. Fassgen Mediat 054065 Rayxime 100 mg Dry
e Suspension
Each 5ml contains:-
Cefixime Trihydrate
≡ Cefixime…………100
mg
(Cephalosporin)
The dossiers have been submitted along with fee of Rs:50,000/each and have been evaluated
with the collaboration of the Incharge Evaluation Cell as per check list.
Decision: Registration Board approved the request of M/s. Quaper (Pvt) Ltd.,
Sargodha for change in contract manufacturer of above products from M/s.
Fassgen Pharma to M/s. Mediate Pharma, Karachi. Permission is at already
approved terms and conditions.
Case No.35 Registration Board in 242nd meeting approved the registration of following drug
of M/s. Olive Laboratories, Rawat.
S.N Existing name with approved Correct formulation/Nomenclature

o Composition
1. 1. Hepatavir 300 mg Tablets 1. Hepatavir 300 mg Tablets
2.Tablets 2.Tablets
3. Each film coated Tablet 3. Each film coated Tablet contains:
contains: Tenofovir Disoproxil
Tenofovir Disoproxil Fumarate Fumarate…300 mg
….30 mg 4. Anti-retroviral / Nucleoside and
4. Anti-retroviral / Nucleoside and Nucleotide Reverse Transcriptase
Nucleotide Reverse Transcriptase Inhibitors
Inhibitors
The Evaluation Cell stated that the firm had correctly applied for Tenofovir Disoproxil
Fumarate 300 mg film coated tablet but inadvertently incorporated as 30mg in agenda and
minutes of 242nd meeting. The abovementioned inadvertent typographical error of the strength
needs rectification as Tenofovir Disoproxil Fumarate 300 mg.
Decision: Registration Board approved the correction as Tenofovir Disoproxil
Fumarate 300mg Tablet.

Case No.36
Registration Board in 244th meeting deferred the following registration applications of M/s.
Welwink Pharmaceutical, Gujranwala for manufacturing by M/s. Weather Fold Pharmaceuticals,
Hattar on contract basis in view of required GMP inspection as mentioned below:
M/s Welwink Acticef 500 mg Powder Form 5 FDA. (Rocephin Deferred for
Pharmaceuticals. for reconstitution of IM 18-07-2012 (Roche) GMP inspection
G.T Road, Injection Dy No SPORCEF(LOWITT of contract
Industrial Estate, Each Vial contains:- 7333 PHARMACEUTICALS manufacturer by
Gujranwala Ceftriaxone Sodium 21-05-2013 (PVT) LTD) panel
Cantt. ≡ Ceftriaxone ……500 Rs. Advised for further comprising of
Gujranwala mg 150,000/- improvement in Dr. Muzammal
(Cephalosporin As Per different sections. H. Najmi,
Manufacturing Antibiotic) SRO (22-03-2014) Director QA
on Contract (USP Specs) 1‟s & LT and Area
basis by vial FID. Contract
M/s Weather giver will be
Folds inspected by
Pharmaceuticals. Area FID as last
Plot 69/2, inspection
Phase-2, report is more
Industrial Estate, than 01 year old
Hattar
-do- Acticef 250 mg Powder Form 5 SPORCEF(LOWITT Deferred for
for reconstitution of IM 18-07-2012 PHARMACEUTICALS GMP inspection
Injection Dy No (PVT) LTD) of contract
Each Vial contains:- 7336 Advised for further manufacturer by
Ceftriaxone Sodium 21-05-2013 improvement in panel
≡ Ceftriaxone…….250 Rs. different sections. (22- comprising of
mg 150,000/- 03-2014) Dr. Muzammal
(Cephalosporin As Per H. Najmi,
Antibiotic) SRO/1‟s Director QA
vial & LT and Area
FID. Contract
giver will be
inspected by
Area FID as last
inspection
report is more
than 01 year old
-do- Acticef 250mg Powder Form 5 BNF. (Rocephin Deferred for
for reconstitution of IV 18-07-2012 (Roche) GMP inspection
Injection Dy No SPORCEF(LOWITT of contract

Each Vial contains:- 7338 PHARMACEUTICALS manufacturer by
Ceftriaxone Sodium 21-05-2013 (PVT) LTD) panel
≡ Ceftriaxone Rs. Advised for further comprising of
………250 mg 150,000/- improvement in Dr. Muzammal
(Cephalosporin As Per different sections. (22-H. Najmi,
Antibiotic) SRO 03-2014) Director QA
USP Specs 1‟s & LT and Area
vial FID. Contract
giver will be
inspected by
Area FID as last
inspection
report is more
than 01 year old
Weather Fold Acticef Injection 500mg Form 5 Rociphen of Gentech Deferred for
Pharmaceuticals (IV) 18-07-12 USA GMP inspection
Hattar Each vial contains: Dy No Rociphen of Roche of contract
Ceftriaxone sodium 7341 Karachi manufacturer by
for ≡ Ceftriaxone …500mg Rs 8000/- Inspection of the M/s panel
(Cephalosporin 21-05-13 Weather Folds comprising of
M/s Welwink Antibiotic) Dy Pharmaceuticals, Hattar Dr. Muzammal
Pharmaceuticals, USP Specs No 3283 was conducted by the H. Najmi,
Gujranwala 1,42,000/- area FID on 22/03/14 Director QA
As per and advised firm for & LT and Area
SRO/ Pack further improvements in FID. Contract
of 1‟s different sections giver will be
inspected by
Area FID as last
inspection
report is more
than 01 year old
-do- Acticef Injection 1gm Form 5 Rociphen of Gentech Deferred for

(I.M.) 18-07-12 USA GMP inspection
Each vial contains: Dy No Rociphen of Roche of contract
≡ Ceftriaxone …….1g Rs 8000/- panel
Cephalosporin 21-05-13 comprising of
Antibiotic Dy No Dr. Muzammal
USP specs 3283 H. Najmi,
1,42,000/- Director QA
As per & LT and Area
SRO/ Pack FID. Contract
of 1‟s giver will be
inspected by

Area FID as last
inspection
report is more
than 01 year old
-do- Acticef Injection 1gm( Form 5 Rociphen of Gentech Deferred for
I.V) 18-07-12 USA GMP inspection
Each vial contains Dy No Rociphen of Roche of contract
≡ Ceftriaxone …….1gm Rs 8000/- panel
Cephalosporin 21-05-13 comprising of
Antibiotic Dy No Dr. Muzammal
USP Specs 3283 H. Najmi,
Rs Director QA
1,42,000/- & LT and Area
As per FID. Contract
SRO/ Pack giver will be
of 1‟s inspected by
Area FID as last
inspection
report is more
than 01 year old
M/s Weather Maxoxim 200 mg/5ml Form 5 International: Suprax Deferred for
Folds Dry powder suspension 18-07-2012 for suspension GMP inspection
Pharmaceuticals. Each 5 ml contains: Dy No 200mg/5ml (FDA) of contract
Plot 69/2, Cefixime Trihydrate 7330 Local: Biozil Dry manufacturer by
Phase-2, USP Rs. Suspension 200 mg/5 panel
Industrial Estate, ≡ Cefixime ……200 mg 150,000/- ml by M/s BioLabs comprising of
Hattar (Cephalosporin As per SRO According to report of Dr. Muzammal
antibiotics) inspection dated 22-10- H. Najmi,
For USP Specs 2014 of M/s Weather f Director QA
old, firm is advised to & LT and Area
M/s Welwink rectify shortcomings in FID. Contract
Pharmaceuticals. various sections. giver will be
G.T Road, According to report of inspected by
Industrial Estate, inspection dated 13-06- Area FID as last
Gujranwala 2013 of M/s Welwink, inspection
Cantt. inspection book was not report is more
Gujranwala available at time of than 01 year old
inspection and firm was
once again directed to
submit their validation
data of areas and
processes before
starting of their
production.

-do- Maxoxim 100 mg/5ml 1.Form 5 -do- -do-
Dry Powder Suspension 2.18-07-
Each 5 ml contains: 2012
Cefixime Trihydrate Dy No
USP 7335
≡ Cefixime ………100 3. 21-05-
mg 2013
(Cephalosporin Rs.
antibiotics) 150,000/-
USP Specs
-do- Maxoxim 400 mg 1.Form 5 -do- -do-
Capsule 2.18-07-
Each capsule contains: 2012
Cefixime trihydrate Dy No
≡ Cefixime …….. 400 7335
mg 3. 21-05-
(Cephalosporin 2013
antibiotics) Rs.
Finished product 150,000/-
Manufacturing
specifications
The panel of Central Licensing Board inspected Weather Fold Pharmaceuticals, on 18-11-
2014 and recommended the Renewal of DML. The Federal Inspector of Drugs Lahore also
inspected the M/s. Welwink Pharmaceutical Gujranwala and stated that the firm possesses the
relevant facility of quality control.
Decision: Registration Board approved the request of M/s. Welwink Pharmaceuticals
for contract manufacturing of above products by M/s. Weather Ford Pharmaceuticals,
Hattar. Permission will be valid till 30.06.2015.
Case No.37
Registration Board in 245th meeting considered the following new molecule of M/s. Global
Pharmaceutical, Islamabad
Dlanz 30mg Capsules 30‘s As Per Registration Board discussed and

Each capsule contains:- SRO agreed to above expert opinions.
Dexlansoprazole …. 30 mg However, the Board advised firm
(Proton Pump Inhibitor) to provide data for stability
studies conducted under zone IV-

A conditions as per ICH / WHO
guidelines for consideration of
Registration Board.
Dlanz 60mg Capsules 30‘s As Per -do-

Each capsule contains:- SRO
Dexlansoprazole …. 60 mg
Zaprin SR 15mg Capsules 60‘s As Per -do-

Cyclobenzaprine HCl (USP)
≡ Cyclobenzaprine ……15
mg (Skeletal Muscle
Relaxant)
Now the firm has submitted the stability report of quality control for period of 12, 9, 6, 3
(months) and initial QC about Dexlansoprazole. Moreover, Cyclobenzaprine has been already
approved in favour of CCL, Lahore in 242nd meeting of DRB. The firm has requested to grant of
registration of above mentioned drugs in view of the relevant explanation.
Decision: Registration Board approved the products. However, the Board advised
concerned P E & R Division and Incharge, PEC to evaluate submitted stability studies of
Zone IVA of Dexlansoprazole 30 & 60mg Capsule. Registration Board authorized its
Chairman for subsequent approval for issuance of registration letter.
Registration Board approved Cyclobenzaprine HCl 15mg Capsule, being me too

product.
Case No.38
Registration Board in 245th meeting deferred the following application of M/s. Global
Pharmaceuticals Islamabad for evaluation of dossier with the collaboration of Evaluation Cell as
per check list:-
Anarob Infusion 026985 1x100 M/s. Mac & M/s. Vision
Each 100 ml contains:- ml Rains Pharmaceuticals,
Metronidazole Pharmaceuticals,
B.P…500 mg
Ofloquin Infusion 026980 1x100 -do- -do-

Each 100 ml contains: ml
Ofloxacin HCl

≡ Ofloxacin….. 200
mg
Nafcin Injection 026979 100 -do- -do-

Each 100 ml contains: ml
Ciprofloxacin Lactate
≡ Ciprofloxacin…..200
mg
The dossiers have been evaluated with the collaboration of Incharge Evaluation Cell as per
check list.
Decision: Registration Board approved request of M/s Global Pharmaceuticals,

Islamabad for change of contract manufacturer of above products from the M/s. Mac &
Rains Pharmaceuticals to M/sVision Pharmaceuticals, Islamabad. Permission is at same
terms and conditions.
Case No.39
M/s. Vision Pharmaceutical, Kahuta Road, Islamabad has requested for transfer of
registration of following drugs from M/s. Vision Pharmaceutical, I-10/3, Islamabad. Previously,
these products were contract manufactured by m/s Mac & Rains Pharmaceuticals, Lahore:-
Levovis IV Infusion
Each 100 ml contains:-
M/s. Mac &
Levofloxacin hemihydrate M/s. Vision
032160 1x100ml Rains
≡ Levofloxacin……… Pharmaceuticals,
Pharmaceuticals,
500ml
Medicip IV infusion
Ciprofloxacin lactate 030701 1x100ml -do- -do-
≡ Ciprofloxacin ......200
mg
M/s. Vision Pharmaceutical, Kahuta Road, Islamabad has developed the relevant
manufacturing facilities and submitted complete dossier along with fee amounting
Rs:50000/dossier. The dossiers have been evaluated with the collaboration of Incharge of the
Evaluation Cell as per check list.

 Cancellation of above registrations from M/s. Vision Pharmaceuticals, I-10/3,
Islamabad.
 Grant of above registrations in name of M/s. Vision Pharmaceutical, Kahuta Road,

Islamabad. Chairman, Registration Board will permit issuance of registration letter
after comments of Cost & Pricing Division about MRP of the drug.
Case No.40
M/s. Metro Pharmaceutical, Islamabad has requested for correction of nomenclature and label
claim of the following drugs as mentioned below:-
Existing /approved formulation Correct Reg No.

formulation/Nomenclature
Myzinc Syrup Myzinc Syrup 075253
Each 5ml contains:- Each 5ml contains:-
Zinc Sulfate Monohydrate…. 20 Zinc Sulphate Monohydrate
mg ≡ Zinc (element)……..…. 20 mg
(USP Specs) (USP Specs)
The management has deposited fee of Rs:5000/- for this purpose. It is pointed out that the
strength of the API is calculated on the basis of content of zinc element.
Decision: Registration Board approved the correction as Zinc Sulphate Monohydrate
equivalent to Zinc (element) 20mg/5ml syrup.
Registration-IV
Case No.41
M/s. Genome Pharmaceutical, Hattar has requested for correction in formulation of
following drugs. Initially these drugs were registered on 2nd August, 2003 and 4th February,
2006 with M/s. Silver Oak Corporation Hattar. The management was changed and the unit was
renamed and registrations of the products approved for Silver Oak Corporation Hattar were
transferred in favour of M/s. Genome Pharmaceuticals. It is pointed out that at the time of
transfer of registration of the products, the brand name was also changed but the strengths of

active pharmaceutical ingredient in the below-mentioned formulations were inadvertently typed
as:
S.N Previous name / Existing name / Incorrect
Reg No.
o Formulation Formulation
Tick-Nil Tablets Citgen Tablets
Each tablet contains:- Each tablet contains:-
1. Cetirizine 2HCl…..10 Cetirizine 030815
mg Dihydrate….10 mg
Solifen Tablets
Proket Tablets
2. Each tablet contains:- 042511
Ketoprofen…………10
Ketoprofen………30 mg
0 mg
It is pointed out that it was inadvertently written as Cetirizine Dihydrate 10 mg per tablet
while transferring the registration from M/s. Silver Oak to M/s. Genome. Similarly, the strength
of Ketoprofen was wrongly mentioned as 30mg/tablet. The correct formulation is mentioned
below in the right column of table.
S.N Existing name with Correct Formulation/ Reg

o Composition Nomenclature No.
1. Citgen Tablet Citgen Tablet
Each tablet Each film coated tablet
contains:- contains:- 03081
Cetirizine Cetirizine Dihydrochloride… 5
Dihydrate…..…..10 10 mg
mg
2. Proket Tablet Proket Tablet
Each tablet Each film coated tablet
04251
contains:- contains:-
1
Ketoprofen……30m Ketoprofen……… 100 mg
g
Decision: Registration Board approved the correction as Cetirizine Dihydrochloride

10mg film coated tablet and Ketoprofen 100mg film coated tablet of the above mentioned
products.

Case No.42
Registration Board approved the application of M/s. Genome Pharmaceuticals, Hattar for
Tablets containing combination of Domperidone Maleate and Cinnarizine in Drug Registration
meeting 214th as mentioned below:-
1. Approved formulations in The formulation issued

214th meeting in the Registration letter)
2. Domenome Tablets Zinom Tablets
Each tablet contains:- Each tablet contains:-
Domperidone Maleate…19.48 Domperidone
mg Maleate......19.10 mg
Cinnarizine………20.40mg Cinnarizine ...........25mg
(Genome’s Specs)
It is pointed out that Domperidone Maleate and Cinnarizine were inadvertently approved as
19.48 mg and 20.4mg respectively. Moreover, the certificate of registration also contained
typographical error regarding Domperidone maleate 19.10mg and Cinnarizine 25mg. The firm
provided the copy of the dossier and requested to correct the Minutes of 214th meeting as well as
the typographical error of the respective formulation along with the correction in certificate of
registration as mentioned below.
Reg No Correct formulation /Nomenclature
053580 Domenome Tablets

Domperidone Maleate……19.1mg
≡ Domperidone…………..15 mg
Cinnarizine………………..20 mg
(Approved formulations in 214th meeting
)
Decision: Registration Board deferred and referred above formulations to Review

Committee.

Case No.43
Registration Board in 243rd meeting approved the registration of following drug of M/s.
Wnsfeild Pharmaceutical Hattar.
S.N Existing name with Composition Correct

o formulation/Nomenclature
1. 1. Alfa-Block 1. Alfa-Block Capsule
2. Capsule 2. Each capsule contains:-
3. Each capsule contains:- 3.Tamsulosin Hydrochloride SR
Tamsulosin Hydrochloride SR pellets 0.2%w/w
pellets……50mg ≡ Tamsulosin HCl……….0.4mg
4. (Selective Alpha-a Adrenergic 4. (USP Specification)
Blocking Agents)
Now the firm has informed that the strength of Tamsulosin HCl pellets is incorrectly
mentioned as 50 mg per capsule. Incharge Evaluation Cell stated that above mentioned error had
been pointed to the firm and it was rectified subsequently and prior to the 243-Meeting. But the
agenda and minutes of 243rd meeting could not be amended. The management has requested for
the appropriate correction and issuance of the certificate of registration accordingly.
Decision: Registration Board approved the correction as Tamsulosin Hydrochloride
SR pellets 0.2%w/w equivalent to Tamsulosin Hydrochloride 0.4mg/Capsule.
Case No.44
M/s. Wisdom Pharmaceuticals Industries, Peshawar requested for issuance of registration

letter of Zoramid (Domperidone) Suspension which was approved in 243rd meeting of
Registration Board with the following formulation:-
Zoramid Suspension
Each 5ml contains:-
Domperidone Maleate eq. to Domperidone….5mg
The registration letter was not issued due to inappropriate active pharmaceutical ingredient
and the ambiguous label claim. With reference to Motilium Suspension (brand leader Johnson &
Johnson) and BNF 66 it is evident that Suspension contains Domperidone 5mg/5ml instead of
Domperidone maleate equivalent to Domperidone 5mg/5ml.

The management was informed that the inappropriate description of active pharmaceuticals
ingredient and label claim needs verification by the Incharge Pharmaceutical Evaluation Cell
because the dossier was evaluated by the PEC and the management has to apply formally for this
rectification.
Mr. Tahir CEO M/s. Wisdom Pharmaceuticals, Peshawar verbally informed, “The
management corrected the formulation and claim of Zormid Suspension and submitted the same
to the PEC before the commencement of DRB meeting-243rd. The correction was neither
incorporated in agenda nor in the relevant minutes and the ambiguity prevailed the approved
minutes”. Instead of proceeding in the proper way, ironically, Mr. Tahir CEO wrote in the letter
No.WPI/DRAP/40/14 dated 11-11-2014, “but due to unknown reason registration letter of our
product has not been issued till to date it is requested to issue registration letter of our product as
soon as possible. If the registration letter is not issued up to 30-11-2014 the case will be sent to
the Honourable Wafaqi Mohtasib (Ombudsman) of Pakistan Islamabad.,” Moreover, the
management forwarded the copies to Honourable Wafaqi Mohtasib (Ombudsman) of Pakistan,
C.E.O DRAP and Director PE&R without waiting for the response of the department according
to the stipulated period of 30-11-2014.
Resultantly the Incharge Evaluation Cell was asked to verify the in appropriation in
formulation and the proclaimed rectifications of Wisdom Pharmaceuticals. The Evaluation Cell
confirmed from the record that stance of firm is true i.e.Wisdom Pharmaceuticals has corrected
the composition as per reference product but the same could not be reproduced into the agenda
and minutes of 243rd meeting of DRB.
Decision: Registration Board deferred the formulation and referred the case to Review
Committee in conformity of decision of 244th meeting.
Case No. 45
Registration Board in 227th meeting held on 26th & 27th August, 2010 deferred the following
registration application of M/s Cherwel Pharmaceuticals, Hattar for manufacturing on basis of
contract till the finalization of contract policy:-
1. M/s. Cherwel Cherzone 250 mg Injection Per As Per 3-10- Deferred till
Pharmaceutic I.V vial SRO 2009 the

als, Hattar Each vial contains:- finalization of
Manufacturin Ceftriaxone Sodium contract
g on Contract ≡ Ceftriaxone…….…….250 policy
basis by mg
M/s.Wise (Cephalosporin)
Pharma,
Islamabad
2. -do- Cherzone 500 mg Injection Per As Per -do- -do-

I.V vial SRO
Ceftriaxone Sodium
≡ Ceftriaxone…….…….500
mg
(Cephalosporin)
3. -do- Cherzone 1 g Injection Per As Per -do- -do-
Each vial contains:- vial SRO
Ceftriaxone Sodium
≡ Ceftriaxone ………….1 g
(Cephalosporin)
4. -do- Getxime 400 mg Capsules 5’s As Per -do- -do-
Cefixime Trihydrate
≡ Cefixime………….….400
mg
(Cephalosporin)
5. -do- Getxime 100 mg Dry 30ml As Per -do- -do-

Suspension SRO
Cefixime Trihydrate
≡ Cefixime
…..…….….100mg
(Cephalosporin)
6. -do- Getxime200mg Dry 30ml As Per -do- -do-

Suspension SRO
Cefixime Trihydrate
≡Cefixime …..…….….200
mg
(Cephalosporin)

7. -do- Welpime 500mg Injection Per As Per -do- -do-
Cefepime HCl with L-
Aginine
≡ Cefepime (anhydrous)
500mg
(Cephalosporin)
8. -do- Welpime 1gm Injection Per As Per -do- -do-

Cefepime HCl with L-
Aginine
≡ Cefepime (anhydrous) 1 g
(Cephalosporin)
9. -do- Biset 1 g Injection Per As Per -do- -do-

Cefoperazone Sodium
≡ Cefoperazone.…… 500 mg
Sulbactam Sodium
≡ Sulbactam…………. 500
mg
(Cephalosporin)
10. -do- Biset 2g Injection Per As Per -do- -do-

Cefoperazone Sodium
≡ Cefoperazone……… 1g
Sulbactam Sodium
≡ Sulbactam…………… 1g
(Cephalosporin)
Now contract manufacturing policy has been finalized and the management of the firm has
deposited the fee of Rs. 50,000/each and requested to change the manufacturer from M/s. Wise
Pharmaceuticals Rawat to M/s. Bloom Pharmaceuticals, Hattar and also to change the brand
name of some product. The Dossiers have been evaluated with the collaboration of Incharge
Evaluation Cell as per check list.
Decision: Registration Board registered above products of M/s. Cherwell
Pharmaceuticals, Hattar on contract manufacturing basis from M/s. Bloom
Pharmaceuticals, Hattar. Permission will be valid till 30.06.2015

Case No.46
M/s. Maxi Care International, Lahore has requested for transfer of following drug from
import for local manufacturing on contract basis by M/s. Welwrd Pharmaceuticals Hattar:-
Reg. Name and Composition of Pack size Demanded
S.N No. Product Price
o.
1 059263 PE-40 Lyophilized Injection Per vial Rs.250.00
Pantoprazole Sodium
≡Pantoprazole……… 40 mg
They have submitted the complete dossier along with fee of Rs. 50,000/- for this purpose.
The dossier has been evaluated by the Incharge Evaluation Cell as per check list.
Decision: Registration Board approved request of Maxi Care International, Lahore for
contract manufacturing of above product from M/s. Welwrd Pharmaceuticals, Hattar.
Permission is at same terms and conditions except that firm will not claim the product as
lyophilized.
Case No.47
M/s. Aries Pharmaceuticals, Peshawar has requested for registration of following drugs
for the export only:-
S.N Name and Composition of
o. Product
1 Xanek Tablets
Alprazolam……….0.5 mg
(USP Spec)
2 Lexonil Tablets
Bromazepam…………3 mg
(Aries Specs)
The management of the firm provide the complete dossier, Fee of Rs,20000/- original export
order and requested for registration of drugs for export purpose only. The dossiers have been
evaluated accordingly.
Decision: Registration Board approved grant of registration of above mentioned
products for the purpose of export only.

