MEDICAL NEGLIGENCE- ANIKET

❖ INTRODUCTION
Medical Negligence is also regarded as malpractise. Medical negligence is generally breach
of duty of Doctor on patient and failing to exercise reasonable care and skill resulting in
physical, mental and financial difficulty to patients. It is civil, criminal and consumer
wrong. Supreme Court of India in Jacob Mathew vs State of Punjab, defined negligence as
actionable negligence. Breach of said duty and consequential damage. International
negligence involves contradiction. Negligence may be defined as the “breach of a duty
caused by the omission to do something which a reasonable man, guided by those
considerations which ordinarily regulate the conduct of human affairs would do, or
doing something which a prudent and reasonable man would not do”. Four vital
elements in a case of medical negligence. They are-
1. A duty to exercise the due care was owed: It is important to show that the doctor or
medical practitioner owed a duty of care to the plaintiff where the latter opted for the
medical treatment.
2. The duty was breached: The plaintiff must prove that the health provider did not
comply to the required and standard care, thus breaching his/her duty.
3. The breach caused an injury: There was a breach of duty and this breach was an
immediate cause to the injury to the plaintiff.
4. Damage: Without damage, there is no basis for a claim, regardless of whether the
medical provider was negligent. However, damage can also occur without any
negligence. An example for it is when someone dies due to a fatal disease.
In ancient times, there was no rule and code concerning with Medical Negligence. However
if we look ancient history work we find a code of conduct of India’s great physician
Charakya in his work which talks of medical negligence. Therefore, we can say that Indian
physicians were also concerned about MEDICAL NEGLIGENCE. Awareness about medical
negligence came through recognition of the same under Consumer Protection Act. Thorough
this act, aggrieved party can start filing criminal negligence cases throughout country.
Supreme Court also in Indian medical association vs VP Shanta brought it under preview of
consumer protection act.
❖ Two Theories Of Negligence- Subjective Theory And Objective Theory
Negligence means careless or unreasonable conduct. But merely unreasonable conduct
without damage is not actionable though it may be a punishable offence. Such conduct when
followed can cause harm to another gives rise to liability for negligence. There are two
theories about the negligence in the law of tort.
1. Subjective Theory- According to this theory of Salmond, negligence denotes ‘State of
mind’. It defines negligence as mental attitude of indifference with respect to conduct. this
state of mind varies from person to person and the person is liable only for his intentional acts
only and not otherwise. It involves a personal element. If a person has acted to the best of his
ability then he cannot be held liable for negligence.
2. Objective Theory – According to this theory of Pollock, negligence is a type of conduct,
which a reasonable man can avoid with a reasonable degree of care and caution. The
‘objective theory’ gives an independent identity to the concept of ‘negligence’ in the law of
tort. It defines it as behaviour or type of conduct and is opposite of diligence, Medical
negligence, in today’s context cannot be seen just as a ‘state of mind’. A person when goes to
a doctor expects a certain degree of care and caution from him, which is implicit in the
services provided by him.
Negligence is not only the result of an act of commission but also is a result of an act of
omission. Some examples of act of commission- includes carrying out treatment (Poonam
verma case- if doctor in homeopathy practise degree practise allopathy he is guilty of
negligence), treatment complication, injury due to wrong practise, medication error via giving
wrong dose and type of drugs, faulty operation and wrong surgeries. So comes under act of
commission.
Act of omission includes failure to take important history of genes, allergy, and failure to
give accept standard of care and treatment, abandoning treatment without authorization.
• CASE LAWS liabiltiies under civil law
In India, the origin of concept of negligence and tortious liability was borrowed from English
Common law but later was developed by Indian judiciary. Supreme Court in Rajkot
Municipal Corporation vs Manjulben Jayantilal Nakum (1997) held that there is no
statutory law in India, unlike in England, regulating damages for tortious liability. In the
absence of statutory law or established principles of law laid by this Court or High Courts
consistent with Indian conditions and circumstances, this Court selectively applied the
common law principles evolved by the courts in England on grounds of justice, equity and
good conscience. Common law principles of tort evolved by the courts in England may be
applied in India to the extent of suitability and applicability to the Indian conditions.
Earlier reliance was taken common law and common law judgements concerning negligence.
But now Indian Judiciary has entrenched on road of medical negligence jurisprudence with
series of landmark judgements and has taken concrete shape in light of various cases-
• sathew vs state of Punjab- The Court held that in criminal law medical professionals are
placed on a pedestal different from ordinary mortals. To prosecute the medical
professionals for negligence under criminal law, something more than mere negligence
had to be proved. Medical professionals deal with patients and they are expected to take
the best decisions in the circumstances of the case. Sometimes, the decision may not be
correct, and that would not mean that the medical professional is guilty of criminal
negligence. Such a medical profession may be liable to pay damages but unless
negligence of a high order is shown the medical professionals should not be dragged into
criminal proceedings. Court held that in a case of criminal negligence against a medical
professional it must be shown that the accused did something or failed to do something in
the given facts and circumstances of the case which no medical professional in his
ordinary senses and prudence would have done or failed to do.
The supreme court of India laid down guidelines in cases of alleged negligence against
medical practitioners in India. At least three weighty considerations must be kept while
trying the issue of medical negligence (i) that legal and disciplinary procedures should
be properly founded on firm, moral and scientific grounds; (ii) that patients will be
better served if the real causes of harm are properly identified and appropriately
 acted upon (iii) that many incidents involve a contribution from more than one
person, and the tendency is to blame the last identifiable element in the chain of
causation.
• Indian medical association vs VP Shanta- Supreme Court held, “A patient who has
been injured by an act of medical negligence has suffered in a way which is recognised
by the law- and by the public at large - as deserving compensation. This loss may be
continuing and what may seem like an unduly large award may be little more than that
sum which is required to compensate him for such matters as loss of future earnings
and the future cost of medical or nursing care. To deny a legitimate claim or to restrict
arbitrarily the size of an award would amount to substantial injustice.” This case gave
effect to consumers who were suffering from medical negligence and included medical
services in the ambit of Consumer Protection Act, 1986 leading consumer to get more
speedy and cheap justice.
On 9 April, 1985, The United Nations General Assembly adopted certain guidelines to
protect the interest of consumers, especially in developing countries. The basic aim was
to enact laws and frame policies in order to achieve and maintain adequate protection for
consumers from hazards to their health and safety, and to ensure availability of effective
consumer redress. The Supreme Court in this case reiterated that, services rendered
to a patient by a medical practitioner (except where the doctor render services free
of charge to every patient or under a contract of personal service) by way of
consultation, diagnosis and treatment, both medical and surgical, would fall within
the ambit of service as defined in section 2(1) (o) of the Consumer Protection Act
1986.
The judgement has faced a lot of opposition from the people involved in the medical field.
However, this judgement has come as a wave of relief for all the consumers. With rampant
increase in commercialisation of services, which also includes medical services, the patient
has now become a mere consumer. Nevertheless, to our dismay we have seen lot of increased
frivolous suit regarding medical negligence. Hence, Majority believe such inclusion of
medical negligence under this statute as unnecessary interference by judiciary in domain of
medicine. The consequences of this judgement was that Doctor started avoiding giving
medicines to avoid such cases.
• Poonam Verma vs Ashwin Patel- The Supreme Court distinguished between
negligence, rashness, and recklessness. A negligent person is one who inadvertently
commits an act of omission and violates a positive duty. A person who is rash knows
the consequences but foolishly thinks that they will not occur as a result of her/ his
act. A reckless person knows the consequences but does not care whether or not they
result from her/ his act. Any conduct falling short of recklessness and deliberate
wrongdoing should not be the subject of criminal liability. Thus a doctor cannot be held
criminally responsible for a patient's death unless it is shown that she/ he was negligent or
incompetent, with such disregard for the life and safety of his patient that it amounted to a
crime against the State. In this particular case, the doctor Mr. Patel in the due course of
treatment was negligent in his acts by practicing the Allopathic system of medication,
though he does not hold any actual locus of practicing the same. In addition to this, the
court also recognizes the nexus between the negligent actions during treatment and the
criminal liability thereof of the doctor for the same. The Supreme Court held that any
 person who does not know a particular system of medicine but then also practices in that
concerned system then he will be held guilty of medical negligence.
Supreme Court in Poonam Verma held Negligence has many manifestations - it may be
active negligence, collateral negligence, comparative negligence, concurrent negligence,
continued negligence, criminal negligence, gross negligence, hazardous negligence,
active and passive negligence, wilful or reckless negligence or Negligence per se. Court
said essential legal duty of medical professional is to exercise due care and skill. Plaintiff
in order to establish medical negligence has to prove that these two were absent to win.
Duty to exercise skill and care exist when doc-patient relationship arises. Doctor who deals
with healer established doc- patient relationship at different level. Doctor should be
competent as per law hence he must possess reasonable experience and highly consultant. He
must have degree of competence via qualifying exams. House surgeon in hospital must have
specialized skill. Breach of duty important in case of medical negligence. In medical
negligence suit, plaintiff is a patient who acts on the behalf of advice rendered by doctors.
Defendant is healthcare provider and includes therapist, hospital (govt. and private) and
shops. Plaintiff has to establish all essential elements for medical negligence claim.
• Spring Meadows Hospital vs Harjol Ahluwalia (1998)-Minor child through his parents
complained before the NCDRC. Child was admitted to the appellant hospital as patient
with diagnosis of typhoid. The nurse asked the child's father to purchase the injection Inj.
Lariago recommended by the Senor Pediatrician to be administered intravenously. On
administering the injection, the child collapsed immediately and suffered cardiac arrest.
child was shifted to the All India Institute of Medical. sciences (AIlMS). The
commission concluded that the child had suffered cardiac arrest because of
intravenous injection of an excessive dose of the injection and that due to
considerable delay in measures to revive the heart, the child's brain had been
damaged. The Commission found that there was clear dereliction of duty on the part
of the nurse and that the hospital was negligent in having employed an unqualified
person as nurse and entrusting the child to her care. It also held that the resident
doctor was negligent since he failed to follow the instruction of the Senior Paediatrician
that the injection should be administered by a doctor. The Commission held that since the
resident doctor and nurse were employees of the appellant hospital, the latter was
Iiable and awarded compensation of Rs 12 .51akh to the chiId and of Rs.5 lakh to
the parents for acute mental agony.
In appeal, the supreme Court observed that Consumer Protection Act was a beneficial
legislation intended to confer. speedier remedy on consumers, its provisions should
receive a liberal construction. The true position hat an error of judgment may or may not
be negligent it depends on the nature of the error. If it is not one that would not have
been made by a reasonable competent professional man professing to have the
standards and type of skill that the defendant held himself out as having, and acting
with ordinary care, then it is negligence, if on the other hand, it is an error if such a
man, acting with ordinary care, might have made, than it is not negligence."
Therefore, both the parents and the child would be 'consumer' and could a such claim and
be awarded compensation. This decision of the Supreme Court highlights that Medical
Professionals which includes Doctors, Nurses, Clinics, Hospitals including the Para
 Medical staff have to be wary of administering proper drugs and even taking care of the
patients.

• Lakshman balakrishna joshi vs dr. trimbak bapu godbole- it was held that "The duties
which a doctor owes to his patient are clear. A person who holds himself out ready to
give medical advice and treatment impliedly undertakes that he is possessed of skill and
knowledge for the purpose. Such a person when consulted by a patient owes him certain
duties viz., a duty of care in deciding whether to undertake the case, a duty of care in
deciding what treatment to give or a duty of care in the administration of that treatment.
A breach of any of those duties gives a right of action for negligence to the patient. The
practitioner must bring to his task a reasonable degree of skill and knowledge and must
exercise a reasonable degree of care. Neither the very highest nor very low degree of
care and competence judged in the light of the particular circumstances of each case is
what the law requires.
• Samira Kohli vs Dr. Prabha Manchanda (2008)- In following case, a 44-year-old
patient complaining of menstrual bleeding for 9 days, underwent an ultrasound test and
was advised laparoscopy test under general anaesthesia for making an affirmative
diagnosis. The patient, while under general anaesthesia, was subjected to a laparoscopic
examination and simultaneously with the consent of the mother waiting outside the
operation thereafter, abdominal hysterectomy (removal of uterus) and (removal of ovaries
and fallopian tubes) were conducted. It was held by the Supreme Court that consent taken
for diagnostic procedure/surgery is not valid for performing therapeutic surgery either
conservative or radical except in life-threatening or emergent situations. It was also held
that where the consent by the patient is for a particular operative surgery; it cannot be
treated as consent for an unauthorized additional procedure involving removal of an organ
on the ground that such removal is beneficial to the patient or is likely to prevent some
danger developing in future, if there is no imminent danger to the life or health of the
patient. The Supreme Court held the doctor liable for malpractice overruling the order
passed by the National Commission for the Redress of Consumer Disputes.

• V. Krishna Kumar vs state of Tamil Nadu (2015)- Supreme Court ordered the Tamil
Nadu government to pay Rs. 1.3 crore to a Chennai-based family whose prematurely-born
girl child lost her eyesight due to lack of neo-natal medical care provided at a government
hospital in Chennai. Bench further ordered the State government to pay Rs. 42.8 lakh as
re-imbursement of medical expenses suffered by the family for the years of treatment.
The case dates back to August 1996 when the baby was born premature at 29 weeks at the
Women and Child Hospital in Chennai. But the family alleged that the doctors at the
government hospital, during the time of discharge, did not conduct mandatory screening
of pre-term infants for the condition of retinopathy of prematurity (ROP) and also
discharged the baby with no advice whatsoever to the parents about the condition and the
need for a review. In 1998, two years after the baby's birth, the family moved the National
Consumer Disputes Redressal Commission complaining of the medical negligence and
seeking a compensation of Rs. 1 crore for their mental agony and the child's permanent
loss of sight.
In cases like the one of V.Krishna Kumar, the Supreme Court has ruled out the
computation of compensation according to the multiplier method and warned
 against the straight jacket approach of using the multiplier method of calculating
damages in medical negligence case. Suggesting the principles of compensation
should be based on “restitutio in integrum” (a person entitled to damages should, as
nearly as possible, get that sum of money which could put him in the same position as he
would have been, if he had not sustained the wrong) should be “the safe one as
recognised in cases”, should be adhered to and applied.

