1.

Checklist for Grant of permission to manufacture/import of Bulk Drug already

approved in the country
S no Documents required to be submitted
nclosed !age no
"es #o
1. Name of Applicant with address
2. Name of Drug
3. Therapeutic Class
4. Date of Approval
5. Application in orm!44 dul" filled and signed #" the
competent authorit"
$. Treasur" Challan of %N& 5'(''')! upto 1 "ear from initial
approval and %N& 15(''')! for other drugs upto 4 "ears
*a. or manufacturing+!
Cop" of manufacturing license in orm!25) orm!2$ for an" #ul,
drug to manufacturer and orm!2-
*#. or import+!
Cop" of drug sale license in orm 2'. and 21.
/. 0harmaceutical 1 Chemical %nformation
A. 2anufacturing 0rocess including flowcharts detailed
manufacturing procedure(
i. %n process chec, procedure and report control
ii. .atch manufacturing record
iii. 0rocess validation report.
.. Complete monograph 3pecifications( methods of anal"sis
including anal"tical method validation report( with
i. %dentification) 4uantification of impurities
ii. 5nantiomeric purit"
iii. &esidual solvent) other volatile impurities 678%9 estimation
methods
C. 3tructural elucidation data
D. Three #atch Certificate of anal"sis
5. 3ta#ilit" data of three different lots as per 3chedule :; of
Drugs and Cosmetics &ules 6 should #e presented in ta#ular form
with details of .atch no( .atch si<e( Date of manufacturing( Date
of initiation( 0ac,aging details9
. 2aterial 3afet" data sheet
=. &eference product characteri<ation
>. Draft specimen ?a#el
-. 3u#!acute to@icit" data generated with the applicantAs #ul,
drug in two species.
1'. CDT?)%0C Test report B
B %n case of application is for grant of N7C for la# testing serial no 1' ma" #e su#mitted at the
time of approval of #ul, drug.
#ote$
%& Submission requirements / methodology$
i. 0lease su#mit 7N5 hard cop" and T>&55 soft copies i.e. Compact Disc 6CD9
60D format( properl" #oo,mar,ed for navigation9 of the dossier.
ii. >ard cop"+ 3ides and front of each volume) file )#inder must #e la#elled with the name
of the applicant compan"( date of su#mission( name of the drug6s9 and the file
num#er 6Num#ering of files+ C@A of C"A files e.g. if there are 1' files( file num#er $
will #e la#elled as ile No. $ ) 1'9.
iii. Dse of multiple volumes) files) #inders is recommended than #inding all the
documents and modules in a ver" huge file. 0refera#l" volumes) files )#inders
should not #e more than 3 inches thic, and use of good 4ualit" #inders is
recommended. All the files should #e ,ept together( #ound #" a good 4ualit" wire
or thread 6%f there are too man" volumes e.g. more than 1'( then multiple grouping
should #e done9.
iv. CDs have to #e la#elled using a mar,er pen with the name of the applicant compan"(
date of su#mission and name of the drug6s9. %f there are multiple CDs for one su#mission
dossier( then the num#ering as mentioned a#ove should #e followed.
v. 3canned copies of onl" signed documents li,e test reports( signature pages will #e
accepta#le and rest of the document has to #e in 0D format with optical character
recognition 67C&9.
vi. The ta#le of content under each head should #e lin,ed to the files 6s9 or relevant
document for eas" trac,ing in CDAs.
vii. Applicant should preserve a duplicate cop" of the su#mitted dossier for an" future
reference and should #e a#le to su#mit multiple copies( if re4uired #" CD3C7.
2. %pprovals of a #e' drug ()ormulation& already approved in the country
S #o Documents required to be submitted
nclosed !age
no.
"es #o
1. Application for permission to 2anufacture )%mport+ 60urpose
should #e mentioned clearl"9
2. Name of the applicant and address
3. Name of the New Drug
a. Composition of the New Drug
#. Dosage orm
c. 0roposed indication for the New Drug
d. Therapeutic rational for proposed dosage form
/. Details of the approval of the New Drug in the countr"
a. Approved Dosage orm
#. Approved composition
c. Approved indication
12. Application in orm 44 dul" signed and stamped #"
authori<ed personal
13. Treasur" challan of %N& 15(''' New Drug approved in
%ndia for more than one "ear( or ` 5'(''' of New Drug is
approved for less than one "ear dul" signed and stamped #"
.an, of .aroda 14. Cop" of valid manufacturing license in orm 25)2/)2$
15. Cop" of valid Test license in orm 2-
1$. 3ource of #ul, drugs along with current regulator" status of
the source with cop" of orm 4$A)45A. 6if o#tained9
1*. Consent letter and cop" of manufacturing licence form supplier of
#ul, drug
1/. %nformation on active ingredients+
a9 .rief Chemical 1 pharmaceutical data
#9 A0% 3pecification including impurit" profile
c9 2ethod of Anal"sis with anal"tical method validation report
d9 Certificate of Anal"sis for three #atches
23. Data on ormulation
a9 2aster manufacturing formula
#9 2anufacturing 0rocedure) 2aster manufacturing &ecord
c9 0roduct development report with 5@cipient compati#ilit"
stud" and force degradation stud".