Case No. 48
Registration Board in 243rd meeting deferred the following application of M/s. Genome
Pharmaceuticals, Hattar for opinion of experts but the panel of experts has not been proposed :-
1. M/s. Genome Genozal Tablets 10’s As Per Deferred for

Pharmaceutical Each tablet contains:- SRO expert opinion.
, Hattar. Balsalazide Disodium
Dihydrate………750 mg
(Genome Spec)
(Anti-inflammatory drug)
2. -do- Rebon-X Tablets 10’s As Per  Deferred due

Each film coated tablet SRO to Methylene
contains:- Chloride.
Strontium citrate………680  Inspection
mg report nil
(Bone stabilizer)  Form 5/ file
partially
signed.
Now the case is again included in the agenda for constitution of panel of expert for expert
opinion. The dossier has been evaluated and rectified by the Evaluation Cell as per check list.
Decision: Registration Board referred above products to following panel for expert
evaluation:
 Genozal Tablets (Balsalazide Disodium Dihydrate………750 mg)
o Brig Dr. Aslam Khan, Member Registration Board.
o Dr. Rauf Niazi, PIMS, Islamabad.
o Dr.Irfan Ahmad, BBH, Rawalpindi
 Rebon-X Tablets (Strontium citrate………680 mg)

o Mr. Abdul Latif Sheikh, AKUH.
o Prof Dr. Rafi-uz-Zaman, Member Registration Board.
o Prof. Dr. Zafar Iqbal, University of Peshawar

Case No. 49
M/s. Swat Pharmaceutical, Swat has requested to transfer the manufacturing site from
M/s. Medera Pharmaceuticals (toll manufacturer) to their own manufacturing unit in view of the
existence of the manufacturing facility:
1. Baxib 250mg Tablets 030449
Ciprofloxacin HCl
≡ Ciprofloxacin……....250 mg
(Quinolone)
2. Baxib 500mg Tablets 030450
Ciprofloxacin HCl
(Quinolone)
3. Baxib 750 mg Tablets 030451
Ciprofloxacin HCl
(Quinolone)
4. Sanlevo 250 mg Tablets 029883
Levofloxacin Hemihydrate
≡ Levofloxacin…………….250 mg
(Quinolone)
5. Sanlevo 500 mg Tablets 029884

≡ Levofloxacin…………….500 mg
(Quinolone)
The management of the firm has deposited the fee of Rs. 20,000/each and requested to
transfer the above mentioned drugs to their own manufacturing site M/s. Swat Pharmaceutical,
Swat. The Dossiers have been evaluated with the collaboration of incharge Evaluation Cell as
per check list.
Decision: Registration Board approved request of M/s. Swat Pharmaceuticals, Swat for
manufacturing of the above products at its own facility. Permission is at same terms and
conditions.

Case No. 50
M/s. Usawa Pharmaceutical, Rislapur has requested to transfer the manufacturing site
from M/s. Caraway Pharmaceuticals (toll manufacturer) to their own manufacturing unit in view
of the existence of the manufacturing facility:
1. Afixim 400 mg Capsule 060248

Cefixime Trihydrate
≡ Cefixime……………… 400 mg
2. Durixil Capsule 500 mg 060249

Cefadroxil Monohydrate
≡ Cefadroxil……………… 500 mg
The management of the firm has deposited the fee of Rs. 20,000/each and requested to
transfer the above mentioned drugs to their own manufacturing site M/s. Usawa Pharmaceutical,
Rislapurt. The Dossiers have been evaluated with the collaboration of Incharge Evaluation Cell
as per check list.
Decision: Registration Board approved request of M/s. Usawa Pharmaceuticals,

Risalpur for manufacturing of the above products at its own facility.
Permission is at same terms and conditions.
Case No. 51
Registration Board in 228th meeting and 238th meeting deferred the following drugs of
M/s. Genome Pharmaceuticals, Hattar for the reasons mentioned below:
1. Perilone Tablets 10’s As Per Deferred for expert

Each tablet contains:- SRO opinion being a new
Paliperidone……….1.5 mg chemical entities.
(Ant-psychotropic)(Genome Spec) (M-228
2. Lanso-SR Capsules 14’s As Per Deferred till

Each SR capsule contains:- SRO submission of
Dexlansoprazole enteric coated application on
Pellets FORM 5-D along

≡ Dexlansoprazole….30 mg with prerequisite fee
(Proton Pump Inhibitor) (M-238)
Now the firm has informed that the same formulations and same strength has been registered
by the Registration Board in favour of Pharmatec. The firm deposited the differential fee and
dossiers have been evaluated by the collaboration of Evaluation Cell as per check list.
Decision: Registration Board approved Lanso-SR Capsules. However, the Board
advised concerned P E & R Division and Incharge, PEC to evaluate submitted stability
studies of Zone IVA of Dexlansoprazole 60mg Capsule. Registration Board authorized its
Chairman for subsequent approval for issuance of registration letter.
Registration Board approved Tablets Paliperidone 1.5mg
Case No.52
The following anomaly cases drugs of M/s. Wnsfeild Pharmaceuticals, Hattar were deferred
in 245th meeting as mentioned below:-
1. Somac 40 mg Injection Per AsAs per Registration Board

Each vial contains:- vial perSRO deferred above
Pantoprazole Sodium SR
29-1-13 products for
Sesquihydrate O scrutinization of
≡ Pantoprazole…..40 mg 29- registration application
(Proton pump inhibitor) 1- as per check list.
13
2. Winomax 500 mg injection Per AsAs per -do-
Each vial contains:- vial perSRO
Azithromycin monohydrate SR
29-1-13
≡ Azithromycin ……..40 mg O
(Anti-infective) 29-
1-
13
3. Lantex 30 mg injection Per AsAs per -do-
Lansoprazole sodium SR
29-1-13
≡ Lansoprazole ……..30 mg O
(Proton pump inhibitor) 29-
1-
13
4. Kalwin 500 mg Injection Per AsAs per -do-
Clarithromycin SR
29-1-13

≡ Clarithromycin …..500 mg O
(Proton pump inhibitor) 29-
1-
13
The dossiers have been evaluated by with the collaboration of Evaluation Cell as per check
list and the term lyophilized will not be claimed by the manufacturer.
Decision: Registration Board approved the registration of above mentioned products.
Case No.53
The following anomaly cases of M/s. Welmark Pharmaceuticals, Hattar were deferred in 237th
meeting of the Drug Registration Board as mentioned below:-
1. M/s. Welmark Carimark 500 mg Injection Per As 16-08- Deferred for

Pharmaceuticals, Each vial contains:- vial per 11 clarification
Hattar Clarithromycin SRO weather
New Section ≡ Clarithromycin …500 mg Lyophilization
(Macrolide) procedure is
mandatory/required
for such
formulation or not.
2. -do- Ezi-mark 500 mg Injection Per As 19-8- do

Each injection contains:- vial Per 2011
Azithromycin dihydrate SRO
≡ Azithromycin ….500 mg
(Macrolide)
Now the firm has removed the word Lyophilized from the formulation and the dossiers have
been evaluated with the collaboration of Evaluation Cell as per check list.

Case No.54.
The following registration application of M/s. Navegal Pharmaceuticals, Hattar were considered
in 225th meeting and approved on the ground that the firm develop new separate Psychotropic
Section. The registration letter was not issued.
1. Zocin 25 mg Tablets 10x10’s REs.2.50 Approved

Each tablet contains:- per tablet
Pentazocine HCl
≡ Pentazocine base.. 25 mg
(Benzomarphan derivative)
2. Fenotal 30mg Tablets 2x15’s Rs.2.70 Approved
Phenobarbital……. 30 mg
(Barbiturate)
3. Buprex 0.2mg Tablets 50’s Rs.0.68 Approved
Buprenorphine HCl
≡ Buprenorphine base0.2
mg
(Thebaine derivative)
4. Gytil 3 mg Tablets 3x10’s Rs.3.50 Approved
Bromazepam……3 mg
(Benzodiazepine)
5. Gytil 6mg Tablets 3x10’s Rs.7.50 Approved
Bromazepam……6 mg
(Benzodiazepine)
6. Xafil 0.25mg Tablets 3x10’s Rs.4.00 Approved
Alprazolam………0.25 mg
(Benzodiazepine)
7. Xafil 0.5mg Tablets 3x10’s Rs.10.00 Approved
Alprazolam……… 0.5 mg
(Benzodiazepine)
8. Xafil 1mg Tablets 3x10’s Rs.10.00 Approved
Alprazolam………1 mg
(Benzodiazepine)
9. Xolpi 10mg Tablets 2x10’s Rs.16.00 Approved
Zolpidem

Hemitartrate….10mg
(Imidazopyridine)
10. Dilamid 1mg Tablets 100’s Rs.1.70 Approved
Lormetazepam ………1mg
(Short Acting
Benzodiazepine)
Now the firm deposited the differential fee of Rs:12000/- each and complete the dossiers.
The dossiers have been evaluated with the collaboration of Evaluation Cell as per check list.
Registration-V
Case No.55: M/S. CCL Pharmaceuticals (Pvt.) Ltd, Lahore- Export Registrations.
M/s. CCL Pharmaceuticals (Pvt.) Ltd; Lahore has requested for registration of following
products for export purpose only:-
S. No Name of Products
1. Cef-OD Chewable Tablet 100mg
Each chewable tablet contains:-
Cefixime trihydrate equivalent to
Cefixime ……………………….. 100mg
2. Bicarb Capsule 600mg
Sodium Bicarbonate ………………… 600mg
The above mentioned products are not available locally. However, product at Sr. No. 1 is
FDA approved and product at Sr. 2 is available in Sri-Lanka. The firm has submitted the
following documents:-
a. Fee of Rs. 20000/- for this purpose.
b. Form-5.
c. Under taking stamp paper.
d. Copy of GMP inspection.
e. CRF clearance certificate.
f. Export orders.

Decision: Registration Board approved the products with following conditions:
 Manufacturer will export the product after complying all the conditions as required
under Drug Act, 1976 including No objection certificate from concerned DRAP
office. Moreover, Federal Inspector of drugs will take sample from each
consignemnet for analysis from CDL, Karachi.
 Manufacturer will also furnish export documents endorsed from custom authorities
in order to ensure the export of the product.
Case No. 56: M/s. Wilshire Labs Lahore - Case deferred for expert opinion
Registration Board in its 237th deferred the following registration application of M/s.
Wilshire Laboratories, Lahore for expert opinion by Brig.(R).Prof. Dr. Muzammil Hasan Najmi,
member Registration Board and submission of differential fee. Initially the case was deferred for
expert opinion and two experts have already been given their opinions as follows. Now
Brig.(R).Prof. Dr. Muzammil Hasan Najmi has also give expert opinion:-
Name of Product Pack Size. MRP
Tripoli 400 mg & 800 mg 10’s 15% less
Each tablet contains:- 100’s brand leader
Metaxalone….400 mg & 800 mg 500’s
S. No. Name of Expert Opinion

1. Prof. Dr. The mode of action of this drug has not been clearly identified,
absolute bioavailability is not known. Impact of age, gender,
Mohammad Hanif
hepatic and renal disease on the pharmacokinetics, carcinogenic
Head Deptt. of potential, safety in pregnancy, safety and effectiveness in
children under age of 12 has not determined. Leucopenia and
Medicine,
haemolytic anemia are among the side effects. The drug is not
Rawalpindi cost-effective.
“Tripoli tablets cannot be recommended for registration for the
Medical College,
adjunctive treatment of acute, painful, musculo-skeletal
Rwp. conditions”
2. Dr. Mughees “I have personal experience of writing this medication as this is
an FDA approved medication and is available in the United State
Sherani, Agha
by the name of “Skelaxin”. Before moving to Pakistan in 2002, I
khan Hospital was practicing in Midland Texas, USA and use to prescribe this
medication”.
Karachi
“It is used as an adjunctive treatment of acute, painful
musculoskeletal conditions and provides earlier relief.”
“It major side effects include drowsiness. It should be given with
caution in older patients and in patients with chronic disease,

especially in liver and kidney diseases.”
“I think this medication can be approved as this has long track
record without major complications or problems.”
3. Brig.(R).Prof. Dr. “Metaxalone is a skeletal muscle relaxant used in treatment of
painful muscle spasm/sprains. The exact mechanism of action of
Muzammil Hasan
the drug is not known but it produce generalized CNS
Najmi depression, which is also responsible for its side effects. It has
significant interactions with other centrally acting drugs like
benzodiazepines and antidepressants. It is considered to be
unsafe in elderly. Safety in pregnancy and location has bot been
determined. The drug is available in USA.
Metaxalone may be registered as a prescription drug to be
marketed with precautions as outlined above”.
The firm has also deposited remaining fee of Rs. 35,000/- for this purpose.
Decision: Registration Board discussed and agreed to above expert opinions.

However, the Board advised firm to provide data for stability studies conducted under zone
Case No.57 : M/s. Highnoon Labs, Lahore- Case deferred for submission of clinical data
The Registration Board in its 245th meeting deferred the following product of M/s.
Highnoon Labs; Lahore for submission of safety and efficacy data of the drugs along with
complete clinical trial data of these formulations:-
Sr.No. Product Name with Pack size Demanded Date of Remarks

composition price submission
and fee
1. Ebernet 1% Cream 10gm Rs.320.00 21-06-2011 Not available
Each gram contains:- Rs. 8000/- in FDA,
Eberconazole (as 27-06-2011 EMA,
nitrate)….10mg Rs. 7000/- Australia and
(anti fungal) 10-7-2013 Japan.
135000/-
(Total: Rs.
150000/-)
Form-5D

In compliance to the decision of registration board, M/s. Highnoon Labs; Lahore has
submitted clinical trial data of the above mentioned product.
Decision: Board deferred above products for expert opinion of following experts on
submitted clinical studies data:
 Dr.Fareed ur Rehman, FFH, Rawalpindi.
 Dr.Afaq, PIMS, Islamabad.
 Mr.Abdul Lateef Shaikh, AKUH
Case No.58 : Permission for Contract Manufacturing due to renovation.

M/s. Highnoon Laboratories Ltd; Lahore has applied for contract manufacturing of their
following products on toll manufacturing basis through M/s. Titlis Pharma, Lahore. Due to
continuous improvement and capacity enhancement program of their manufacturing plant, they
have planned for renovation/up gradation of their granulation-I area while granulation-II area
will remain operational. Therefore they have applied for contract manufacturing of the products
manufactured in granulation-I to avoid shortage of these products:-
S. No. Name of Drug(s) Reg. No.
1. Cyrocin Tablet 250mg 011406
Ciprofloxacin
2. Cyrocin Tablet 500mg 011407
Ciprofloxacin
3. Hilin Capsule 100mg 048917
Pregabalin
Pregabalin
Pregabalin
Pregabalin
7. Oxaquin Tablet 400mg 043660
Moxifloxacin
8. Aria Tablet 1mg 014742
Ketotfen (Fumarate)
9. Inhibitol Capsule 30mg 020613
Lansoprazole (pellets)
10. Neupentin Capsule 100mg 035763
Gabapentin
11. Neupentin Capsule 300mg 035764
Gabapentin

12. Voxiquin Tablet 250mg 038991
13. Voxiquin Tablet 500mg 038992
14. Senegy-OD Tablet 10mg 017672
Loratidine
They have deposited fee of Rs. 50,000/- for each product and have furnished application
dossiers along with toll agreement.
It is submitted that in total there are 83 registered in tablet and capsule sections, however
firm has applied for 14 products only i.e. for products of granulation-I area. Orders are solicited,
whether such cases can be processed as per new toll policy.
Decision: Registration Board deferred the case and advised firm to provide complete
renovation plan with time frame for consideration of the Board. Form-5 will be checked as
per check list approved by Registration Board.
Case No. 59: M/s. Phamrawise Labs (pvt.) Ltd; Lahore - Transfer of registration due to
change of name of the firm without change in manufacturing site.
The name of M/s. Fakma Pharma, Lahore was changed from M/s. Fakma Pharma, Lahore
to M/s. Pharmawise Labs (Pvt.) Ltd; Lahore in 2000 on their request. The firm had requested that
either to change all letters regarding registrations with new name or issue a letter to reflect the
said change in each of the registration letter. However, they had not deposited any fee for this
purpose. The case was presented in Board meeting No. 164th on 30-07-2001 and the Registration
Board had decided as under:-
“The request of the firm was not acceded to and the firm was directed to deposit the
requisite fee of Rs. 8000/- for each product for transfer of registration in the new name”.
It is submitted that as per practice in vogue, in case a company changes their name / title apply
for transfer of registration from previous name to new name with full registration fee. However,
the owner of the firm has the view that there is no provision in law for transfer of registration on
same premises.

The case was also referred to Law Division for comments. Law Division in their reply
referred to the case of change of name of M/s. Breeze Pharma, Islamabad to M/s. ICI, Pakistan
Ltd; due to change in management. The issue was as to whether M/s. ICI Pakistan Ltd; require a
fresh license for manufacturing of drugs on leased premises or license of M/s. Breeze Pharma,
Islamabad would be a valid one for manufacturing of drugs.
In this regard, Law Division was of the opinion that license issued by competent
authority was issued to drug manufacturing facility/plant/premises and inspection was done for
drug manufacturing facility, plants, its premises and also of the qualifications of the management
under rule 15, 16 of Drug (Licensing Registering & Advertising) Rules 1976. It would therefore,
be wrong to state that license was issued to the premises and not the management. Law Division
has further referred to Section 196 of the Companies ordinance 1984 which states that business
of a company is run and managed by the Directors of a company. Therefore, lease agreement
between Breeze Pharma, & M/s. ICI amounts to transfer of license which is un-authorized under
the said rules.. It is also been suggested that referring Division (DRAP) shall suitable amend the
rules, so that such like complications due to silent position of rules can be averted in future.
Decision: Registration Board decided to seek opinion of Legal Affairs Division, DRAP in
the matter.
Case No. 60: M/s Servier Research & Pharmaceuticals (Pakistan) (Pvt.) Ltd; Lahore- Case
deferred for confirmation of registration in France
Registration Board in its 245th meeting deferred the following products of M/s. Servier
Research and Pharmaceuticals (Pakistan) Limited Lahore till confirmation of registration status
of Nartrilam 5 and 10 mg tablets in France:-
S. Name of Drug(s) with Pack Demande Fee & form

No. formulation size d price
1 Natrilam 10mg Tablets 30‘s Rs.72.52/ 20-6-2012
Each tablet contains:- Tablet Rs.8000/-
Indapamide SR…..1.5mg 30-04-13
AmlodapineBesilate…..10mg Rs. 130,000/-
(Antihypertensive diuretic + Total Fee Rs. 150,000/-
Calcium antagonist) Form 5-D

2 Natrilam 5 mg Tablets 30‘s Rs.36.26/ 05-04-2011 Rs.8000/-
Each tablet contains:- Tablet 30-04-13
Indapamide SR…..1.5mg Rs. 130,000/-
Amlodapineas Total Fee Rs. 150,000/-
Besilate…..5mg Form 5-D
(Antihypertensive diuretic +
Calcium antagonist)
The management of the firm has provided legalized free certificate of the products in
France and have requested to grant them registration of above mentioned products.
Decision: Board decided to defer the product for expert opinion of following experts on
clinical studies data:
 Brig(R). Dr. Muzamil H. Najmi, Member Registration Board
 Dr. Shahid Nawaz, PIMS, Islamabad.
 Brig. Dr. Sohail Aziz, AFIC, Rawalpindi.
Case No. 61: M/s. English Pharma, Lahore- Case Deffred For Expert Opinion
Registration Board in its 243rd meeting deferred the following product of M/s. English
Pharma, Lahore for expert opinion of Prof. Dr. Ghias Butt; Prof. Mumtaz Ahmad, Benazir
Bhutto hospital and Prof. Muzamil Tahir, Sh Zayed Hospital, Lahore:-
S. No. Name of Drug(s)

1. Ucholin 10mg Tablet
Bethanechol Chloride equivalent to Bethanechol ……………. 10mg
Two experts have provided their opinion as under:-
Name of expert Comments

Prof. Ghias-ud-Din Butt, Bethanechol chloride is indicated for the treatment of acute
PIMS, Islamabad postoperative and postpartum non obstructive (functional) urinary
retention and for neurogesic atony of the urinary bladder with
retention. It works by helping the bladder muscle to squeeze better,
thereby improving your ability to urinate.
Because of the selective action of bethanechol, nicotinic symptoms of
cholinergic stimulation are usually absent or minimal when orally or
subcutaneously administered in therapecutic doses, while muscarinic
effects are prominent.
Special care is required if this drug is given to patients receiving

ganglion blocking compounds because a critical fall in blood pressure
may occur. Usually, severe abdominal symptoms appear before there is
such a fall in the blood pressure. Safety and effectiveness in pediatric
patients have not been established.
Price is a matter of regulator authorities but considering the
effectiveness of Molecule or patients Bethanechol HCl availability
in Pakistan must be assured at affordable price. The maximum
price should not exceed Rs. 30 for 10mg tablet.
Prof. Dr. Mumtaz Ahmad This medicine is used to treat certain bladder problems such as the
Benazir Bhutto Shaheed inability to urinate or empty the bladder completely due to certain
Hospital, Rawalpindi causes (e.g surgery, bladder muscle problems). It works by helping the
bladder muscle to squeeze better, thereby improving your ability to
urinate.
Synthetic choline ester with effects similar to those of acetylcholine
(ADh). Acts directly on postsynaptic receptor, and since it is not
hydrolyzed by cholinesterase, its actions are more prolonged than those
of Ach.
Dosage must be individualized, depending on the type and severity of
the condition to be treated. Preferably gives the drug when the stomach
is empty. If taken soon after eating, nausea and vomiting may occur.
Due to non availability of local brand price is at a high and
different prices are charged by patients in different areas. I
therefore recommended the immediate allocation of local
manufacturing of the drug so that the patients can also benefit from it.
There also have been incidents reported for high rates and over
charging of drug due the smuggled version of the drug.
Decision: Registration Board discussed and agreed to above expert opinions.

However, the Board advised firm to provide data for stability studies conducted under zone
Case No. 62: Case deferred for confirmation of storage facilities
Registration Board in its 245th meeting deferred the following product of M/s. Rasco
Pharma, Lahore for further deliberation on storage condition of the Misoprostol API. Chairman,
Registration Board advised members and stakeholders to forward their scientific comments on
storage condition of the Misoprostol API for consideration of Registration Board:-

Name of Drug(s) Form & demanded MRP. Competitor & specification
Aerotec-75 Tablet 1. Form 5 Arthrotec (Pfizer)
(Inner core is enteric coated with outer 2. Fast Track Manufacturers‘s Specs
core as immediate release) 3. As per SRO/blister of 2×10
Each tablet contains:- tablets
Diclofenac Sodium ….. 75mg 4. 29.06.2011/Rs.8000
Misoprostol …….. 200mcg 5.21.05.2013/Rs.52000/4237
NSAID + mucosal protective
The firm has now provided assessment report (EMA) of misoprostol API which is reproduced as
under:-
Misoprostol, as described in the Ph.Eur., is an only liquid which is very unstable and
difficult to be process into a drug product in liquid form. The stability of misoprostol is
significantly enhanced when it is dispersed in hypromellose. Hence, misoprostol dispersed in
hypromellose is used as an intermediate in the manufacture of misoprostol tablet. The
dispersion consists of a powder that can be stored at 5+3 °C, whereas the actual active
substance is an oily liquid that needs to be stored at -20 °C.
The certificate of analysis of the misoprostol API of the firm shows that the product is
Misoprostol 1% HMPC dispersion (White to off-white powder) and it is to be stored at 2-8 °C.
The panel of inspectors has already been recommended the storage facility of the firm for above
mentioned product. They have requested to grant them registration of above mentioned products.
A panel of inspectors comprising DDG (E & M), Lahore & area FID inspected the firm on
18-06-2014 for verification of manufacturing and storage facilities for misoprostol raw material.
The panel had recommended as under:-
“the management had provided cold cabinet to maintain temperature range from 2 to 8 C° at the
time of inspection. The panel member physically inspected the cabinet and found that the
conditions for storage were maintained. The overall sanitation and hygienic in this area was
satisfactory. SOPs for handling the raw material during sampling and dispensing were
available. The panel was satisfied with storage and production facilities at the time of inspection
to manufacture the Aerotec-75 Tablet”.