• V. Krishna Rao vs Nikhil super speciality hospital (2010)-In following case Supreme
Court held that in certain cases, principle of “res ipsa liquitor” will be applicable and in
the said case, the plaintiff was awarded an amount of Rs. 2 lakh from the defendant as
there was a pure case of negligence on the part of defendant. Complaint’s wife got
admitted in Respondent hospital, who was suffering from fever and chills. She was
wrongly treated for typhoid instead of malaria for four days. As a result of said wrong
treatment she died. On the complaint, District Forum found that there was negligence on
the part of the hospital and awarded compensation. The order of the District Forum was
reversed by the State Commission and as well by the National Commission. But the
Supreme Court set aside the orders passed by the State Commission and National
Commission and restored the order passed by the District Commission. In this case the
Supreme Court held that Court should reconsider the parameters set down in Bolam test
as a guide to decide cases in medical negligence and specially in view of Article 21 of the
Constitution which encompasses within its guarantee, a right to medical treatment and
medical care. Court recently held that ‘there cannot be a mechanical or straitjacket
approach that each and every medical negligence case must be referred to experts
for evidence.

• Malay Kumar Ganguly vs Sukumar Mukherjee (2009)-Whether the Courts are bound
by the opinion given by an expert on a particular fact in a case? Hon’ble Supreme Court
has answered this question in the case titled as Malay Kumar Ganguly v/s Dr. Sukumar
Mukherjee, wherein it has been held that, a Court is not bound by the evidence of the
experts which is to a large extent advisory in nature. The Courts have full powers to
derive its own conclusion upon considering the opinion of the experts which may be
adduced by both sides, cautiously, and upon taking into consideration the
authorities on the point on which he deposes. The opinion could be admitted or
denied. Whether such evidence could be admitted or how much weightage should be
given thereto, lies within the domain and discretion of the Court. The evidence of an
expert should, however, be interpreted like any other evidence.
The Supreme Court redefined medical negligence saying that the quality of care to be
expected of a medical establishment should be in tune with and directly proportional to its
reputation. The decision also says that the court should take into account patient’s
legitimate expectations from the hospital or the concerned specialist doctor. In the instant
case there is negligence in the treatment rendered to the Patient with respect to the time
and manner in which the Patient was shifted from the 3 floor ICU to the 12 floor ICU.
Having regard to the fact that the Patient was in the Hospital for a period of 8 months; in
a coma for a period of almost three years; the bills filed towards medical expenses
amounting to 16,93,010.00 (excluding the mediclaim amount of 3,75,000/-) and the
expenses incurred post discharge, when the Patient was in a coma, and also the mental
 agony suffered by the Patient’s family, the aspect of restitutio in integrum, and the
Patient’s age, we are of the view that awarding an amount of 30,00,000/- (Thirty Lakhs)
to be paid by the Hospital would meet the ends of justice.
• In Dr.Kunal Saha v. Dr. Sukumar Mukherjee,2006, the National Consumer Commission
summarised the medical negligence law and gave Real test for determining deficiency
in service- Well laid down tests for determining deficiency in service are – whether
there is failure to act in accordance with standard of a reasonable competent
medical practitioner? Whether there was exercise of reasonable degree of care? The
degree of standard or reasonable care varies in each case depending upon expertise of
medical man and the circumstances of each case. “The practitioner must bring to his task
a reasonable degree of skill and knowledge, and must exercise a reasonable degree of
care. Failure to use due skill in diagnosis with the result that wrong treatment is given is
negligence. Neither the very highest nor a very low degree of care and competence,
judged in the light of the particular circumstances of each case, is what the law requires,
and a person is not liable in negligence because someone else of greater skill and
knowledge would have prescribed different treatment or operated in a different way; nor
is he guilty of negligence if he has acted in accordance with a practice accepted as proper
by a responsible body of medical men skilled in that particular art, even though a body of
adverse opinion also exists among medical men; nor is a practitioner necessarily negligent
if he has acted in accordance with one responsible body of medical opinion in preference
to another in relation to the diagnosis and treatment of a certain condition, provided that
the practice of that body of medical opinion is reasonable.”

• Bolitho vs City and Hackney Health Authority 1998 -A 2-year-old boy arrived at the
hospital experiencing breathing problems. The doctor on shift, was requested to deal with
the child’s breathing abnormalities. Unfortunately, the doctor could not receive the “call”
due to low battery on her bleep. As a result, the child died. The child’s mother brought a
claim in negligence, saying that the child needed intubation and the doctor failed to
attend.
The main issue in was to establish that the defendant breached their duty of care to the
claimant. The claimant must prove a casual link between the breach and the harm caused
by the breach. According to Bolam v Friern Hospital professionals won’t be in breach of
their duty if they acted in accordance with the practices accepted as proper by a
responsible body of other professionals with relevant expertise.
The doctor, who did not show up, testified that they would not have intubated the child
anyways, even if they did show up. An expert agreed on this that it was a proper practice.
It was held as the doctor claimed, she would not intubate the child even if she had
attended. The House of Lords stated that the defendant (doctor) could not argue that her
breach of not attending did not cause harm. Because, if she attended, she may have
breached her duty anyways by not intubating a child. The House of Lords held that it was
important to identify if the doctor would have been in a breach of duty if she had attended
and did not intubate the child. According to Bolam test, the practice accepted as proper by
a responsible body of professionals must be based on logical and defensible grounds. In
this case, not intubating the child was not irresponsible action, therefore, there was
no breach.
• Bolam v Friern Hospital Management Committee 1957 1 WLR 582 - The defendant
was the body who employed a doctor who had not given a mentally-ill patient, muscle-
relaxant drugs nor restrained them prior to giving them electro-convulsive therapy. The
claimant suffered injuries during the procedure. The claimant sued the defendant,
claiming the doctor was negligent for not restraining them or giving them the drug.
Establishing the tort of negligence involves establishing that the defendant breached their
duty of care to the claimant. To establish breach, the claimant must establish that the
defendant failed to act as a reasonable person would in their position. This standard is
higher in the case of professionals: they must act as a reasonable professional would. The
issue in this case was how to assess the standard of care imposed on a professional
defendant where a substantial portion of professionals opposed a particular practice, while
others did not.
The High Court held that the doctor had not breached his duty to the patient, and so
the defendant was not liable. McNair J set out the test for determining the standard of
care owed by medical professionals to their patients (sometimes referred to as the ‘Bolam
test’). The professional will not be in breach of their duty of care if they acted in a
manner which was in accordance with practices accepted as proper by a responsible
body of other medical professionals with expertise in that particular area. If this is
established, it does not matter that there are others with expertise who would disagree
with the practice. As the methods used in this case were approved of by a responsible
portion of the medical profession, there was no breach.

❖ Liability under CPA

The Consumer protection Act, 1986 came into existence to provide justice and aid in various
sphere of the human activity one of them is medical services. The definition of the consumer
defined in the Act is wide enough to encompass not only the goods but also the services. The
Consumer Protection Act of 1986 was enacted with an objective to provide better protection
of the interests of the Consumers. This is indeed highly progressive piece of Social Welfare
Legislation. The provisions of this Act are intended to provide effective and efficient
safeguards to the consumers against various types of exploitations and unfair dealings. Unlike
other laws, which are basically punitive or preventive in nature, the provisions of the Act are
compensatory.
Patient is consumer under the consumer protection act and the services provided to the patient
will fall under the definition of the service defined under the consumer protection act.
Medical negligence or medical malpractice entails professional negligence due to an act or
omission by a health care provider in which the treatment provided by him/her falls below the
accepted standard of practice in the medical community and this treatment results in injury to
the patient or in extreme cases, death of the patient.
WHO IS A CONSUMER?1
“Consumer” means any person who—
buys any goods for a consideration which has been paid or promised or partly paid and
partly promised, or under any system of deferred payment and includes any user of such

1
Section 2(d) of Consumer Protection Act, 1986
goods other than the person who buys such goods for consideration paid or promised or
partly paid or partly promised, or under any system of deferred payment when such use is
made with the approval of such person, but does not include a person who obtains such
goods for resale or for any commercial purpose; or
hires or avails of any services for a consideration which has been paid or promised or
partly paid and partly promised, or under any system of deferred payment and includes any
beneficiary of such services other than the person who ‘hires or avails of the services for
consideration paid or promised, or partly paid and partly promised, or under any system of
deferred payment, when such services are availed of with the approval of the first mentioned
person but does not include a person who avails of such services for any commercial
purposes;
By this definition, it can be clearly documented that, definition of the consumer is wide
enough to cover the patient who promises to pay medical expenses.
Whereas service under Consumer Protection Act, 1986 means, service of any description
which is made available to potential users and includes the provision of facilities in
connection with banking, financing, insurance, transport, processing, supply of electrical or
other energy, board or lodging or both, housing construction, entertainment, amusement or
the purveying of news or other information, but does not include the rendering of any service
free of charge or under a contract of personal service;
This definition provides list of the certain category of the services. However it is not an
exhaustive. Hence, medical services also fall within the purview of this definition. However,
in order to bring the service within the purview of the definition following criteria need to
satisfy:
1. Services should not be free of charge
2. It should not be under a contract of personal service
Therefore, medical services render free of the charge or under the contract of personal
services will be outside the scope of the definition of the services itself.
The word ‘deficiency’ has been defined by Section 2(1)(g) of the Consumer Protection Act,
1986 as follow:”Deficiency’ means, any fault, imperfection, shortcoming or inadequacy in
the quality, nature, and manner of performance that is required to be maintained by or
under any law for the time being in force or has been undertaken to be performed by a
person in pursuance of a contract or otherwise, in relation to any service.”
Therefore it can be clearly documented that, deficient service provided by medical
practitioner is actionable and it can be fall under the purview of the above definition.
Liability under civil laws- kindly refer from page 30-36 of pkg negligence matieral
 Right to health
International and Constitutional provision regarding right to health
❖ INTRODUCTION
Health being one of the most important fundamental right needs extra protection by specific
legislations. Our Constitution also requires the State to ensure health and nutritional well-
being of all people. Before independence the health care sector was in dismal condition as the
number of mortality rate owing to diseases was high. But since independence the main
emphasis has been the health care sector.
Healthy society is a collective gain and every govt must raise it. Govt assistance is req to
assist people. In constitution, also lot of prov deal with it. Constitution requires high standard
of health and nutrition of all people. Health care helps in universe health coverage. If we go
through laws enacted and history of enactment of medical law in india, first ever code of
medical was Hippocrates Oath by 5th CE Greek physician. Modern version is Declaration of
Geneva by WHO and is accepted by international medical fraternity. Constitution of WHO
says Health is a state of complete physical, mental and social well-being and not merely the
absence of disease or infirmity. The enjoyment of the highest attainable standard of health
is one of the fundamental rights of every human being without distinction of race, religion,
political belief, economic or social condition. The health of all peoples is fundamental to
the attainment of peace and security and is dependent on the fullest co-operation of
individuals and States. The achievement of any State in the promotion and protection of
health is of value to all.. Health is dependent on cooperation of state.
The right to health emerged from the broader development of social rights litigation, which
has been attributed largely to an activist Supreme Court’s liberal interpretations of its powers
of review, as well as to the substantive rights guaranteed under the Constitution of India.
India health care is regulated by federal structure. State are responsible for health care and
central govt responsible for family planning and set national health policy and international
treaty and help state. Under federal structure state have duty for healthcare facilities. Central
govt has considerable vision on it. Central govt sponsors treatment vaccines and disease
prevention scheme of TB, malaria etc taken at state level. National healthcare policy changed
in 2017. Earlier we had five year plan but on recommendation niti ayog launched for 3 years
from 2017-2020. Certain achievements was expected through this 2017-2020 action plan-
adequate investment in public finance in health, effective prioritize in prevention health,
effective management of public healthcare, addressing human challenge in distribution and
skill,
Covid-19 taught world that if keeping aside nation interest if not looked on health
aspect it would be detrimental for survival. Rapid spread of disease like sars and
COVID shows need for collective action and need for international solution to complex
health threats. Forces of globalization have been influenced by habits at international
sphere no state can alone ensure health of its citizens. Travel and migration, crowding
together, livestock’s of goods shows heath is transmission is effective concern requiring
global governance. So countries coming together for research to cure from this kind of
disease.
In india also, health is public policy matter which is important to government.

