MCQs

1) The transplantation of human organs Act:

1994

2) which of the following is not the objective of Indian medicine central council Act, 1970

Conducting exams in medical colleges

3) for the medical termination of pregnancy of act 1971, an adult woman is sound health whose
consent is mandatory among the following?

Only the women consent is enough, according to mtp act

4) a drug not labelled in the prescribed manner shall be treated as:

Misbranded drug,

5) if the pregnancy of the women is beyond 12 weeks upto 20 weeks, for the medical termination
of pregnancy act 1971,

Opinion of the two doctors is necessary

6) ------of the following is not a legal father:

A man married to a women undergoing IVF treatment for which he did not provide the sperm if
he doesn’t consent to the treatment.

7) which of the following is false:

Sec 304 of IPC an act done good faith for the benefit of the person without consent

8) consumer protection act 2019, pecuniary jurisdiction of a national commission

Above 10 crores

9) In which case the supreme court of India observed the medical services rendered by the
medical practitioners are covered under section 2(1) of Consumer Protection act 1986, it includes
three services or services under a contract of personal services?
Indian medical association vs vpshanta

10) pick the rightful form of PCP NDT act

Pre conception and pre-natal diagnostic techniques act

11) in which case court widened the scope art 21 of the constitution; the govt responsibility to
provide medical aid in every person in the country and help in the welfare of the state

Paschim banga keth mazdoor Samithi vs state of W.B

12) A doctor is not liable in negligence of the medical client which is stated in accordance with
the practice accepted by the proper and responsible body of medical man skilled in the particular
art was held in;

Bolam case

13) the central drugs laboratory is situated in

Kolkata

14) who among following is the chairman of the drug technical and advisory board

The director general of health services

15) according the Indian law what is the minimum age of the person for the employment in
factory:

14 years

16) according to national institute of health care and excellence, the definition of infertility is

Failed to conceive after frequent unprotective sexual intercourse for 1-2 years, in couples in the
reproductive age group.

17) convention of elimination of all forms of discrimination against women CEDA, was adopted
in the united nations general assembly,

1979
18) pre implantation of a genetic diagnosis is,

Regulated by the common law

19) according to the organ transplantation act 1994, what is the punishment for the doctor found
guilty of removing organs without authority.

2-5 years but presently (2011 amendment) the punishment is upto 10 years

20) In which Case court laid down a duty of doctor if a injured person approaches him

Paramanandakatara vs uoi

Problem case:

Johnson & Johnson

Case analysis: Bolam vs Friend Hospital

Facts:

Hector Bolam was a psychiatric patient who went to Friern Hospital as a voluntary patient for
issues related to recurrent depression. After diagnosis, the doctors decided that he has to be treated
with ECT (Electroconvulsive Therapy) and Bolam agreed to the same.

Now, ECT at that time existed in two forms:-

 Unmodified ECT – in which during the ECT neither some muscle relaxant is administered to
the patient nor any anesthesia.
 Modified ECT – in which during the ECT anesthesia, muscle relaxant are administered and
the patient is tied during the procedure.

Bolam was given an unmodified ECT and he was not even restrained during the procedure. He was
given unmodified ECT for 7 to 10 times a day each session. In the 3rd session his depression
improved, but at the same time since he was not administered with any muscle relaxant or anesthesia,
hence he developed muscle fracture called acetabulum (both sides of pelvis bone is fractured). When
he came to know about this he filed a suit for damages against the hospital.
Issues:

 Whether the doctors were in contravention of duty of care and did not acted as a rationale
person?
 How to determine whether or not standard care of practice was followed or not when there
are different viewpoints with regards to that practice by a substantial portion of medical
professional?

Contentions:

On behalf of plaintiff

 He argued that hospital was negligent for not administering muscle relaxant during the
process of ECT.
 That the hospital was negligent for not restraining him before and during the process of ECT.
 He argued that the hospital did not warn him about the risks involved in an Unmodified ECT,
i.e. they did not take any informed consent from the plaintiff and hence are liable to pay
damages.