Decision: Keeping in view discussion regarding requirement of storage facility for
Misoprostol and inspection report of the firm, the Board approved the product
(Misoprostol with 1% dispersion HPMC) and with change in brand name.
RRR Section
Case No. 63: Applications for Re-Registration of drugs
Following firms have applied for registration of drug as they failed to apply for renewal of
registration in time:-
M/s. Ambrosia Pharmaceuticals, Islamabad

S. Reg. Name of Drugs with Date of Renewal Application Documents
No. No. composition Initial Reg. Application Receiving Provided
Due Date Date for by the firm
Re-Reg.
1. 035357 Ambrocillin 250mg 18-12-2004 17-12-2009 17-10-2012 (i). Form-5
Tablets (ii). Initial
Each tablets contains:- Reg. Letter
Amoxicillin (as (iii). CRF
Trihydrate)…….250mg NOC
(iv). Fee
Rs.20,000/-
2. 035358 Ambrocillin 500mg -do- -do- -do- -do-
Tablets
Each tablets contains:-
Amoxicillin (as
Trihydrate)…….500mg
3. 041411 Micozole N Ointment 04-10-2005 03-10-2010 -do- -do-
Contains:-
Miconazole
Nitrate……………2%
4. 041412 Isozole Vag Cream -do- -do- -do- -do-
Contains:-
Isoconazole
Nitrate…………..1%
5. 041414 Sexatin N Cream -do- -do- -do- -do-
Each gm cream
contains:-

Bufexamac………50mg
Neomycin
Sulphate……….2500IU
Nystatin……100,000IU
6. 042917 Monorate Ointment -do- -do-
Contains:-
Mometasone
Furoate…….0.1% w/w
M/s. Woodward Pakistan (Private) LTD., Karachi.
Re-Reg.
1. 055717 Bactizith 500mg Capsule 07-04-2009 06-04-2014 24-06-2014 (i). Form-5
Each capsule contains:- (ii). Initial
Azithromycin (as Reg. Letter
Dihydrate)……..500mg (iii). Fee
(USP Specification) Rs.20,000/-
M/s. Macter International Limited, Karachi.
Re-Reg.
1. 000483 Genticyn HC Cream 06.9.2006 05.9.2011 24-11-2014 (i). Form-5
Each gm contains:- (ii). Initial
Gentamicin Sulphate Reg. Letter
Hydrocotisone Acetate (iii). CRF
NOC
(iv). Fee
Rs.20,000/-
2. 010186 Genticyn B Cream -do- -do- -do- -do-
Each gm contains:-
Gentamicin Sulphate
Betamethasone Valerate
3. 007701 Multigesic Cream -do- -do- -do- -do-
Each gm contains:-
Diethylamine Salicylate
4. 000497 Genticyn Cream -do- -do- -do- -do-
Each gm contains:-

Gentamicin Sulphate
Decision: Registration Board decided to defer the case till opinion of stake holders in the
matter as decided in Item No. IV(c).

Item No. VII Registration of Biological Drugs – Biological Evaluation & Research Division
Case No. 01. Expert Committee for Biological Drugs
The Drug Registration Board in its 241st Meeting decided to strength the expert
committees on biological drugs for the technical evaluation of biological drugs. The earlier
committee was not functional due to resignation of 01 member and absence of another member
due to tour abroad. The proposal of constitutions of new expert committees on biological drugs
was floated with draft notifications for separate expert committees for human and veterinary
biological drugs and were processed as per law with the approval of Federal Government.
However, the Law, Justice and Human Rights Divisions raised certain queries/ legal aspects
regarding composition of committees and role of secretariat officers in the committees, which
needed to be rectified before the notifications are finalized. The notifications were re-visited and
necessary amendments were made in consultation with the Law, Justice and Human Rights
Division. The process of official notification of expert committees is in final stages. However,
due to non functional ECBD, no fresh cases can be placed before the Registration Board.
However, miscellaneous cases of already registered biological drugs are placed before the Board
for its consideration in this meeting.
Decision: Registration Board noted the information.
Case No. 02. Change of manufacturing site for already registered drugs of M/s. R.G.
Pharmaceutica (Pvt), Ltd., Karachi.
M/s R.G. Pharmaceutica (Pvt) Ltd., Karachi has submitted the following
applications for change in manufacturing site of their already registered drugs;
S.# Product & Existing Manufacturing New Manufacturing Site

Registration No. site
1. Ferti-C 5000IU Livzon (Group) Livzon (Group) Pharmaceutical
Chorionic Pharmaceutical Zhohai, Factory.
gonadotrophin for Guangdong, China Address: No.38, Chuangye Road
Injection North, Liangang Industrial Zone,
(Reg. No070931) Zhuhai, Guangdong, China.
2. Ferti-C 1000IU Livzon (Group) Livzon (Group) Pharmaceutical
Chorionic Pharmaceutical Zhohai, Factory.
gonadotrophin for Guangdong, China Address: No.38, Chuangye Road

Injection North, Liangang Industrial Zone,
(Reg. No 070930) Zhuhai, Guangdong, China.
3. Ferti-M 150IU Livzon (Group) Livzon (Group) Pharmaceutical
Menotropin for Pharmaceutical Zhohai, Factory.
Injection Guangdong, China Address: No.38, Chuangye Road
(Reg. No 070929) North, Liangang Industrial Zone,
Zhuhai, Guangdong, China.
4. Ferti-M 75IU Livzon (Group) Livzon (Group) Pharmaceutical

Menotropin for Pharmaceutical, Factory.
Injection Zhohai, Guangdong, Address: No.38, Chuangye Road
(Reg. No 070928) China North, Liangang Industrial Zone,
Zhuhai, Guangdong, China.
As per SOP defined by the Drug Registration Board in its 240th Meeting, the firm has
provided following documents;
1. Application with required fee as per SRO (Rs.100, 000/- per product).
2. Copy of registration letter and last renewal status.
3. NOC for CRF clearance (Not required for Importer)
4. Original legalized CoPP, having address of new manufacturing site.
The source is from China, which falls under category, where the inspection abroad is mandatory.
Decision: Registration Board approved the request of the firm. Inspection of the foreign
manufacturer shall be conducted as per Import Policy. The Board authorized its Chairman
for issuance of letter for change in manufacturing site on the recommendation of inspection
report if it is of recommendation. If inspection report is of not recommendation, then case
will be placed before Registration Board.
Case No. 03. Request for change of importer and manufacturing site for already
registered drugs by m/s. Avior Pharmaceuticals (Pvt) Ltd., Karachi.
M/s. Avior Pharmaceuticals (Pvt) Ltd., Karachi has submitted applications for transfer of
products from M/s Global Pharmaceuticals (Pvt) Ltd. The firm has also informed that the
manufacturing site is also changed by the foreign principal. The details are as under: -
S.# Product & Existing New Manufacturing Site
Registration No. Manufacturing site
1. Tropin 2000iu Inj M/s Harbin M/s Harbin Pharmaceutical Group
Each vial contains: - Pharmaceutical Group Bioengineering Co., Ltd., No.99
Recombinant Human of Bioengineering Co. Zhuhai Road Limin Development
Erythropoietin Ltd., Harbin China Zone Hulan District, Harbin,

2000iu Heilongjiang Province, P.R. of
Reg No. 062218 China
2. Tropin 4000iu Inj M/s Harbin M/s Harbin Pharmaceutical Group
Erythropoietin Ltd. China Zone Hulan District, Harbin,
Reg No. 62219 China
Tropin 6000iu Inj M/s Harbin M/s Harbin Pharmaceutical Group
Erythropoietin Ltd. China Zone Hulan District, Harbin,
Reg No.066152 China
4. Auspogen 300ug per M/s Harbin M/s Harbin Pharmaceutical Group

vial Pharmaceutical Group Bioengineering Co., Ltd., No.99
G.CSF Ltd. China Zone Hulan District, Harbin,
Reg No. 062217 Heilongjiang Province, P.R. of
China
5. Refron 3 MIU Inj M/s Harbin M/s Harbin Pharmaceutical Group
Each vial contains Pharmaceutical Group Bioengineering Co., Ltd., No.99
Interferon Alpha 2b Ltd. China Zone Hulan District, Harbin,
3MIU Heilongjiang Province, P.R. of
Reg No. 047665 China
M/s Avior Pharmaceuticals (Pvt) Ltd, Karachi has provided following documents as per SOP
defined by the Drug Registration Board in its 240th Meeting;
i) Application on Form 5 A along with fee as defined under SRO (Rs.
100,000 per product).
ii) Copy of registration letters and last renewal status.
iii) NOC for CRF clearance (Not applicable to importers)
iv) Termination letter (Original) of previous importer M/s. Global
Pharmaceuticals (Pvt) Ltd
v) Authority letter/sole agent letter (original) from manufacturer in favour of
M/s Avior Pharmaceuticals (Pvt) Karachi.
vi) No objection letter from Global Pharmaceuticals in favor of M/s. Avior
Pharmaceuticals for transfer of Registration.
vii) Original and legalized CoPP of all above products.
viii) Site Master file.

Case No. 04. Change of manufacturing site for already registered drugs of M/s.
Pharmaevo (Pvt) Ltd, Karachi.
M/s. PharmaEvo (Pvt) Ltd., Karachi has submitted application for change of
manufacturing site of their already registered drugs. The details are as under: -
Product / Registration Previous Name of New Name of Manufacturing

No. Manufacturing Site site
EPOSINO 4000IU/ML Sandong Kexing Shandong Kexing Bioproducts
Each pre-filled syringe Bioproducts Co., Ltd., Co., Ltd. No.2666, Chuangye
contains: - China Road, Mingshui development
Recombinant Human Zone, Zhangqiu, Shandong,
Erythropoietin…4000IU China.
(Reg No. 045690)
EPOSINO 2000IU/ML Sandong Kexing Shandong Kexing Bioproducts
Each pre-filled syringe Bioproducts Co., Ltd., Co., Ltd. No.2666, Chuangye
contains: - China Road, Mingshui development
Recombinant Human Zone, Zhangqiu, Shandong,
Erythropoietin…2000IU China.
Erythropoietin
Reg No. (045689)
M/s PharmaEvo (Pvt) Ltd, Karachi has provided following documents to support their request as
per SOP decided by the DRB in its 240th Meeting:-
3. NOC for CRF clearance.
4. Original legalized CoPP for new manufacturing site.
5. Site Master file

Case No. 05. Change of manufacturing site for already registered drugs by M/s. Roche
Pakistan, Ltd, Karachi.
M/s. Roche Pakistan Ltd., Karachi has submitted application for change of manufacturing
site. The details are as under: -
Product / Registration Previous Name of New Name of Manufacturing

No. Manufacturing Site site
Avastin 100mg/4ml M/s F. Hoffmann- La M/s F. Hoffmann La-Roche Ltd.,
injection Roche Ltd., Basel, Wurmisweg 4303, Kaiseraugst,
Each ml contains: Switzerland Switzerland.
Bevacizumab 25mg
Reg No. 043004
Avastin 400mg/16ml M/s F. Hoffmann- La M/s F. Hoffmann La-Roche Ltd.,
injection Roche Ltd., Basel, Wurmisweg 4303, Kaiseraugst,
Each ml contains: Switzerland Switzerland.
Bevacizumab 25mg
Reg No. 043005
M/s Roche Pakistan Ltd, Karachi has provided following documents to support their claim:-
1. Application on Form 5-A with required fee as per SRO (Rs.50, 000/- per product).
4. Original CoPP provided for new manufacturing site, however the CoPP is not
notarized and legalized from Embassy of Pakistan
5. Site Master file
The drugs is used for Matastatic Carcinoma of the Colon are rectum breast cancer and other
types of cancers. The site falls under category of Stringent Regulatory Authorities. It is proposed
that the request of the firm may be approved with condition that change of site letter shall be
issued after submission of legalized CoPP through permission from Chairman Registration
Board.
Decision: Registration Board approved request of the firm. The firm will provide legalized
CoPP of the product and authorized its Chairman for issuance of letter in light of Import
Policy for Finished Drugs.

Case No. 06. Request for exemption of printing of registration and MRP on vial M/s.
Popular International (Pvt) Limited, Karachi
M/s Popular International (Pvt) Ltd., Karachi has submitted the following requests for
exemption of printing of Registration Number & MRP on inner vials as exemption for Urdu
Version granted to them vide letter No. F.1-19/95-Reg-I (Pt) dated 11th July, 2007. The firm has
informed that their principal print lot number, date of manufacturing and date of expiry on each
vial and outer box and finally print registration number on each box before shipment whereas
MRP is printed locally by us on outer box. However due to limited space on the inner vial the
principal cannot print registration and MRP. Further the company has informed that laser
printing may denature the products. The details of their request are as under: -
S.# Product Name Registration Generic Name

No.
1. KOATE – DVI 007965 Antihemophilic Factor –
VIII(Human)
2. HyperRAB S/D 007972 Rabies Immune Globulin
(Human)
3. HyperHEP B S/D 012835 & Hepatitis B Immune Globulin
007971 (Human)
4. PLASBUMIN 007967 Albumin (human)
UMAN 059249
ALBUMIN
5. IMMUNORHO 059296 Rho (D) Immune Globulin
059297 (Human)
6. GAMMARAAS 031350 Intravenous Immune Globulin
(Human)
Decision: Registration Board decided to call firm,s representative in its forthcoming

meeting for presentation of their case along with labeling/ printing status/ evidence of
similar products available in the market.

Case No. 07 Request for additional pack size by M/s. Snam Pharma, Lahore
M/s Snam Pharma, Lahore has requested to approve additional pack against their
already registered products. The firm has deposited an amount of Rs.5,000/- as prescribed fee for
each product. The detail is as under with justification: -
S.# Product Name Regn Existing Additional Justification

No. pack size Pack
1. Biocan R Injection ad 057167 10x5ml. (1m1)x20 The single dose of Biocan R
us vet 5x20ml single dose is necessary as it will be
used in single dog
vaccination, and it is
demanded by the market.
2. Ornipet lyof.ad.us.vet 059171 200doses. 5000 x 10 Large dose pack size in

500 doses. doses poultry is convenient in the
1000 doses. large poultry formers and
2500 doses. dose of 5000 bird packing is
10x200 doses demanded by the market.
10x500 doses
10x1000
doses
10x2500
doses
3. Ornibron 057169 10x200 doses 5000 x 10 Large dose pack size in
lyof.ad.us.vet 10x500 doses doses poultry is convenient in the
10x100 doses large poultry formers and
10x2500 dose of 5000 bird packing is
doses demanded by the market.
4. Orniprim 057170 10x200 doses 5000 x 10 Large dose pack size in
lyof.ad.us.vet 10x500 doses doses poultry is convenient in the
10x100 doses large poultry farmers and
10x2500 dose of 5000 bird packing is
doses demanded by the market.
5. Ornibur intermediate 059172 500 doses 2500 x 10 Large dose pack size in
lyof.ad.us.vet 1000 doses doses. poultry is convenient in the
1000 doses large poultry farmers and
2000 doses dose of 2500 bird packing is
5000 doses demanded by the market.
10x500 doses
10x1000
doses
10x2000

doses
10x5000
doses
Decision: Registration Board deferred the request and advised the firm to provide legalized
CoPP of the product for confirmation of availability of applied packs.
Case No. 08 Request for additional pack size by M/s Marush (Pvt) Ltd, Lahore
M/s Marush (Pvt) Ltd, Lahore with the request to approve additional pack against
their already registered products. The firm has deposited an amount of Rs.5,000/- prescribed fee.
The detail is as under with justification: -
S.# Product Name Regn Existing Additional Pack Justification

No. pack size
1. CEVAC 039910 1000 doses. 2000 vial More recently market trends
TRANSMUNE 4000 vial and demand of formers have
IBD VACCINE 8000 vial changed due to initiation of
multiple large sized
commercial farms and
integrated units which,
demands medium and
bigger packs keeping in
view their convenience and
economy in usage.
To demonstrate the benefits
for users regarding
introduction of additional
packs a detailed study as per
DRA’s format.
Decision: Registration Board deferred the request and advised the firm to provide legalized
CoPP of the product for confirmation of availability of applied packs.

Case No. 09 Withdrawal of applications for registration of finished drugs by M/s. Sami
Pharmaceuticals, Karachi.
M/s Sami Pharmaceuticals (Pvt) Ltd, Karachi has requested for surrender of
applications for registration of finished drugs to be imported from M/s Xiamen Amoytop Biotech
Co. Ltd, Xiamen, Fujian, P.R. China. These drugs were considered favourable in meeting No. M-
225 dated 15.05.2010 and registration for the same were to be granted after satisfactory
inspection of the manufacturer’s facility abroad which could not be done till to date. However,
the firm was voluntarily withdrawn these long outstanding applications and will have no
objection if registrations for the same are granted either to M/s Xiamen Amoytop Biotech Co.
Ltd and/or to any other party so authorized by them. The details of withdrawn applications are
as under: -
Sl.# Name of company Drug name with MRP Shelf life Remarks
composition
1. M/s Sami Relkin 1.5mg Injection As per latest 24 months Approved
Pharmaceutical(Pvt) Each vial contains: - decision
Ltd, Karachi./M/s Oprelvekin Recombinant taken by
Xiamen Amoytop Human Interleukin-11 PAC
Biotech Co., Ltd., (rHulL-11)…..1.5mg
Xiamen, Fujian, (Immunostimulants)
P.R. China
2. M/s Sami Relkin 3mg Injection As per latest 24 months Approved
Pharmaceutical(Pvt) Each vial contains: - decision
Ltd, Karachi./M/s Oprelvekin Recombinant taken by
Xiamen Amoytop Human Interleukin-11 PAC
Biotech Co., Ltd., (rHulL-11)…..3mg
Xiamen, Fujian, (immunostimulants)
P.R. China
Decision: The request of the firm was acceded to and the Board rejected the above
registration applications.

Case No. 10 Grant of registration of solution for injection - M/s. Macter International
Limited, Karachi
M/s. Macter International Limited, Karachi has requested for registration of
solution for injection for local manufacturing. The firm has deposited an amount of Rs. 50,000/-.
The composition detail is as under: -
Name of Company Raw Material Quantity/0.6Ml

M/s Macter International Sodium Chloride 3mg
Limited, Karachi Glycine 0.225mg
Polysorbate 80 0.06mg
Water for Injection Qs to 0.6mL
The solvent is required to be co-packed with the product free of cost. The case of manufacturing
of locally manufactured biological product was decided in the 244th Meeting of the Drug
Registration Board including lyophilized pegylated interferon products of the company which is
under implementation process.
Request of the company for grant of registration of solvent is submitted for the approval of
Registration Board.
Decision: The request of the firm for grant of registration of solvent was approved.
Case No. 11. Change of manufacturing site for already registered drugs by M/s. Hospital
Services & Sales, Karachi and change of brand name.
M/s Hospital Services & Sales, Karachi has submitted the applications for change of
manufacture site and brand name of their already registered vaccine for below mentioned
product;
Sl.No. Reg. Previous Brand Proposed Brand Existing New proposed

No. Name and Name Manufacturing manufacturing
composition. Site site
1. 053813 EASYFIVE – EASYFIVE – TT M/s. Panacea M/s. Panacea
Pentavalent Pentavalent Vaccine Biotech Ltd., Biotech Limited,
Vaccine Each dose 0.5ml New Delhi, Malpur, Baddi,
Each dose 0.5ml contains: - India. Distt. Solan
contains: - Diphtheria Toxoid: (H.P.) 173 205,
Diphtheria 20Lf (30IU) Inda.
Toxoid: 20Lf Tetanus Toxoid:
(30IU) 7.5Lf(40IU in guinea
Tetanus Toxoid: pig and 60 IU in

7.5Lf(40IU in mice)
guinea pig and Pertussis Vaccine:
60 IU in mice) 12OU (4IU)
Pertussis r-Hepatitis B surface
Vaccine: 12OU antigen (HBsAg):
(4IU) 10mcg
r-Hepatitis B Haemophilus type b
surface antigen conjugate vaccine:
(HBsAg): 10mcg.
10mcg
Haemophilus
type b conjugate
vaccine: 10mcg.
M/s Hospital Services & Sales, Karachi has provided following documents to support their
request:-
1. Application on Form 5-A with required fee as per SRO (Rs.100, 000/- per
product).
4. Original CoPP provided for new manufacturing site.
5. Site Master file
6. The firm has also provided evidence of WHO prequalification of EASYFIVE –
TT vaccine.
Decision: Request of the firm for grant of registration of solvent exclusively to be used with
EASYFIVE – Pentavalent Vaccine, Regn No. 053813 was approved.
Case No. 12. Case of import of interferon from Cuba instead of China by M/s. Macter
International (Pvt) Ltd., Karachi.
The case was discussed in the 244th Meeting of Drug Registration Board. The decision of the
case was as below:
Decision: Registration Board discussed the matter in detail and advised

investigation officer to further clarify following points:
a) On which documents the firm obtained clearance of Heberon Alfa R-2-
b Registration No.047675 from DRAP, Karachi along with dates of
invoice, airway bill/BL, LC date and other relevant information.
b) After grant of approval of change of source, what is legal status of
renewal application submitted by the firm from previous source?

c) What is the status of recall of stocks, the legal course of
holding/restricting the stocks from sale was followed or otherwise,
after “not to dispose of order” on Form-1 dated 28.10.2013?
The decision of the Board was communicated to DDG (E&M) with request to clarify the points
raised by the Drug Registration Board. In response to Directorate of Biological’s letter dated 5th
November, 2014. The Deputy Director General (E&M), DRAP, Karachi has stated that.
a) The documents on which the firm obtained clearance of Heberon Alpha R 2-b,
Registration No. 047675 from DRAP, Karachi are follows: -
i. Attested invoices.
ii. Copy of Airway bill/Bill of lading.
iii. Copy of L.C. dated 23.05.2013 as swift of M/s. Meezan Bank, Karachi
Pakistan.
b) The lyophilized source from Cuba; Product name: Heberon Alpha 3MIU injection
(interferon Alpha 2b3 MIU) Registration No. 022820 vide letter No.F. 3-6/98-Reg-II
(M-137).
2. The liquid source from china product name: Heberon Alpha 3 MIU (Interferon R 2-b
3MIU) Registration No. 047675 vide letter No.F.3-1/2008-Reg-I (M-212).
3. The legal status with justification as I understand is the change of dosage form for
another Registration No.047675 which becomes legal as source was changed only for
Registration No. 047675 of the same product. The first source relates to the Heberon Alpha
3MIU (Interferon R 2-b 3MIU) (Registration No. 022820) but the change of source from Cuba to
China is for Heberon Alpha 3MIU (Inteferon R 2-b 3MIU) (Registration No. 047675) in liquid
form. T he former dosage form was lyophilized. Hence, it is concluded that M/s. Changchun
Heber Biological Technology Co. Ltd., China is the sister concern of M/s. Heber Biotech S.A.
La Havana, Cuba the basic approved site and the product release authority of both the sources
Cuba and China is same. Hence, there is no product Safety, Quality, Efficacy and Economic
value related issued found. As the lot was released by NCLB, Islamabad also the importer (M/s.
Macter International Pvt. Ltd.) applied for the renewal of the said product on form 5-B of the
rule 26 of the Drug renewal for registration on 18.07.2013 and also deposited the required fee
under SRO 1117(I)/2012 which is pending with RRR section, DRAP. Therefore there is no harm
to allow them to market the aforesaid lot in favour of the importer in public interest so required
as protected under rule 27 of the Drugs (Licensing, Registering & Advertising) Rules, 1976
(copies of both the application for registration renewal are enclosed.

As far as the grant of approval of change of source is also valid under rule 26 of
the Drugs renewal for registration dosage form of which is physically different as described
above. On the other hand, the legal status of renewal application submitted by the firm from
previous source is also legal as there is no legal embargo if the previous source is rejuvenated by
the applicant that is valid under SRO 145(I)/1976 if pending with the board concerned and
1117(i)/2012.
(i) The status of recall of stocks is laying hold in the cold storage area of the
importer.
(ii) The legal course of holding/restriction of the stocks were followed by the
firm. Through, they are now not bound to sell after the expiration of the
period of the order on Form-I dated 28.10.2013 which is only for the
period of 14 days by the undersigned.
Conclusion:
After having sufficient documents evidences for both the sources of same product, having
different registration for different sources and renewal also pending though applied well in time
under rules, suffice the need of legal protection to import from the either source being the
custodian of two registrations originally and subsequently renewed as per law enacted under
condition of registration under Drug Act 1976.
The intention of the importer depicts that the change of source of one registration from Cuba to
China is positive for the adequate / free availability of life saving drugs in public interest.
Concluding all pros and corns of this investigation the contention and intention of the importer
was found positive professional approach and no evidence was found to contravene the Drugs
Act 1976 and rules prevails thereunder.
Hence the DDG (E&M) has recommended to allow the importer M/s Macter International (Pvt)
LTd, to make this life saving drug available and restriction as imposed after lot release may also
be withdrawn.
Decision: Registration Board discussed that the firm has violated the Drug Act, 1976
and rules framed there under and decided to issue show cause notice to the company, as
why not the consignment be re-exported or legal action be taken as per procedure, after
giving opportunity of personal hearing to the firm in the next meeting.