❖ RIGHT TO HEALTH UNDER INTERNATIONAL COVENANTS

There are international conventions also treating health as human rights. Basic treaties like
UDHR, 1948, ICCPR, ICESR also includes human rights of highest attainable standard of
physical and mental health and sexual health. It provides for health regardless sex, race.
• UDHR art 25-Everyone has the right to a standard of living adequate for the health
and well-being of himself and of his family, including food, clothing, housing and
medical care and necessary social services, and the right to security in the event of
unemployment, sickness, disability, widowhood, old age or other lack of livelihood in
circumstances beyond his control.
• ICESCR art 7,12-
Article 7- The States Parties to the present Covenant recognize the right of everyone
to the enjoyment of just and favourable conditions of work which ensure, in
particular- Safe and healthy working conditions
Article 12- The States Parties to the present Covenant recognize the right of
everyone to the enjoyment of the highest attainable standard of physical and
mental health.
• CEDAW- article 10,12, 14
Article 10(h)- States Parties shall take all appropriate measures to eliminate
discrimination against women in order to ensure to them equal rights with men in the
field of education and in particular to ensure, on a basis of equality of men and
women as to Access to specific educational information to help to ensure the health
and well-being of families, including information and advice on family planning.
Article 11(1)(f)- States Parties shall take all appropriate measures to eliminate
discrimination against women in the field of employment in order to ensure, on a
basis of equality of men and women, the same rights, in particular-The right to
protection of health and to safety in working conditions, including the safeguarding
of the function of reproduction.
Article 12- States Parties shall take all appropriate measures to eliminate
discrimination against women in the field of health care in order to ensure, on a basis
of equality of men and women, access to health care services, including those
related to family planning.
Article 14(2)(b)- States Parties shall take all appropriate measures to eliminate
discrimination against women in rural areas in order to ensure, on a basis of equality
of men and women, that they participate in and benefit from rural development and,
in particular, shall ensure to such women the right- To have access to adequate
health care facilities, including information, counselling and services in family
planning;

• International Convention on the Elimination of All Forms of Racial

Discrimination–art 5(1)(e)(iv)- In compliance with the fundamental obligations laid
down in article 2 of this Convention, States Parties undertake to prohibit and to
eliminate racial discrimination in all its forms and to guarantee the right of everyone,
 without distinction as to race, colour, or national or ethnic origin, to equality before
the law, notably in the enjoyment of the following rights- The right to public
health, medical care, social security and social services;

• Art 24 of Convention on the Rights of the Child- States Parties recognize the right
of the child to the enjoyment of the highest attainable standard of health and to
facilities for the treatment of illness and rehabilitation of health. States Parties shall
strive to ensure that no child is deprived of his or her right of access to such health
care services.

• Convention against Torture, 1987 & Prisoner convetion1955 laid principles for
treatment of prisoners affecting health of prisoners.

• WHO- The constitution of WHO which importantly was estb in 12 june, 1948
through art 57 of un charter. the alma ata declaration which came existence on 6-12
sept, 1978 at alma ata in Kazakhstan defined primary health care in detail it imp for
primary and secondary level health care. ART 57 of UN CHARTER- The various
specialized agencies, established by intergovernmental agreement and having wide
international responsibilities, as defined in their basic instruments, in economic,
social, cultural, educational, health, and related fields, shall be brought into
relationship with the United Nations in accordance with the provisions of Article 63.

❖ RIGHT TO HEALTH IN INDIA

In india we have following article in constitution,
Article 42- Provision for just and humane conditions of work and maternity relief
Article 47-Duty of the State to raise the level of nutrition and the standard of living and
to improve public health
Art 21- Right to life and personal liberty
Medical law is concerned with improving health of individual. Health being most important
FR, needs specific legislation for protection. Our constitution requires state to ensure health
and nutritional well-being. Health is collective gain so no government should smother it.
According to a data, primary health care in India is provided through a network of more than
1, 46,000 health centres, 23000 primary health centres and 4000 sub centres. At district level
on average 150-bedded hospital, dispensaries are there which spread over town and villages.
Heath sector of India comprises of govt and private sector. Curative, preventive and
protective services provided. At govt level, minimal charges are taken form patients while in
private charges are quite expensive. MRI in govt sector costs in Rs. 3000 cost Rs. 7000 in
private. Private hospitals plays important role in multi-speciality health and curative services.
Different cities have multi-speciality hospitals. In Lucknow, also super speciality hospital
provides best facilities but are highly expensive. Provision of health care by public sector is
responsibility shared by central, state and local govt. Primary healthcare responsibility is with
state and Central Govt focus on population stabilization and disease control. National Health
program deals with prevention of communicable disease, child health.
At time of independence, only 8% medical care provided was provided by private sector. But
after so many years we have more than 85% outpatient care covered by private sector. Private
sector has dominant presence in education pharmaceutical, hospital construction. Over 75%
human resources, 68% of estimated hospital and 37% of bed in country are in private sector
out of which mostly located in urban areas. Private sector predominance in health sector has
led to inequality in healthcare and right to equality of constitution is compromised. Hospital
rates are 6 times higher than poor facilities of govt in village. Such inequities led to sorry
situation in case of children and women. Pregnant Women of villages are dying more in
comparison to urban women who are pregnant as in cities facilities are there but in village
there is only govt facility.
In India, there are indigenous or traditional medical practitioners. Throughout country, main
forms are Ayurveda or Yunani. Ayurveda deals with cause symptoms and treatment based on
aspect of well being and Yunani is based on herbal practise. It is based on traditional system
of medicine. Vaidya is practitioner of Ayurveda treatment. Hakim is Arabic word practitioner
of Yunani medicine. Health policy of India was formulated after 1975, then indian govt
started integrating western oriented medical system and after that they have introduced so
many western technologies. Main problem affecting primary health care is curative concern
and reluctance of staff to work in rural area. No doctor or staff are interested to go in health
centre in villages, they want to be in urban town having facilities of communication,
electricity. Govt doctors also avoid residing in villages. Geographical distribution varies
accordingly to socio, economic condition. PHC’s also vary on socio economic condition. Fast
pace of development has led to emergence of healthcare on profit basis. Mini hospitals came
up with 5 star facilities. In rural areas, basic health care facility still remains a distant dream.
Infrastructure in most country under developed. Most number of doctors resign posts in rural
areas. Healthcare is available only during 10-5 P.M. in rural areas and in case of emergency
patients are to be taken to nearby town. Private hospital also located only in urban as
difficulty to get staff in rural areas.
British came up in India came with procedures. Colonial govt enacted Corners act in
Bombay and Calcutta. It defined role of medical professional in autopsy. After this in, 1857,
medical general council act was passed and registration was required under GMC. Later
came Bombay medical act, Bengal also passed same and madras also in 1914 passed such
provincial acts. These acts were followed by Indian medical degree act in 1916. Medical
council of india, national level statutory body constituted after indian medical council act
1933. Govt constituted national medical commission act, which deals with education. Each
state has it medical council, which tells rules guidelines and procedures. State govt send
reports to MCI. State medical council can re-enter name in register and if any mis-
professional conduct can be reported as per ethics released. No action against medical
practitioner can be taken unless given time to heard as per principle of criminal justice
system.

❖ RIGHT TO HEALTH AND ROLE OF JUDICIARY

Another failure can be counted in implementation is of in-conceived and ineffective
health program at expense of universal care. Still pregnant women dying. We saw dead
body eaten by dogs. Based on various judgements of courts, we saw PIL brought up
before courts and relief was observed. Right to health care is wide canvas of
rehabilitative and palliative healthcare. Right to healthcare cannot be perceived unless
doc-patient ratio or nurse patient ratio above required ratio rate and spread uniformly
over geographical network. Standard treatment protocol need to be kept at place.
Responsibilities of doctor need to be spelt out. Constitution also says right to life as
fundamental and obliges govt to ensure right to health for all. “health rights litigation”
encompasses all cases seeking enforcement of the constitutional right to health by the
Supreme Court and High Courts. India’s public health policies and infrastructure are
clearly inadequate to meet the needs of its population. Therefore, the right to health
emerged and developed out of litigation that responded to these inadequacies.*
International human rights instruments guarantee everyone the right “to the enjoyment of the
highest attainable standard of physical and mental health,” which is subject to progressive
realization. The Supreme Court has found the enforcement of this right to be “a most
imperative constitutional goal whose realization requires interaction [of] many social and
economic factors.” Over time, the scope of the right to health has evolved according to the
remedies devised by the Supreme Court.
While Supreme Court and High Court decisions outline specific minimum obligations
encompassed by the right to health, a comprehensive definition of the core content of the
right has yet to be articulated. At a minimum, the right includes an individual’s entitlement to
adequate health care(which has been held to include emergency health care) and to “adequate
medical facilities.
The Supreme Court has issued mandatory orders regarding the provision of accessible,
available, and quality primary health care. The Court has also prescribed minimum standards
regarding the provision of emergency medical facilities, calling on state and central
governments to take the following actions: ensure adequate facilities at primary health centers
and upgrade hospitals at the district and subdistrict levels; increase availability of specialized
treatment; create a centralized communication system to ensure availability of beds; and
improve overall ambulatory availability and care. Government actors have been ordered to
fulfill their public health responsibilities in environmental health cases, including the
collection and disposal of garbage, the development of emissions standards, and the
implementation of compensation schemes for victims affected by industrial pollution.
In LIC of India vs. Consumer Education and Research Centre, the plaintiffs had sought
certain details of insurance policies from the respondents. After obtaining such details,
plaintiffs made a framework outline of these policies and submitted to the respondents. These
proposals were subsequently rejected by the respondents on the grounds that they did not
meet the minimum statutory requisites. They instead laid down their own guidelines for
acceptance of these policies. The plaintiffs filed a writ petition before the concerned High
Court, alleging that the administrative actions undertaken by such defendants were
unconstitutional under the test of reasonableness (as laid down under Article 14, 19 and
21 of the Constitution) in addition to being totally arbitrary and opposed to public
policy standards. In doing so, they filed a writ petition under Article 226 of the Constitution
before the State High Court seeking judicial relief. The Apex Court’s Verdict held in a
contract of insurance the rates of insurance must be totally reasonable, as should be the
premium amount. If both are arbitrary and opposed to public policy then the whole contract is
liable to be set aside. Thus, as the defendant’s policy terms were unconscionable and opposed
to public policy altogether, it was constitutionally void-in- law and thus liable to be set aside
by the High Court.
Courts also have judicial review power. SC has used review power extensively. In 1981,
prison conditions were deplored and court held right to life means right to live with dignity,
clothing and shelter. In Francis Coralie vs. Union Territory of Delhi(This case dealt with
rights of prisoners), apex court held that the right of life and personal liberty is not a
provision enacting a Fundamental right and the attempt of the Court should always be to
expand the reach and ambit of the Fundamental Rights rather than to attenuate its meaning
and content. The fundamental right to life is the most precious human right and should hence
be interpreted in an expansive spirit that will intensify its significance by enhancing the
dignity and worth of and individual and his life. The Court went to the extent of analyzing the
meaning of ‘life’ to determine what entails the right to life. The Court recommended it to be
not merely restricted to animal existence but meaning more than just physical survival. It also
held that the right to life includes the right to live with human dignity and to fulfil the bare
necessities of life.
In 1992, in a minority opinion in C.E.S.C. Ltd. Etc vs Subhash Chandra Bose, Apex court
realized need of health and stated Health is a state of complete physical, mental and
social well-being and not merely the absence of disease or infirmity. The enjoyment of
the highest attainable standard of health is one of the fundamental rights of every
human being without distinction of race, religion, political belief, economic or social
condition. Article 21 in addition to Right to Health also includes good working conditions
and maintenance of workers.
Between 1989-95, we saw health related issues with respect to life. Medical treatment of
prisoner was often in news. Court relying on Newspaper report brought via PIL in Pt.
Parmanand Katara v. Union of India. News report of a scooterist who was knocked
down by a car and died due to lack of medical treatment. The scooterist died while he
was being transported to the other hospital. Supreme Court read, “every citizen
brought for treatment should instantaneously be given medical aid to preserve life and
thereafter the procedural criminal law should be allowed to operate. Protection of life
was held to be a sacred duty of the State under Article 21. Nonetheless, the right had an
overarching effect that would make it mandatory for each doctor, whether from a private or
governmental hospital, to extend his services with expertise to preserve life. It was hence
decided that this obligation was paramount and any law or procedure that hindered it would
have to step away. Court also expressed better hygienic condition at workplace and
livelihood. Court further issued health and safety guidelines in lines with consumer health
reaserch centre case.
In 1996, right to health was made independently justiciable when govt. was made to give
compensation as petitioner was decline treatment by seven hospitals. In Paschim Banga
Khet Mazdoor Samity & Ors v State of West Bengal, The petitioner sustained serious
injuries after falling off a train. He was refused treatment at six successive State hospitals
because the hospitals either had inadequate medical facilities or did not have a vacant bed.
The Court declared that the right to life enshrined in the Indian Constitution (Article 21)
imposes an obligation on the State to safeguard the right to life of every person and that
preservation of human life is of paramount importance. This obligation on the State stands
irrespective of constraints in financial resources. The Court stated that denial of timely
medical treatment necessary to preserve human life in government-owned hospitals is a
violation of this right. The Court asked the Government of West Bengal to pay the petitioner
compensation for loss. It also entrenched on speedy medical assistance to workers.
In State of Punjab and Ors. v. Mohinder Singh Chawala, the court held that the
government had a constitutional obligation to pay for medical bills incurred by its
current and retired employees and as per the policy formulated by the state, it
necessarily had to pay the bills. The Court held that it was absurd that while the patient
underwent treatment in one hospital, rates of another hospital would be applicable to
him. Enforcement of right to life is integral part of constitution is not limited to
employees only of public and private but to all citizens. Right to health is integral to
right to life. Government has constitutional obligation to provide the health facilities. If the
Government servant has suffered an ailment which requires treatment at a specialized
approved hospital and on reference whereat the Government servant had undergone such
treatment therein, it is but the duty of the State to bear the expenditure incurred by the
Government servant.
In 2001 right to healthy environment was also recognized in MC Mehta case and thus court
protected basic human right .
In Mahednra pratap singh vs state of Orissa, pertaining to the failure of the government in
opening a primary health care centre in a village, the Court held that the Government is
required to assist people and its endeavour should be to see that the people get treatment and
lead a healthy life. Primary health centres should thus be of principal concern and it would be
at odds with public health if a Government caused hindrance to the establishment of such
centres. Healthy society is a collective gain and no Government should make any effort to
smother it. Primary concern should be the primary health centre and technical fetters cannot
be introduced as subterfuges to cause hindrances in the establishment of health centre.
In Kapila hingurani vs state of Bihar, court has added another gem to the crown of human
rights jurisprudence and reaffirmed that the states responsibility of protecting fundamental
rights can not be dispensed with, neither in the name of lack of resources nor divided
responsibility under the so-called federal structure. The judiciary has been increasingly
viewed as an institution to the saviour of people and such moves only reaffirm public faith
that is reposed on it as a last resort. In this case, court rejected govt pleas of budgetary
shortage for not granting remedy on violation of Fr. In case of health and nutrition, govt
cannot deny on budgetary constraints.
In Vincent Panikurlangara v. Union of India, The Petitioner filed public interest litigation
in the Supreme Court to sought directions for implementation of an adequate, central
policy and establishment of a central drug standards authority, with suitable
enforcement powers to ban harmful and injurious drugs. The Supreme Court held
Article 144 of the Constitution mandated statutory bodies to aid the Court. The Court
stated that it was for the Union Government to decide on questions of policy, it
nevertheless opined that the State should make useful drugs available at reasonable
price to be within the common man's reach. Enunciating the role of the State in
reference to the health of its citizenry, the Court held that in a welfare state, the State
should create conditions conducive to good health. It held that the State had an
obligation to enforce production of quality drugs, eliminate injurious ones from the
medicines market and provide a drug policy. The Court further noted that the maintenance
and improvement of public health was indispensable to the very physical existence of the
community. Court laid stress on improvement of public health and prohibition of drugs
injurious to health as one of the primary duties of the State. The State's obligation to enforce
production of qualitative drugs and elimination of the injurious ones from the market must
take within its sweep an obligation to make useful drugs available at reasonable price so as to
be within the common man's reach.