On behalf of defendant

 Chances of death were more in case muscle relaxant would have been used, whereas chances
of fracture in ECT were minimal.
 Decision was taken on the basis of professional expertise, since the mortality risk were higher
if relaxants are used and fracture risk were lower, hence decision of hospital is justified.
 The soothing medication shall be administered only when the risk of unmodified ECT is
higher than average risk. In this case there was no justification as to why use of soothing
medicine should be considered necessary.

Judgment:

Judge McNair called upon experts from the medical field and set up an expert board to determine the
issue related to the administration of muscle relaxant or anaesthesia during ECT. One group of
experts stated that anaesthesia and muscle relaxant are considered dangerous and consist of high risk
to the patient, hence use of anaesthesia should be avoided. (it is to be noted that this case is of 1957
and during that period anaesthesia was a newly invented drug used in surgeries and other medical
treatment, but was considered dangerous due to presence of adverse affect) The other set of expert
group said that, the hospital should have given anaesthesia and muscle relaxant to Bolan, because
then the pelvis fracture could have been avoided and also they should have warned Bolam of the
probable outcome of the treatment.

Finally judge McNair applied his judicial mind and held that, there was no medical negligence on
part of the hospital.

He laid down the following test to determine whether the hospital should be held liable for medical
negligence or not:-

 He said that a Doctor is not guilty of negligence if he has acted in accordance with a practice
accepted as proper by a responsible body of medical professionals skilled in that particular
art.
 If a doctor reached the standard of a responsible body of medical opinion then he is not
considered liable under negligence.

This is also called the “peer review system”, where an expert group of the same profession with the
professional knowledge will be made and they would judge whether the actions of the defendant
match up to the required standard of care.

Failure to use such care as a reasonably prudent and careful person would use under the similar
circumstances will result in negligence, since the doctors were able to follow one of the practices
which was prevalent at that time the doctors are not negligent.

Analysis

This is considered one of the landmark judgments in the medical jurisprudence and one of the first
judgments to have discussed medical negligence in detail. It stated that medical negligence cannot be
determined in the same manner as ordinary negligence is determined. It laid the principle of Bolam
test i.e. standard of care of a professional will not be judged according to a actions of a rational
prudent man rather will be judged if it fulfils the standard recognized by a body of professional
experts in the particular field. The bolam test was followed and evolved to a next level in the case of
Royal Hospital, 1985 where court held that, the medical practitioner need not inform the patient of
remote side effects or risks that are minimal in probability because before the treatment or during the
treatment a patient is going through a crucial time and the only effect that mention of risk can have
on the patient’s mind can be in the direction of deterring the patient from undergoing the treatment
which is in the expert opinion is in the patient’s interest. Both these cases gives a negative approach
to the concept of informed consent, which clearly states that a patient need to be told of every aspect
of risk associated and method of treatment undertaken before proceeding with taking consent from
the patient.

Similarly, in the year 1997, Bolitho vs Hackney health authorities case the court held a different
opinion than that of the bolam test, court stated that “the court is not bound to hold that a defendant
doctor escapes liability for negligent treatment or diagnosis just because he leads evidence from a
number of medical experts who are genuinely of the opinion that the defendant’s treatment or
diagnosis accorded with sound medical practice.”

Bolam was re-examined and revised in the 2015 Supreme Court decision of Montgomery v
Lanarkshire Health Board.

Essay: Constitution as part of right to health.

According to the World Health Organization (WHO), health is a state of complete physical,

mental and social well being and not merely the absence of disease. The WHO goes on to
clarify that it is the state’s legal obligation to ensure uniform access to “timely, acceptable, and
affordable health care of appropriate quality as well as to provide for the underlying determinants
of health, such as safe and potable water, sanitation, food, housing, health-related information
and education, and gender equality” to all its people. In India, this right, which is a natural
corollary to promoting public health, is protected under the Constitution of India in multiple
ways.