d9 0rocess validation protocol and &eport
e9 inished product specification including impurit" profile
f9 inished product 2ethod of Anal"sis
g9 inished product Anal"tical method validation report
h9 inished product Certificate of Anal"sis for three #atches)
three validation #atches
i9 %n process 4ualit" control chec, specifications
E9 3ta#ilit" stud" data report as per re4uirements of schedule
; mentioning #atch si<e. 6 should #e presented in ta#ular
form with details of .atch no( .atch si<e( Date of
manufacturing( Date of initiation( 0ac,aging details9
,9 Dissolution &elease 0rofile 6in case of oral dosage form9
l9 Comparative Dissolution &elease 0rofile with the Approved
formulation 6in case of oral dosage form9
m9 Comparative evaluation with pharmaceutical e4uivalence
with international #rand6s9 or approved %ndian #rands(
if applica#le
n9 Cop" of proposed 0ac,age %nsert which should include
generic name of all active ingredientsF compositionF dosage
form)s( indicationsF dose and method of administrationF use
in special populationsF contraindicationsF warningsF
precautionsF drug interactionsF undesira#le effectsF overdoseF
pharmacod"namics and pharmaco,inetic propertiesF
incompati#ilitiesF shelf!lifeF pac,aging informationF
storage and handling instructions.
o9 Draft specimen of ?a#el and Carton
3-. &egulator" status in other countries( as appropriate.
a9 Names of the countries where the drug is
mar,eted)approved for proposed Dosage orm ) New
&oute of Administration along with pac,age insert and)or
copies of approval in ,e" countries.
#9 Names of the countries where the drug is withdrawn( if
an"( with reasons
c9 ree sale certificate 63C9 or Certificate of
0harmaceutical 0roduct 6C7009( in case of import.
43. .io 54uivalence).ioavaila#ilit" stud" 0rotocol 6As the case
ma" #e9
a9 .5 protocol
#9 3tud" s"nopsis
c9 Dnderta,ing #" investigators as per Appendi@ 8%% od
schedule ; and C8.
d9 %nform consent form 6with assurance of providing audio!
video recordings( Address( 4ualification( occupation(
annual income of su#Eects along with( name and address
of nominee.
e9 Compensation clause as per &ule 122 DA.
f9 Cop" of C5thics CommitteeA approval letters along with
registration details.
5'. Gustification on .io e4uivalence stud" waiver( if re4uested
1$. %n case of parenteral formulation( 3u#!acute to@icit" data
conducted with the proposed drug formulation.
#ote $
%& Submission requirements / methodology
i. 0lease su#mit 7N5 hard cop" and T>&55 soft copies i.e. Compact Disc 6CD9 60D
format( properl" #oo,mar,ed for navigation9 of the dossier.
ii. >ard cop"+ 3ides and front of each volume) file )#inder must #e la#elled with the name
of the applicant compan"( date of su#mission( name of the drug6s9 and the file
num#er 6Num#ering of files+ C@A of C"A files e.g. if there are 1' files( file num#er $
will #e la#elled as ile No. $ ) 1'9.
iii. Dse of multiple volumes) files) #inders is recommended than #inding all the
documents and modules in a ver" huge file. 0refera#l" volumes) files )#inders
should not #e more than 3 inches thic, and use of good 4ualit" #inders is
recommended. All the files should #e ,ept together( #ound #" a good 4ualit" wire
or thread 6%f there are too man" volumes e.g. more than 1'( then multiple grouping
should #e done9.
iv. CDs have to #e la#elled using a mar,er pen with the name of the applicant compan"(
date of su#mission and name of the drug6s9. %f there are multiple CDs for one su#mission
dossier( then the num#ering as mentioned a#ove should #e followed.
v. 3canned copies of onl" signed documents li,e test reports( signature pages will #e
accepta#le and rest of the document has to #e in 0D format with optical character
recognition 67C&9.
vi. The ta#le of content under each head should #e lin,ed to the files 6s9 or relevant
document for eas" trac,ing in CDAs.
vii. Applicant should preserve a duplicate cop" of the su#mitted dossier for an" future
reference and should #e a#le to su#mit multiple copies( if re4uired #" CD3C7.
B& *n case the application is for Clinical +rial /Bio equivalence permission+
a. Ade4uate chemical and pharmaceutical information should #e provided to ensure the
proper identit"( purit"( 4ualit" 1 strength of the investigational product( the amount of
information needed ma" var" with the 0hase of clinical trials( proposed duration of trials(
dosage forms and the amount of information otherwise availa#le.
#. %n case of applications for protocol amendments of alread" approved studies( applicants
should su#mit cop" of approval of protocol( amended new protocol( summari<ed list of all
the new changes incorporated along with Eustification ) reasons for the change.
c. 5thics Committee Approval+ 5thical approval should #e o#tained from 5thics
Committee located in the same area where the clinical trial site is located.
d. The proposed clinical trial stud" centres should #e geographicall" distri#uted in the
countr" and should also include clinical sites which have their own %nstitutional 5thics
Committee.