CONSENT
Consent and Indian Law
Consent means free, voluntary agreement or compliance. Consent represents the ethical and
legal expression of a person's right to have their autonomy and self-determination respected.
A doctor may treat without consent in a patient’s best interests as a matter of necessity in an
emergency, where the patient lacks capacity. However, if the patient has capacity it is no
defence to argue that treatment without consent was in the patient’s best interests. The term
‘consent’ can be linked to the medical profession and has been interpreted in the following
acts:
1. Indian contracts act, §11 and 13.

Sec.13 of Indian contract act lays down that two or more persons are said to be in consent
with each other when they agree upon the same thing in same manner. Moreover, as per
section 11 of the Act, only those who have attained the age of majority and are of sound mind
are capable of entering into a contract. Meaning by those who are barred in section 11, are
not capable of rendering their consent.
2. IPC, §87-91

Section 90 of IPC defines consent in negative terms. As per this section, any consent given
under the following five circumstances will not be true consent. Analysis of this section
shows that consent is not true consent if it is given —
o By a person under fear of injury or,
o By a person who is under misconception of the facts and person who obtain consent
knows or has reason to believe that or consent was given in consequence of such fear /
misconception.
o By intoxicated person or,
o By a person who is of unsound mind or, unable to understand the nature and
consequences of that to which he gives consent.
o By a person who is below the age of 12 yrs.
Sections 87 to 91 of Indian penal code deals with consent. Section 88 of IPC lays down that
an act is not offence if it is not intended or not known to be likely to cause death, which
causes any harm to a person from whose benefit it is done in good faith with his consent to
suffer it. Thus after a valid consent if surgeon operates on patient and patient dies on the
operation table, then the surgeon can not be held guilty of murder. Persons who are non-
qualified in medical profession are not allowed to take the plea of this section, as they are not
said to do the act in good faith. For a person who is under twelve years of age, or is of
unsound mind, his/her guardian or any other person who has lawful charge of that person, can
give consent, according to section 89 of IPC. IPC 52 says that an act is only done in good
faith if it is done with due care and attention. Section 91 of IPC serves as a corollary to
sections 87 to 89. It states that the exceptions contained in sect 87 to 89 do not extend to acts,
which are offences independently of any harm, which they may cause to the person, giving
consent. Thus causing miscarriage (unless caused in good faith for the purpose of saving the
life of the women) is an offence independently of any harm which it may cause or be
intended to cause to the women and the consent of the women or of her guardian for causing
such miscarriage does not justify the act ( 91 IPC ) .
3. Indian Medical Council Code of Ethics Regulations, 2002, §7.16

Section 7.16 of the Indian Medical Council Code of Ethics Regulations, 2002, states: 'Before
performing an operation the physician should obtain in writing the consent from the husband
or wife, parent or guardian in the case of minor, or the patient himself as the case maybe. In
an operation which may result in sterility the consent of both husband and wife is needed.
4. Doctrine of loco parentis

The legal doctrine of Locoparentis means in place of the parent. It states that in emergency
involving children, when their parents or guardian are not available, consent is taken from the
person in charge of the child. Caregivers and management in hospital and health case have
the duty of care in place of the parent. And hence this doctrine is being followed in the
medical profession.
5. Consumer protection act.

Failure of taking informed consent is considered as a deficiency in medical services under the
section 2(1)(f) of the Consumer Protection Act, 1986 or section 2(11) of the New consumer
protection act of 2019. Deficiency has been stated in the 2019 act as –
"deficiency" means any fault, imperfection, shortcoming or inadequacy in the quality, nature
and manner of performance which is required to be maintained by or under any law for the
time being in force or has been undertaken to be performed by a person in pursuance of a
contract or otherwise in relation to any service and includes—
(i) any act of negligence or omission or commission by such person which causes loss or
injury to the consumer; and
(ii) deliberate withholding of relevant information by such person to the consumer;
Cases
 A. In Rambiharilal v. Dr JN. Shrivasta the plaintiff's wife complained of severe pain in
the abdomen and was diagnosed with appendicitis. The surgeon did not explain the
side effects of chloroform anaesthesia before taking consent of the patient for an
operation for appendicitis. During operation, the patient's appendix was found to be
normal. The surgeon proceeded to remove the gall bladder without the consent of the
husband waiting outside and without caring for the ill effects of keeping the patient
under chloroform, especially when her kidneys were affected. The patient died of
hepatorenal failure. The surgeon was held negligent.
B. In Arun Balakrishnan Iyer v. Soni Hospital, during an operation for ovarian cysts,
there was an emergency situation and the uterus was removed. The coñsent of the
patient could not be taken as she was under anaesthesia but her husband's consent was
taken. The doctor did her duty and it was held that the removal of uterus without the
consent of patient was not negligence.

Situations Where Consent Need Not be Taken

There are four exceptions where treatment can begiven to a patient without obtaining consent.
i. First, the patient can be treated in an emergency situation without obtaining consent.
ii. Treatment without consent can also be given when the patient is psychotic, senile, an
infant, or otherwise not in a position to give consent.
iii. Treatment can be given without consent if the medical professional believes strongly
that obtaining informed consent would be harmful to the patient. This is known as
therapeutic privilege
iv. Treatment without consent can also begiven if the patient asks specifically not to be
told about treatment decisions and asks the medical professional to carry out treatment
which is in his or her best interest.

Consent need not be taken under the following circumstances as well-

1. Examination under court order,
2. New admissions to prisons,
3. Members of armed forces, and
4. Immigrants
Types of Consent
Two types of consents are taken by medical professionals in India before commencing
treatment. These are implied and expressed consent. Implied consent is a verbal consent
which is legally valid. Such implied consent is only for ordinary medical examination like
examination of pulse, recording of blood pressure etc. It does not cover the consent for pelvic
examination, injections, or any major interventions. For further treatment, an expressed
consent is required.
The second type of consent is expressed consent which may be oral or written. This type of
consent is mainly taken before a major diagnostic or therapeutic modality which carries a
definite and major risk. An oral consent is sometimes legally valid, but in the current
situation of medical litigation, written consent is preferred for major procedures because
patient may, at later stage, deny that any oral consent was given.
Informed Consent
Informed consent is the process in which a health care provider educates a patient about the
risks, benefits, and alternatives of a given procedure or intervention. The patient must be
competent to make a voluntary decision about whether to undergo the procedure or
intervention. Patient autonomy is an accepted principle in medical ethics. Informed consent is
considered an essential safeguard of patient autonomy, where autonomy means, 'a capacity
for independent decisions and action. Informed consent must be preceded by disclosure of
sufficient information. Consent can be challenged on the ground that adequate information
has not been revealed to enable the patient to take a proper and knowledgeable decision.
Therefore, accurate, adequate and relevant information must be provided truthfully in a form
(using non-scientific terms) and language that the patient can understand.

Origin of ‘Informed Consent’

The legal precedent for informed arises from the case of Schloendorff v. Society of New York
Hospitals in 1914, USA, in which a surgeon failed to take consent for hysterectomy.
Benjamin Cardoza, J. observed that “Every human being of adult years and sound mind has a
right to determine what shall be done with his own body and the surgeon who performs
operation without his (patient's) consent commits assault for which he is liable in damages.”
This case established the concept of autonomy of a patient undergoing treatment and a
competent adult's right to refuse treatment.
The actual phrase “informed consent “entered American jurisprudence in 1957 in a California
medical malpractice case. In Salgo V Stanford University, patient’s legs were paralyzed when
his physician performed aortography to locate an obstruction in his abdominal aorta3.
Apparently, the treating physician had not counseled the patient at the risk inherent in the
procedure. In its decision, the court held that “a physician violates his duty to his patient and
subjects himself to liability if he holds any facts which are necessary to from the basis of an
intelligent consent by the patient to the proposed treatment.”

Bolam Test and it’s applicability

The law for consent has evolved to a great extent in USA and UK. In UK, it is called real
consent while in USA it is called 'informed consent'. The English law regarding disclosure of
risk follows the Bolam principle which originated from the case of in the case of Bolam v
Friern Hospital Management Committee [1957] 1 WLR 582. According to this case, a doctor
is not negligent if he acts in accordance with the practice accepted at the time as proper by a
responsible body of medical opinion, even though other doctors adapt a different practice. In
other words, in which a doctor might be able to avoid a claim for negligence if he can prove
that other medical professionals would have acted in the same way.
In Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Mandsley Hospital,
the House of Lords adopted the Bolam test and followed the reasonable doctor standard
regarding the duty of disclosure risk of proposed treatment. It is important for medical
professionals to provide as much information as possible for informed decision making. A
similar view is adopted by the Supreme Court of India in the Samira Kohli case. The SC
observed that, 'In India, Bolam test has broadly been accepted as the general rule.'
Bolam was rejected in the 2015 Supreme Court decision of Montgomery v Lanarkshire
Health Board.

Cases
A. In Dr. Janaki S Kumar and Anr versus Mrs. Sarafunnisa case in an allegation of
performing sterilisation without consent, it was contended that consent was obtained
during the course of surgery. The commission held that the patient under anaesthesia
could neither understand the risk involved nor could she give a valid consent. It was
observed that when one speaks of consent, that should be informed consent. The
person who should give consent must be aware of the risks involved and on that
awareness the patient should give consent. When, as indicated, the patient was in
general anesthesia neither could she understand the risks involved nor could she give
consent. It may be understood that it is only in emergency that the consent may be
done away. Otherwise, the consent is necessary and that to in writing.

B. In a case Aplarain Jayanand Rathod v. Dr. Shailesh Shah the operation of

appendicitis was performed without written consent under the guise of removal of
stitches and no explanation was given for the second operation. The State commission
found that the Doctor was deficient in service and was liable for compensation. In
patients who are more prone for anxiety / full disclosure in presence of malignancy or
unavoidable total results the doctor should use therapeutic privilege in the interest of
patient, disclose the fact to the kin rather than to the patient.

C. Malay Kumar Ganguly v. Sukumar Mukherjee, SC

The deceased approached Dr. Sukumar Mukherjee complaining of acute pain, fever
and rashes, where she was administered a higher-than-recommended dosage. With the
situation degrading, she was left in the care of dermatologist Balram Haldar and
physician Abani Roychowdhury. However, most culpably, Dr. Mukherjee did not
 even prescribe I.V. (intravenous) fluid and adequate nutritional support which was
mandatory in that condition. She contracted TEN which is a rare skin condition
caused by a result to drugs, where the top layer of skin detaches from the lower layer
all over the body. No sign of improvement could be seen and hence, Anuradha was
taken to Breach Candy Hospital in Mumbai, where she died on 28 May 1998.
The supreme court without reference to its previous judicial opinion in Samira Kohli
emphasized on the need of doctors to engage with the patients during treatment,
especially when the line of treatment is contested, has serious side effects and
alternative treatments exist, and observed that “[i] n the times to come, litigation may
be based on the theory of lack of informed consent.”