Case No. 13. Import of Insulatard Penfill Syringe from the previous source by M/s N o v o
Nordisk Pharma (Pvt), Clifton Karachi.
The case of the firm was discussed in 244th Meeting of Drug Registration Board. The
case details are as below: -
M/s Novo Nardisk has applied for the change of source of their registered product
namely Insulatard Penfill 100iu/ml 5x3ml (Registration No.010341). The decision of the
Registration Board in its 242nd meeting is as follows: -
S.No. Product & API Existing Proposed
Regn.No. Manufacture secondary secondary
Site packaged packaged
import site import site
1 Insulatard Novo Novo Nordisk Novo Nordisk
Penfill ® Nordisk A/S A/S Production S.A.S.
100 IU/ml 5x3 Novo Alle Novo Alle 5 bis, rue Edmond
ml DK-2880 DK-2880 Poillot
(R.No. 010341) Bagsvaerd Bagsvaerd 28000 Chartres
Denmark Denmark France
Past Decision: The Board approved the new EMA approved site mentioned above for import
of the above mentioned products subject to COPP from new site.
Accordingly the change of source letter was issued to the firm on 7th April, 2014 clearly
mentioning that the previous source of import stands cancelled. The Assistant Drugs Controller,
Karachi has informed that M/s Novo Nordisk, Karachi has imported Insulatard Penfil 100IU/M
(Reg NO. 010341) from Denmark on 20th May, 2014 which is the earlier source of import. The
ADC, Karachi was requested to submit complete case along with his recommendations. The
ADC Karachi has stated that he is of the opinion to revoke the orders of sales restrictions as the
safety, quality and economic value of drug in question. The officer has also stated that sale of the
drug may be allowed in the public interest so required.
It is submitted that the source of import was cancelled by the Drug Registration Board vide letter
No. 2-1/2014-DDC (BD)(M-242), dated 7th April, 2014. Under section 23 subsection 1(a) (vii)
“no person shall himself or by any other person on his behalf export, import or manufacture for
sale or sell any drug which is not registered or is not in accordance with the conditions of
registration”. The firm has violated the Drugs Act, 1976.

The case of the firm was decided as under: -
“DECISION: Registration Board approved request of the firm. However the
Board advised firm to provide/submit copy of L/C (original or duly certified) for
establishing the fact that the import order was placed well before the date of
grant of change of manufacture site by DRAP and authorized its Chairman for
permission to issue the letter for sale of drug”.
The firm was asked to provide the documents as per decision of the Drug Registration Board,
however, the company has provided following documents: -
i) Signed distribution Agreement between Novo Nordisk A/S Novo Alle

2880 Bagsveard Denmark and Novo Nordisk Pharma (Pvt) Ltd, 113,
Shahrah-e-Iran, Mian Clifton Karachi by indicating that in place of L/C
the term of payment is 360 days from the date of invoice, which is also
mentioned on custom invoice.
ii) Customs Invoice.
The firm informed that they have not established L/C as per their own system. The case was
submitted to the Chairman Registration Board for decision. The Chairman has desired to place
the case before the Drug Registration Board for decision.
Decision: Registration Board discussed that the firm has violated the Drug Act, 1976
and rules framed there under and decided to issue show cause notice to the company for
not providing the copy of L/C with opportunity of personal hearing, as per procedure of
Drug Registration Board.
Case No. 14. Deferred case of 241st meeting for Poulvac ® SE Vaccine by M/s. Hi-tech
Pharmaceutical, Lahore.
The following case of M/s. Hi-Tech Pharmaceutical, Lahore was deferred in 241st Meeting of Drug
Registration Board reasons mentioned in the last column below: -
Sl.# Applicant Name and Specs ECBD Committee Decision

Recommendation
6. M/s Hi-Tech Poulvac ® SE Recomme More data is Deferred
Pharmaceutical, Vaccine nded required for
Lahore Each 0.5ml dose clarification
Manufactured contains: - from the
by: Salmonella enteritidis application
M/s Pfizer Phase Type regarding

Animal Health 4….RP…> 1.0/dose at use of
(Pfizer Inc), release. formalin
2000 Rockford Salmoella enteritidis concentrati
Road, Charles Phase Type on and
City, Iova, USA 8…RP….>1.0/dose at review by
release. already
Salmonella enteritidis constituted
Phase Type committee
13a…RP…> 1.0/dose and
at release 37% veterinary
Formaldehyde. expert of
Solution…..0.0006ml ECBD.
White oil….0.1995ml
Arlacel-83…0.1105ml
Tween-
80…0.001105ml
Saline….q.s to 0.3ml
(For Veterinary Use)
The firm has submitted application to Animal Husbandry Commissioner Dr. Qurban Ali and
submitted clarification to Director Biological Drugs, DRAP, Islamabad. Clarification submitted to
DRAP and comments of Animal Husbandry Commissioner are tabulated below: -
Clarification submitted by the firm to DRAP Comments of Animal Husbandry

Commissioner
 For inactivation, formalin is added to the “Formalin is used to produce inactive bacter
total volume of the bacterial suspension, vaccines. For this purpose, 37% formalindehy
not over 1% gas is added to water to produce reage
 Source of formalin brand used holds 37% commonly known as formaline, which is th
formaldehyde solution, of this 37% used in a very small concentration (as is used
branded formaldehyde stock solution, the subject product “Poulvac SE” at the rate
maximum upto 1% of formalin is used in 1% to the total volume of bacterial suspension
total volume of the bacterial suspension. Therefore, 37% formaldehyde solution
 Dose of Poulvac SE is 0.3mL/bird and formalin at the rate of 1% is part of norm
each dose contains 0.0006mL i.e. 0.2% of procedure to produce such inactivated vaccines”
37% formaldehyde solution.
Decision: Registration Board referred the case to Expert Committee on Biological Drugs
(Vet) for its consideration.

Case No. 15. Change of manufacturing site for already registered drugs of M/s. Pfizer
Pakistan, Karachi.
M/s Pfizer Pakistan, Karachi had submitted the following application along with
prescribed Fee Rs. 50,000/- for the product as well as CoPP from new manufacturing site. The
details are as under: -
S.# Product & Existing New Manufacturing

Registration No. Manufacturing site Site
1. Prevenar 13 Baxter Pharmaceutical Pfizer Ireland
Suspension for Solutions LLC 927 Pharmaceuticals
injection South City Curry Pike, Grange Castle
(Reg # 066110) Bloomington IN, USA Business Park,
Clondalkin, Dublin 22
Ireland.
M/s Pfizer Pakistan Ltd, Karachi has provided following documents to support their claim:-
1. Application with required fee as per SRO (Rs.50, 000/- per product) being the
innovative.
5. GMP of manufacturing site.
6. Site Master file
Decision: The request of the company was acceded by the Board as per CoPP issued by the
EMA.
Case No. 16
M/s Novo Nordisk, Karachi had requested for registration of Histidine solvent in
Prefilled Syringe for already registered drugs NovoSeven 50KIU (1mg) Powder for solution for
Injection (Reg No. 066157) each vial contains: Eptacog alfa (activated)1mg and NovoSeven
100KIU (2mg) Powder for Solution for Injection (Reg No. 66158) alongwith Hisitidine 2ml each
vial contains Eptacog alfa (Activated) 2mg. The firm has deposited an amount of Rs. 50,000/- for
each product. The composition detail is as under: -
Name of Company Raw Material Quantity/0.6mL

Novo Nordisk, Karachi Powder and solvent 01mg/vial

for solution for (50KIU/vial)
injection
Novo Nordisk, Karachi Powder and solvent 02mg/vial
for injection for (1000KIU/vial
injection
Decision: Registration Board deferred the case for confirmation of status of solvent in
CoPP.
Case No. 17. Extension in exemption for the biological drugs imported from M/s Ferring
Germany.
Atco Laboratories Limited, Karachi have submitted that they are importing
following Biological drugs from M/s Ferring Pharmaceutical, Germany since 1994 that are in the
process of shifting their manufacturing facility and it would not be possible for them during this
period to incorporate all requirements according to their local labeling rules on the packaging
material. As these products are rare/ already in the market and patient needs them, therefore, M/s
Atco Laboratories Limited, Karachi has requested for extension in exemption in Labeling and
Packing Rules for the Biological Imported Drugs for at least twenty months are more: -
Sl. # Reg. Name of Exemption requested Quantity

No. Drug(s)
1. 016110 Decapeptyl i) Generic Name not in bracket. 924 units.
0.1mg injection ii) Drug registration number to be printed
locally.
iii) MRP to be printed locally.
iv) Urdu instruction to be printed locally.
v) Pharmaceutical specification.
vi)
2. 016111 Decapeptyl -do- 2638 units.
3.75mg
injection
3. 032143 Menogon -do- 6106 units.
Injection
4. 016153 Glypressin 1mg -do- 3438 units.
Injection

This case has been discussed in 243 Meeting of Drug Registration Board and deferred for
confirmation of pharmacological group. The firm has provided the pharmacological group as per
following details: -
Sl. # Product name Generic Name Pharmacological Group
1. Decapeptyl 0.1mg injection Triptorelin Acetate Eq. Triptorelin is synthetic form
to 95.6UG of Gonaderelin. Triptorelin
Triptorelin/ml causes an increase in the
amount of FSH and LH
release from the Pituitary
gland.
2. Decapeptyl 3.75mg injection Triptorelin Acetate Triptorelin is synthetic form
Corresponding to of Gonaderelin. Triptorelin
3.75mg/Single Dose causes an increase in the
amount of FSH and LH
release from the Pituitary
gland.
3. Menogon Injection Menotrophin 75IU Gonadotrophic Hormone
(used in infertility).
4. Glypressin 1mg Injection 1mg Terlipressin Terlinpressin is an analog of
Acetate Pentahydrate vasopressin used for Bleeding
In 11mg Dry Substance of esophageal varices, spactic
shock and hepato-renal
syndrome.
Decision: Registration Board acceded to the request of the firm for relaxation for the
Urdu version at the time of import for the products referred above subject to local printing
at the licensed premises of M/s. Atco Laboratories Ltd. Karachi for one year. The firm will
comply with all the rest of conditions as per rules for labeling, before importing to
Pakistan.
Case No. 18. Change of manufacturing name for already registered drug of M/s. Allmed
Laboratories, Karachi
M/s Allmed Laboratories, Karachi has submitted the following application for change of
name of manufacturer along with CoPP from new manufacturer as well as fee of Rs. 50,000. The
detail is as under: -
S.# Product & Existing name of New Manufacturer

Registration No. manufacturer name
1. ATG – Fresenius S M/s Fresenius Biotech M/s Neovii Biotech
Concentrate for GmbH Germany GmbH, AM Haag 6-7,
solution for 82166 Grafelfing

infusion. Germany,
Each ml contains:-
Rabbit
Immunoglobulin
20mg
(Reg No. 033134)
M/s Allmed Laboratories, Ltd, Karachi has provided following documents to support their
claim:-
Decision: The request of the firm was approved as per CoPP provided by the firm.
Case No. 19. Change of name of manufacturing site for already registered drug of M/s.
Wyeth Pakistan Limited, Karachi.
M/s Wyeth Pakistan Limited, Karachi has submitted the following application for change of
name of manufacture site for their already registered product along with copy of CoPP from new
manufacturer as well as fee of Rs. 100,000/-. The detail is as under: -
S.# Product & Existing name of New Manufacturer

Registration No. manufacturer name
1. Premarin 0.3mg M/s. Wyeth Medica Pfizer Ireland
tablet Conjugated Ireland Pharmaceuticals
Estropgens USP Little Connell New Little Connell New
(Desiccated with bridge Country Kildare, Bridge Country
Lactose at Ireland Kildare, Ireland.
4.29%)…0.3mg.
1. Application with required fee as per SRO (Rs.100,000/- per product).
4. Original legalized CoPP for new name of manufacturer.
5. GMP of manufacturing site.
6. Site Master file
Decision: The request of the company was approved as per CoPP.

Case No. 20. Extension in shelf life of Poliomyelitis Vaccine of M/s. Hospital Services &
Sales, Karachi.
M/s. Hospital Services & Sales, Karachi has submitted the following application for
extension in shelf life of already registered drug from 24 months to 36 months: -
Sl. Name of Drug with Registration No. Existing Shelf Life Demanded Shelf Life
No.
1. Poliomyelitis Vaccines Inactivated, 24 months (02 years) 36 months (03 years)
Suspension for Injection 0.5ml
vial/dose (IM/SC)
The firm has submitted for following documents: -
a. Application on Form 5A with required fee as per relevant SRO (Rs. 5000/-).
b. Copy of registration letter and last renewal status.
c. NOC for CRF clearance (not required in case of importer).
d. Justification for proposed change.
e. Approval of regulatory body of country of origin / Original and legalized
Certificate of Pharmaceutical Product as per WHO format indicating shelf life 36
months.
f. Free sale certificate and GMP certificate
g. Stability studies for product 2-80C.
h. The firm has also provided WHO prequalification evidence indicating the shelf
life from 24month to 36 month at 2-80C.
Usually extension of shelf life case is placed before the Drug Registration Board after
getting the experts opinion from different experts. However considering the polio emergency in
the country and WHO prequalified data of the said drug, the case is placed before the board for a
decision.
Decision: The request of the firm was approved. WHO status shall be checked from
WHO website before issuance of letter to the company. It shall also be mentioned in the
registration letter that incase of any change in WHO status, the company shall immediately
report to the Board and decision of the Board shall stand cancelled.

Case No. 21. Local manufacturing of Allergen vaccines by M/s. Pakcure Pharma, Rawat.
The case of manufacturing of Allergen vaccines by M/s. Pakcure Pharma, Rawat was
under consideration of Board. The following products were discussed in different meetings of the
Board.
Applicant Product specifications Registration No. of Decision

similar product
already in the
market as
manufactured by
NIH, Islamabad
M/s Pakcure Allergex-MP 016742 Deferred for
Pharma, Rawat, Product specific
Islamabad. Each ml contains: inspection by the
Beef protein extract…….10mcg panel.
Chicken protein extract. 10mcg
Egg protein
extract……...10mcg
Fish protein
extract……..10mcg
Mutton protein extract..10mcg
Shelf Life: 6 months when

stored at +2 to +8˚C
Allergy vaccine,
immunostimulant
M/s Pakcure Allergex-Px1 -do- Deferred for
Cannabis sativa protein extract
panel.
10mcg
Acacia niloticaa protein extract
10mcg
Eucalyptus globulus protein
extract 10mcg
Pininus longfolia protein
extract 10mcg
House dust extract 10mcg

Allergy vaccine,
immunostimulant

M/s Pakcure Allergex-Px2 -do- Deferred Product
Pharma, Rawat, specific inspection
Islamabad. Each ml contains: by the panel.
10mcg
10mcg
extract 10mcg
extract 10mcg
Mixed grass extract of Lolim
temulentum + Cynodon
dactylon …10mcg
House dust extract ..10mcg

Allergy vaccine,
immunostimulant
panel.
10mcg
10mcg
extract 10mcg
extract 10mcg
Paper mulberry extract…10mcg
Thrasher extract…10mcg
Raw cotton extract…10mcg

Allergy vaccine,
immunostimulant

panel.
10mcg
10mcg
extract 10mcg
extract 10mcg
Paper mulberry extract…10mcg
Thrasher extract…10mcg

Allergy vaccine,
immunostimulant
The product specific inspection of the company was conducted and presented before the board in
its 243rd Meeting wherein the deficiencies of the facility were discussed and the board decided as
under;
Past Decision: - The Board decided to defer the case till removal of deficiencies. Reference
may also be sent to the Licensing Board to ensure compliance as per requirement of Biological
Drugs.
The firm after making improvements, approached again for the inspection. The inspection of the
company was again carried out by the panel. The panel observed that the firm has not made
substantial improvements. However, the panel was also of the opinion that the company may be
allowed trial manufacturing to ensure that all necessary requirements are met by the company.
The trial manufacturing is not for utilization of allergy vaccines for human use.
In the light of inspection report and recommendations of the panel, the case is placed before the
Board for a decision.
Decision: The Board offered personal hearing to Mr. Agha Sadrad ud Din, CEO of the
company. The applicant explained his status of improvements and assured the Board for
its compliance. The Board decided to conduct the inspection of the company by already
approved panel as and when the firm informs for compliance and will be ready for
inspection. The report of panel shall be considered in the next meeting of Board.

Case No. 22. Court case of M/s Forward Solution V/S DRAP.
The case of M/s Forward Solution was discussed in 243rd Meeting of the Drug Registration
Board. The board decided that since the case is sub judice and under the consideration of the
Honorable Court. The firm M/s. Well Pharma, Lahore will be asked to substantiate their claim of
sole agent of the manufacturer in order to satisfy the legal procedure.
The decision of the board was communicated both the companies. M//s Well Pharma, Lahore has
not provided any sole agent agreement.
The firm M/s Forwarded Solution filed a writ petition in the Honourable Islamabad High
Court, Islamabad on 13.09.2014 on the grounds that the Drug Regulatory Authority of Pakistan
is not granting the Registration due to inaction of the functionary of the Drug Regulatory
Authority of Pakistan (CEO, DRAP, Director, Registration and Director Biological Products).
Parawise comments have been prepared and submitted to the Lawyer of DRAP for finalization
and submission to Honourable Court. Meanwhile, Federal Investigation Agency (FIA) has also
directed to appear before them to provide the details of the case, probably on the complain of
aggrieved company for non grant of registrations. The matter is submitted for information of the
Honorable Drug Registration Board and necessary instruction/orders if any.
Decision: The information was noted by the Board.

Item No: VIII Quality Control Cases – Quality Assurance & Lab Testing Division
Case No. 01: Deferred Cases
Sr. Name of Firm CDL Report Appellate Testing Detail / Decision

No Drugs
1 Kohsar DS M/s Kohs Substandard with Firm challenged The Board was
Tablets Pharmaceuticals regard to :- the report after 30 apprised about the
(Pvt) Ltd days as per record background of the
(Artimether & Assay for provided by FID case as under:-
Lumifantrin) Hyderabad. Artemether: so the request was
Tablets  The Sample of
Found:- 80.256% not valid for re Kohsar DS Tablets
testing by the
Batch No. 001
Appellate Lab manufacture by M/s
Batch No.001 NIH Islamabad Kohs
Limit: 90% to
under Section Pharmaceuticals
110% (Pvt) Ltd
22(5) of Drugs Act
1976 Hyderabad, drawn
Mfg. Sep-13
on 10-10-2013 from
Exp. Aug-15 Does not comply manufacturer’s
premises by FID
Hyderabad, was
declared substandard
(F. No. 03- Remarks:- The by Federal
63/2013) sample is of Government Analyst
substandard CDL, Karachi vide
Test report No.
quality under the
852/2013 dated 10-
Drugs Act 1976. 12-2013. The firm
did not respond
FID’s explanation
Test report No. letter dated 17-12-
2013 so reminder
852/2013
letters dated 06-01-
2014 and 30-01-
2014 were issued by
the FID. The firm
vide its response
dated 11-02-2014
disagreed and
challenged the CDL
report. As per record
provided by the FID

the report was
conveyed to the firm
by the FID vide
letter dated 17th
December 2013,
while the firm
challenged the report
vide its letter dated
11th February 2014.
The FID nominated
following as
responsible persons.
i. Owner of the
firm, M/s Kohs
Pharmaceuticals
(Pvt) Ltd.,
ii. Quality Control

Incharge of M/s
Kohs
Pharmaceuticals
(Pvt) Ltd
iii. Mirza
Saleemullah,
Production
Manager, M/s
Kohs
Pharmaceuticals
(Pvt) Ltd
 The FID has not

given any
recommendations
nor made any
comments
regarding validity
of the act of
challenging the
CDL report by the
firm. However, as

per record provided
by the FID, it
appears that firm
has challenged the
report after the 30
days period
prescribed under
Section 22(4) of
Drugs Act 1976,
therefore, the
request was not
valid for retesting
by Appellate Lab.
 As per
responsibility fixed
by the FID, show
cause notices dated
05-05-2014 were
issued to the firm
and the accused
persons of the firm.
 The case was
placed before Drug
Registration Board
in its 244th meeting
held on 23-24th July
2014. The accused
of the firm were
also called for
personal hearing in
the said meeting of
the Board but they
could not appear
before the Board.
The Board decided
to defer the case
and provide a final
opportunity of
personal hearing to
the accused.
 The case was
again placed
before Drug
Registration Board

held on 29-30th
September 2014.
The accused of the
firm were also
called for personal
hearing in the said
meeting of the
Board but they
could not appear
before the Board.
The Board decided
to defer the case
and provide a final
opportunity of
personal hearing to
the accused.
The case was
presented before the
registration board in
its 246th meeting on
11-12-2014. The
Board decided the
case as under in the
light of personal
hearing of Mr.
Pardeep Kumar
Director of the firm:-
Decision:-
The Board took the

following decision
i. Cancellation of
Kohsar DS
Tablets
Registration
No 070898.
ii. Panel
Inspection for
PSI.
iii. The panel will
be constituted
by Director

QA&LT.
2. Dozabitol M/s Kohs Sub-Standard:- Firm challenged The Board was

Pharmaceuticals the report after 30 apprised about the
(Paracetamol (Pvt) Ltd With regard to days as per record background of the
Syrup. assay for provided by FID case as under:-
Hyderabad Paracetamol so the request was
 The Samples of
Found :-82.2984% not valid for re Dozabitol Syrup,
Batch No. DB testing by the
Batch No. DB110
110 Appellate Lab, manufacture by M/s
NIH Islamabad Kohs
Mfg-Jul -13 Limit:- 90% to
under section Pharmaceuticals
110%
Exp. Jun-15 22(5) of Drugs Act (Pvt) Ltd
1976 Hyderabad, drawn
on 10-10-2013 from
Does not comply manufacturer’s
premises by FID
Hyderabad, were
(F.No. 03- declared substandard
12/2014)-QC Remarks:- The by Federal
sample is of Government Analyst
substandard CDL Karachi vide
Test report No.
quality under the
848/2013 dated 27-
Drugs Act 1976. 11-2013. . In
response to FID’s
explanation letter,
Test report No. the firm disagreed
and challenged the
848/2013 CDL report. As per
record provided by
the FID the report
was conveyed to the
firm by the FID vide
letter dated 03rd
December 2013 and
reminder was issued
vide letter dated 30-

01-2014 for firm’s
response in the
matter. The firm
challenged the report
vide its letter
received in DRAP
Karachi office on
13-02-2014. so the
request for retesting
was not valid as the
same was received
by FID office after
30 days The FID has
nominated following
as responsible
persons.
i. Owner of the
firm, M/s Kohs
Pharmaceutical
s (Pvt) Ltd.,
ii. Quality Control

Incharge, M/s
Kohs
Pharmaceutical
s (Pvt) Ltd
iii. Mirza
Saleemullah,
Production
Manager, M/s
Kohs
Pharmaceutical
s (Pvt) Ltd
 The FID has not

given any
recommendations
nor made any
comments
regarding validity
of the act of
challenging the

CDL report by the
firm. However, as
per record provided
by the FID, it
appears that firm
has challenged the
report after the 30
days period
prescribed under
Section 22(4) of
Drugs Act 1976,
therefore, the
request was not
valid for retesting
by Appellate Lab.
 As per
responsibility fixed
by the FID, show
case notices dated
05-05-2014 were
issued to the firm
and the accused
persons of the firm.
 The case was
placed before Drug
Registration Board
held on 23-24th
July 2014. The
accused of the firm
were also called
for personal
hearing in the said
meeting of the
Board but they
could not appear
before the Board.
The Board decided
to defer the case
and provide a final
opportunity of
personal hearing to
the accused.
 The case was
again placed

before Drug
Registration Board
held on 29-30th
September 2014.
The accused of the
firm were also
called for personal
hearing in the said
meeting of the
Board but they
could not appear
before the Board.
The Board decided
to defer the case
and provide a final
opportunity of
personal hearing to
the accused.
The case was
11-12-2014. The
Board decided the
light of personal
hearing of Mr.
Pardeep Kumar
Decision:-
The Board took the

following decision
i.. Cancellation of
Registration of
Dozabitol
(Paracetamol
Syrup

Registration
No.006201.
ii. Panel
Inspection
for PSI.
iii. The panel
will be
constituted
by Director
QA&LT
3. Dozabitol M/s Kohs Sub-Standard with Sub-Standard The Board was