,. % drug already approved by the -icensing %uthority mentioned in .ule /1
proposed to be marketed 'ith ne' indication
S #o Documents required to be submitted
nclosed !age
no "es #o
1. Application for permission to 2anufacture )%mport)Clinical
trial+ 60urpose should #e mentioned clearl"9
2. Name of the applicant with address
3. Name of the New Drug
a. Composition of the New Drug
#. Dosage orm
c. 0roposed indication for the New Drug
d. Therapeutic rational for proposed indication
4. Details of the approval of the New Drug in the countr"
a. Approved Dosage orm
#. Approved composition
c. Approved indication
5. Application in orm 44 dul" signed and stamped #" authori<ed
personal
$. Treasur" Challan of %N& 15(''' New Drug approved in %ndia for
more than one "ear( or %N& 5'(''' of New Drug is approved for less
than one "ear and not su#mitted challan earlier for the same
drug.
*. Cop" of valid manufacturing license in orm 25)2/)2$
/. Cop" of valid Test license in form 2-
-. %n case of new drug( 3ource of #ul, drugs along with current
regulator" status of the source with cop" of orm 4$A)45A. 6if
o#tained9
1' Consent letter and cop" of manufacturing licence form supplier of #ul,
drug
11. %nformation on active ingredients+
a9 .rief Chemical 1 pharmaceutical data
#9 A0% 3pecification with impurit" profile
c9 2ethod of Anal"sis with method validation report
d9 Certificate of Anal"sis for three #atches
12. Data on ormulation
a9 2aster manufacturing formula
#9 2anufacturing 0rocedure) 2aster manufacturing &ecord
c9 0roduct development report with 5@cipient compati#ilit" and
forced degradation stud"
d9 0rocess validation protocol) &eport
e9 inished product specification
f9 inished product 2ethod of Anal"sis
g9 inished product Anal"tical method validation report
h9 inished product Certificate of Anal"sis for three consecutive
#atches) three validation #atches
i9 %n process 4ualit" control chec, specifications
E9 3ta#ilit" stud" data report as per re4uirements of schedule ;
mentioning #atch si<e. 6 should #e presented in ta#ular form with
details of .atch no( .atch si<e( Date of manufacturing( Date of
initiation( 0ac,aging details9
,9 Dissolution &elease 0rofile 6in case of oral dosage form9
l9 Comparative Dissolution &elease 0rofile with the Approved
formulation 6in case of oral dosage form9
m9 Comparative evaluation with pharmaceutical e4uivalence with
international #rand6s9 or approved %ndian #rands( if
applica#le
n9 Cop" of proposed 0ac,age %nsert which should include
generic name of all active ingredientsF compositionF dosage
form)s( indicationsF dose and method of administrationF use in
special populationsF contraindicationsF warningsF precautionsF
drug interactionsF undesira#le effectsF overdoseF
pharmacod"namics and pharmaco,inetic propertiesF
incompati#ilitiesF shelf!lifeF pac,aging informationF storage and
handling instructions.
o9 Draft specimen of ?a#el and Carton
Sr No 10 to 12 is not applicable, if applicant holds manufacturing or Import and
marketing permission for the proposed drug product [ Except 11(n and 11(o!
13. Therapeutic &ationale and Eustification for the proposed
Additional %ndication
14. &egulator" status in other countries( as appropriate.
a9 Names of the countries where the drug is
2ar,eted) approved for proposed indication along with pac,age
insert and)or copies of approval in ,e" countries.
#9 Names of the countries where the drug is withdrawn( if
an"( with reasons
c9 ree sale certificate 63C9 or Certificate of
0harmaceutical 0roduct 6C7009( in case of import.
15. .io 54uivalence).ioavaila#ilit" stud" 0rotocol 6As the case ma" #e9
a9 .5 protocol
#9 3tud" s"nopsis
c9 Dnderta,ing #" investigators as per Appendi@ 8%% od schedule
; and C8.
d9 %nform consent form 6with assurance of providing audio!video
recordings( Address( 4ualification( occupation( annual income
of su#Eects along with( name and address of nominee.
e9 Compensation clause as per &ule 122 DA.
f9 Cop" of C5thics CommitteeA approval letters along with
registration details.
1$. Clinical trial protocol in case of proposed Additional dosage form
is not approved in ,e" countries. 6Chec,list alread" given in New
Drug application9
%. CT protocol
%%. 3tud" s"nopsis
%%%. Dnderta,ing #" investigators as per Appendi@ 8%% of schedule
; and C8.
%8. %nform consent form 6with assurance of providing audio!video
recordings( Address( 4ualification( occupation( annual income
of su#Eects along with( name and address of nominee.
8. Compensation clause as per &ule 122 DA.
8%. Cop" of C5thics CommitteeA approval letters along with
registration details.
8%%. Case record form 6C&9
8%%%. 3ite details( which includes %nvestigators name and address(
T"pe of >ospital 62ultispecialt") =overnment) 0rivate9 (
Num#er of #eds( emergenc" facilities( 5thics Committee
registration details( etc9
1*. Gustification on Clinical trial waiver( if re4uested.
1/. 0u#lished report of Clinical trial)Gournal)literature with respect to
proposed Additional %ndication.