D. In Samira Kohli v. Dr. Prabha Manchanda (SC), a 44-year-old patient complaining of

menstrual bleeding for 9 days, underwent an ultrasound test and was advised
laparoscopy test under general anesthesia for making an affirmative diagnosis. The
patient, while under general anesthesia, was subjected to a laparoscopic examination
and simultaneously with the consent of the mother waiting outside the operation
theater, abdominal hysterectomy (removal of uterus) and bilateral salpingo-
oophorectomy (removal of ovaries and fallopian tubes) were conducted. It was held
by the Supreme Court that consent taken for diagnostic procedure/surgery is not valid
for performing therapeutic surgery either conservative or radical except in life-
threatening or emergent situations. It was also held that where the consent by the
patient is for a particular operative surgery; it cannot be treated as consent for an
unauthorized additional procedure involving removal of an organ on the ground that
such removal is beneficial to the patient or is likely to prevent some danger
developing in future, if there is no imminent danger to the life or health of the patient.
Supreme Court in the process of arriving at its judicial opinion examined the concept
of “real consent” in the UK and “informed consent” in the US and finding the US
standards to be too high and unsuitable for Indian conditions expressly rejected the
same. It was further held that a doctor must secure the consent of the patient, and such
consent should be “real and valid,” “adequate information” is to be furnished to the
patient to enable him or her to make a balanced judgment, remote possibilities need
not be disclosed, and the nature and extent of information to be furnished will be such
as is considered “normal and proper by a body of medical men skilled and
experienced in the particular fie

E. Mr X. v Hospital Z, SC
 In this case, A man was supposed to marry his fianceé but it was called off since he
was diagnosed as an HIV positive patient and his doctor disclosed this fact to his
fianceé. The man contended that the respondent hospital and doctor had breached
their duty under medical ethics by disclosing the information without his consent.
The supreme court has acknowledged the sanctity that confidentiality in the medical
profession is vital. But, the court after going through the guidelines on HIV infection
and AIDS issued by the general medical council of great Britain noted that the doctor-
patient privilege allowed for exceptions when the “public interest would override the
duty of confidentiality, particularly where there is an immediate or future health risk
to others.” Moreover, recognizing the right to privacy as a fundamental right
emanating from the right to life and personal liberty under Article 21 of the
constitution of India, that as one of the basic Human Rights the right of privacy is not
treated as absolute and limits may be placed on these rights so long there is a
compelling state interest and such action as may be lawfully taken when the health or
morals or protection of rights and freedom of others are at stake. Ultimately, using
this rationale the Hon’ble Supreme court upheld the action of the respondent hospital,
in disclosing the HIV positive status of the appellant to the hitherto prospective bride
and others.

F. Selvi v S/o Karnataka,

The appeal to the SC highlighted the instances where individuals who were accused
of a crime, the suspects or witnesses involved in an investigation were being subjected
to Narco-analysis, Brain Electrical Activation Profile (BEAP), Functional Magnetic
Resonance Imaging (FMRI) and Polygraph tests without their consent. And whether
the same is constitutionally valid w/o violating article 20(3) and 21?
It was held by the Hon'ble three judge bench of the Supreme Court that no individual
should be forcibly subjected w/o their consent to any of the techniques in question,
whether in the pretext of investigation in criminal cases or otherwise. Such a practice
would amount to an unwarranted intrusion into the personal liberty of an individual.
However, the court also pointed out that voluntary administration of the said
techniques shall be valid provided that proper safeguards are followed. The bench
further elaborated that even when the subject has given his consent to undergo any of
these tests, the results of such tests cannot by themselves be admitted as evidence
because the subject does not exercise his conscious control over the responses during
the test. However, any information or material that is subsequently discovered with
the help of voluntary administered test results can be admitted, in accordance
with Section 27 of the Evidence Act, 1872.
The Court placed reliance on the guidelines published by the National Human Rights
Commission for the Administration of Polygraph Test (Lie Detector Test) on an
Accused in 2000 which said that no lie detector tests should be administered w/o
consent of the accused. The court held that these guidelines should be strictly adhered
to and similar safeguards should be adopted for conducting the `Narco-analysis
technique' and the `Brain Electrical Activation Profile' test.

G. Poona Medical Foundation v Marutturao Tikare, 1995

 The National Commission had held that there was no question of negligence for
failure to supply the medical records to patients unless there is a legal duty on the
hospital to give the records. The alleged hospital had provided a detailed discharge
summary to the patient.
H. Joslin Chrysostom Vs. S. Lourdu (02.02.2001 - SCDRC Tamil Nadu):
MANU/RE/0032/2001 (Consumer Court)

Facts: She (S. Lourdu) was admitted in the Government Headquarters Hospital on the
Police Memo as an inpatient and eventually got discharged on 28.11.1992.
When she was discharged from the hospital, she prayed for a certificate and
particulars of treatment to which the opposite party, doctor, refused to issue. She
would state that the act of the opposite party, doctor, in refusing to issue the certificate
and other particulars of treatment given to her in the said hospital would amount to
deficiency in service on his part. For such deficiency in service, she claims
compensation in a sum of Rs. 50,000/-.
The opposite party doctor contend that she was not at all admitted in their hospital as
an inpatient. She took treatment as an outpatient for a specified period.
Held – The act of the complainant in launching a complaint as against the opposite
party doctor for the refusal to issue a certificate and other particulars of treatment
which he had given to the complainant when especially there is no obligation caused
on him to do so, would definitely tantamount to institution of a complaint as against
the opposite party doctor either frivolously or vexatiously.
As per Section 26 of the Consumer Protection Act, the complaint is liable to pay to
the opposite party doctor a sum of Rs. 1,000/- by way of cost for the institution of
such frivolous or vexatious complaint.
 Pre-conception & Pre-natal Diagnostics Techniques (PC & PNDT) Act, 1994

About PCPNDT Act: Introduction

The Pre-conception & Pre-natal Diagnostics Techniques (PC & PNDT) Act, 1994 was
enacted in response to the decline in Sex ratio in India, which deteriorated from 972 in 1901
to 927 in 1991. The main purpose of enacting the act is to ban the use of sex selection
techniques before or after conception and prevent the misuse of prenatal diagnostic technique
for sex selective abortion.

The Act has three aspects viz. prohibitory, regulatory and preventive. In order to look into
various policy and implementation matters, the Act provides for the setting up of various
bodies along with their composition, powers and functions. The Act allows pre-natal
diagnostic techniques to be conducted only for the purposes of detection of the abnormalities
namely; Chromosomal abnormalities, genetic metabolic diseases, heamoglobinopathies, sex-
linked genetic diseases, congenital anomalies, or any other abnormalities or diseases
specified by Central Supervisory Board. Because the purposes have been specified, no
relative or husband of the pregnant women can seek, or encourage the conduct of any pre-
natal diagnostic techniques.

Offences under this act include conducting or helping in the conduct of prenatal diagnostic
technique in the unregistered units, sex selection on a man or woman, conducting PND test
for any purpose other than the one mentioned in the act, sale, distribution, supply, renting etc.
of any ultra sound machine or any other equipment capable of detecting sex of the foetus.

The act was amended in 2003 to improve the regulation of the technology used in sex
selection. The Act was amended to bring the technique of pre conception sex selection and
ultrasound technique within the ambit of the act.

The amendment also empowered the central supervisory board and state level supervisory
board was constituted. In 1988, the State of Maharashtra became the first in the country to
ban pre-natal sex determination through enacting the Maharashtra Regulation of Pre-natal
Diagnostic Techniques Act.

IMPORTANT PROVISIONS

Section 4 of the PNDT Act of 1994 talks about Regulation of pre-natal diagnostic
techniques:
(1) No place including a registered Genetic Counseling Centre or Genetic Laboratory or
Genetic Clinic shall be used or caused to be used by any person for conducting pre-natal
diagnostic techniques except for the purposes mentioned above. (2) No pre-natal diagnostic
techniques shall be conducted except for the purposes of detection of any of the following
abnormalities, namely, chromosomal abnormalities, genetic metabolic diseases,
haemoglobinopathies, sex-linked genetic diseases, congenital anomalies, any other
abnormalities or diseases as may be specified by the Central Supervisory Board; (3) No
PNDT shall be used or conducted unless the person qualified to do so is satisfied that any of
the following conditions are fulfilled, namely that (i) age of the pregnant woman is above
thirty-five years (ii) the pregnant woman has undergone of two or more spontaneous
abortions or foetal loss (iii) the pregnant woman had been exposed to potentially teratogenic
agents such as drugs, radiation, infection or chemicals (iv) the pregnant woman has a family
history of mental retardation or physical deformities such as spasticity or any other genetic
disease

Section 5 of the PNDT Act of 1994 talks about the Written Consent of Pregnant Woman
and Prohibition of Communicating the Sex of Foetus.

(1) No person referred to in clause (2) of section 3 shall conduct the pre-natal diagnostic
procedures unless (a) he has explained all known side and after effects of such procedures to
the pregnant woman concerned; (b) he has obtained in the prescribed form her written
consent to undergo such procedures in the language which she understands; and (c) a copy of
her written consent is given to the pregnant woman.

Section 6 of the PNDT Act of 1994 prohibits the determination of sex, stating that no
Genetic Counselling Centre or Genetic Laboratory or Genetic Clinic, or no person shall
conduct or cause to be conducted in its Centre, Laboratory or Clinic, pre-natal diagnostic
techniques including ultrasonography, for the purpose of determining the sex of a foetus.

Section 16 of the PNDT Act of 1994, talks about the functions of the Board, which shall
consist of important dignitaries of the government as well as special doctors. The Board shall
have the following functions, namely (i) to advise the Government on policy matters relating
to use of pre-natal diagnostic techniques (ii) to review implementation of the Act and the
rules made there under and recommend changes in the said Act and rules to the Central
Government (iii) to create public awareness against the practice of pre natal determination of
sex and female foeticide (iv)to lay down code of conduct to be observed by persons working
at Genetic Counselling Centres, Genetic Laboratories and Genetic Clinics (v)any other
functions as may be specified under the Act.

Section 18 of the PNDT Act of 1994, talks about the provisions of Registration of Genetic
Counselling Centres, Genetic Laboratories or Genetic Clinics. One of the main provisions of
this section says that no person shall open any Genetic Counselling Centre, Genetic
Laboratory or Genetic Clinic after the commencement of this Act unless such Centre,
Laboratory or Clinic is duly registered separately or jointly under this Act.

Section 19 of the PNDT Act of 1994 states that the Certificate Of Registration shall be done
by the appropriate authority after holding an inquiry and after satisfying itself that the
applicant has complied with all the requirements of this Act and the rules made thereunder
and having regard to the advice of the Advisory Committee in this behalf, grant a certificate
of registration in the prescribed form jointly or separately to the Genetic Counselling Centre,
Genetic Laboratory or Genetic Clinic, as the case may be.

Section 20 of the PNDT Act of 1994 gives emphasis on Cancellation or Suspension of

Registration whereby:- (1) The Appropriate Authority may suo moto, or on complaint, issue a
notice to the Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic to show cause
why its registration should not be suspended or cancelled for the reasons mentioned in the
notice.

Section 21 of the PNDT Act of 1994 provides for provisions of Appeal, thus stating that the
Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic may, within thirty days
from the date of receipt of the order of suspension or cancellation of registration passed by
the Appropriate Authority under section 20, prefer an appeal against such order to either the
Central government or the State government.

Section 22 of the PNDT Act of 1994 states that the following persons are Prohibited of
advertisement relating to pre-natal determination of sex and punishment for contravention:
(1) No person, organisation, Genetic Counselling Centre, Genetic Laboratory or Genetic
Clinic shall issue or cause to be issued any advertisement in any manner regarding facilities
of pre-natal determination of sex available at such Centre, Laboratory, Clinic or any other
place. (2) No person or organisation shall publish or distribute or cause to be published or
distributed any advertisement in any manner regarding facilites of pre-natal determination of
sex available at any Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic or any
other place.

Section 27 of the PNDT Act of 1994 states that all offence under this act shall be cognizable,
non-bailable and non-compoundable.

Section 28 of the PNDT Act of 1994 talks about the Jurisdiction of the Court. Subsection 1
to this section says that no court shall take cognizance of an offence under this Act except, on
a complaint made by—(a) the Appropriate Authority concerned, or any officer authorized in
this behalf by the Central Government or State Government, as the case may be, or the
Appropriate Authority or, (b) a person who has given notice of not less than thirty days in the
manner prescribed, to the Appropriate Authority, of the alleged offence and of his intention to
make a complaint to the court.

Judicial pronouncements

The Judiciary has played and continues to play a vital role in the prevention of atrocities
against women, in general, and female foeticide, in particular.

In the landmark case of Centre For Enquiry Into Health And Allied Themes (CEHAT) v.
Union Of India & Others, petitioners concerned about the implementation of the Act, moved
the Union of India to Court for effective implementation and execution of the provisions of
the Pre-Natal Diagnostic Techniques Act, 1994, which had failed at achieving its goals of
preventing female feticide. The court warned the Centre, States and Union Territories to
effectively comply with the mandates of the Act and also clarified to the appropriate
authorities that it was empowered to take criminal action against violators. The Court directed
for amendment of the Act in view of emerging technology and the Act was amended in 2003
to Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act,
1994.The Court also directed the formation of the National Committee (National Monitoring
and Implementation Committee— NMIC) to monitor the implementation of The Act.

The constitutionality of The PCPNDT Act, 1994 was challenged in Vinod Soni & Anr. v.
Union of India on the ground that it violates Article 21 of the Constitution to the extent it
includes the liberty of choosing the sex of the child. The petition was dismissed by the
Bombay High Court and the Act was held constitutional.