(Paracetamol Pharmaceuticals regard to:- apprised about the
Syrup. (Pvt) Ltd With regard to:- background of the
Assay for i. Assay for case as under:-
Hyderabad Paracetamol:-
paracetamol:-
Found:- 88.62%  The Sample of
Batch No. DB Dozabitol Syrup
089 85.52%
Batch No. DB089
manufacture by M/s
Limit:- 95.0% to Does not comply Kohs
105% with BP 2011.
Pharmaceuticals
Mfg- Jan-13 (Pvt) Ltd
ii. Description
Hyderabad, drawn
Exp- Dec-14 pink colored syrup
on 21-03-2013 from
Does not comply having un manufacturer
with BP 2011 dissolved masses premises by FID
which do not Hyderabad, was
disperse even on declared substandard
(F.No. 03- by Federal
Remarks:- The shaking
31/2013)-QC Government
sample is of Analyst, CDL
substandard Karachi vide Test
quality under the Does not comply report No. 535/2013
Drugs Act 1976. with BP 2011, dated 06-05-2013.
which states that On explanation letter
suspension may issued by the FID,
the firm requested
show a
Appellate testing
sedimentation under section 22(5)
Test report No. which is readily of Drugs Act 1976.
535/2013 dispersed on The Appellate
Laboratories also

shaking. declared the sample
sub-standard vide
test report No.08-
MNHRS/2013 dated
Test report No.08- 06th August 2013.
MNHRS/2013 The repot of
Appellate
Laboratories was
forwarded to the FID
for sending complete
case along with
recommendation and
name of the
responsible persons.
The FID in response
has nominated
following as
responsible person
with request for
permission for
prosecution and
cancellation of
registration.
i. Owner of the
firm, M/s Kohs
Pharmaceuticals (Pvt)
Ltd., Hyderabad.
ii. Miss
Rakhshanda Perveen
(Quality Control
Manger).
iii. Production
Manager of the firm
 As per responsibility
fixed by the FID,
show cause notices
dated 07-05-2014
were issued to the
firm and the accused
persons of the firm..
 The case was

placed before Drug
Registration Board
held on 23-24th
July 2014. The
accused of the firm
were also called
for personal
hearing in the said
meeting of the
Board but they
could not appear
before the Board.
The Board decided
to defer the case
and provide a final
opportunity of
personal hearing to
the accused. They
have been called
for personal
hearing again
accordingly.
 The case was
again placed
before Drug
Registration Board
held on 29-30th
September 2014.
The accused of the
firm were also
called for personal
hearing in the said
meeting of the
Board but they
could not appear
before the Board.
The Board decided
to defer the case
and provide a final
opportunity of
personal hearing to
the accused.
The case was

11-12-2014. The
Board decided the
light of personal
hearing of Mr.
Pardeep Kumar
Decision:-
The Board took the

following decision
i.. Cancellation of
Registration of
Dozabitol
(Paracetamol
Syrup
Registration
No.006201.
ii. Panel
Inspection for
PSI.
iii. The panel will
be constituted
by Director
QA&LT.
4. Stearox 1ml M/s Gyton Sub-Standard Not Challenged The Brief about the
Pharmaceutical background of the
Injection Lahore With regards to:- Batch No. case is as under:-
Batch No. H110112,
H110112 i. pH The samples of
Determined 5.94 Stearox Injection
Batch No. H110112,
Mfg:-01-12 Limit 7.0 to 8.5 Manufactured by M/s
Guyton
Exp:-01-14 Does not comply
Pharmaceutical
with USP 34
Lahore drawn by FID

ii. Assay for Karachi from Central
Dexamethasone Pharmacy of JPMC,
(F.No.03- Karachi on 26-02-
25/2013 QC) Phosphate 14.59% 2013, was declared
Limit 90% to 115% Substandard vide test
report No.261/2013
Does not comply dated 03-04-2013 by
with USP 34 Federal Government
Analyst. The FID has
identified following
persons responsible in
the case.
. Mr. Talat
Ahmad Anjum
(Q.C In-
charge)
.Muhammad Imran
Khalil
(Production In-charge)
 As per procedure
show cause notices
was issued to the
firm 20th February
2014 and above
accused, offering
opportunity of
personal hearing
before the Drug
Registration Board.
They have also
been called for
personal hearing
accordingly.
 The case was
placed before
244th meeting of
Registration
Board which
decided the case

as under:-
“The accused of the
firm were called for
personal hearing, but
they could not appear
before the Board. The
Board decided to defer
the case and a final
opportunity of
personal hearing shall
be given in next
meeting of the Board”
Accused as identified
by FID Lahore has
also been called for
personal hearing
accordingly. The case
was again placed
before 245th meeting
of Refistration Board
which decided the
case as under:-
Decision:- Mr.
Muhammad Salman
Ali, Advocate High
Court appeared on
behalf of M/s Guyton
Pharmaceutical
Lahore. The Board did
not accept power of
Attorney on behalf of
the firm. The Board
decided the case as
under:-
i. The production of
the injection Stearox
1ml Registration No.

040336 shall be
stopped. One more
opportunity of
personal hearing is
granted with the
direction that the
Management and
Technical Personnel
shall appear before the
Board failing which
the ex-parte decision
shall be taken.
ii. The Board further

decided that the firm
will recall all the
marketed batches of
sub-standard drugs
from distribution / sale
outlets / institutional
supplies if any and
area FID shall take
report from the firm
and submit a
compliance report to
Chairman Registration
Board.
In the light of decision

taken in 245th meeting
of Registration Board
The One more
opportunity of
personal hearing is
granted with the
direction that the
Management and
Technical Personnel
shall appear before the
Board failing which

the ex-parte decision
shall be taken.
The case was

11-12-2014. The
Board decided the
light of personal
hearing of Mr. Bilal
Khurshid Chief
Executive of the
firm:-
Decision:-
The Board took the

following decision:-
i. Area FID Mr.

Abdul Rasool
Shiekh to take
the samples of
the batch and
submit the
investigation
report of the
case again as
the firm has
disowned the
supply of
specific Batch.
ii. The
production of
the firm in the
steroidal
Injectable
section shall
be stopped
along with
suspension of
registration of

Stearox 1ml
Registration
No. 040336
which had
already been
suspended in
245th meeting
till
investigation
of the case is
finalized.
iii. The firm will
be asked to
provide on
stamp paper
regarding
their
statement of
disownership
of supply of
this batch.
iv. The case will
be submitted
before the
Registration
Board after
the
completing
the
investigation.
Case No. 02 New Cases.

Sr. Name of Drugs Firm CDL Report Appellate Testing Detail / Decision
No
1. Rehumetic 50 M/s Rehmat Sub-Standard with No Challenged The background of

Tablets Pharma regard to:- the case is as under:-
(Diclofenac Lahore.
i. Assay for diclofenac
Potassium)
Potassium:-
The FID has
Determined submitted the
Batch No. RT012 amount/tablet:- 48.44mg investigation report.
The FID has fixed
the responsibility
Mfg Date:-03-14 Stated amount/tablet:- and submitted the
50mg name of Directors,
Exp Date:- 03-16 Production Incharge,
Quality Control
Incharge as under:-
Percentage:- 96.88%
(F.No.03-42/2014-
i. Mr. Bashir
QC) Fail on Dissolution test
Ahmed, Chief
as under:-
Executive,
M/s Rehmat
ii. Dissolution test:- Pharma,
Sheikhupura
Tablet No:- (%)age Road,
1. 17.25 Lahore.
2. 14.37 ii. Mr. Muzaffar
Bashir
3. 17.82
Production
4. 13.5
Incharge
5. 12.94
M/sp Rehmat
6. 16.10 Pharma,
Sheikhupura
Road

Lahore.
Limits: Not less than iii. Mr. Muhammad

75.0% Sarwar, Quality
Control Incharge,
M/s Rehmat Pharma,
Does not comply with Sheikhupura Road,
USP 37 Lahore.
The FID has

Remarks:- The sample concluded that the
is of substandard firm has violated
quality under the Drugs Section 23(1)(a)(v)
Act 1976. of the Drug Act,
1976 and rules
framed there under.
Test Report No. The tablet Rehumetic

LHR.136/2014 50 was declared
substandard by CDL
on the basis of
dissolution test. The
firm vide its reply
dated 18-08-2014 to
FID did not
challenge the report
and requested to
drop the proceeding
against them in the
interest of justice.
The FID has
submitted the copies
of recall of the
product from market
by M/s Rehmat
pharma, Lahore.
Keeping in view
above since the firm
has not challenged

the report of CDL
therefore the report
dated 21st July, 2014
is the adducing
evidence under the
law.
As per procedure a
show cause notice
was issued to the
firm and other
accused, offering
opportunity of
personal hearing
before the Drug
Registration Board.
The case was

11-12-2014. The
Board decided the
light of personal
hearing of Mr. Abid
Hussain Awan
Technical Advisor
and Mr. Muhammad
Sarwar QC Incharge
of the firm:-
Decision:-
The Board took the

following decision
i. Warning to
the firm.
ii. Destroy the

recalled
quantity
(1,34000) of
Rehumetic
50mg tablets
in presence
of area FID
Lahore. The
area FID will
submit the
report of
destruction
to the
Directorate
of QA/LT.
iii. The firm will
submit the
measures
taken to
overcome
such
incidence in
future.
3. D. Dron M/s Epharm Adulterated & Not challenged The Board was
(Dexamethason) Laboratories, Substandard with apprised about the
Injection Karachi. regards to Description:- background of the
(IM/IV) case as under:-
Finding of Lab:-
 The samples of D-
Dron Injection
Batch No. Batch No DF.137
Colorless solution in
DF.137 & DF-138
clear glass ampoule. Out manufactured by
of 25 ampoules (referred M/S Epharm
portion of sample) one Laboratories,
Mfg:- 06-13 ampoule contain black Karachi were
particles and another taken by FID
EXP:- 06-15 Hyderabad at
ampoule contains white
Karachi on 29-01-
fibers. 2014 from
& manufacturer’s
premises. The
samples were

Does not comply with declared
Description Adulterated &
Substandard by
Federal
Government
Remarks:- Analyst vide test
reports
No.KQ.60/2014 &
KQ.61/2014 dated
The sample is of 18th February
“Adulterated & 2014 respectively.
Substandard” under the  The FID
Drugs Act 1976. communicated the
test reports to the
firm vide his letter
No.05-10/2014-
FID-H (K) 255-
257 dated 19-02-
2014. The firm in
their reply
mentioned about
Adulterated & their right of
exercise the power
Substandard with
under subsection
regards to Description:- (4) of Section 22
of Drugs Act 1976
Finding of Lab:- for retesting of
their samples from
appellate lab
Clourless solution in Islamabad. As per
submission of
clear glass ampoule. Out
complete case by
of 15 ampoules (referred the FID, the firm’s
portion of sample) two reply was received
ampoules contain black in the office of
particles. DRAP Karachi on
08-04-2014 which
was well after the
Batch No.
expiry of time
DF.138 Does not comply with allowed under
Description section 22(4) of
Mfg:- 07-13
the Drugs Act
EXP:- 07-15 1976 and hence
not valid as per
FID’s remarks.

Remarks:-  The FID has
furnished the
names of the
following persons
(F.No.03- The sample is of of the firm
10/2014-QC) “Adulterated & responsible for
Substandard” under the committing the
Drugs Act 1976. offence under the
law.
i. M/S Epharm
Laboratories
Karachi.
ii. Mr. Asad
Ilyas
Nainitalwala
,
Director,
iii. Mr. Ahmed
Nadeem
Qasmi,
QC
Manager,
iv Dr.
Mohammad
Khokhar
Production
Manager,
 Show cause
notices were
issued to the firm
and other accused,
offering
opportunity of
personal hearing
before the Drug
Registration
Board after the
approval of the
competent
authority. They
have been also

called for personal
hearing
accordingly.
The case was
11-12-2014. The
Board decided the
light of personal
hearing of Mr. Asad
Ilyas Director of the
firm and Mr. Ahmed
Nadeem Qasmi QC
Manager of the firm.
Decision:-
The Board took the

following decision
i. The Board
decided to
suspended the
registration of
D-Dron
Injection
Registration
No.058424
(IM/IV) for a
period of three
months.
ii. PSI Inspection

by a panel
comprising of
Director DTL
Quetta and area
FID will be
conducted and

they will submit
the report to the
Registration
Board
3. i. Loose pink M/s Ankaz Substandard with regard Substandard with The Board was
cloured tablets- Pharmex to “Assay” regard to “Assay” apprised about the
Rumin (Pvt) Ltd for Ibuprofen (BP) background of the
(Ibuprofen) for Ibuprofen: case as under:-
Karachi
400mg Tablets Determined amount/Tab
 The Federal
=49.512mg Stated:- Inspector of Drug,
400mg/Tab Karachi-III vide
Batch No. Nil Stated amount/tab
his letter dated 21-
=400mg 04-2014 informed
Mfg Date:- Nil that he alongwith
Found:- 313mg/tab. Dr. Shahid
Exp Date:- Nil Hussain, FID
Percentage:- 12.378%
Karachi and others
Percentage:- raided the
premises of M/s
78.29%
Limit: 95% to 105% Ankaz Pharmax
(Pvt) Ltd., Karachi
on 19-04-2014 at
Limit: 95% to 07.45 AM. The
Does not comply 105% raid was
conducted on the
source
information of
Remarks:- The sample FIA Crime Circle
Does not comply
is of substandard Karachi. Deputy
with BP 2011
quality under the Drugs Director FIA Mr.
Act 1976. Fakeer
Muhammad
headed the raid
alongwith his
Conclusion:- team. Ten samples
of different
Test Report No. The sample is of products were
RKQ.212/2014. substandard taken from the
quality on the basis manufacturers
premises for

of tests performed. test/analysis on
the prescribed
Form-3.
 The FID vide his
investigation
report of the case
intimated that
eight samples of
the drugs taken
have been
declared to be
substandard by the
Federal
Government
Analyst, CDL
Karachi. In the
light of the same,
the FID issued
explanation letter
regarding the
matter of
manufacture and
sale of
substandard drugs
to the firm. As per
documents
provided by the
FID, the firm
challenged the test
reports and
requested to get
the samples
retested from the
Appellate
Laboratory, NIH
Islamabad. The
Appellate
Laboratory also
declared the drug
sample under
reference as
Substandard.
 The FID
concluded that the
manufacturer is

guilty of
manufacturing
substandard drugs
and de-registered
drug in violation
to the provisions
of Drugs Act 1976
and rules framed
there under. He
has requested for
cancellation DML
of the firm or
permission to
lodge the
prosecution
against the firm.
 Following persons
of the firm have
been held
responsible for
committing the
offence by the
FID.
i. Ali Abbass,
Managing
Director of the
firm.
ii. Akbar Ali

Production
Incharge.
iii. Safdar Alam,
Quality Control
Incharge.
Show cause
notices were
issued to the firm
and other accused,
in the light of the
test reports of the

Appellate Lab and
report of the FID,
offering them
opportunity of
personal hearing
before the Drug
Registration
Board.
 They have also

been called for
personal hearing
accordingly.
 The Federal
Inspector of
Drugs, Karachi-III
vide his letter
dated 21-04-2014
informed that he
alongwith Dr.
Shahid Hussain,
FID Karachi and
others raided the
premises of M/s
Ankaz Pharmax
(Pvt) Ltd., Karachi
on 19-04-2014 at
07.45 AM. The
raid was
conducted on the
source
information of
FIA Crime Circle
Karachi. Deputy
Director FIA Mr.
Fakeer
Muhammad
headed the raid
alongwith his
team.

 The FID vide his
investigation
report of the case
intimated that
eight samples of
the drugs taken
have been
declared to be
substandard by the
Federal
Government
Analyst, CDL
Karachi. In the
light of the same,
the FID issued
explanation letter
regarding the
matter of
manufacture and
sale of
substandard drugs
to the firm. As per
documents
provided by the
FID, the firm
challenged the test
reports and
requested to get
the samples
retested from the
Appellate
Laboratory, NIH
Islamabad. The
Appellate
Laboratory
declared the drug
sample under
reference as
Misbranded.
 The FID
concluded that the
manufacturer is
guilty of

manufacturing
substandard drugs
and de-registered
drug in violation
to the provisions
of Drugs Act 1976
and rules framed
there under. He
-do.
has requested for
cancellation DML
of the firm or
permission to
lodge the
Substandard with regard prosecution
to :- against the firm.
Assay for Ibuprofen: of the firm have
been held
Determined responsible for
amount/Tablet committing the
=24.756mg offence by the
FID.
Stated amount/tablet i. Ali Abbass,
=200mg Managing
Director of the
firm.
Percentage:- 12.378% ii. Akbar Ali
Production
Substandard with Incharge.
Limit: 95% to 105% regard to “Assay”
ii. Loose pink iii. Safdar Alam,
for Ibuprofen (BP)
cloured tablets- Quality Control
Rumin Incharge.
Does not comply
(Ibuprofen)
Stated:-
200mg Tablets  As per procedure
200mg/tab Show cause
Remarks:- The sample notices were
is of substandard quality issued to the firm
Batch No. Nil under the Drugs Act Found:- and other accused,
1976. in the light of the
Mfg Date:- Nil 153.38mg/tab. test reports of the
Test Report No. Appellate Lab and

Exp Date:- Nil RKQ.213/2014 report of the FID,
offering them
Percentage:- opportunity of
76.69% personal hearing
before the Drug
Registration
Board.
Limit: 90% to
105%
 They have also
been called for
personal hearing
Does not comply accordingly.
with BP 2011
The FID vide his

investigation report
of the above case
Conclusion:- also reported that the
firm was found
The sample is of manufacturing its
substandard one of de-registered
quality on the basis product namely
of tests performed. syrup Rumin
mentioning the old
manufacturing date
Test Report on the label. It has
No.09- been intimated that
-do- Substandard with regard MNHSR/2014 Syrup Rumin was
to :- found stored in bulk
in big vessel placed
Assay for Ibuprofen: in liquid
manufacturing areas
Determined
of the firm. A huge
amount/Tablet
quantity of finished
=350.71mg
goods of same de-
Stated amount/tablet registered syrup was
=400mg also seen placed in
Substandard with finished good wear
regard to “Assay” house
for Ibuprofen (BP)

Stated:-  The FID

400mg/tab concluded that the
Limit: 95% to 105% manufacturer is
guilty of
iii. Tablet manufacturing
Rumin Found:- substandard drugs
(Ibuprofen) Does not comply 319.24mg/tab. and de-registered
400mg drug in violation
to the provisions
Remarks:- The sample Percentage:- of Drugs Act 1976
and rules framed
(Blister packing) is of substandard quality 79.81%
there under. He
under the Drugs Act has requested for
1976. cancellation DML
of the firm or
Batch No. 1105 Test Report No. Limit: 95% to permission to
RKQ.215/2014 105% lodge the
Mfg Date:- 1-12
prosecution
Exp Date:- 12-14 against the firm.
Does not comply
of the firm have
with BP 2011 been held
responsible for
committing the
offence by the
FID.
Conclusion:-
The sample is of i. Ali Abbass,

substandard Managing
quality on the basis Director of the
of tests performed. firm.
Substandard with regard
to :-
Test Report ii. Akbar Ali
Assay for Ibuprofen:
No.08- Production
Determined MNHSR/2014 Incharge.
amount/Tablet
iii. Safdar Alam,
=30.945mg
Quality Control
Stated amount/tablet

-do- =200mg Incharge.
Substandard with  As per record of

regard to “Assay” Quality Control
Percentage:- 15.4725% for Ibuprofen (BP) Section,
registration of this
product was
cancelled by DRB
Limit: 95% to 105% Stated:- in its 237th
200mg/tab meeting held on
26-02-2013,
Does not comply which was
communicated of
Found:- the firm vide their
145.60mg/tab. officer letter
Remarks:- The sample bearing No.03-
is of substandard 16/2012-QC,
quality under the Drugs Percentage:- dated 22-03-2013.
Act 1976. 72.80%
Show cause
Test Report No. Limit: notices were
95% to issued to the firm
RKQ.206/2014 105% and other accused,
iv. Tablet
in the light of
Rumin report of the FID,
(Ibuprofen) and record of QC
200mg Does not comply Section regarding
with BP 2011 the de-registration
of the product
offering them
Batch No. 640 opportunity of
personal hearing
(Jar Packing) before the Drug
Conclusion:-
Registration
The sample is of Board.
Mfg Date:- 2-13 substandard
quality on the basis They have also been
Exp Date:- 01-16
of tests performed. called for personal
hearing accordingly
Test Report
Substandard with regard

to :- No.012-
NHSR/2014
Assay for
Sulphamethoxazole:
The Board was
Determined apprised about the
amount/Tablet =101.328 background of the
mg case as under:-
=800mg Misbranded with
 The Federal
the following Inspector of Drug,
remarks:- Karachi-III vide
Percentage:- 12.666% his letter dated 21-
“Labeling on the 04-2014 informed
immediate pack is that he alongwith
not legible. More Dr. Shahid
Does not comply over batch Hussain, FID
number and Karachi and others
raided the
expiry date is
premises of M/s
Remarks:- The sample printed with Ankaz Pharmax
-do- is of substandard removable ink and (Pvt) Ltd., Karachi
quality under the Drugs some strips found on 19-04-2014 at
Act 1976. without batch 07.45 AM. The
numbers and raid was
Test Report No. conducted on the
expiry date which
RKQ.207/2014 source
is violation of the
information of
labeling and FIA Crime Circle
packing rules of Karachi. Deputy
Drugs Act 1976. Director FIA Mr.
Fakeer
Muhammad
headed the raid
Conclusion:- The alongwith his
sample is team. Ten samples
misbranded. of different
products were
taken from the
manufacturers
Test Report premises for
No.06- test/analysis on
the prescribed

MNHSR/2014 Form-3.
v.. Biprim (Co-

Trimoxazole) DS  The FID vide his
Tablets investigation
report of the case
intimated that
eight samples of
Batch No. 305 the drugs taken
have been
(Blister packing) declared to be
substandard by
the Federal
Government
Analyst, CDL
Karachi. In the
Mfg Date:- 11-13
light of the same,
Exp Date:- 10-16 the FID issued
explanation letter
regarding the
matter of
manufacture and
sale of
substandard drugs
to the firm. As
per documents
provided by the
FID, the firm
challenged the
test reports and
requested to get
the samples
retested from the
Appellate
Laboratory, NIH
Islamabad. The
Appellate
Laboratory
declared the drug
sample under
reference as of
standard quality.
 As per Section 22

(5) of the Drugs
Act 1976 and the
report of
conclusive
evidence so in the
light of the same
the present case
with regard to
drug under
vi. Rumin reference may be
filed.
(Iburofen)
The sample is of .
Suspension
standard quality with
 Submitted for
regard to tests Information of the
performed. Board please.
Batch No.408
Test report No.
RKQ.210/2014.
Mfg Date:-03-13
-Do-
Exp Date:-02-16
vii. Biprim DS Substandard with regard

(Co- to :-
Trimoxazole)
Tablets Assay for
Sulphamethoxazole:
Determined
Batch No. 305 amount/Tablet =101.328 -Do-
(Jar packing) mg
The case was
Stated amount/tablet presented before the
=800mg registration board in
Mfg Date:- 11-13
Exp Date:- 10-16 11-12-2014. The
Percentage:- 12.666% Board decided the
light of personal
Does not comply hearing of Mr. Salim
Isharat Husain,

Technical Consultant
on behalf of M.D of
viii. Biprim Remarks:- The sample the firm.
is of substandard
(Co- quality under the Drugs Decision:-
Trimoxazole) Act 1976.
Tablets The Board in view
of personal hearing
of Mr Saleem Isharat
Test Report No. Hussain on behalf of
Batch No. 524 RKQ.209/2014 Managing Director
(Blister packing) Substandard with regard Ankaz Pharmex and
to :- available
record/facts of the
Mfg Date:- 01-13 Assay for case decided as
Sulphamethoxazole: under:-
Exp Date:- 12-15
Determined 1. The Board
amount/Tablet =101.328 decided to cancel
mg the registration of
the following
ix. Loose white products as per its
=800mg
cores consideration:-
claimed/suspecte Percentage:- 12.666%
i. Loose Pink
d of Tablets-
Does not comply Colored Tablets-
Rumin Rumin
(Ibuprofen) Remarks:- The sample (Ibuprofen)
200mg is of substandard quality 400mg Tablets.
Registration No.
under the Drugs Act
007545
1976. ii. Loose Pink
Batch No. Nil
Test Report No. colored Tablets-
Mfg Date:- Nil RKQ.208/2014 Rumin
(Ibuprofen)
Exp Date:- Nil Substandard with regard 200mg Tablets,
to :- Reg. No. 007543.
(F.No.03-
17/2014-QC) Assay for Ibuprofen: iii. Tab. Rumin
400mg. (Blister
Determined
Packing) Reg.
amount/Tablet

=30.945mg No. 007545
Stated amount/tablet iv. Tab. Rumin

=200mg 200mg (Jar
Packing) Reg. No.
007543.
v. Tab. Biprim (Co-
Trimoxazole)
DS (Blister
Limit: 95% to 105% Packing) Reg.
No. 008409
vi. Rumin
Does not comply
(Ibuprofen)
Suspension, Reg.
No. 008526
Remarks:- The sample
is of substandard N.A 2. The Board
quality under the Drugs further decided to
Act 1976. recommend to the
Central Licensing
Board for
cancellation of the
Test Report No.
Drug
RKQ.214/2014
Manufacturing
The Sample has License of the firm
been declared of on the violation of
Standard Quality manufacturing of
-Do- on the basis of tests already De-
performed. registered product
i.e. Rumin
Test Report
Suspension Reg.
No.013-
No. 008526.
MNHSR/2014
The Sample has

been declared of
Standard Quality of
the basis of tests
performed

Test Report No.07-
MNHSR/2014
The Sample has

been declared of
Standard Quality
on the basis of tests
performed by the
Appellate Lab,
NIH, Islamabad.
(Test Report
No.010-
MNHSR/2014)
4. Kemycillin M/s Alkemy Substandard with regard Sub-Standard The Board was
(Ampicillin) Pharmaceutica to :- apprised about the
Syrup l Laboratories With regard to:- background of the
Assay for Ampicillin Assay for case as under:-
Hyderabad.
Determined Ampicillin:- The Sample of
Batch No. A- amount/5ml:- Kemycillin Syrup
1028 =103.32mg Stated 125mg/5ml
Batch No A-1028,
Stated amount /5ml i. First day Found manufactured by M/s
Alkemy
Mfg. Oct-13 =125mg =101.14mg/5ml
Pharmaceutical
Laboratories P/9,
Exp. Use with in
SITE Hyderabad
three years Percentage:-
Percentage:- 82.66% Sindh was taken by
80.91% FID Hyderabad at
Karachi on 24-04-
(F. No. 03- 2014 from
34/2014) Limit: 90% to 120%
manufacturer’s
premises. It was
i. On 07th declared substandard
Does not comply Day Found
by Federal
=
78.53mg/5 Government Analyst
ml vide Test report No.
Remarks:- The sample KQ.230/2014 dated
is of substandard 27th May 2014. In
quality under the Drugs Percentage:-

Act 1976. 62.82% response to the
explanation letter
issued by the FID,
Test report No. the firm challenged
KQ.230/2014 the CDL report and
Limit:- 80-120% requested for
Appellate Testing
under Section 22(5)
Does not comply of Drugs Act, 1976.
with BP 2011. The Appellate
Laboratory also
declared the sample
as Substandard vide
Conclusion:-
test report No. 015-
The sample is of MNHSR/2014 dated
substandard 08th August 2014.
quality on the basis The FID in response
of tests performed. to this office letter
dated 29th August
2014 concluded that
Test report No. the firm has violated
015-MNHSR/2014 Section 23(1)(a)(v)
of Drugs Act 1976.
FID has
recommended
immediate action
under Section 7(11)
of the Drugs Act
1976 and has
furnished the names
of the following
persons of the firm
responsible for the
offence.
i. M/s Alkemy
Pharmaceutical
Laboratories

(Pvt.) Ltd
Hyderabad,
ii. Mr.Fraz Ahmed
Sheikh,
Managing
Director,
iii. Mr. Asif Najeeb

Laghari,
QC Manager,
iv. Mr.Abid Ali

Khoso
Production
Incharge,
 As per
responsibility
fixed by the FID,
show case notices
dated 05-05-2014
were issued to the
firm and the
accused persons
of the firm.