#ote$
%& Submission requirements / methodology
i. 0lease su#mit 7N5 hard cop" and T>&55 soft copies i.e. Compact Disc 6CD9 60D
format9 of the dossier.
ii. >ard cop"+ 3ides and front of each volume) file )#inder must #e la#elled with the name
of the applicant compan"( date of su#mission( name of the drug6s9 and the file
num#er 6Num#ering of files+ C@A of C"A files e.g. if there are 1' files( file num#er $ will
#e la#elled as ile No. $ ) 1'9.
iii. Dse of multiple volumes) files) #inders is recommended than #inding all the
documents and modules in a ver" huge file. 0refera#l" volumes) files )#inders
should not #e more than 3 inches thic, and use of good 4ualit" #inders is
recommended. All the files should #e ,ept together( #ound #" a good 4ualit" wire or
thread 6%f there are too man" volumes e.g. more than 1'( then multiple grouping should #e
done9.
iv. CDs have to #e la#elled using a mar,er pen with the name of the applicant compan"( date
of su#mission and name of the drug6s9. %f there are multiple CDs for one su#mission
dossier( then the num#ering as mentioned a#ove should #e followed.
v. 3canned copies of onl" signed documents li,e test reports( signature pages will #e
accepta#le and rest of the document has to #e in 0D format with optical character
recognition 67C&9.
vi. The ta#le of content under each head should #e lin,ed to the files 6s9 or relevant document
for eas" trac,ing in CDAs.
vii. Applicant should preserve a duplicate cop" of the su#mitted dossier for an" future
reference and should #e a#le to su#mit multiple copies( if re4uired #" CD3C7.
B& *n case the application is for clinical trial / Bio equivalence permission$
a. Ade4uate chemical and pharmaceutical information should #e provided to ensure the proper
identit"( purit"( 4ualit" 1 strength of the investigational product( the amount of information
needed ma" var" with the 0hase of clinical trials( proposed duration of trials( dosage forms
and the amount of information otherwise availa#le.
#. %n case of applications for protocol amendments of alread" approved studies( applicants
should su#mit cop" of approval of protocol( amended new protocol( summari<ed list of all
the new changes incorporated along with Eustification ) reasons for the change.
c. 5thics Committee Approval+ 5thical approval should #e o#tained from 5thics Committee
located in the same area where the clinical trial site is located.
d. The proposed clinical trial stud" centres should #e geographicall" distri#uted in the
countr" and should also include clinical sites which have their own %nstitutional 5thics
Committee.
0. % drug already approved by the -icensing %uthority mentioned in .ule /1
and proposed to be marketed as a 1#e' Dosage )orm / #e' .oute of
%dministration2.
S #o Documents required to be submitted
nclosed !age
#o "es #o
1. Application for permission to 2anufacture )%mport)Clinical
trial+ 60urpose should #e mentioned clearl"9
2. Name of the applicant with address
3. Name of the New Drug
a. Composition of the New Drug
#. 0roposed Dosage orm
c. 0roposed indication
d. Therapeutic rational for proposed New Dosage orm ) New
&oute
4. Details of the approval of the New Drug in the countr"
a. Approved Dosage orm and route of administration
#. Approved composition
c. Approved indication
5. Application in orm 44 dul" signed and stamped #" authori<ed
personal
$. Treasur" Challan of %N& 15(''' New Drug approved in %ndia for
more than one "ear( or %N& 5'(''' of New Drug is approved for less
than one "ear and not su#mitted challan earlier for the same drug.
*. Cop" of valid manufacturing license in orm 25)2/)2$
/. Cop" of Test license in form 2-
-. %n case of new drug( 3ource of #ul, drugs along with current
regulator" status of the source with cop" of orm 4$A)45A. 6if
o#tained9
1'. Consent letter and cop" of manufacturing licence form supplier of #ul,
drug
11. %nformation on active ingredients+
a9 .rief Chemical 1 pharmaceutical data
#9 A0% 3pecification with impurit" profile
c9 2ethod of Anal"sis with method validation report
d9 Certificate of Anal"sis for three #atches
12. Data on ormulation
a9 2aster manufacturing formula
#9 2anufacturing 0rocedure) 2aster manufacturing &ecord
c9 0roduct development report with 5@cipient compati#ilit" stud"
and forced degradation stud".
d9 0rocess validation protocol) &eport
e9 inished product specification
f9 inished product 2ethod of Anal"sis
g9 inished product Anal"tical method validation report
h9 inished product Certificate of Anal"sis for three consecutive
#atches) three validation #atches
i9 %n process 4ualit" control chec, specifications
E9 3ta#ilit" stud" data report as per re4uirements of schedule ;
mentioning #atch si<e. 6 should #e presented in ta#ular form with
details of .atch no( .atch si<e( Date of manufacturing( Date of
initiation( 0ac,aging details9
,9 Dissolution &elease 0rofile 6in case of oral dosage form9
l9 Comparative Dissolution &elease 0rofile with the Approved
formulation 6in case of oral dosage form9
m9 Comparative evaluation with pharmaceutical e4uivalence with
international #rand6s9 or approved %ndian #rands( if
applica#le
n9 Cop" of proposed 0ac,age %nsert which should include
generic name of all active ingredientsF compositionF dosage
form)s( indicationsF dose and method of administrationF use in
special populationsF contraindicationsF warningsF precautionsF
drug interactionsF undesira#le effectsF overdoseF
pharmacod"namic and pharmaco,inetic propertiesF
incompati#ilitiesF shelf!lifeF pac,aging informationF storage
and handling instructions.
o9 Draft specimen of ?a#el and Carton
13. Therapeutic &ationale and Eustification for the proposed
new dosage form ) new route of administration
14. &egulator" status in other countries( as appropriate.
a9 Names of the countries where the drug is
mar,eted)approved for proposed Dosage orm ) New &oute of
Administration along with pac,age insert and)or copies of approval
in ,e" countries.