In the case of Voluntary Health Association of Punjab v. Union of India, (MOST IMP.
CASE, GUIDELINES SATED BELOW) Petitioner filed a writ petition before the Supreme
Court of India to examine the ways in which the Indian state governments have addressed the
problem of sex-selective abortion in India. The Court determined that states failed to
effectively implement or enforce the Pre-Conception and Pre-Natal Diagnostic Techniques
(Prohibition on Sex-Selection) Act, 1994. Justice K.S. Radhakrishnan issued several orders
and directions to map out unregistered clinics to ensure they did not purchase ultra-
sonography machines, seize illegally sold ultrasonography machines, and hold workshops to
inform communities about the Act’s obligations. Justice Dipak Misra observed that, in order
to enforce these laws effectively, the awareness campaigns must encompass social and moral
impetus for the Act in order to serve the purpose of implementing legislation effectively and
to maintain “humanism” and also that, for The Act to be successful the society must be made
aware of the equal role of women in society.

The Honorable Supreme Court has given judgment, on the implementation of PCPNDT Act
as follows: Voluntary Health Association of Punjab v. Union of India
· The Central Supervisory Board and the State and Union Territories Supervisory Boards,
constituted under Sections 7 and 16A of PNDT Act, would meet at least once in six months,
so as to supervise and oversee how effective is the implementation of the PNDT Act.
· The State Advisory Committees and District Advisory Committees should gather
information relating to the breach of the provisions of the PC&PNDT Act and the Rules and
take steps to seize records, seal machines and institute legal proceedings, if they notice
violation of the provisions of the PC&PNDT Act.
· The authorities should ensure also that all Genetic Counselling Centers, Genetic
Laboratories and Genetic Clinics, Infertility Clinics, Scan Centers etc. using preconception
and pre-natal diagnostic techniques and procedures should maintain all records and all forms,
required to be maintained under the Act and the Rules and the duplicate copies of the same be
sent to the concerned District Authorities, in accordance with Rule 9(8) of the Rules.
· States and District Advisory Boards should ensure that all manufacturers and sellers of
ultra-sonography machines do not sell any machine to any unregistered centre, as provided
under Rule 3-A and disclose, on a quarterly basis, to the concerned State/Union Territory and
Central Government, a list of persons to whom the machines have been sold, in accordance
with Rule 3-A(2) of the Act.
· Steps should be taken by the State Governments and the Union Territories to educate the
people of the necessity of implementing the provisions of the Act by conducting workshops
as well as awareness camps at the State and District levels.
· The authorities concerned should take steps to seize the machines which have been used
illegally and contrary to the provisions of the Act and the Rules there under and the seized
machines can also be confiscated under the provisions of the Code of Criminal Procedure and
be sold, in accordance with law.
· The various Courts in this country should take steps to dispose of all pending cases under
the Act, within a period of six months. Communicate this order to the Registrars of various
High Courts, who will take appropriate follow up action with due intimation to the Courts.

Issues and challenges:

The main problem in implementation is that in most of the cases, both the service providers
and the service seekers operate in agreement to defeat the provisions of the act and there is no
complainant. Fraternity bias in implementation of act has been seen as district health
authorities find it difficult to register cases against other colleague doctors. Lack of job clarity
for the officers and staff who are given responsibility of implementation in the districts. Lack
of commitment expressed through irregular meetings and non-punishment of offenders by the
authorities. Lack of indicators for assessment of implementation of the act as no inbuilt
indicators are there in the programme implementation. National advisory board meetings are
not happening regularly. Monitoring of the implementation of the act is data based leading to
increased burden of health department as no extra staff is given for this activity in the
districts.

The easy availability of technology is making it easier to translate son preference into the
elimination of female foetus. The crime takes place with the involvement of both parties (the
doctor motivated by money, and the woman coerced by family and social pressure). Evidence
for a legal case is difficult to put together and there may be limitations for the use of
circumstantial evidence. There are limits to the quality of evidence from clinic records alone.
While the law sought to punish sex determination, it is rendered ineffective because of the
liberal MTP act which allows abortion on the ground of mental trauma. This is left to the
discretion of the doctor to define and is grossly misused for monetary benefit. Results of sex
determination tests are given verbally by doctors and are difficult to prove. The sex selection
industry is run by medical professionals who have, so far, shown little inclination in this
problem. More complex, is to prove that a woman is having an abortion because she is
carrying a female foetus. Amniocentesis, chorionic biopsy, ultrasound (Prenatal Diagnostic
Techniques) etc, have been allowed by the law for purposes of detecting genetic
abnormalities in the fetus and as such they cannot be banned.

Conclusion

Purpose of enactment could only be actualized and its object fruitfully realized when
authorities under the Act carry out their functions with devotion, dedication, and
commitment. People involved in awareness campaigns should have boldness and courage and
there should not be any iota of confusion or perplexity in their thought or action. They should
bear in mind that they were required to change the mindset of people, the grammar of society,
and unacceptable beliefs inherent in the populace.

It has been observed that complete laxity by the authorities as well as sheer carelessness is
responsible for the ineffective implementation of the Act. They have also failed to apprise the
masses on the necessary social, cultural, and legal awareness that a female fetus cannot be
killed without a specific command by law. The actions of the involved doctors and medical
practitioners who are unqualified and said that the present generation invites the sufferings on
its own and also sows the seeds of suffering for the future generation. The result is ultimately
the reduced sex ration which in turn leads to manifold social problems. It also stressed that no
awareness campaign can ever be complete unless there is a real focus on the prowess of
women and the need for women empowerment.

MTP Act, 1971

The MTP Act acts as an exception to Section 312 of the Penal Code, 1860 (“IPC”), which
criminalises the act of “voluntarily causing a woman with child to miscarry” save for the
purpose of it being carried out in good faith to save the life of the woman”. The MTP Act was
created to legislatively govern the exception to the criminalisation of abortion under section
312 of the IPC, in order to enable medical practitioners to terminate pregnancies under
certain conditions.

The act was passed in 1971 with the object to liberalise and to permit termination of
pregnancy. The act contains no provisions inconsistent with the object of the Preconception
and Prenatal Diagnostic Techniques Act, 1994. The act sets out three circumstances when
medical termination is possible:
1. To protect the mother’s health, strength or life
2. On humanitarian grounds such as when the pregnancy devices from a sex crime like rape
3. When there is a substantial risk that the child born would suffer from deformities and
diseases.
Practitioner the medical practitioner who terminate the pregnancy in the manner and the
circumstances mentioned under the act shall not be liable to prosecute for any offence under
the IPC in light of the express provision contained in section 3(1). Section 8 also provides
immunity to a doctor for any damage caused or likely to be caused for any act done in good
faith under the Act. It states that “Only a registered medical practitioner has a right for the
termination of pregnancy in certain circumstances”.

Important provisions of this Act

Section 2(d) of the Medical Termination of the Pregnancy Act 1971 defines ‘Registered
Medical Practitioner’. According to it, ‘a Registered Medical Practitioner ’means any medical
practitioner who possesses required medical qualifications which is defined in Section 2 of
the Indian Medical Council Act 1956 and whose name has been registered in the state
medical register and who possess required medical skills in gynaecology and obstetrics which
are prescribed under the said act.
Section 3 of the Medical Termination of the Pregnancy Act 1971 provides that “When
pregnancies may be terminated by the registered medical practitioners”.
1. A registered medical practitioner should not be guilty of any offence which has been
mentioned in the IPC or any other law during the time of the termination of pregnancy by
him according to the provisions of the law.
2. Where the duration and time of pregnancy have not exceeded more than 12 weeks.
3. Where the duration and time of pregnancy have exceeded 12 weeks but not the 20 weeks,
in this case by the opinions of the two medical practitioners in good faith.
4. The continuation of the pregnancy will be a grave danger for a woman’s physical or mental
health.
5. When there is anticipation that the child born out of this pregnancy will be prone to
detrimental physical and mental health and will be handicapped.
6. One important point is to be noted, guardian’s or parent’s written consent is required for
terminating the pregnancy of any minor girl or any girl who is above the age of eighteen but
is insane or lunatic.

Amendment Act, 2020

The Medical Termination of Pregnancy (Amendment) Act , 2020 which was passed by the
Upper House recently attempts to bring about certain changes in the present law relating to
medical termination of pregnancy.
In its Statement of Objects and Reasons, the Bill identified that with the advancement of
medical technology there is a scope to increase the upper gestational limit for terminating
pregnancies, which up till now stood at twenty weeks, but with the passing of the Bill, would
stand at twenty-four weeks. The Bill does away with the anachronistic lower limit of twelve
weeks and upper limit of twenty weeks as threshold for termination of pregnancies.
The proposed amendments include substitution of certain sub-sections, insertion of certain
new clauses under some sections in the existing Medical Termination of Pregnancy Act,
1971, with a view to increase upper gestation limit for termination of pregnancy under certain
conditions and to strengthen access to comprehensive abortion care, under strict conditions,
without compromising service and quality of safe abortion.
That being said, there are certain riders to these thresholds. First, even up till the increased
twenty-weeks lower-limit, the decision to continue or terminate the pregnancy is still not at
the discretion of the pregnant woman. If the pregnancy is within twenty weeks, one registered
medical practitioner should be of the opinion formed in good faith that the pregnancy, if
continued would result entail a risk to the life of the pregnant woman or a grave injury to her
physical or mental health; or a substantial risk that if the child is born, it would suffer from a
serious physical or mental abnormality.
Another welcome change brought by the Bill is that in cases where the termination of
pregnancy is deemed necessary on the diagnosis of 'substantial' foetal abnormalities by a
Medical Board, the upper limit of termination provided under section 3 would not apply.
Further, if the pregnancy was a result of a failed device or method used by the woman or her
partner (note the word 'partner' in place of 'husband' used in the 1971 Act) to prevent the
pregnancy or limiting the number of children, then it would be considered that the resulting
pregnancy would constitute grave mental injury to the pregnant woman. This is a remarkable
and a welcome amendment as it would include pregnancies resulting from live-in
relationships or even casual sexual relations as opposed to pregnancies resulting from the
institution of marriage only.
The Bill mandates the government to set up a medical board in every state and union
territory. This board will be responsible for the diagnosis of substantial foetal “abnormalities”
that require termination after 24 weeks.

Important Cases

In Suchita Srivastava v. Chandigarh Admn, the Court held that the right to make
reproductive choices is a dimension of ‘personal liberty ’guaranteed by Article 21 and
further, that “reproductive choices can be exercised to procreate as well as to abstain from
procreating”.
In Devika Biswas v UOI, the Court again held that the right to life and personal liberty under
Article 21 encompasses reproductive rights. It emphasised that this includes the right to
“access a range of reproductive health information, goods, facilities and services to enable
individuals to make informed, free, and responsible deci- sions about their reproductive
behaviour.”
The Indian Supreme Court has developed strong jurisprudence on reproductive rights. In the
landmark privacy judgment, Justice Chandrachud stated that reproductive choice should be
read within the personal liberty guaranteed under Article 21 of the Indian Constitution.

Analysis of the Amendment Act

1. the proposed amendment still requires one doctor to sign off on termination of pregnancies
up to 20 weeks old, and two doctors for pregnancies between 20-24 weeks old. The overall
upper gestational limit for terminating pregnancies has been increased from 20 to 24
weeks. However, it is conditioned for a “certain category of women”. This category has
not been defined in the Act but will be prescribed by the MTP Rules. Thus, it is not based
on request or isn’t at the pregnant person’s will but on a doctor’s opinion. This is, in fact, a
step backwards from the draft MTP Amendment Bill of 2014, which proposed that a
pregnancy up to 12 weeks old could be terminated “on request of a woman”
2. while the 2020 Bill extends contraceptive failure as a ground for abortion to any “woman
or her partner” – as opposed to only married women – the inclusion of the term “partner”
suggests that women will still have to cite relational grounds when they seek abortions.
 This provision will exclude large numbers of single women, especially from marginalised
groups, such as sex workers. Additionally, this provision continues to use “woman” and
excludes transgender, intersex and gender-diverse persons.
3. the Bill considers only eugenic reasons for terminations after 24 weeks of gestation. If safe
abortions can be performed at any stage of the pregnancy in case of foetal “abnormalities”,
then they should be permitted on other grounds, such as a sudden change in circumstances
due to separation from or death of a partner, or a change in financial situation, domestic
violence, etc. Disability rights advocates have argued that foetuses with potential
disabilities should not be singled out for abortions. This reinforces the notion that persons
with disabilities have less value than persons without disabilities, and that all foetuses with
“abnormalities” should be terminated. It should be the sole discretion of the pregnant
person, in consultation with their doctor, to carry a pregnancy to full term or to abort, even
if the foetus has a potential disability, cognitive impairment and/or other medical
conditions.
4. The Bill replaces the phrase “by any married woman or her husband” with “any woman or
her partner”, and also adds “or preventing pregnancy” after the phrase “limiting the
number of children”, which is a positive step and in line with what the 2014 draft
amendment Bill had proposed. However, this provision still restricts abortion to a
heteronormative framework, as the imagination of the law is limited to the use of
contraceptives to limit children or prevent pregnancy within a ‘partnership ’that is likely to
exclude many marginalised groups, including sex workers.
5. the proposed amendment uses the word “women” throughout, although access to abortion
services is critical not only for cisgender women but also for transgender, intersex and
gender-diverse persons. Therefore, any legislative framework on abortion must ensure that
all individuals, irrespective of gender, have access to safe, affordable and legal services.
The word ‘women’, therefore, should be replaced by ‘person’.
6. Also, it will be nearly impossible to constitute Boards with a panel of specialists in most
regions of the country. Additionally, the bureaucratic process will delay the abortion, and
costs incurred by the pregnant person to travel to the Board can create financial setbacks.
India already undergoes “Distress Financing” which occurs due to high out-of-pocket
expenditure among the poor and marginalised, resulting in medical poverty. These Boards
are unconstitutional and violate the fundamental rights of pregnant persons by subjecting
them to multiple invasive examinations and causing unnecessary delays in the termination
process.
 CLINICAL TRIALS

Introduction
Clinical trials form an integral part of the drug discovery process worldwide. Clinical trials
are the set of practices required to certify a new drug molecule as safe and efficacious for the
market. Medical research, in general, is a good thing and absolutely necessary to cure number
of chronic diseases.