The case was
11-12-2014. The
Board decided the
light of personal
hearing of Mr. Asif
Najeeb Laghari QC
Decision:-
The Board took the

following decision:

i. Suspended
the
registration
of
Kemycillin
(Ampicillin)
Syrup, Reg.
No. 022520
for a period
of six (06)
months.
ii. Panel
Inspection
for PSI.
iii. The panel
will be
constituted
by Director
QA&LT
5. Empoir 500mg M/s Alkemy Sub-Standard:- Substandard with The Board was
(Ciprofloxacin) Pharmaceutica regard to apprised about the
Tablets. l Laboratories With regard to Dissolution test background of the
Dissolution test case as under:-
Hyderabad. Determined:-
Tablet 01= 38.23% 59.9% The Sample of
Batch No. 283 Empoir 500mg
Tablet 02= 48.94% 57.71% (repeated) Tablets Batch 283
Tablet 03= 39.30% Limit:- Not less manufactured by M/s
Mfg Date- 03-14 than 80% of the Alkemy
Tablet 04= 32.26%
stated amount Pharmaceutical
Exp Date. 02-17
Tablet 05= 39.15% Laboratories (Pvt.)
Ltd, P/9, SITE
Tablet 06= 39.15% Hyderabad was taken
Does not Complies
by FID Hyderabad at
with USP 32
Karachi on 24-04-
(F.No. 03-
Limit:- Not less than 2014 from
33/2014)-QC
80% manufacturer’s
premises. The
Sample was declared
Conclusion:-
Does not comply with substandard by

USP 35. The sample is ofFederal Government
substandard Analyst CDL
quality on the basis
Karachi vide Test
Remarks:- The sample of tests performed.report No.
is of substandard KQ.228/2014 dated
quality under the Drugs 15th May 2014. In
Act 1976. response to the
explanation letter
Test report No. issued by the FID,
014-MNHSR/2014 the firm challenged
Test report No.
the CDL report and
KQ.228/2014
requested for
Appellate Testing
under Section 22(5)
of Drugs Act, 1976.
The Appellate
Laboratory also
declared the sample
as Substandard vide
test report No. 014-
MNHSR/2014 dated
12th August 2014.
The FID in response
to this office letter
dated 18th September
2014 has concluded
that the firm has
violated Section
23(1)(a)(v) of Drugs
Act 1976. FID has
furnished the names
of the following
persons of the firm
responsible for the
offence.
i. M/s
Alkemy
Pharmaceutical

Laboratories (Pvt.)
Ltd Hyderabad,
ii.
Mr.Fraz
Ahmed Sheikh,
Managing Director,
iii. Mr.
Asif Najeeb Laghari,
QC Manager,
iv.
Mr.Abid Ali
Khoso
Production Incharge,
 .As per
responsibility
fixed by the FID,
show case notices
have been issued
to the firm and
other accused
persons of the
firm.
The case was
11-12-2014. The
Board decided the
light of personal
hearing of Mr. Asif
Najeeb Laghari QC
The case was


11-12-2014. The
Board decided the
light of personal
hearing of Mr. Asif
Najeeb Laghari QC
Decision:-
The Board took the

following decision
i. Suspended
the
registration
of Empoir
500mg
(Ciprofloxaci
n) Tablets
Reg. No.
039367 for a
period of six
(06) months.
ii. Panel
Inspection
for PSI.
iii. The panel
will be
constituted
by Director
QA&LT
Case No. 03 Substandard Rifacin (Rifampicin Suspension BP 60ml) manufactured by M/s

Pharmawise Labs Pvt Ltd Lahore
Brief Background
The FID Islamabad-II on 03-04-2012 drew samples of Rifacin Suspension Batch No.152
of M/s Pharmawise Labs (Pvt) Lahore, from T.B Center, Asghar Mall Road Rawalpindi for

test/analysis. The samples were declared substandard by the F.G Analyst vide test report
No.T.B.64/2012 dated 01-08-2012. The firm did not challenge the report and case was
accordingly processed and decided by the Registration Board in its 237th meeting, held on 26-02-
2013 and cancelled the registration of the product under reference. The firm filed an appeal
before Appellate Board against the decision of DRB vide appeal No.04/2013, dated 06-09-2013,
which was dismissed by the Appellate Board in its 140th sitting.
. .The firm filed a writ petition No.4442-2013, before Honorable Islamabad High Court,
Islamabad against the decision of Appellate Board but the Court upheld the decision of Appellate
Board. The firm filed a C.P.L.A No. 2/2014 before the Honorable Supreme Court of Pakistan
which in its order dated 22-08-2014 the directed to retest the sample in accordance with law.
Accordingly the sample was sent to Appellate Lab (NIH) for retesting which also declared the
sample is of Sub-standard quality.
S.No. CDL Test Report No. Appellate Test Report No.016- Remarks
TB.64/2012 & Findings MNHSR/2014 & Findings
1. i. pH Determined 5.18 i. pH Determined 4.75 The sample is of
ii. Limits:- 4.2 to 4.8 Does not
ii. Limits:- 4.2 to 4.8 Comply with Substandard
comply with BP 2011 BP 2011 . quality on the
iii. Volume Determined 60ml basis of test
Assay for Rifampicin Complies with volume stated on the performed by
i. Determined amount per ml label FGA CDL
=15.514mg/ml Assay for Rifampicin Karachi and
i. Determined amount per ml Appellate Testing
ii. Stated amount / ml= =17.31mg/ml Lab Islamabad.
20mg/ml
ii. Stated amount / ml= 20mg/ml
iii. Percentage:- 77.57%
iv. Limits:- 90% to 110% iii. Percentage:- 86.63%
Does not comply with BP iv. Limits:- 90% to 110%
2011 Does not comply with BP 2011
The case is submitted of the consideration / decision of Registration Board under

intimation to Assistant Registrar motion for Deputy Registrar Judicial in the light of brief
background please.
Decision:-

The Board after through celebration decided as under:-
1. Up held the decision of cancellation of registration of substandard Rifacin

(Rifampicin Suspension BP60ml), Regn. No. 037528 manufactured by M/s
Pharmawise Labs (Pvt) Ltd., Lahore taken in 237th meeting, Registration
Board.
2. The Board further decided that the case with brief background shall be
intimated to Assistant Registrar motion for Deputy Registrar Judicial in the
light of decision of the Board and substandard test report by the Appellate
Lab NIH Islamabad and Medical Superintended T.B Hospital Asghar Mall
Road Rawalpindi for their further necessary action if any.
3. The firm will recall all its supplied batches to T.B Hospital Asghar Mall Road
Rawalpindi under intimation to area FID-II Islamabad.
Case No. 04 Deaths of persons allegedly due to consumption of cough syrup

manufactured by M/S Ethical Laboratories (Pvt) Ltd and M/S Reko Pharmecal
Laboratories Lahore
The Registration Board in its 245th meeting decided the case as under:-
Decision:- Registration Board decided that Mr. Jamil Anwar Member of the Registration Board, Deputy
Director General (E&M) Lahore & Islamabad will furnish the pending status of these petitions filed by
M/s Ethical laboratories Pvt Ltd and M/s Reko Pharmacal Lahore for consideration of the Board in its
up-coming meeting
The pending status of the petitions filed by M/s Reko and Ethical Laboratories pvt Ltd Lahore
have not yet been received from the Honorable member Mr. Jamil Anwar, and DDG (E&M) Lahore and
Islamabad as communicated to them.
Decision: Registration Board again decided that that Mr. Jamil Anwar Member,
Registration Board, Deputy Director General (E&M) Lahore & Islamabad will furnish
the pending status of these petitions filed by M/s Ethical laboratories Pvt Ltd and M/s
Reko Pharmacal Lahore for consideration of the Board in its up-coming meeting

Case No. 05 Damage Samples for Board Portion
Board portion of sealed samples from ADC Quetta and FID Peshawar were received in damage
conditions (File No.13-09/2013-QC)
S. Product & Batch No. Manufacturer Condition

No.
1. Canrce Tablets M/s Merck (Pvt) Ltd Badly damaged, broken carton
Q18 Quetta and seal.
2. Optifam Tablets M/s Merck (Pvt) Ltd Badly damaged, broken carton
38 Quetta and seal.
3. Naproxen Imported Raw M/s Merck (Pvt) Ltd Badly damaged, glass broken
Material Quetta bottle and seal.
4. Metformin-Hcl Imported M/s Merck (Pvt) Ltd Badly damaged, glass broken
Raw Material Quetta bottle and seal.
5. Tablet Klaribact 250mg M/s Merck (Pvt) Ltd Badly damaged, broken carton
Q64 Quetta and seal.
6. Liquid Glucose Rafhan Maiz Pakistan Badly damaged, leaked bottles
014270-Bulk and torn memorandum.
7. Liquid Serbetol Made in China Badly damaged, leaked bottles
00470114 and torn memorandum
. The Board portions of the samples at serial No. 1-5 have been sent by ADC Quetta
whereas the samples at serial No.6-7 have been sent by FID Peshawar. Both officers had been
informed telephonically about the status of these samples.
. The Registration Board in its 238th meeting allowed the QC Section to get fresh samples
from the inspectors if they are received in damage conditions. In view of above following
proposal is submitted.
i. The FID Peshawar and ADC Quetta may be advised to take special care for
packing and transportation of the Boards portion of samples in future all the
DDGs in the field offices may also be advised to instruct FIDs/ADCs to
ensure appropriate packing and sealing of such samples.
ii. FID Peshawar and ADC Quetta may be advised to draw fresh samples, of the same
batches/raw materials, of damaged drugs for test analysis.
Decision:- The Board approved the proposals of QC Section and Directed that all
DDGs, FIDs and ADCs be asked to send the Board Portion intact form and ensure
appropriate packing and sealing of such samples before sending. In future such
approvals will be taken from Director QA/LT on file.

Case No. 06 Manufacture and supply of sub-standard Hepaferon Injection by M/s Pharmedic,
Lahore to Govt of Khyber Pakhtoonkhawa
BRIEF BACK GROUND: The case of M/s Pharmedic Laboratories (Pvt) Ltd was discussed with
reference to the decision taken in also 243rd & 244th meeting of Registration Board which is reproduced
as under.
Decision taken in 243rd Meeting of Registration Board

i The Federal Inspector of Drugs Peshawar is advised to get the case completed
covering details of findings, conclusion fixation of responsibilities with his
recommendations.
ii. The Board further decided to get update regarding Suo Moto notice taken by
Hounrable Peshawar High Court Peshawar and fate of case referred to NAB
Khyber Pakhtoon Khawa.
The FID Peshawar has submitted the investigation of the case fixing the responsibility of name of
persons accused & co accused in manufacture and sale of substandard Hepaferon Injection Batch No 80-
87 which are involved directly or indirectly. The FID has also submitted the suo moto judgment a copy of
Honorable High Court Peshawar but did not submitted the report regarding investigation by NAB.
Name of accused persons.
i. Mr. Iftikhar Ahmed Shiekh Director/C.E.O

ii. Mr. Mazhar Hussain Production Incharge.
iii. Mr. Asim Mehmood Quality Control Inchage
Name of Co-accused persons.
Dr. Chuhan Director

Dr. Sharif, Director
Dr. Ghulam Subhani Director Hapatitis Program
Mubarik Shah, Store Keeper LRH Hapatitis Program
Dr. Nigar Ahmed, Ms DHQ Mardan.
Mr. Aurengzaib, Store Incharge, DHQ Mardan.
The case was again presented before 244th meeting of the Board in the light of recommendations of
the FID Peshawer as above which decided the instant case as under:-
Decision:- The Board decided to issue show cause notices to accused of M/s Pharmadic
Laboratories (Pvt) Ltd Lahore regarding manufacture and supply of substandard Injection
Hepaferon (3MIU) Interferon Alpha 2a to government of KhyberPakhtoonKhawa.

The The FID Peshawar has submitted the complete investigation of the case fixing the
responsibility of name of persons accused / co-accused in manufacture and sale of substandard Hepaferon
Injection Batch No 80-87and proposed their names for prosecution under Section 23(1)(a)(v)(vii) and 23
(1)(a)(vii), 23(1)(b)(f) which are involved directly or Indirectly in this case some of the co-accused are
employees of Government of Khyber Pakhtoon Khawa.
As directed by Chairman Registration Board the case is again submitted for consideration of the
Registration Board keeping in view of the Public health at large, Suo Moto Notice by Peshawar High
Court, & NAB investigation in instant case please.
Decision:- The Board decided that Federal Inspector of Drugs Peshawar will be asked
to submit the certified copies of decisions of Drug Court Peshawar and Peshawar High
Court, Peshawar in the instant case with in 07 days. Reference will be sent to Law division
to ascertain whether government officials under provincial governments can be issued
show cause notice for violations any provision of Drug Act, 1976 or otherwise.
The Show Cause Notice to the accused of firms will be issued after the receipt of the
letter from the FID and approval from Chairman, Registration Board. However, show
cause to government officials will be served after clarification from Law Division.
Case No.07 Supply of substandard /adulterated injection of cil 100ml to DHQ hospital
Hafizabad (25000 vials) and M/s Medisearch Pharma (Pvt) Ltd., 5-km, Raiwind Manga
Road, Lahore which supplied Almajax 250ml Suspension to DHQ Hospital Hafizabad
(35600 bottles).
The Secretary Provincial Quality Control Board (PQCB) Punjab Mr. Tallat Farooq Ahmad
has forwarded two recommendations to DRAP as under:-
i. The Federal Government Cancel the Drug Manufacturing License of M/s

Mediceena Pharma, (Pvt) Ltd., 27-KM Raiwind Road Lahore on supply of Sub-
standard / Adulterated injection Ofcil 100ml to DHQ Hospital Hafizabad (25000
vials) and M/s Medisearch Pharma (Pvt) Ltd., 5-KM, Raiwind Manga Road, Lahore
which supplied substandard Almajax 120ml Suspension to DHQ Hospital
Hafizabad (35600 bottles).
ii. The Federal Government Cancel the Registrations of the said drugs of M/s
Mediceena Pharma, (Pvt) Ltd., 27-KM Raiwind Road Lahore and M/s Medisearch
Pharma (Pvt) Ltd., 5-KM, Raiwind Manga Road, Lahore.

Brief Background
The Provincial Quality Control Board (PQCB) after scrutiny of the report of Government
analyst i.e report Nos. TRA. 22863 & 22864 dated 21-11-2014 Batch No. JX168 of Almajax
suspension, and statement of the Drug Inspector observed that this is a criminal negligence on
the part of manufacturers and gross loose in GMP compliance. The Punjab Government (PQCB)
observed that there is a dire need to take quick action against the said firms to safeguard the
public health at large and submitted the above mentioned recommendations.
The case is placed before Registration Board for decision on the recommendations of
(PQCB) Punjab by Registration Board regarding cancellation of Registrations of Drugs of these
firms as per law with the proposal that recommendations may also be send to Division of
Licensing for further necessary action at their end so that public health may be saved from risk.
Decision:- The Board decided as under:-
a. To get the complete investigation along with all the reports and case
background from the Secretary Provincial Quality Control Board Health
Department Government of Punjab Lahore through the DDG (E&M)
Lahore.
b. The area FID Lahore will be asked to submit the case background in
writing along with all relevant reports for perusal of the Registration
Board for decision.
The Board further decided the case shall be forwarded to Directorate of Licensing for
further necessary action in the light of recommendation of the Provincial Quality Control
Board (PQCB) Punjab.

Item No.IX Registration of Medical Devices – Medical Devices Division
Case No.01. Applications for registration of medical devices for import.
Registration Board considered the following applications of medical

devices for import and decided as mentioned against each. Approved applications have already
been recommended by Expert Committee on Medical Devices and are subject to inspection of
manufacturer abroad, verification of storage facilities etc as per policy:-
A) Cannulas:
S.No Name of Importer and Name of Medical Price Pack size Shelf Decision
. Manufacturer/Exporter. Device life
1. M/s Kaf Surgical & JRZ Intravenous Decontrolled till (14G, 5 Approved.
Disposable Equipments, Canula without policy decision 16G, 18G, years
GF-116, Panorama Centre, Wings without by the Policy 20G,
Plot No.248, Staff Lines, Injection Port Board/ Federal 22G, 24G,
Fatima Jinnah Road, (Pencil Type). Government. 26)
Karachi/
Manufactured by
50 per box
M/s Plasti Lab S.A.R.L,
Roumieh El Metn,
Industrial Area, Main
Road, Khoury Bldg,
P.O.Box 70407, Beruit,
Lebanon.
2. M/s Kaf Surgical & JRZ Intravenous -do- (14G, 5 Approved.

Disposable Equipments, Canula without 16G, 18G, years
GF-116, Panorama Centre, Wings without 20G,
Plot No.248, Staff Lines, Injection Port 22G, 24G,
Fatima Jinnah Road, (Pen Type) 26)
Karachi/
Manufactured by

M/s Plasti Lab S.A.R.L,
Roumieh El Metn, 50 per box

Industrial Area, Main
Road, Khoury Bldg,
P.O.Box 70407, Beruit,
Lebanon.
3. M/s Lab Link Enterprises, Nipro Safelet Decontrolled till (16G,18G, 5 Approved.
192-N, Block-II, PECHS, Cath (I.V policy decision 20G, years
Cannula Pen by the Policy 22G, 24G)
Karachi. Type) Board/ Federal
Manufactured by: Government
50 per box
M/s PT Nipro Indonesia
Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,
Indonesia.
4. M/s Lab Link Enterprises, Nipro Wing Cath -do- (16G, 5 Approved.
192-N, Block-II, PECHS, (I.V Cannula with 18G, 20G, years
Injection Port & 22G, 24G)
Karachi. Wing)
Manufactured by:
50 per box
Kav, 122B, 23 & 24, Desa
Indonesia.
5. M/s. A. Feroz & Co., Star IV. Catheter -do- (14G, 5 Approved.
Medicine Street No.1, with Injection 16G, 18G, years
Marriot Road, Karachi Port. 20G, 22G,
24G)

Manufactured by
M/s. Engineering 100 per

Technical Plastic Industries box
(Enteplin-Egypt) 10th of
Ramadan City, Industrial
Zone, A-1 Part 41/3.
Sharqia, Egypt.
B: Infusion Set:
S.No Name of Importer and Name of Medical Price Pack Shelf Decision
. Manufacturer/Exporter. Device size life
1. M/s Lab Link Enterprises, Nipro Infusion Decontrolled till 1’s 5 Approved.
192-N, Block-II, PECHS, Set policy decision years
by the Policy
Karachi. Board/ Federal
Manufactured by: (with needle) Government

Kav, 122B, 23 & 24, Desa
Indonesia.
C: Syringes:
S.No Name of Importer and Name of Medical Price Pack Shelf Decision
. Manufacturer/Exporter. Device size life
1. M/s Lab Link Enterprises, Nipro Disposable Decontrolled till 1ml 5 Deferred
192-N, Block-II, PECHS, Syringe (with policy decision years for
needle) by the Policy 3ml clarification
Karachi. Board/Federal from the

Manufactured by: Government 5ml applicant
regarding
M/s PT Nipro Indonesia 10ml non-
Jaya, Kawaran Industri permanent
Suryacipta, JI Surya Utama 20ml
marking of
Kav, 122B, 23 & 24, Desa 10ml &
Kutamekar, Kec, Ciampel, 20ml
Karawang, Jawa Barat, syringes
Indonesia. with delible
ink.
2. M/s Lab Link Enterprises, Nipro Disposable -do- 30ml 5 Deferred

192-N, Block-II, PECHS, Syringe years for
(without needle) 50ml clarification
Karachi. from the
Manufactured by: applicant
regarding
M/s PT Nipro Indonesia non-
Jaya, Kawaran Industri permanent
Suryacipta, JI Surya Utama marking of
Kav, 122B, 23 & 24, Desa 30ml &
Kutamekar, Kec, Ciampel, 50ml
Karawang, Jawa Barat, syringe with
Indonesia. delible ink.
3. M/s Lab Link Enterprises, Nipro Disposable -do- 1 ml 5 Approved.

192-N, Block-II, PECHS, Syringe U-100 years
Insulin with
Karachi. needle
Manufactured by:

Kav, 122B, 23 & 24, Desa
Indonesia.

Case No.02. Withdrawal of registration applications of medical devices.
The following importing firms are withdrawing their registration applications of

medical devices as mentioned against each. The firms have also not deposited differential fee as
per revised fee schedule for their products:-
S.No Name of Importer and Name of Medical Demanded Shelf Remarks

Manufacture/Exporter. Device (s) price & Pack life
size
1. M/s Otsuka Pakistan Ltd. Jive Stent (PTCA Decontrolled till 2 Reference
30-B Sindhi Muslim Balloon Catheter) policy decision years No.27/12/
Cooperative Housing by the Policy Stent-Reg.
Society, Karachi. Board/ Federal
Manufactured by Government. Dated:
M/s Micro Port Medical 26-12-2011.
(Shanghai) Co. Ltd.,
China.
2. M/s Otsuka Pakistan Ltd. Firebird (Rapamycin Decontrolled till 12 Reference
30-B Sindhi Muslim Eluting Stainless Steel policy decision month No.26/12/
Cooperative Housing Coronary Stent by the Policy s Stent-Reg.
Society, Karachi. System) Board/ Federal
China.
3. M/s Otsuka Pakistan Ltd. Firebird-2 (Rapamycin Decontrolled till 09 Reference
30-B Sindhi Muslim Cobalt Chromium policy decision month No.30/12/
Cooperative Housing Coronary Stent by the Policy s Stent-Reg.
China.
4. M/s Otsuka Pakistan Ltd. Mustang Stent Decontrolled till 2 Reference
30-B Sindhi Muslim (Stainless Steel policy decision years No.28/12/
Cooperative Housing Coronary Stent by the Policy Stent-Reg.
Manufactured by
Government. Dated :
M/s Micro Port Medical
26-12-2011.