#9 Names of the countries where the drug is withdrawn( if an"( with
reasons
c9 ree sale certificate 63C9 or Certificate of 0harmaceutical 0roduct
6C7009( in case of import.
15. .io 54uivalence).ioavaila#ilit" stud" 0rotocol 6As the case ma"
#e9
a9 .5 protocol
#9 3tud" s"nopsis
c9 Dnderta,ing #" investigators as per Appendi@ 8%% od schedule
; and C8.
d9 %nform consent form 6with assurance of providing audio!video
recordings( Address( 4ualification( occupation( annual income
of su#Eects along with( name and address of nominee. e9 Compensation clause as per &ule 122 DA.
f9 Cop" of C5thics CommitteeA approval letters along with
registration details.
1$. Clinical trial protocol in case of proposed Additional dosage form
is not approved in ,e" countries. 6Chec,list alread" given in New
Drug application9
a9 CT protocol
#9 3tud" s"nopsis
c9 Dnderta,ing #" investigators as per Appendi@ 8%% of schedule ;
and C8.
d9 %nform consent form 6with assurance of providing audio!video
recordings( Address( 4ualification( occupation( annual income of
su#Eects along with( name and address of nominee.
e9 Compensation clause as per &ule 122 DA.
f9 Cop" of C5thics CommitteeA approval letters along with
registration details.
g9 Case record form 6C&9
h9 3ite details( which includes %nvestigators name and address( T"pe
of >ospital 62ultispecialt") =overnment) 0rivate9 ( Num#er of
#eds( emergenc" facilities( 5thics Committee registration details(
etc9
1*. .io 54uivalence stud" re4uirement 6in case of oral dosage form as
appropriate as per Appendi@ H of 3chedule ;9
1/. Gustification on Clinical trial and .io e4uivalence stud" waiver(
if re4uested.
1-. Animal to@icolog" data as per 3chedule ;.
a&. Systemic to3icity studies4
i. single dose to@icit"
ii. repeated dose to@icit"
b&. -ocal to3icity
i. Dermal to3icity 6for products meant for topical
6dermal9 application9
ii. 5cular to3icity 6for products meant for ocular
instillation9
iii. *nhalation to3icity 6conducted with the formulation
proposed to #e used via inhalation route9
iv. 6aginal to3icity 6for products meant for topical
application to vaginal mucosa9
v. !hotoallergy or dermal phototo3icity 6re4uired if the drug
or a meta#olite is related to an agent causing
photosensitivit" or the nature of action suggests such a
potential9
c&. .ectal tolerance test 6or all preparations meant for rectal
administration9
2'. 0u#lished report of Clinical trial)Gournal)literature with respect to
proposed Dosage orm ) New &oute of Administration.
#ote$
%& Submission requirements / methodology
i. 0lease su#mit 7N5 hard cop" and T>&55 soft copies i.e. Compact Disc 6CD9 60D
format9 of the dossier.
ii. >ard cop"+ 3ides and front of each volume) file )#inder must #e la#elled with the name
of the applicant compan"( date of su#mission( name of the drug6s9 and the file
num#er
6Num#ering of files+ C@A of C"A files e.g. if there are 1' files( file num#er $ will #e
la#elled as ile No. $ ) 1'9.
iii. Dse of multiple volumes) files) #inders is recommended than #inding all the
documents and modules in a ver" huge file. 0refera#l" volumes) files )#inders
should not #e more than 3 inches thic, and use of good 4ualit" #inders is
recommended. All the files should #e ,ept together( #ound #" a good 4ualit" wire or
thread 6%f there are too man" volumes e.g. more than 1'( then multiple grouping should #e
done9.
iv. CDs have to #e la#elled using a mar,er pen with the name of the applicant compan"( date
of su#mission and name of the drug6s9. %f there are multiple CDs for one su#mission
dossier( then the num#ering as mentioned a#ove should #e followed.
v. 3canned copies of onl" signed documents li,e test reports( signature pages will #e
accepta#le and rest of the document has to #e in 0D format with optical character
recognition 67C&9.
vi. The ta#le of content under each head should #e lin,ed to the files 6s9 or relevant document
for eas" trac,ing in CDAs.
vii. Applicant should preserve a duplicate cop" of the su#mitted dossier for an" future
reference and should #e a#le to su#mit multiple copies( if re4uired #" CD3C7.
B& *n case the application is for clinical trial / Bio equivalence permission$
a. Ade4uate chemical and pharmaceutical information should #e provided to ensure the proper
identit"( purit"( 4ualit" 1 strength of the investigational product( the amount of information
needed ma" var" with the 0hase of clinical trials( proposed duration of trials( dosage forms
and the amount of information otherwise availa#le.
#. %n case of applications for protocol amendments of alread" approved studies( applicants
should su#mit cop" of approval of protocol( amended new protocol( summari<ed list of all
the new changes incorporated along with Eustification ) reasons for the change.
c. 5thics Committee Approval+ 5thical approval should #e o#tained from 5thics Committee
located in the same area where the clinical trial site is located.
d. The proposed clinical trial stud" centres should #e geographicall" distri#uted in the
countr" and should also include clinical sites which have their own %nstitutional 5thics
Committee.