A set of guidelines are already in place in India for the ethical conduct of studies to safeguard
the interests of patients or volunteers participating in the study. Globalization of international
clinical trials creates new questions regarding ethics in conduct of clinical trials in human
subjects and conducting research on marginalized or oppressed populations. Research
subjects' have long been controversial, even after decades of debate, experience, and
Regulation. In this review, this paper aims at discuss the International and National Laws on
Clinical Trials, ethics in clinical research, next it reviewed some current controversies on
clinical trials and concludes with a discussion we need more standards and Legislations for
future medical research on human subjects.

Clinical Trials Practice in India

Global clinical research is exploring India. Yet, it is certainly not the West that is introducing
clinical research to India. Two ancient scripts, Charaka Samhita (a textbook of medicine) and
Sushruta Samhita (a textbook of surgery), compiled as early as 200 B.C. and 200 A. D.
respectively, show India's age-old proficiency in medical research. However, a lot has
changed in the clinical research scenario since then4. Today, clinical trials are conducted
through a regulated approach following certain guidelines laid down by the International
Conference on Harmonization (ICH), which is spearheaded by U.S.A., Europe and Japan.
There are number of laws governing clinical research in India.

Indian Acts/Orders related to Clinical Trials

• Drugs and Cosmetics Act – 1940
• Medical Council of India Act – 1956, (amended in the year2002)
• Central Council for Indian Medicine Act – 1970
• Guidelines for Exchange of Biological Material (MOH order, 1997)
• Right to Information Act – 2005,
 • The Biomedical Research on Human Subjects (regulation, control and safeguards)
Bill – 2005

Even though we have number of legislations the important one for clinical trials is The Indian
Council of Medical Research (ICMR) – 1947(amended in the year2002) , which was set up in
order to foster a research culture in India, improve and develop infrastructure and foster
community support. The Drugs and Cosmetics Act, The Medical Council of India (MCI) Act
states that all clinical trials in India should follow the ICMR guidelines of 2000. The ICMR
has a mechanism of review for its own institutions, and so do other government agencies.
Every doctor is governed by the MCI Act. Any doctor doing wrong in a trial or in practice
can be prosecuted and the hospital can be closed.

The MCI Act is very strong; the MCI has the power to take punitive measures. The Drugs
Controller General of India (DCGI) is responsible for regulatory approvals of clinical trials in
India. The DCGI's office depends on external experts and other government agencies for
advice. Additional permissions are required for the export of blood samples to foreign central
laboratories.5 The ICMR has a Central Ethics Committee on Human Research (CECHR).
This committee audits the functioning of this Institutional Ethics Committee (IEC). The
recently amended Schedule Y of Drugs and Cosmetic Rules order the composition of the IEC
as per the ICMR guidelines. The DCGI's office in collaboration with WHO ICMR and many
committed research professionals, has been conducting training programs for members of the
Ethics Committees across the country.

Clinical Trial Registration in India

In order to make clinical data and reports available to all, an online clinical registry has been
initiated by the Indian Council of Medical Research (ICMR) for the registration of any
interventional trial to ensure the following goals:

• Transparency and accountability of clinical research

• Internal validity of clinical trials
• To oversee the ethical conduct of clinical trials
• Reporting of results of clinical trials

The clinical trial registry of India (CTRI) is the online registry of prospective clinical trials in
India. This is the initiative started by the National Institute of Medical Statistics (NIMS) of
the Indian Council of Medical Research and is supported by the Department of Science and
Technology (DST) and the World Health Organization (WHO).

CTRI will create a database of prospective clinical trials in India after their registration. The
data and reports of these clinical trials and their status will be available to the public and
professionals free of cost after formal registration on their website.9Currently, the registration
of clinical trials is only voluntary and not mandatory. With increased awareness about this
initiative and wide acceptance of the purpose of CT registration, it is likely that it may
become mandatory in the future for initiation of clinical trials in India.

It has been affirmed that CT registration should be done before the actual enrollment of study
subjects in the trial. The principal investigator or sponsor should share the responsibility of
CT registration. In the case of multi-centric studies, the lead investigator or sponsor should
ensure that the CT is registered. For the registration of a CT, it is essential to declare 20 items
relevant to the CT as determined by the International Clinical Trial Registration Platform
(ICTRP) of the World Health Organization (ICRTP-WHO). For registration with the CTRI,
additional items related to the EC or IRB's permission and that of Director Controller General
of India (DCGI) are included. At the end of a successful registration, each CT is assigned a
unique WHO identification number called the Unique Trial Reference Number (UTRN).

International Laws on Clinical Trials:

There are many international instruments that confer and safeguard the rights of participants
in clinical trials. Modern ethics in human research mainly emerged after World War II, when
Nazi physicians used prisoners for inhumane 'experiments'. This resulted in the creation of
the Nuremberg Code in 1947, which clearly stated voluntary consent as an absolute
requirement for human subjects' research11. As a result, it became almost impossible to
conduct any clinical research in mentally impaired and other vulnerable groups. In 1964, the
Declaration of Helsinki – proposed by the World Medical Association – changed some of the
absolute rules of the Nuremberg code; for example, it allowed the use of surrogate consent in
the case of individuals with impaired decision making 12. International Covenant on Civil
and Political Rights (ICCPR) – 1966 (particularly Article 7 as it relates to consent for medical
and scientific experiments) 13; the Council for International Organizations of Medical
Sciences (CIOMS) international ethical guidelines -1993 (since revised) 14; and, the
International Conference on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use – Good Clinical Practice: Consolidated Guidelines -199615.
On a European level [EU], the EU has issued its directive on good practice in clinical trials16
and the Council of Europe has issued a Convention on Human Rights and Biomedicine on
biomedical research17. Most recently, UNESCO has developed a Universal Declaration on
Bioethics and Human Rights.18

The Nuremberg Code and the ICCPR do not seriously focusing on human rights in clinical
trials. Neither document recognizes the distinction between therapeutic and non-therapeutic
research. This fundamental deficiency is that they have largely been ignored by the medical
profession. According to article 1 of the Nuremberg Code and Article 7 of ICCPR (both
addressing consent) means consent would be necessary in all circumstances i.e. those who
become unconscious due to an accident or disease or those who are mentally handicapped
could not, if no standard treatment exists, be offered new therapeutic measures that might
restore their health or save their lives. Such a rigid interpretation would mean that the
respective provisions exclude many of those they were designed to protect. Furthermore,
Article 7 of ICCPR is to be reads "No one shall be subjected to torture or to cruel, inhuman or
degrading treatment or punishment. In particular, no one shall be subjected without his free
consent to medical or scientific experimentation."

The Article prohibits experiments that violate the integrity of the person by cruel, undignified
or inhuman treatment. Clinical research carried out in accordance with general principles
would not violate this provision. Yet the right to health argument confounds this. Recently
XVI International AIDS Conference in Toronto, UNAIDS presented an ethical argument as
to why trial participants that seroconvert during a trial do not require access to effective
treatment19. UNAIDS representatives considered these issues as ethical and not obligatory
legal issues.

However, CIOMS guidelines make some reference to the Declaration of Helsinki and it is the
fundamental document in the field of ethics in biomedical research."20 The recent version
also enunciates the laudable goal that "the research is responsive to the health needs and the
priorities of the population or community in which it is to be carried out; and any intervention
or product developed, or knowledge generated, will be made reasonably available for the
benefit of that population or community."21 Nevertheless, as stated in the Declaration of
Helsinki, human rights issues are coming to be seen as within the proper domain of public
law and private law remedies such as negligence and the tort of trespass do not constitute a
potent deterrent for unscrupulous researchers operating in under-developed countries where
access to legal advice is scarce and/or prohibitively expensive. But in reality a strong civil
law is helping effected people at the end of the trials.

Ethics in Clinical Research

Most basic and complex principle of clinical research ethics is informed consent. An ethically
valid informed consent has four key components: disclosure, understanding, voluntariness,
and competence. This creates challenges for researchers in pediatrics, psychiatry, emergency
and critical care medicine. One can take surrogate consent or waived consent in the following
circumstances they are for example where a study of people at risk for Alzheimer's disease,
more than 90% thought that surrogate consent was acceptable for minimal risk studies as well
as randomized trials of new medications. Whereas in case of intensive care and surgery
patients their consent is also informed consent, but in reality people are not aware of the fact
that they are in clinical trials. This is revealed in number of studies.

However, it is important to recognize that if surrogate consent were eliminated, then it would
virtually eliminate almost all critical care research because many critically ill patients are
incompetent or unable to make a sound decision22. Family members are frequently
unavailable, may not know the patient's wishes, or may not be specifically legally authorized
to give consent for the patient's involvement in research. Therefore, some have questioned
whether the concept of informed consent is even applicable to research involving the
critically ill.23

For example in USA only certain emergency and resuscitation research can be done without
prospective informed consent. This is based on the 1996 US Food and Drug Administration
(FDA) 'Final Rule' and the US Department of Health and Human Services' parallel 'Waiver of
Informed Consent' regulations. These require community consultation, public notification,
and independent data and safety monitoring to allow exemption from informed consent 24

These regulations further stipulate that they can only be applied to emergency research for
which human subjects can not give informed consent because of their life-threatening
conditions (for example, unconsciousness); the condition requires immediate intervention;
available treatments are unproven or unsatisfactory; clinical equipoise exists; the research
might directly benefit the subject; the research intervention must be administered before
informed consent from the subjects' legally authorized representative is feasible; and the
responsible IRB concurs and documents that these conditions had been met. Other methods
such as deferred consent, implied consent, or delayed consent are no longer deemed
acceptable, despite previous use in early resuscitation research25. However, in the 10 years
since the release of the Final Rule, investigators in the USA have reported variability in IRB
interpretation, and have called for standardization and refinement of the rule. To address
these concerns, as well as concerns from ethicists and other stakeholders, the FDA recently
announced a public hearing on emergency research to be held on 11 October 2006. An
updated FDA guidance document is expected following this hearing that is intended to assist
IRBs, investigators, and sponsors in the development and conduct of emergency research
using exception from informed consent.2

Clinical Trials in a Covid-19 Environment3

Clinical trials are the pharmaceutical equivalent of a marathon. It often takes 8-9 years for a
certain drug to reach patients and the bulk of this time is spent in the development process.
However, in 2020, the robust race for development of COVID-19 vaccine across countries
led to processes being fast-tracked, while ensuring patient safety, quality and efficacy were
not compromised. Clinical trial protocols were amended to accommodate the flexibility that
was required to mitigate the pandemic induced risks. The Regulators and the Ethics
Committees accorded priority review for such amendments. These measures, while in no way
reducing the rigour and robustness of the clinical trial process, resulted in reduced approval
timelines and some virtual processes which further reduced clinical trial timelines.

Necessary changes for availability of faster drugs/vaccines in India

In India, there is a huge disease burden and existence of a large unmet medical need for our
patients. This creates an opportunity to find newer treatment options for our patients locally.
Covid-19 has brought to the forefront the need to strengthen India’s entire clinical research
ecosystem so that it can effectively scale-up to meet the needs of Indian patients. Though, we
will need to build our infrastructure at the back end to keep pace with the requirements.

The impact of Covid-19 on faster drug/vaccine availability has been enormous. Initial
advancements to bring faster drugs in the markets was recently noticed with Central Drugs
Standard Control Organisation (CDSCO) approving close to 60 trials in September and
October 2020, of which approximately 25% were Covid-19 studies.

2
http://www.legalserviceindia.com/article/l286-Clinical-Trails-In-India.html
3
https://health.economictimes.indiatimes.com/news/industry/impact-of-covid-19-on-clinical-research-trials-in-
2020-and-what-to-look-for-in-2021/80156174
The road ahead for clinical research & trials in 2021

Taking steady steps considering the pandemic, the Regulators and the Ethics Committees in
India accorded priority review for the amended clinical trial protocols. It is crucial that these
steps should be continued in 2021 and beyond for India to have an important role in the
global clinical research community.

When it comes to the methods of delivery, India is positioned to take advantage of its
economical and scalable IT infrastructure to facilitate ‘new-age’ clinical research. Hybrid
clinical tests that incorporate traditional methods with technologies like artificial intelligence
and machine learning to provide real-time data on patient outcomes. This could streamline
the development process and increase the speed with which drugs can be brought to market.

Clinical trials in India in 2021 and beyond is likely to see widescale adoption of digital
technologies for e.g., digital biomarkers, digital informed consent, e-health record directly
feeding data to the e-CRF, etc. With the increasing penetration of mobile and internet
services, India is poised to lead the way in implementing tech-driven clinical trials. Remote-
based, decentralised trials with patients participating in clinical trials from the comfort of
his/her home would also be a big advantage in a country like India and in 2020, we have seen
the regulators and the Ethics Committees agreeing with this approach. We are hopeful that
this will continue in the future too. Additionally, we will also see an enhancement in the
patient centric approaches for designing and conducting clinical trials as the patients are at
the heart of all that we do in clinical trials.

Finally, the pandemic has caused wide-scale awareness amongst the general public about the
importance of clinical trials to prove the safety and efficacy of drugs and vaccines. This
should continue since it will aid greatly in the development of innovative treatment options
for the patients.