(Shanghai) Co. Ltd., China.
5. M/s. Intek Corporation, Blazer CoCr Alloy Decontrolled till 24 The firm
Rawalpindi. / Coronary Stent policy decision months has
by the Policy
Manufacturer: Delivery System Board/ Federal informed
M/s. OrbusNeich (Cobalt Chromium Government. that further
Medical B.V. Drs, W. Stent). action on
Van Royenstraat, AN (Medical Device). this product
Hoevelaken, The is no more
Netherlands. required.
Shipped From:-
M/s. Asia Cardiovascular
Products Ltd., Kwai
Chung, N.T. Hong Kong.
Decision: Registration Board considered the request of the firms for withdrawal of their
applications for registration of above mentioned medical devices and approved
the request.
Case No.03. Cancellatiuon of sole agency agreement.
M/s. A.H Distributors, Kh-1183, Lane No.5, Peshawar Road, Rawalpindi had
applied for registration of Primum Guiding Catheter and Pointer Angiographic Catheter for
import from foreign manufacturer i.e. Pendra Care International B.V Van der Waalspark 22 9351
VC leek the Netherlands. The importing firm was advised to complete the
documents/information including fresh authorization letter and differential fee as per revised fee
schedule but the importing firm has not responded till now. The authorization letter of principal
manufacturer in respect of importer M/s A.H Distributors, Rawalpindi was expired on 31-12-
2011. The manufacturer M/s Pendra Care International B.V Netherlands, has sent a termination
letter in respect of M/s A.H Distributors for the above mentioned products directly to Drug
Regulatory Authority of Pakistan. In the aforementioned letter the manufacturer has confirmed
that they terminated the business relationship with A.H Distributors, Rawalpindi.
Decision: The Board after thorough discussion decided that final reminder should be
issued to the firm for submission of all deficient documents including fresh

authorization letter from the principal manufacturer, attested by the
Embassy of Pakistan in the country of origin and the prescribed differential
fee. If the applicant fails to provide the aforesaid documents and prescribed
differential fee within 15 days, the above mentioned applications shall not be
entertained for registration.
Case No.04. Case remanded back by the Appellate Board.
The Registration Board in its 240th meeting held on 7th November, 2013 considered and
rejected the following medical device of M/s Mana & Co, Karachi due to the reason mentioned
below against the product:-
S.No. Name of Importer and Name of Medical Demanded Shelf Decision

Manufacturer/Exporter. Device price & life
Pack size
1. M/s Mana & Co, Medicare IV Decontrolled 5 Rejected
204 New Medicine Market, Near Catheter with (14G, 16G, years due to
Densohall, Karachi. Injection Port. 18G, 20G, incomplete
Manufactured by 22G, 24G ) and
M/s Jiangxi Huali Medical unsatisfact
Instrument Co.Ltd. Yudu ory
Industrial Zone,Ganzhou, Jiangxi, stability
China. profile.
Rejection letter was issued to the importing firm. The said firm filed an appeal against the
decision of Registration Board before Appellate Board. The Appellate Board in its 142nd
meeting held on 24th June, 2014 decided as under:-
“The Board in light of the stability data submitted before it and taking a lenient view
decided to remand the case to the Registration Board for decision under the rules.”
Decision: Registration Board decided to ask the importing firm to submit complete
stability profile for the above mentioned device for review.

Case No.05 Miscellaneous Cases.
a. Relaxation in the condition of Drug (Labeling & Packaging) Rules, 1986. (Deferred
in 245th meeting of Registration Board).
M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi has requested for relaxation in
condition of Drug (Labeling & Packaging) Rules, 1986 i.e. Urdu version, Pak Registration
Number and MRP of their already registered imported Prowler Micro Catheters (Registration
No.074692).
The firm has submitted that Prowler family of Micro Catheters being labeled as
per the requirement of Medical Device directives 93/42, GHTF labeling recommendation. As
Prowler Micro Catheters belongs to sterile sensitive class of medical device and it is supplied in
sterile peel open packages after carrying out all recommended package integrity and sterility
validation tests. To ensure the sterility of product till it is received by key user, packaging
qualification testing is performed on all Prowler Micro Catheters which are packaged in a
preformed tray, sealed in packaging pouch and placed in a folding carton. The same sterilized
pack being supplied in all International countries. The firm has deposited the required fee for
above mentioned product.
The firm has further submitted that the demand forecast of Prowler Micro Catheters in
Pakistan is only 1% of the global supply, so it is not viable for their Principal manufacturer to
produce country specific packs for such a small volume. Therefore, the firm requested for the
following approval:-
“That they may be allowed to import Prowler Micro Catheters in international

packs provided that company will perform ink jet printing of Urdu version, Pak
Registration No. and maximum retail price at their locally licensed premises.”
The case was placed before Registration Board in its 245th meeting and the Board
deferred the case and decided to call the firm M/s Johnson and Johnson Pakistan (Pvt) Ltd,
Karachi for personal hearing alongwith samples of the product in the forthcoming meeting of the
Board. Accordingly letter was issued to the firm for personal hearing alongwith provision of
samples.

Decision: Registration Board deferred the case and decided to call the firm M/s Johnson
and Johnson Pakistan (Pvt) Ltd, Karachi for personal hearing alongwith
samples of the product in the next meeting of the Board.
b. Inspection of Manufacturer Abroad M/s Biosensors Interventional Technologies Pte

Ltd., Kampong Ubi, Industrial Estate, Singapore.
The Registration Board in its 238th meeting held on 5TH & 6TH August, 2013
considered and approved the following medical devices of M/s Promed International, Islamabad
subject to inspection of manufacturer abroad, local storage facility etc:-
S. Name of Importer and Name of Medical Device Demanded Shelf

No Manufacturer/Exporter (s) Price & Life
Pack Size
TM
1. M/s. Promed International, Power Line PTCA Decontrolled 36
Ground Floor, Jamil Mohsin Catheter months
Mansion, G-6 Markaz, 1’s
Islamabad. Balloon Dia (mm):
Manufacturer: 1.5, 2.0, 2.5, 2.75, 3.0,
Biosensors Interventional 3.5, 4.0.
Technologies Pte Ltd.,
Kampong Ubi, Industrial Balloon Length (mm):
Estate, Singapore. 10,15, 20, 25, 30.
(Many product codes)
2. M/s. Promed International, Bio Matrix TM Drug Decontrolled 19

Ground Floor, Jamil Mohsin Eluting Coronary Stent months
Mansion, G-6 Markaz, System. 1’s
Islamabad
Legal Manufacturer: Stent Inner Dia (mm):
Biosensors Europe SA, Ch- 2.25, 2.5, 2.75, 3.0, 3.25,
1110 Morges, Switzerland. 3.50, 4.0.
Manufacturing Site:
Biosensors Interventional Stent Length (mm):
Technologies Pte Ltd., 8, 11, 14, 18, 23, 24, 28.
Kampong Ubi, Industrial
Estate, Singapore. (Many product codes)

3. M/s. Promed International, BioMetrix Flex TM Drug Decontrolled 24
Ground Floor, Jamil Mohsin Eluting Coronary Stent months
Mansion, G-6 Markaz, System 1’s
Islamabad
Legal Manufacturer: Stent Inner Dia (mm):
Biosensors Europe SA, Ch-1110 2.25, 2.5, 2.75, 3.0, 3.50,
Morges, Switzerland. 4.0.
Manufacturing Site:
Biosensors Interventional
Stent Length (mm):
Technologies Pte Ltd., Kampong 8, 11, 14, 18, 24, 28, 33,
Ubi, Industrial Estate, 36.
Singapore. (Many product codes)
4. M/s. Promed International, Gazelle Coronary Stent Decontrolled 24
Ground Floor, Jamil Mohsin System months
Mansion, G-6 Markaz, 1’s
Islamabad Stent Dia (mm):
Legal Manufacturer: 2.25, 2.5, 2.75, 3.0, 3.25,
Biosensors International Pte. 3.50, 4.0.
Ltd, 21 Kallang Avenue,
Singapore Manufacturing Stent Length (mm):
Site: 8, 11, 14, 18, 23, 24, 28.
Biosensors Interventional
Technologies Pte Ltd., (Many product codes)
Kampong Ubi, Industrial
Estate, Singapore.
Accordingly the inspection of manufacturer abroad has been carried out by the panel
comprising Mr. Sayyad Hussain Khan, DDC (LA) and Ms. Sara Mehreen, ADC, DRAP,
Islamabad on 1st and 2nd September, 2014. The panel has not recommended the products for
registration on the basis of following major concerns:-
(i) Firm is importing stents in finish form either from Germany or from China. So
there was no way to verify their manufacturing standard.
(ii) Sterility testing is outsourced and either performed in Malaysia or Germany. So
the panel was not able to check the process of sterilization for the applied
products. However, final release of the products is firm itself.
(iii) As the firm was shifting to their own constructed new premises and few
operations including microbiological testing had already been shifted to the new
premises. So the panel was not able to check their microbiological testing
process as inspection of new premises was not the mandate of the panel.

(iv) One of the applied products namely BioMatrix Flex Drug Eluting Coronary Stent
is not on free sale in the country of origin, which is one of the conditions for
registration of imported drugs in Pakistan.
Decision: Regiastration Board discussed the inspection report in detail and keeping in
view nature of the observations being critical rejected the above applications of M/s.
Promed International, Iislamabad manufactured by M/s. Biosensors Interventional
Technologies Pte Ltd., Kampong Ubi, Industrial Estate, Singapore.

Item No.X: Local Manufacturing of Biological Drugs.
The following cases for the local manufacturing biological drugs were decided in the
244th Meeting of the Drug Registration Board. The details of the cases and decisions taken by the
Drug Registration Board in its 242nd, 243rd and 244th Meeting are as below: -
Sl.# Applicant Product Specifications

1. Getz Pharma, Karachi. Eptifib Solution for Infusion 75mg/100ml
2. Getz Pharma, Karachi Eptifib Solution for Injection 20mg/10ml
3. Getz Pharma, Karachi Enoxa Injection

20mg/0.2ml Injection Each Pre-filled
syringe
4. Getz Pharma, Karachi Enoxa 40mg/0.4ml Injection
Each Pre-filled syringe
5. Getz Pharma, Karachi Enoxa

60mg/0.6ml Injection
6. Getz Pharma, Karachi Enoxa
80mg/0.8ml Injection
7. Getz Pharma, Karachi Gilia solution for injection
Glatiramer acetate 20mg/ml
8. Getz Pharma, Karachi Lira Solution for injection

6mg/ml Solution for Injection in Cartridge
9. Getz Pharma, Karachi . Menocon

Lyophilized Powders for Injection 1000 IU
USP
10. Getz Pharma, Karachi Menocon
Lyophilized Powders for Injection 5000 IU
USP
11. Getz Pharma, Karachi Menoget
Menotropins 75IU /2ml vial
12. Getz Pharma, Karachi Menoget
Menotropins 150IU / 2ml vial
13. Getz Pharma, Karachi Neupeg injection

14. Getz Pharma, Karachi Getiferon
Solution for Injection
3 MIU in Vials
Solution for Injection 5MIU in Vials
3 MIU in Pre-Filled Syringes Each Pre-
Filled
5 MIU in Pre-Filled Syringes
18. Getz Pharma, Karachi Uniferon Solution for Injection
3 MIU in Vials
5 MIU in Vials
3MIU in Pre-Filled Syringe
5MIU in Pre-Filled Syringes
22. Getz Pharma Unipeg 80 Solution injection 180mcg/mL
in vial
23. Getz Pharma Unipeg 40 Solution injection 180mcg/0.5
mL in Prefilled Syringe
24. Getz Pharma Unipeg Solution injection 180mcg/mL in
vial
25. Getz Pharma Unipeg Solution injection 180mcg/0.5mL
in Prefilled syringe
Applicant Product Specifications

26. Macter International Heberon 2a Injection 3MIU/0.3ml.
Limited, Karachi (Liquid Solution)
27. Macter International Heberon 2a Injection 5MIU/0.5ml.

Limited, Karachi (Liquid Solution)
28. Macter International Heberon 2a Injection 3MIU/ml
Limited, Karachi (Lyophilized Powder)
29. Macter International Heberon 2a Injection 5MIU/ml

Limited, Karachi (Lyophilized Powder)

30. Macter International Peg-In Injection
Limited, Karachi 50mcg /0.5ml
(Lyophilized Powder)
31. Macter International Peg-In Injection 80mcg /0.5ml
Limited, Karachi
35. Macter International Neupeg
Limited, Karachi 6mg/ml Injection Each vial
36. Macter International, Prance Injection
Karachi. Recombinant Human Basic Fibroblast
growth factor.
37. Macter International, Macgrastim Injection
Karachi. Pre-filled Syringe
Granulocyte colony stimulating factor.
Applicant Product specifications

38. Hilton Pharma (Pvt) Xiro Injection
Ltd., Karachi. Filgrastim 300ug
39. Hilton Pharma (Pvt) Lameo Injection 3MIU
Ltd., Karachi. Interferon alfa 2a
40. Hilton Pharma (Pvt) Lameo Injection 5MIU
Ltd., Karachi. Interferon alfa 2a
Applicant Product specifications

41. M/s Nextar Pharma Nexfil 150 Injection
(Pvt) Ltd., Karachi
42. M/s Nextar Pharma Nexfil 300 Injection

(Pvt) Ltd., Karachi Each Prefilled syringe
43. M/s Nextar Pharma Pegaron Injection

(Pvt) Ltd., Karachi

44. M/s Nextar Pharma NP-POETIN 2000 INJECTION
(Pvt) Ltd., Karachi
45. M/s Nextar Pharma NP-POETIN 4000 INJECTION
(Pvt) Ltd., Karachi
Decision of 242nd Meeting of Drug Registration Board. Product Approved, however, cGMP /
COPP is required of the finished Drug manufactured using this particular drug substance in the
country of origin. Biosimilarity data of locally manufactured drug needs to be disclosed by the
local manufacturer. However the minutes of the meeting were quarantine due to observation of
members of Drug Registration Board.
Decision of 243rd Meeting of Drug Registration Board: - Decision recorded in 242nd Meeting
upheld. Further, all firms will submit Bio-comparability data followed by regular Pharmaco-
vigilance report.
Final Decision of the Drug Registration Board in its 244th Meeting: -
“ a) Biosimiliarity is the principal requirement for the registration of biological

drugs, as it is part of requirements of DRAP Act, 2012 mainly focusing on
patient safety and also to promote biological production and availability of
biological products.
b) All those manufacturing units which have been approved by Central
Licensing Board for manufacturing of biological drugs and also had
qualified product specific inspection by panel of Registration Board, are
allowed registrations of applied biological drugs for local manufacturing on
case to case basis. Item for which product specific inspection is required,
then it will be conducted by already constituted panel of Registration Board.
c) Local manufacturer will provide legalized documents from concerned
regulatory body confirming the status of licensed manufacturer of
concentrate/bulk source in its country of origin. Moreover manufacturer
will provide legalized documents for confirmation that finished product is
also available in market from the same biological material. Case will be
processed for issuance of registration letter after fulfillment of above
mentioned requirements, with following conditions:
i. Registration is exclusively for trial manufacturing of the drug and
manufacturer shall not be allowed in any way to sale/utilize these
trial manufactured drugs. Manufacturer will perform biosimilarity
studies as per WHO guidelines confirming the biosimilarity of
applied product to original innovator product.
ii) Manufacturer will submit actual result of conducted biosimilarity
studies to the Biological Division for its scientific evaluation
through Expert Committee on Biological Drugs (ECBD).
Moreover manufacturer will also provide sufficient quantity of
these trial manufactured drugs to Biological Division for testing by

National Control Laboratory for Biological (NCLLB) as per WHO
guidelines.
iii) Recommendation of ECBD and report of NCLB will be submitted
to Registration Board for permission of commercial manufacturing
of the product or otherwise.
d) This decision supersedes all the already taken decisions so far in the
earlier meetings of Registration Board on the subject cases”.
The decision of the Board was communicated to the concerned companies. In response to
which the companies have submitted documents. The documents of M/s Nextar, Karachi were
complete and inspections of the company already conducted supported the trial manufacturing of
biological products. Accordingly trial production of 04 products out of 05 products (for one
product COPP was missing) was allowed to the company. Product specific inspection of the
company has not been conducted. The Board may decide the requirement of product specific
inspection of the company.
The documents of M/s Getz Pharma, Karachi required further support (COPP not provided) of
their case and under process while M/s Hilton has not responded yet. Two products of M/s
Macter Pharma, Karachi i.e., Prance and Macgrastim are to be imported in the form of
labelled finished vial and repacked locally which may be dealt as per procedures of import policy
for finished drugs. For rest of the products the documents submitted by the company are under
review.
The case of local manufacturing of biological drugs was also under examination of
Honourable Ombudsman on the complaint of M/s Macter International, Karachi. The
findings/recommendations of the Honourable Wafaqi Mohtasib are as below: -
The record of DRAP showed that more than 300 drugs of similar formulation
were freely available in the market. Moreover, DRAP had already
registered/approval more than 500 vaccines. The complainant’s case was
approved in 243rd board meeting with certain conditions which the complainant’s
fulfilled. He was never informed as to why without assigning any reason new
conditions were imposed. It was surprising to note that although the decision of
243rd meeting had become final and the minutes were displayed on DRAP Website
yet again the earlier decision was revised in 244th Board meeting and fresh
stringent requirements were proposed. The record also indicates that the drugs
registration board did not work in a systematic and organized manner. The
complainant’s case was examined and scrutinized by an expert committee and
cleared by the drug registration board which included technical experts and
eminent health professionals. It was noteworthy that the conditions prevalent at
the time of submission of application by the complainant were met and
subsequently additional conditions were applied retrospectively which was an
unfair practice. New conditions could only have been applied to fresh application.
After finalization of the decision of the 243rd Drug Registration Board Meeting,
imposition of a new condition by DRAP tantamount to mal-administration in

terms of Article 2(2) of the President’s Order No.1 of 1983. It is therefore,
recommended that: -
1) The complainant’s product be registered in line with the decision of
243rd board meeting and already done in the case of more than 300
registered biological products which are already being manufactured
in accordance with previous requirements.
2) There should be no discrimination and the complainant be allowed a
time frame as had been granted to other manufacturers of registered
biological products to bring their products in conformity with the new
requirements.
Compliance should be reported within 30 days of the receipt of a copy of these
findings or the reasons for not doing so be submitted in terms of Article 11(2) of
the President’s Order No 1 of 1983. Under provision of Article 11(2A) of P.O. 1
of 1983 read with section 13 of Federal Ombudsmen Institutional Reforms Act,
2013 and Article 32 of P.O. 1 of 1983 under which any person, aggrieved by a
decision or an order by the Wafaqi Mohtasib may also, within thirty days: -
(a) File a review petition before the Wafaqi Mohtasib; or

(b) Make a representation to the President.
Discussion:
On the direction of the Honorable Ombudsman, the case was taken up by the Drug
Registration Board on priority.
The matter related to local manufacturing of biological drugs was discussed on 10th
December, 2014 in the meeting. The Board discussed / examined in detail its earlier decisions
taken in 243rd and 244th Registration Board meeting regarding registration of biological drugs.
The Board observed that there is no difference in both decisions and in later meeting (244th), the
Board only devised implementation process for decision taken in 243rd meeting. The members of
the Board also examined the decision of Honorable Ombudsman and the whole matter of local
manufacturing of biological drugs was re-examined with holistic approach, keeping in view
ensuring the public health and safety, efficacy, quality of locally manufactured biological drugs.
It was also agreed by the Board that these local manufacturers (M/s. Macter International
Karachi, M/s. Getz Pharma Karachi, M/s. Nextar Pharma, Karachi and M/s. Hilton Pharma,
Karachi) will be provided an opportunity for appraising their views with the Registration Board
on next day.
Following representatives of four manufacturers attended the meeting for presentation of
their case.

i. Mr. Abdur Jabbar Saya (M/s. Nextar, Karachi)
ii. Syed Asghar Abbass Alve (M/s. Nextar, Karachi)
iii. Mr. Saleem Riaz (M/s. Hilton Pharma, Lahore)
iv. Dr. Salman Ahmad (M/s. Macter Pharma, Karachi)
v. Mr. Farooq Mustafa (M/s. Macter Pharma, Karachi)
vi. Mr. Zeeshan Ahmad (M/s. Getz Pharma, Karachi)
vii. Mr. Ayub Malik (M/s. Getz Pharma, Karachi)
viii. Mr.Shamim Ahmad, PPMA representative for the meeting
The firms unanimously presented / argued that Registration Board previously did not implement/
demand CoPP/ Free sale certificate from local manufacturer of biological drugs. But now only
GMP certificate of the foreign manufacturer can be provided which should be accepted by the
Drug Registration Board. Moreover, the condition of providing bio-similarity data should not be
imposed as per previous practice of the Registration Board for already registered locally
manufactured drugs as this condition will result in further delay which can be very damaging to
new biopharmaceutical units. Condition of clinical studies should not be imposed. The
manufacturer shall ensure the quality, safety and efficacy of locally manufactured biological
drugs by them.
Representatives of the firms, PPMA and Pharma Bureau re-iterated that already
registered biological drugs may be re-assessed in light of safety, efficacy and quality parameters.
Decision: After all detailed discussion and directions of the Ombudsman, Registration
Board decided as follows:
1. As the Registration Board in 244th meeting has already approved registration of
biological drugs for four manufacturers (M/s. Macter International Karachi, M/s.
Getz Pharma Karachi, M/s. Nextar Pharma, Karachi and M/s. Hilton Pharma,
Karachi) for local manufacturing. In order to issue registration letter, the Board
advised these manufacturers to provide following document as discussed and agreed
during the deliberations with manufacturers:
a. The firms shall provide legalized GMP certificate of biological drug
manufacturer abroad (who will provide concentrate / ready to fill bulk of
biological drug to Pakistani manufacturers for further processing) as an
evidence that the manufacturer is an authorized manufacturer of that
particular biological drug in its country of origin.

b. The firm shall provide studies conducted by manufacturer abroad (dully
verified with statement for correctness / genuineness of data) regarding
structural similarity of subject biological drug product (concentrate/ ready to
fill bulk for further processing) with reference biological product
(innovator).
c. The local manufacturer shall be authorized to manufacture the finished
biological product and then perform bio-comparability studies including
identity testing to parent molecule, purity testing, in vitro biological activity,
potency and toxicity with support of iso-electro focusing data, gel
electrophoresis, Western-Blot and other analytical techniques) and stability
studies of finished biological product. Data provided by the local
manufacturer shall be evaluated by the Expert Committee on Biological
Drugs. Recommendation of the committee shall be considered by the
Registration Board for issuance of registration letter.
d. The firms shall conduct parallel bio-similarity studies as per WHO
guidelines immediately after grant of registration and shall submit complete
studies with in two (2) years in any case. Manufacturer will provide progress
report to this effect to Directorate of Biological Drugs on quarterly basis.
e. Regular monitoring through pharmacovigilance reporting system shall be
observed through proper pharmacovigilance cell of the manufacturer and
report will be forwarded to the National Pharmacovigilance Centre, Division
of Pharmacy Services and Biological Division of DRAP. In case of any severe
adverse event, immediate mandatory reporting procedure shall be followed.
f. If any of the conditions is not fulfilled or public health risk reported at any
stage, the drug registration shall stand cancelled with immediate effect.
g. All the provisions as contained in the Drugs Act, 1976 and rules made there
under including provisions of Lot Release certification from National
Control Laboratory for Biologicals shall be strictly adhered to.
2. Already registered biological drugs shall be reviewed in the same manner.
3. New applications for registration of biological drugs shall be considered after
compliance of above point.