7. % drug already approved by the -icensing %uthority mentioned in .ule /1
no' proposed to be marketed as a 18odified release dosage form2.
S #o Documents required to be submitted
nclosed !age no
"es #o
1. Application for permission to 2anufacture )%mport)Clinical
trial+ 60urpose should #e mentioned clearl"9
2. Name of the applicant with address
3. Name of the New Drug
a. Composition of the New Drug
#. Dosage orm
c. 0roposed indication for the New Drug
d. Therapeutic rational for 2odified release dosage form
4. Details of the approval of the New Drug in the countr"
a. Approved Dosage orm and route of administration
#. Approved composition
c. Approved indication
5. Application in orm 44 dul" signed and stamped #" authori<ed
personal
$. Treasur" Challan of %N& 15(''' New Drug approved in %ndia for
more than one "ear( or %N& 5'(''' of New Drug is approved for less
than one "ear and not su#mitted challan earlier for the same drug.
*. Cop" of valid manufacturing license in orm 25)2/)2$
/. Cop" of valid Test license in form 2-
-. %n case of new drug( 3ource of #ul, drugs along with current
regulator" status of the source with cop" of orm 4$A)45A. 6if
o#tained9
1'. Consent letter and cop" of manufacturing licence form supplier of #ul,
drug
11. %nformation on active ingredients+
a9 .rief Chemical 1 pharmaceutical data
#9 A0% 3pecification with impurit" profiling
c9 2ethod of Anal"sis with method validation report
d9 Certificate of Anal"sis for three #atches
12. Data on ormulation
Data on ormulation
a9 2aster manufacturing formula
#9 2anufacturing 0rocedure) 2aster manufacturing &ecord
c9 0roduct development report with 5@cipient compati#ilit" stud"
and forced degradation stud".
d9 0rocess validation protocol) &eport
e9 inished product specification
f9 inished product 2ethod of Anal"sis
g9 inished product Anal"tical method validation report
h9 inished product Certificate of Anal"sis for three consecutive
#atches) three validation #atches
i9 %n process 4ualit" control chec, specification
E9 3ta#ilit" stud" data report as per re4uirements of schedule ;
mentioning #atch si<e. 6 should #e presented in ta#ular form with
details of .atch no( .atch si<e( Date of manufacturing( Date of
initiation( 0ac,aging details9
,9 Dissolution &elease 0rofile 6in case of oral dosage form9
l9 Comparative Dissolution &elease 0rofile with the Approved
formulation 6in case of oral dosage form9
m9 Comparative evaluation with pharmaceutical e4uivalence
international #rand6s9 or approved %ndian #rands( if
applica#le
n9 Cop" of proposed 0ac,age %nsert which should include
generic name of all active ingredientsF compositionF dosage
form)s( indicationsF dose and method of administrationF use in
special populationsF contraindicationsF warningsF precautionsF
drug interactionsF undesira#le effectsF overdoseF
pharmacod"namic and pharmaco,inetic propertiesF
incompati#ilitiesF shelf!lifeF pac,aging informationF storage
and handling instructions.
o9 Draft specimen of ?a#el and Carton
13. Therapeutic &ationale and Eustification for the proposed
new dosage form ) new route of administration
14. &egulator" status in other countries( as appropriate.
a9 Names of the countries where the drug is
mar,eted)approved for proposed 2odified Dosage orm along
with pac,age insert and)or copies of approval in ,e" countries.
#9 Names of the countries where the drug is withdrawn( if
an"( with reasons
c9 ree sale certificate 63C9 or Certificate of
0harmaceutical 0roduct 6C7009( in case of import.
15. .io 54uivalence).ioavaila#ilit" stud" 0rotocol 6As the case ma"
#e9
a9 .5 protocol
#9 3tud" s"nopsis
c9 Dnderta,ing #" investigators as per Appendi@ 8%% od schedule
; and C8.
d9 %nform consent form 6with assurance of providing audio!video
recordings( Address( 4ualification( occupation( annual income
of su#Eects along with( name and address of nominee. e9 Compensation clause as per &ule 122 DA.
f9 Cop" of C5thics CommitteeA approval letters along with
registration details.
1$. Clinical trial protocol in case of proposed Additional dosage form
is not approved in ,e" countries. 6Chec,list alread" given in New
Drug application9
a9 CT protocol
#9 3tud" s"nopsis
c9 Dnderta,ing #" investigators as per Appendi@ 8%% of schedule
; and C8.
d9 %nform consent form 6with assurance of providing audio!
video recordings( Address( 4ualification( occupation( annual
income of su#Eects along with( name and address of
nominee.
e9 Compensation clause as per &ule 122 DA.
f9 Cop" of C5thics CommitteeA approval letters along with
registration details.
g9 Case record form 6C&9
h9 3ite details( which includes %nvestigators name and address(
T"pe of >ospital 62ultispecialt") =overnment) 0rivate9 (
Num#er of #eds( emergenc" facilities( 5thics Committee
registration details( etc9
1*. .io 54uivalence stud" re4uirement 6in case of oral dosage form
as appropriate as per Appendi@ H of 3chedule ;9
1/. Gustification on Clinical trial and .io e4uivalence stud" waiver( if
re4uested.