Extra - https://ijmsweb.com/clinical-research-during-coronavirus-disease-pandemic-
challenges-and-way-forward/

Ishwar Singh Bindra & Ors vs The State Of U.P on 2 May, 1968
The Inspector of Drugs, Agra Region, filed a complaint in July 1963 before a Magistrate at
Mathura alleging a preparation called anti-phlogistic plaster was manufactured and sold by a
firm of which the first two -appellants were partners and the third appellant was the Manager;
the label on the plaster showed the constituents to be three drugs which are to be found in
pharmacopoeias prescribed under the Drugs Act, 1940 but did not bear a manufacturing
licence number and other particulars required to be given under r. 96 of the Drug Rules,
1945. As the drug fell within the mischief of s. 17(e) of the Act, it must be deemed to be
'misbranded'. Moreover the label of the plaster showed that it was -a Unani preparation which
was apparently a false and misleading claim. Accordingly,- it was alleged that offences had
been committed under s. 18(a)(ii) read with ss. 27(a) and (b) of the Act for selling a
misbranded drug as per s. 17(f) and s. 17(e) respectively of the Act and under s. 18(b) lead
with s. 27(b) of the Act for selling the same drug which had been manufactured without a
licence required for the purpose under the Act. The appellants filed a petition under s. 561A
of the Criminal Procedure Code in the High Court in March 1964 and claimed inter alia that
the plaster was not a drug as defined in the Act and praying that the entire proceedings
pursuant to the complaint be quashed. It was contended that in the definition. of a drug in s. 3
(b) (i) of the Act in the expression "other than medicines and substances exclusively used or
prepared for use in accordance with the Ayurvedic or Unarni Systems of medicine' the adverb
"exclusively" governed the word "use' only and did not govern the words "prepared for use".
The High Court was of the view that the intention of the legislature appeared to be to exclude
from the definition of drug such medicines and substances which were used exclusively in
accordance with the Ayurvedic or Unani system of medicine or which were prepared for use
exclusively in accordance with the aforesaid system; but it declined to go into the disputed
questions of fact as to whether the plasters in question fell within the exception as this was
required to be determined on expert evidence On appeal to this Court by certificate,

HELD: dismissing the appeal : The expression "substances" in the definition of drug
contained in s. 3(b) means something other than "medicines". The word "and" used in the
definition of drug in s. 3(b)(i) between "medicines" and "substances" is to be read
disjunctively. [225 F--G] The scheme of cl. (i) of s. 3(b) is to take in all medicines substances
with the exception of such medicines or substances which are 220 exclusively used or
prepared for use in accordance with the Ayurvedic or Unani system of medicines. The
exception made in the case of the latter class of medicines or substances was essentially
meant to cover only such medicines or substances which were used in the Ayurvedic or
Unani system or were prepared for use in accordance with those systems. [226 A-B]
Medicines or substances have to be taken as a whole and in the present cases it would have to
be decided by the trial court whether the plasters in question are medicines which are
exclusively used or which have been prepared for use exclusively in accordance with the
Ayurvedic or Unani system of medicine. The High Court was right in its view that the adverb
"exclusively" must be taken to govern the words "used" as well as "prepared for use"; but
each individual ingredient or component of the preparation in question will not be the
decisive or determining factor and what the court will have to decide after recording such
evidence as may be Produced will be whether the plasters satisfy the above test. If they fulfill
that test they would be excluded from the definition of drug as contained in s. 3 (b) (i).

Can vaccination be mandated for the cititzens of the country?

The health policies of the government and, sometimes, the directives of international health
organizations like the WHO may dictate the adoption of vaccination against polio, smallpox,
etc. The massive scale of the operation this involves may include administration of drugs at
school, at railway stations and many other public places with a degree of persuasion that the
recipient may not be able to resist." In some cases, the drug administration may not require
that recipient of the drug give any consent chat may seem to violate the fundamental precept
of autonomy.

The actions of the doctor shall be only for the benefit of the patient. The treatment for the
betterment of the patient shall be the primary concern, and any possible benefit to the doctor
(monetary or research~based) shall be’ only incidental, This principle shall still ‘saborn to
patient’s autonomy, since the perception of what is good to a patient a must also be viewed,
as such by the patient in the ultimate choice of “whether or not a particular treatment is
acceptable to the patient.

Jacobson v. Massachusetts, 197 US 11 (1905)

Cities in Massachusetts could require that all residents be vaccinated, as authorized by a state
statute. This type of regulation was adopted by the city of Cambridge. Mr. Jacobson believed
that the scientific basis for vaccination was unsound and that he would suffer if he was
vaccinated. The Massachusetts Supreme Court found the statute consistent with the
Massachusetts state constitution, and Jacobson appealed to the United States Supreme Court.
The Supreme Court examined the issue of whether involuntary vaccination violated
Jacobson's "'inherent right of every freeman to care for his own body and health in such way
as seems to him best" The Court bifurcated this question, first considering the right of the
state to invade Jacobson's person by forcing him to submit to vaccination.
The court held that in order to protect public health and safety, the scope of the state’s police
power includes the authority to enact reasonable regulations to do so. The Constitution
secures liberty for every person within its jurisdiction, but does not give an absolute right for
each person to be free from restraint at all times and in all circumstances. Every person is
required to be subject to various restraints for the common good. The efforts by Cambridge
to stamp out smallpox are substantially related to the protection of public health and safety.
There has been nothing to clearly justify the Court holding the statute to be unconstitutional.
Compulsory vaccination was cited as a ‘proper exercise of the police power’. Since the
state’s police power enables it to enact ‘health laws’ reflecting dominant medical beliefs and
those of majority of society, the opinion of the minority should not subvert the opinion of the
majority.

The state legislatures in USA have granted ‘three types of exemptions ‘from compulsory
vaccination, with the availability of each type varying depending on the state. Such
exemptions are not absolute ii n, that if the local department of health declares a public health
emergency, the exemptions can be cancelled.

1. On advice of a physician
2. Religious exemptions
3. Philosophical exemptions

‘When considering whether life-saving treatment should be given or ” continued, three

separate questions have to be answered: first, whether the contemplated treatment is futile;
second, whether it is in the best interests of the patient; and third, whether resources should
be deployed to provide it.

Mandatory COVID Vaccination in India-

On 3 January, India's top Drug controller gave approval for two vaccines for confined use
against Coronavirus, despite the fact that stage III clinical preliminaries for Covidshield and
Covaxin are as yet continuous in India. In a country with the second most number of
contaminations on the planet and in excess of 150 000 deaths, the pandemic driven by
information on new infection variations fuelled endorsement."

On April 4, the Maharashtra government issued a notification that said transport workers,
delivery service providers, roadside vendors, factory workers and construction workers must
get vaccinated “at the earliest as per government guidelines”. Until they are vaccinated, they
must get an RT-PCR test done every two weeks, presumably at their own expense.

Anyone who is eligible to take the vaccine but does not, is irresponsible, immoral and
criminal. For those who don’t like the term “mandatory”, an alternative is to make proof of
vaccination a requirement for work, travel, and entry to public spaces – as the Maharashtra
government’s notification reads. The Indian Medical Association has
actually recommended linking vaccine certificates to the public distribution system.

The primary objective of the Covid-19 vaccine is to protect individuals against severe disease
or death, and individuals have the right to decide whether or not they wish to take the
vaccine, for their own protection. Calls for mandatory vaccination or immunity certificates
are not based on science, public health policy or ethics. Mandatory vaccination will
exacerbate the inequities of differential access to vaccines, punish those who do not wish to
take the vaccine, and deny people the basic right to work. Fake vaccine certificates will join
fake RT-PCR negative tests in the list of Covid-19 scams.

Vaccine hesitancy is a combination of many factors, including opacity in regulatory approval

(true for both vaccines currently available in the programme) as well as in the investigation of
adverse events following immunisation, and poor communication on the vaccine itself.
Coercion will only increase hesitancy, not decrease it.

https://scroll.in/article/991630/compulsory-covid-19-vaccination-wont-help-coercion-will-
increase-hesitancy-not-reduce-it
 Doctor-Patient Relationship

INTRODUCTION

There are many identities based on the doctor-patient relationships. It is principally a

fiduciary relationship, based on mutual good faith and trust. A legal relationship between the
two also exists. This deals with contractual obligations, tortious liabilities and standard of
care accepted of doctors.

From the legal viewpoint, it is generally acknowledged that there are three major dimensions
to the patient-doctor relationship. The first dimension is contractual: Once a relationship is
initiated, it is subject to the principles of the law of contracts. Second, in a consensual
relationship, doctors are required to obtain competent informed consent from their patients
before care and treatment can be provided. Third, quality assurance concerns require that the
doctor apply appropriate standards of care in providing service to the patient. Doctors have
become subject to fiduciary law, which acknowledges that in certain legal relationships
where one party is more powerful than the other, the more powerful party, in this case the
physician, is subject to a higher standard than is imposed by traditional principles in the law
of contracts or torts.

Though a doctor-patient relationship is not established, the courts have imposed a duty upon
the doctor. In the words of the Supreme Court “every doctor, at the governmental hospital or
elsewhere, has a professional obligation to extend his services with due expertise for
protecting life” (Parmanand Kataria vs. Union of India). These cases are however, clearly
restricted to situations where there is danger to the life of the person. Impliedly, therefore, in
other circumstances the doctor does not owe a duty.

Privacy

A vast body of literature argues in favour of the individual’s right to privacy in general, and
especially in health-related matters. Within fiduciary relationships, like the doctor-patient
relationship, the fiduciary’s (doctor’s) duty of confidentiality allows people (patients) to share
private information in a limited manner while still maintaining its privacy vis à vis other
parties.

Medical privacy involves the confidentiality of patient-provider encounters, along with the
secrecy and security of information memorialized in physical, electronic and graphic records
created as a consequence of patient-provider encounters. Privacy includes confining data to
people having a place with an arrangement of particularly approved beneficiaries. Each
individual in the medicinal field is required to take the Hippocratic vow, which incorporates
the obligation of the parental figure to ‘keep mystery’ and ‘never uncover’ ‘all that may go to
his/her insight. In other words, right to medical privacy has to be balanced with right to
healthy life of another whose right will be affected unless such information is disclosed to
her/him.

In India, there are two specific provisions which forbid doctors from disclosing any
information relating to a patient. As per The Indian Medical Council (Professional Conduct,
Etiquette and Ethics) Regulations, 2002, section 2.2 Patience, Delicacy and Secrecy,
“confidences concerning individual or domestic life entrusted by patients to a physician and
defects in the disposition or character of patients observed during medical attendance should
never be revealed”.

Also, as per The Indian Evidence Act, 1872, ‘the proof of good faith in transactions where
one party is in relation of active confidence’, that is the care provider (in such case), binds the
doctors from disclosing the details of a case.

While all health professionals are bound to keep the patient’s information obtained during
care or treatment confidential, the code of ethics, which is not absolute in nature, also outlines
certain exceptions like the need for involvement of other health professionals for
improvement in treatment, or to ensure safety of the patient from themselves, or when asked
by a court of law. It states, as per Rule 7.14 the physician “shall not disclose the secrets of a
patient that have been learnt in the exercise of his/her profession except in a court of law
under orders of the Presiding Judge; in circumstances where there is a serious and identified
risk to a specific person and/or community; [or in case of] notifiable diseases.”

The RTI Act also does not grant others the right to request information about an individual
that is generated within fiduciary relationships, even if the doctor or researcher is a
government employee and the medical or research record is housed in a government
institution, unless public interests outweigh the individual’s interest in the privacy of the
information.

MR. X v. HOSPITAL Z
Mr. X proposed Ms. Y for marriage, which was duly accepted by her. However, the marriage
was later called off after the hospital Z revealed to the family, including Ms. Y, that Mr. X
was HIV (+). Mr. X filed a plea before the National Consumer Disputes Redressal
Commission against Hospital Z, on the grounds that there exists a privileged relationship
between a doctor and his patient and the same had been violated by the respondents. The
hospital had breached their medical ethics by revealing information related to Mr. X’s HIV
status, making them liable to pay damages. The NCDRC dismissed the petition and
accordingly, an appeal was filed.

Three main issues were identified from the grounds of challenge put forth by the appellant,
viz.:

1. Whether the hospital had a duty to maintain the confidentiality of the appellant’s medical
reports and whether such duty was violated?

2. Whether the disclosure of the appellant’s HIV status amounted to a violation of the right to
privacy, making the hospital liable to pay damages?

3. Whether the appellant’s right to marry was affected by the violation of his privacy?

In its judgment, the court held that even though the relationship between a doctor and his
patient is a privileged one, however, such privilege is not absolute. There are exceptions to
this, that is when a person does have a right to privileged information but the other person (in
this case the Doctor) has no correlative duty or has a bigger duty than that right initially, such
as in the case of Mr. X. In the instant case, the right to privileged information involved a
threat to the life of another person i.e. Ms. Y. The provisions in the Code of Medical Ethics
provide for such exceptions concerning the maintenance of confidentiality.[vi] Therefore, it is
safe to assume that such information which concerns public interest or which may harm the
public at large must be disclosed.

Conclusion

Privacy and confidentiality are important values, linked to the protection of autonomy and
individuality, which are themselves highly prized in a democratic society like India.
Protection of privacy and confidentiality in the fiduciary doctor-patient relationship serve
important individual and public health interests as their guarantee encourages people to seek
necessary medical care and disclose information necessary for personal and public health.
But none of these rights are absolute and could be breached in case of greater public interest.
The public interest should be construed narrowly so as to allow greater privacy and
confidently to the patients.