Item No.XI: Applications for transfer of registrations
Various firms (column II) have applied for transfer of registrations. Registration Board
on 10.12.2014 advised P E & R Division to bring such applications for its consideration. Various
applications were considered as per following details:
S. No. Name of Name of Date of Registration Name of product with
applicant(s) existing application, No. composition
manufacturer Diary No . &
Form
I II III IV V VI
1. M/s M/s Akhai 20-06-2014 017889 Traxon 1gm IM/IV
GlaxoSmithKlin Pharmaceutical Dy.No.594 Injection
e Pakistan Ltd, s, Karachi Form-5 Each vial contains:-
Kara Rs.40000/- Ceftriaxone Sodium
…………..1gm
2. -do- -do- 20-06-2014 017890 Traxon 500mg IM/IV
Dy.No.595 Injection
Form-5 Each vial contains:-
Rs.40000/- Ceftriaxone Sodium
…………..500mg
3. -do- -do- 20-06-2014 017891 Traxon 250mg IM/IV

Dy.No.596 Injection
Form-5 Each vial contains:-
Rs.40000/- Ceftriaxone Sodium
…………..250mg
4. M/s Martin Dow M/s Martin 10-02-2014 027216 Biprofin Tablets

Ltd, Karachi Dow Dy.No.113 Each tablet contains:-
Pharmaceutical Form-5 Flurbiprofen
s (Pakistan) Rs.20,000/- …………..50mg
Ltd, 45-KM,
Multan Road,
Lahore
5. -do- -do- 10-02-2014 027216 Biprofin Tablets
Dy.No.112 Each tablet contains:-
Form-5 Flurbiprofen
Rs.20,000/- …………..100mg
6. -do- -do- 10-02-2014 049189 Fexinol-D Tablet

Form-5 Pseudoephedrine HCl

Rs.20,000/- …….120mg
Fexofenadine HCl
………. 60mg
7. -do- -do- 10-02-2014 018485 Covatine Coated Tablet

Form-5 Captodiamine HCl
Rs.20,000/- ……….50mg
8. -do- -do- 14-04-2014 042810 Fexinol Tablets 30mg

Form-5 Fexofenadine HCl
Rs.20000/- ……30mg
9. -do- -do- 14-04-2014 024311 Fexinol capsule

Dy.No.342 Each capsule contains:-
Rs.20000/- ……80mg

Rs.20000/- ……120mg

Rs.20000/- ……180mg
12. M/s Novartis M/s Novartis 24-06-2014 022204 Lozal 20mg Capsule
Pharma Pharma Dy.No.636 Each capsule contains:-
(Pakistan) Ltd, (Pakistan) Ltd, Form-5 Omeprazole
(DML (DML Rs.20,000/- …………..20mg
No.000193), No.000010),
West Wharf Jamshoro. 18-09-2014
Road, Karachi Dy.No.800
Rs.80,000/-
13. M/s Elko M/s Macquin’s 12-11-2013 048507 Aqua Teas Eye Drops
Organization International, Dy.No.1003 Each ml contains:-
(Pvt.) Ltd, Karachi Form-5 Dextran………1mg
Karachi Rs.20,000/- HPMC……….3mg

Glycerin……...2mg
(Manufacturer’s
Specification)
14. -do- -do- 12-11-2013 044457 MetaDex Eye / Ear

Dy.No.1003 Drop
Form-5 Each ml contains:-
Rs.20,000/- Ciprofloxacin…..3mg
Dexamethasone..1mg
(Manufacturer’s
Specification)
15. -do- -do- 12-11-2013 044449 Blepharite Eye Drop

Dy.No.1003 Each ml contains:-
Form-5 Sulfacetamide…0.10g
Rs.20,000/- Prednisolone
Acetate.…..2mg
Phenyephrine
HCl……..1.2mg
(Manufacturer’s
Specification)
16. M/s M/s AGP (Pvt.) 26-06-2013 015027 Atarax Syrup

GlaxoSmithKlin Ltd, Karachi Dy.No.1084 Each 5ml contains:-
e Pakistan Ltd, Form-5 Hydroxyzine
F-268, S.I.T.E, Rs.20,000/- Dihydrochloride..10mg
(DML
No.000233)
Karachi
17. -do- -do- 26-06-2013 007591 Atarax Tablet 10mg
Form-5 Hydroxyzine
Rs.20,000/- Dihydrochloride..10mg
18. -do- -do- 26-06-2013 002287 Navidoxine Tablet

Form-5 Meclozine
Rs.20,000/- Dihydrochloride..25mg
Pyridoxine
Hydrochloride..50mg
19. -do- -do- 26-06-2013 034675 Xyzal Tablet

Dy.No.1084 Each film coated tablet
Form-5 contains:-
Rs.20,000/- Levocetirizine
Dihydrochloride………
…….5mg
20. -do- -do- 26-06-2013 016937 Zyrtec Syrup

Dy.No.1084 Each ml contains:-
Form-5 Cetirizine 2HCl
Rs.20,000/- ………….1mg
21. -do- -do- 26-06-2013 011020 Zyrtec Tablet 10mg

Form-5 Cetirizine 2HCl
Rs.20,000/- ………….1mg
22. M/s Bosch M/s Bosch 12-03-2014 037306 Ambac Injection 0.75gm
Pharmaceuticals Pharmaceutical Dy.No.190 Each vial contains:
(Pvt.) Ltd, s (Pvt.) Ltd, Form-5 Ampicillin sodium USP
(DML (DML Rs.20,000/- eq. to
No.000707), No.000350), Ampicillin…….500 mg
Karachi (Plant- Karachi (Plant- Sulbactam Sodium USP
II) I) eq. to
Sulbactam……250 mg
23. -do- -do- 12-03-2014 037629 Ambac Injection 1.5gm

Dy.No.188 Each vial contains:
Form-5 Ampicillin sodium USP
Rs.20,000/- 1.06gm eq. to
Ampicillin………1gm
Sulbactam Sodium USP
0.545gm eq. to
Sulbactam……500 mg
24. -do- -do- 12-03-2014 042424 Bactamox Plus 0.75gm
Dy.No.189 Injection
Form-5 Each vial contains:
Rs.20,000/- Amoxicillin Sodium (as
Amoxicillin Sodium
Anhydrous)B.P …0.50
gm
….0.25gm

(USP Specification)
25. -do- -do- 12-03-2014 042425 Bactamox Plus 1.5gm
Dy.No.187 Injection
Amoxicillin Sodium
Anhydrous)B.P …1.0
gm
….0.5gm
(USP Specification)
26. -do- -do- 12-03-2014 042426 Bactamox Plus 3gm

Dy.No.186 Injection
Amoxicillin Sodium
Anhydrous) B.P …2.0
gm
….1.0gm
(USP Specification)
27. -do- -do- 12-03-2014 015906 Boschoclox Injection

Dy.No.185 250mg
Rs.20,000/- Cloxacillin Sodium USP
eq. to 250mg
Cloxacillin Base
28. M/s M/s 14-06-2012 0001859 Kenacomb Cream

GlaxoSmithKlin GlaxoSmithKli Dy.No.315 Each gram contains:-
e Pakistan Ltd, ne Pakistan Form-5 Triamcinolone
Korangi Plant Ltd, Rs.8,000/- Acetonide USP …1mg
Karachi West Wharf, 29-04-2013 Nystatin USP
Karachi Rs.12000/- ………….100,000 units
Gramidicin USP
………...0.25mg
29. -do- -do- 14-06-2012 005026 Kenacomb Ointment

Dy.No.314 Each gram contains:-
Form-5 Triamcinolone

Rs.8,000/- Acetonide USP ….1mg
29-04-2013 Nystatin USP
Rs.12000/- ………….100,000 units
Gramidicin USP
……………...0.25mg
Neomycin Sulphate eq.
to 2.5mg base
30. -do- -do- 14-06-2012 009452 Kenalog Orabase

Dy.No.316 Ointment
Form-5 Each gram contains:-
Rs.8,000/- Triamcinolone
29-04-2013 Acetonide USP ….1mg
Rs.12000/-
31. M/s Hilton M/s Brookes 11-07-2013 021661 Zinum 250mg Injection
Pharma, Karachi Pharma, Dy.No.692 Each vial contains:-
Karachi Form-5 Ceftazidim Sodium
Rs.20,000/- ……….250mg
32. -do- -do- 11-07-2013 021662 Zinum 500mg Injection

Dy.No.693 Each vial contains:-
Form-5 Ceftazidim Sodium
Rs.20,000/- ……….500mg
33. -do- -do- 11-07-2013 021663 Zinum 1gm Injection

Form-5 Ceftazidim Sodium
Rs.20,000/- ……….1gm
34. -do- -do- 11-07-2013 021664 Axone 250mg Injection

Form-5 Ceftriaxone Sodium
Rs.20,000/- …….250mg
35. -do- -do- 11-07-2013 021665 Axone 500mg Injection

Rs.20,000/- …….500mg
36. -do- -do- 11-07-2013 021666 Axone 1gm Injection


Rs.20,000/- …….1gm
37. M/s Indus M/s Nimrall 05.11.2014 054553 Rudra 5mg Tablet
Pharma, Karachi Laboratories, Dy.No.394 Each tablet contains:-
Islamabad Form-5 Rosuvastatin (as
Rs.20,000/- Calcium) …….5mg
38. -do- -do- 05.11.2014 054554 Rudra 10mg Tablet

Form-5 Rosuvastatin (as
Rs.20,000/- Calcium) …….10mg
39. M/s Sante (Pvt.) M/s Elko 18-09-2014 070516 Dequsan Throat / Mouth
Ltd, Karachi Organization Dy.No.657 Spray Solution
(Pvt.) Ltd, Form-5 Each 100ml contains:-
Karachi Rs.20,000/- Dequalinium Chloride
BP………15mg
Benzalkonium Chloride
BP………..35mg
40. M/s Pfizer M/s wyeth 06-02-2014 000083 Ativan 1mg Tablets
Pakistan Ltd, Pakistan Ltd., Dy.No.68 (Lorazepam)
DML Karachi Form-5
No.000025 contract Rs.20,000/-
(Formulation) at manufactured
B-2, SITE, by M/s Spencer
Karachi & Co
(Pakistan) Ltd,
Karachi.
41. -do- -do- 06-02-2014 000084 Ativan 2mg Tablets

Dy.No.68 (Lorazepam)
Form-5
Rs.20,000/-
42. M/s Ambrosia M/s Spencer & 29-10-2014 006348 Calcipan-T 50 mg
Pharmaceuticals Co, Karachi Dy.No.634 Tablet
, Rawat Form-5 Each tablet contains:-
Calcium
Rs.20,000/-
Pantothenate……..50
mg
43. -do- -do- 29-10-2014 067454 Infacol 40 mg Drops

Each ml contains:-

Dy.No.635 Simethicone
Form-5 …………40 mg
Rs.20,000/-
44. -do- -do- 29-10-2014 008801 Infacol Suspension
Dy.No.633 Each 5 ml contains:-
Form-5 Dicyclomine HCl
……….5 mg
Rs.20,000/-
Simethicone ………
…50 mg
45. M/s Glitz M/s Caraway 784; 09.12.2014 066362 G-Cal 5 mg Injection
Pharma, Pharmaceutical Rs.50000/- Each ampoule contains:-
Islamabad , Rwat Form 5 Cholecalciferol eq. to
Cholecalciferol
……………. 5 mg
46. M/s Focus & M/s Highnoon 970; 10.12.2014 027104 Helezol 20 mg Capsule
Rulz, Islamabad Labs, Lahore Rs.20000/- Each delayed-release
Form 5 capsule contains:-
Omeprazole enteric
coated pellets 8.5%
≡ Omeprazole……. 20
mg
47. -do- -do- 976; 10.12.2014 051054 Helezol 40 mg Capsule

Rs.20000/- Each delayed-release
Omeprazole enteric
coated pellets 8.5%
≡ Omeprazole……. 40
mg
48. -do- -do- 971; 10.12.2014 025098 Angiocard 2.5mg

Rs.20000/- Capsule
Form 5 Each sustained-release
capsule contains:-
Nitroglycerin SR Pellets
≡ Nitorglycerin……..2.5
mg
49. -do- -do- 969; 10.12.2014 025099 Angiocard SR 6.5 mg

Rs.20000/- Capsule
Form 5 Each sustained-release
capsule contains:-
Nitroglycerin SR Pellets
≡ Nitorglycerin……..6.5
mg

50. -do- -do- 974; 10.12.2014 024929 Artonec 50 mg Capsule
Rs.20000/- Each delayed-release
Diclofenac Sodium
enteric coated pellets
≡ Diclofenac Sodium
…... 50 mg
51. -do- -do- 972; 10.12.2014 024930 Artonec SR-100 Capsule

Rs.20000/- Each sustained-release
Diclofenac Sodium
sustained release coated
pallets
≡ Diclofenac Sodium
….100 mg
52. -do- -do- 973; 10.12.2014 027105 Neopres 5 mg Tablet

Rs.20000/- Each tablet contains:-
Form 5 Amlodipine Besylate eq.
to
Amlodipine……….5mg
53. -do- -do- 968; 10.12.2014 027106 Neopres 10 mg Tablet

Rs.20000/- Each tablet contains:-
Form 5 Amlodipine Besylate eq.
to Amlodipine…10 mg
54. -do- -do- 975; 10.12.2014 051057 Delergic 5 mg Tablet

Rs.20000/- Each film coated tablet
Form 5 contains:-
Desloratidine……..5 mg
55. M/s. Synchro M/s. Obsons 05-06-2013 059991 Obdin Tablet 5mg
Pharmaceutical Pharmaceutic 926 Each tablet contains:-
s Lahore als, Lahore Form-5 Desloratadine…. 5mg
56. -do- -do- 05-06-2013 025404 Azrocin Suspension
5549 Each 5ml contains:-
Form-5 Azithromycin
dihydrate eq. to
Azithromycin.. 200mg
57. -do- -do- 05-06-2013 054157 Obflox Tablet
5548 Each tablet contains:-
Form-5 Levofloxacin
Hemihydrate
equivalent to

Levoflocaxin
…………. 500mg
58. -do- -do- 05-06-2013 030488 Obflox Tablet
Form-5 Levofloxacin
Hemihydrate
equivalent to
Levoflocaxin
…………. 250mg
59. -do- -do- 05-06-2013 054166 Obpra Capsule 40mg
5554 Each capsule
Form-5 contains:-
Enteric coated pellets
of Esomeprazole
magnesium trihydrate
eq. to Esomeprazole
…………… 40mg
60. -do- -do- 05-06-2013 029834 Vincam Capsule 20mg
5552 Each capsule
Form-5 contains:-
Piroxicam…… 20mg
61. -do- -do- 05-06-2013 025406 Rubinol Tablet
Form-5 Flurbiprofen.. 100mg
62. -do- -do- 05-06-2013 025403 Azrocin Capsule
5553 Each capsule
Form-5 contains:-
Azithromycin
dihydrate….. 250mg
63. -do- -do- 05-06-2013 054153 LevortizinTablet
Form-5 Leocetirizine
dihydrate 5mg
64. -do- -do- 05-06-2013 054165 Obpra Capsule
5555 Each capsule
Form-5 contains:-
Esomeprazole
magnesium trihydrate
enteric coated pellets
equivalent to
Esomeprazole
…………. 20mg
65. M/s. Searle IV M/s. the 22-04-2014 018632 Metronzine Injection
Solutions Searle 780 Each 100 ml
(Pvt.) Ltd; Company, Form-5

Lahore Karachi contains:-
Metronidazole
……….. 500 mg
66. -do- -do- 22-04-2014 044077 Vaptor 20 mg Tablets
Calsium) 20 mg
67. -do- -do- 22-04-2014 047384 Searl-α 0.5 mcg
790 Tablets
Form-5 Each tablet contains:-
Alfacalcidol
……………0.5 mcg
68. -do- -do- 22-04-2014 047391 Rhulef 20 mg Tablets
778 Each film coated
Form-5 tablet contains:-
Leflunomide
…………. 20 mg
69. -do- -do- 22-04-2014 014408 Gravinate Injection
782 Each ml contains:-
Form-5 Dimenhydrinate
………… 50 mg
70. -do- -do- 22-04-2014 047383 Searl- α 1 mcg Tablet
Form-5 Alfacalcidol
……………….. 1 mcg
71. -do- -do- 22-04-2014 067114 Peditral Liquid
797 Each 5 ml contains:-
Form-5 Sodium Chloride
…...... 17.50 mg
Potassium Chloride
…… 7.50 mg
Trisodium Citrate
Dihydrate .. 14.5 mg
Dextrose… 100.00 mg
(Flavour: Orange)
Form-5 Sodium Chloride ......
17.50 mg

Potassium Chloride
…… 7.50 mg
Trisodium Citrate
Dihydrate .... 14.5 mg
(Flavour: Regular)
787 Each film tablet
Form-5 contains:-
Leflunomide…. 10 mg
74. -do- -do- 22-04-2014 047382 Searl- α 0.25 mcg
789 Tablet
Form-5 Each tablet contains:-
Alfacalcidol….0.25
mcg
75. -do- -do- 22-04-2014 058022 Co-Olesta Tablet
Form-5 Olmesartan…... 20 mg
Hydrochlorothiazide
….. 12.5 mg
76. -do- -do- 22-04-2014 044075 Vaptor Tablets
Form-5 Rosuvastatine (as
Calcium) 5 mg
77. -do- -do- 22-04-2014 050736 Olesta 20 mg Tablet
Form-5 Olmesartan
Medoxomil … 20 mg
78. -do- -do- 22-04-2014 050737 Olesta 40 mg Tablet

Form-5 Olmesartan
Medoxomil … 40 mg
Form-5 Sodium Chloride ……
17.50 mg
Potassium Chloride
….. 7.50 mg

Trisodium Citrate
Dihydrate .. 14.5 mg
(Flavour: Banana)
Form-5 Sodium Chloride ……
17.50 mg
Potassium Chloride
….. 7.50 mg
Trisodium Citrate
Dihydrate….. 14.5 mg
Dextrose...100.00 mg
(Flavour: Bubble gum)
81. -do- -do- 22-04-2014 058023 Co-Olesta Tablet
Form-5 Olmesartan ... 40 mg
Hydrochlorothiazide
….. 12.5 mg
82. -do- -do- 22-04-2014 044048 Simbex Tablets
Form-5 Simvastatin …. 10 mg
Ezetimibe …… 10 mg
83. -do- -do- 22-04-2014 044076 Vaptor Tablet
Calcium) 10 mg
84. -do- -do- 22-04-2014 044049 Simbex Tablets
Form-5 Simvastatin.. 20 mg
Ezetimibe …… 10 mg
Form-5 Leflunomide
…………… 100 mg
86. -do- -do- 22-04-2014 060631 Levomac Infusion
876 Requested for Each 100 ml
Form-5 change of contains:-
name Levofloxacin.. 500 mg

87. -do- -do- 22-04-2014 060632 Moxirains Infusion
781 Requested for Each 250 ml
Form-5 change of contains:-
name Moxifloxacin as HCl
…… 400 mg
(Mac & Rains Specs)
88. M/s. The M/s. The 23-10-2013 018627 Sermol Suspension
Searle Searle 487 Each 5ml contains:-
Company Company Form-5 Paracetamol…..120mg
Limited 32- Limited F-
Km Multan 319, S.I.T.E,
Road, Lahore Karachi
(DML # (DML #
000647) 000016)
89. -do- -do- 23-10-2013 018628 Sermol Forte
486 Suspension
Form-5 Each 5ml contains:-
Paracetamol
………….. 250mg
90. -do- -do- 23-10-2013 018629 Sermol Tablet
Form-5 Paracetamol ………..
500mg
91. M/s. Allmed M/s. Ever 21-02-2013 052455 Hemfil Syrup
(Pvt.) Ltd; Green 469 Each 5ml contains:-
Lahore at same Pharmaceutic Form-5 Iron Polymaltose
premises als (Pvt.) Ltd;
complex eq. to
Plot No. 509
Sundar Elemental Iron
Industrial …………….. 50mg
Estate, Lahore
92. -do- -do- -do- 052434 Hemifim-F Tablet
Iron hydroxide
Polymaltose complex
…. 100mg
Folic Acid … 0.35mg
93. -do- -do- -do- 059964 Uriflow Capsule
Each capsule
contains:-
Tamsulosin

Hydrochloride
…………….. 0.4mg
94. -do- -do- -do- 052462 Protx 20mg Capsuel
Each capsule
contains:-
Esomeprazole
……………… 20mg
95. -do- -do- -do- 052460 Protx 40mg Capsuel
Each capsule
contains:-
Esomeprazole
……………… 40mg
96. -do- -do- -do- 052422 Everlom-400 Tablet
Lomefloxacin as HCl
….. 400mg
97. -do- -do- -do- 063136 Ichunil D Syrup
Each 10ml contains:-
Pseudeophedrine
(HCl) . 13.3mg
Phlocodine ... 3.33mg
Paracetamol … 200mg
98. -do- -do- -do- 063135 Ichunil D Syrup
Each 10ml contains:-
Pseudeophedrine
(HCl) . 13.3mg
Phlocodine . 3.33mg
Paracetamol… 200mg
Diphenhydramine
…….. 3.33mg
99. -do- -do- -do- 052424 Okcin-200 Tablet
Ofloxacin …. 200mg
100. -do- -do- -do- 052440 Meamin Capsule

Each capsule
contains:-
Mecobalamin..500mcg
101. -do- -do- -do- 067918 Everlose Syrup

Each 5ml contains:-
Lactulose …. 3.35mg
102. -do- -do- -do- 067898 Methemin Injection
Each ml contains:-
Mecobalamin..
500mcg
103. -do- -do- -do- 052444 Itrdym Capsule
Each capsule
contains:-
Itraconazole ... 100mg
104. -do- -do- -do- 052461 Sopra-Praz Capsule
Each capsule
contains:-
Lansoprazole… 30mg

 Cancellation of above registrations from name of manufacturer (column II) except
item at S.No.45 as it is case for change of contract manufacturer, which is deferred
for processing in light of contract manufacturing policy.
 Grant of above registrations in name of manufactyrer (column III). Chairman,
Registration Board will permit issuance of registration letter after evaluation /
completion of Form 5A as per check list approved by Registration Board, renewal
status and comments of Cost & Pricing Division about MRP of the drug.
Meeting ended with a vote of thanks to and from the chair.

______________________________________________________________________________
End of the Document
PE&
Digitally signed
by PE&R
DN: cn=PE&R, o,
ou=DRAP,
R
email=drobaid@
yahoo.com, c=US
Date: 2015.01.09
12:28:11 +05'00'

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Minutes for 246th Meeting of Registration Board held on

10-11th December, 2014.

Item No. Detail of Item Page No(s)

Item No.I Confirmation of minutes of 245th meeting Registration Board 06-08

Item No.II Agenda points referred by Members, Registration Board 08-10

Item No.IV Matters referred for deliberation by Registration Board 16-56

Item No.V Registration of drugs - Pharmaceutical Evaluation Cell 57-272

Item No.IX Registration of Medical Devices – Medical Devices Division 462-472

Item No.X Local Manufacturing of Biological Drugs. 473-480

Item No.XI Applications for transfer of registrations 481-496

Minutes 246th Meeting Registration Board Page 1

1. Lt General (R) Karamat Ahmed Karamat. Member

2. Prof.Dr.Rafi uz Zaman Saeedul Haq Member

4. Brig.Dr.Aslam Khan, Member

5. Dr. Muhammad Arshad, Member

6. Abdul Razak Member

Minutes 246th Meeting Registration Board Page 2

1. In future agenda will be circulated about 07 days before the meeting.

2. Registration Board deliberated on agenda point referred by Director DTL, Quetta

Minutes 246th Meeting Registration Board Page 3

5. Registration Board discuused comments of its members, stakeholders and international

7. Registration Board discussed matter regarding non-availability of finished drugs in

Minutes 246th Meeting Registration Board Page 4

These conditions will also be applicable to products approved for exports

Minutes 246th Meeting Registration Board Page 5

Agenda Item No II:

Case No. 50. Cases deferred by Registration Board.

Item No.VII: Miscellenous cases. Case No.15.

Minutes were approved after incorporation of above points.

Minutes 246th Meeting Registration Board Page 6

S. Name of Name of product(s) Date of application,

Minutes 246th Meeting Registration Board Page 7

Item No II: Agenda points referred by Members, Registration Board.

 Dr. Amanullah Khan, Director DTL, Quetta:

a. PPMA Representation from North zone.

Minutes 246th Meeting Registration Board Page 8

b. Registration of drugs under Drugs Act, 1976.

(I) Dr. Amanullah Khan, Director Drugs Testing Laboratory Government of

Decision: Registration Board advised pharmaceutical Evaluation & Registration

 Mr.A.Q.Javed Iqbal, Director QA & LT, DRAP.

Minutes 246th Meeting Registration Board Page 10

The key feature of the trial is as under:

Title Polio End-game strategies-Poliovirus Type 2 challenge study. A Five Arm

Minutes 246th Meeting Registration Board Page 11

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S.No. Expert Name Opinion

Drug Name Quantity required

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S.No Name of Firms 2mg tablets 8mg tablets

 Pharmacy Services Division, DRAP will forward revised protocols to Narcotic

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Registration Board in 245th meeting discussed following comments of Director Malaria

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b. Transfer of registered drugs.

i) With change in manufacturing site:

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In view of above, directions /guidance of Registration Board is solicited to process cases