1-. 0u#lished report of Clinical trial)Gournal) literature with respect to
proposed 2odified Dosage orm.
2'. %n case of inEecta#le formulation( su#!acute to@icit" data
conducted with the applicant drug formulation.
#ote$
%& Submission requirements / methodology
i. 0lease su#mit 7N5 hard cop" and T>&55 soft copies i.e. Compact Disc 6CD9 60D
format9 of the dossier.
ii. >ard cop"+ 3ides and front of each volume) file )#inder must #e la#elled with the name
of the applicant compan"( date of su#mission( name of the drug6s9 and the file
num#er 6Num#ering of files+ C@A of C"A files e.g. if there are 1' files( file num#er $ will
#e la#elled as ile No. $ ) 1'9.
iii. Dse of multiple volumes) files) #inders is recommended than #inding all the
documents and modules in a ver" huge file. 0refera#l" volumes) files )#inders
should not #e more than 3 inches thic, and use of good 4ualit" #inders is
recommended. All the files should #e ,ept together( #ound #" a good 4ualit" wire or
thread 6%f there are too man" volumes e.g. more than 1'( then multiple grouping should #e
done9.
iv. CDs have to #e la#elled using a mar,er pen with the name of the applicant compan"( date
of su#mission and name of the drug6s9. %f there are multiple CDs for one su#mission
dossier( then the num#ering as mentioned a#ove should #e followed.
v. 3canned copies of onl" signed documents li,e test reports( signature pages will #e
accepta#le and rest of the document has to #e in 0D format with optical character
recognition 67C&9.
vi. The ta#le of content under each head should #e lin,ed to the files 6s9 or relevant document
for eas" trac,ing in CDAs.
vii. Applicant should preserve a duplicate cop" of the su#mitted dossier for an" future
reference and should #e a#le to su#mit multiple copies( if re4uired #" CD3C7.
B) *n case the application is for clinical trial / Bio equivalence permission$
a. Ade4uate chemical and pharmaceutical information should #e provided to ensure the proper
identit"( purit"( 4ualit" 1 strength of the investigational product( the amount of information
needed ma" var" with the 0hase of clinical trials( proposed duration of trials( dosage forms
and the amount of information otherwise availa#le.
#. %n case of applications for protocol amendments of alread" approved studies( applicants
should su#mit cop" of approval of protocol( amended new protocol( summari<ed list of all
the new changes incorporated along with Eustification ) reasons for the change.
c. 5thics Committee Approval+ 5thical approval should #e o#tained from 5thics Committee
located in the same area where the clinical trial site is located.
d. The proposed clinical trial stud" centres should #e geographicall" distri#uted in the
countr" and should also include clinical sites which have their own %nstitutional 5thics
Committee.
9. % drug already approved by the -icensing %uthority mentioned in .ule /1
proposed to be marketed 'ith %dditional Strength
S #o Documents required to be submitted
nclosed !age
#o "es #o
1. Application for permission to 2anufacture )%mport)Clinical
trial+ 60urpose should #e mentioned clearl"9
2. Name of the applicant with address
3. Name of the New Drug
a. Composition of the New Drug
#. Dosage orm
c. 0roposed indication for the New Drug
4. Details of the approval of the New Drug in the countr"
a. Approved Dosage orm
#. Approved composition
c. Approved 3trength along with %ndication
5. Application in orm 44 dul" signed and stamped #" authori<ed
personal
$. Treasur" Challan of %N& 15(''' New Drug approved in %ndia for
more than one "ear( or %N& 5'(''' of New Drug is approved for less
than one "ear and not su#mitted challan earlier for the same
drug.
*. Cop" of valid manufacturing license in orm 25)2/)2$
/. Cop" of Test license in form 2-
-. in case of new drug( 3ource of #ul, drugs along with current
regulator" status of the source with cop" of orm 4$A)45A. 6%f
o#tained9
1'. Consent letter and cop" of manufacturing licence form supplier of #ul,
drug
11. %nformation on active ingredients+
a9 .rief Chemical 1 pharmaceutical data
#9 A0% 3pecification with impurit"
c9 2ethod of Anal"sis with method validation report
d9 Certificate of Anal"sis for three #atches
12. Data on ormulation
a9 2aster manufacturing formula
#9 2anufacturing 0rocedure) 2aster manufacturing &ecord
c9 0roduct development report
d9 0rocess validation protocol) &eport with 5@cipient compati#ilit"
stud" and orced degradation profile.
e9 inished product specification
f9 inished product 2ethod of Anal"sis
g9 inished product Anal"tical method validation report
h9 inished product Certificate of Anal"sis for three consecutive
#atches) three validation #atches
i9 %n process 4ualit" control chec, specification
E9 3ta#ilit" stud" data evaluation a s per re4uirements of schedule ;
mentioning #atch si<e. . 6 should #e presented in ta#ular form with
details of .atch no( .atch si<e( Date of manufacturing( Date of
initiation( 0ac,aging details9
,9 Dissolution &elease 0rofile 6in case of oral dosage form9
l9 Comparative Dissolution &elease 0rofile with the Approved
formulation 6in case of oral dosage form9
m9 Comparative evaluation with international #rand6s9 or
approved %ndian #rands( if applica#le
n9 Cop" of proposed 0ac,age %nsert which should include
generic name of all active ingredientsF compositionF dosage
form)s( indicationsF dose and method of administrationF use in
special populationsF contraindicationsF warningsF precautionsF drug
interactionsF undesira#le effectsF overdoseF pharmacod"namics and
pharmaco,inetic propertiesF incompati#ilitiesF shelf!lifeF
pac,aging informationF storage and handling instructions.
o9 Draft specimen of ?a#el and Carton
%nformation on active ingredients+
13. Therapeutic &ationale and Eustification for the proposed
Additional 3trength
14. &egulator" status in other countries( as appropriate.
a9 Names of the countries where the drug is
2ar,eted) approved for proposed additional strength along with
pac,age insert and)or copies of approval in ,e" countries.
#9 Names of the countries where the drug is withdrawn( if
an"( with reasons
c9 ree sale certificate 63C9 or Certificate of
0harmaceutical 0roduct 6C7009( in case of import.
15. .io 54uivalence).ioavaila#ilit" stud" 0rotocol 6As the case ma" #e9
a9 .5 protocol
#9 3tud" s"nopsis
c9 Dnderta,ing #" investigators as per Appendi@ 8%% od schedule
; and C8.
d9 %nform consent form 6with assurance of providing audio!video
recordings( Address( 4ualification( occupation( annual income
of su#Eects along with( name and address of nominee. e9 Compensation clause as per &ule 122 DA.
f9 Cop" of C5thics CommitteeA approval letters along with
registration details.
1$. Clinical trial protocol in case of proposed Additional 3trength is not
approved in ,e" countries. 6Chec,list alread" given in New
Drug application9
a. CT protocol
#. 3tud" s"nopsis
c. Dnderta,ing #" investigators as per Appendi@ 8%% of schedule
; and C8.
d. %nform consent form 6with assurance of providing audio!video
recordings( Address( 4ualification( occupation( annual income
of su#Eects along with( name and address of nominee.
e. Compensation clause as per &ule 122 DA.
f. Cop" of C5thics CommitteeA approval letters along with
registration details.
g. Case record form 6C&9
h. 3ite details( which includes %nvestigators name and address(
T"pe of >ospital 62ultispecialt") =overnment) 0rivate9 (
Num#er of #eds( emergenc" facilities( 5thics Committee
registration details( etc9
1*. Gustification on Clinical trial and .io e4uivalence stud" waiver( if
re4uested.
1/. 0u#lished report of Clinical trial)Gournal)literature with respect to
proposed Additional 3trength.
1-. %n case of inEecta#le formulation( su#!acute to@icit" data
conducted with the applicant drug formulation.
#ote$
%& Submission requirements / methodology
i. 0lease su#mit 7N5 hard cop" and T>&55 soft copies i.e. Compact Disc 6CD9 60D format9 of
the dossier.
ii. >ard cop"+ 3ides and front of each volume) file )#inder must #e la#elled with the name of
the applicant compan"( date of su#mission( name of the drug6s9 and the file num#er
6Num#ering of files+ C@A of C"A files e.g. if there are 1' files( file num#er $ will #e
la#elled as ile No. $ ) 1'9.
iii. Dse of multiple volumes) files) #inders is recommended than #inding all the documents
and modules in a ver" huge file. 0refera#l" volumes) files )#inders should not #e more
than 3 inches thic, and use of good 4ualit" #inders is recommended. All the files should #e
,ept together( #ound #" a good 4ualit" wire or thread 6%f there are too man" volumes e.g.
more than 1'( then multiple grouping should #e done9.
iv. CDs have to #e la#elled using a mar,er pen with the name of the applicant compan"( date of
su#mission and name of the drug6s9. %f there are multiple CDs for one su#mission dossier( then
the num#ering as mentioned a#ove should #e followed.
v. 3canned copies of onl" signed documents li,e test reports( signature pages will #e accepta#le
and rest of the document has to #e in 0D format with optical character recognition 67C&9.
vi. The ta#le of content under each head should #e lin,ed to the files 6s9 or relevant document for
eas" trac,ing in CDAs.
vii. Applicant should preserve a duplicate cop" of the su#mitted dossier for an" future
reference and should #e a#le to su#mit multiple copies( if re4uired #" CD3C7.
B) *n case the application is for clinical trial / Bio equivalence permission$
a. Ade4uate chemical and pharmaceutical information should #e provided to ensure the proper
identit"( purit"( 4ualit" 1 strength of the investigational product( the amount of information
needed ma" var" with the 0hase of clinical trials( proposed duration of trials( dosage forms and
the amount of information otherwise availa#le.
b. %n case of applications for protocol amendments of alread" approved studies( applicants
should su#mit cop" of approval of protocol( amended new protocol( summari<ed list of all the
new changes incorporated along with Eustification ) reasons for the change.
c. 5thics Committee Approval+ 5thical approval should #e o#tained from 5thics Committee
located in the same area where the clinical trial site is located.
d. The proposed clinical trial stud" centres should #e geographicall" distri#uted in the countr"
and should also include clinical sites which have their own %nstitutional 5thics Committee.