Right to Health is a part and parcel of Right to Life and therefore right to health is a fundamental
right guaranteed to every citizen of India under Article 21 of the Constitution of India. We owe
the recognition of this right to the fact that the Supreme Court of India, through a series of
judicial precedents, logically extended its interpretation of the right to life to include right to
health.

The Directive Principles of State Policy (DPSP), enshrined in Chapter IV of the Constitution of
India, require the state to, among other duties,

 promote the welfare of its people (Art.38);

 protect their health and strength from abuse (Art 39(e));

 provide public assistance in case of sickness, disability or “undeserved want” (Art 41);

 ensure just and humane conditions of work; and

 raise nutrition levels, improve the standard of living and consider improvement of public
health as its primary duty (Art 47).

In addition to the DPSP, some other health-related provisions can be found in the 11th and 12th
Schedules, as subjects within the jurisdictions of Panchayats and Municipalities, respectively.
These include the duty to provide clean drinking water, adequate healthcare and sanitation
(including hospitals, primary health care centers and dispensaries), promotion of family welfare,
development of women and children, promotion of social welfare, etc.

The Constitution of India does not expressly recognize Right to Health as a fundamental right
under Part III of the Constitution (Fundamental Rights). However, through judicial
interpretation, this has been read into the fundamental right to life & personal liberty (Article 21)
and is now considered an inseparable part of the Right to Life.

The role of Indian Supreme Court in protecting the health of the public at large is noteworthy.
The Supreme Court has repeatedly observed that the expression “life” in Article 21 means a life
with human dignity and not mere survival or animal existence as held in the case of Francis
Coralie Mullin vs The Administrator, Union Territory of Delhi. Right to life has a very broad
scope which includes right to livelihood, better standard of life, hygienic conditions in the
workplace & right to leisure. Right to Health is, therefore, an inherent and inescapable part of a
dignified life. Article 21 should also be read in tandem with the directive principles of state
policy, cited above, to truly understand the nature of the obligations of the state in this respect.

In the case of Bandhua Mukti Morcha v. Union of India, the Supreme Court held that although
the DPSP are not binding obligations but hold only persuasive value, yet they should be duly
implemented by the State. Further, the Court held that dignity and health fall within the ambit of
life and liberty under Article 21.

In the case of Paschim Banga Khet Mazoor Samity v. State of West Bengal, the scope of Article
21 was further widened, as the court held that it is the responsibility of the Government to
provide adequate medical aid to every person and to strive for the welfare of the public at large.

Further, the Supreme Court in the case of Parmanand Katara v Union of India, held that every
doctor at Government hospital or otherwise has the professional obligation to extend his services
with due expertise for protecting life of a patient.

In the subsequent case of Consumer Education and Research Centre V. Union of India held
that right to health and medical aid to protect the health and vigor of a worker, both while in
service and post-retirement, is a fundamental right under Article 21.

Therefore, it is the duty of the State to care for the health of the public at large and the Central
Government and various State governments have, rightfully and proactively, taken various
measures to contain the entry and spread of the COVID-19 pandemic.

Short notes:

Salient features on Transplantation of Human Organ Act

An organ transplant is a surgical operation where a failing or damaged organ in the human body
is removed and replaced with a new one. An organ is a mass of specialized cells and tissues that
work together to perform a function in the body. The heart is an example of an organ. It is made
up of tissues and cells that all work together to perform the function of pumping blood through
the human body. Any part of the body that performs a specialized function is an organ. Therefore
eyes are organs because their specialized function is to see, skin is an organ because its function
is to protect and regulate the body, and the liver is an organ that functions to remove waste from
the blood.

The Transplantation of Human Organs Act was thus passed by Parliament in 1994. The act
legalises 'brain death' making removal of organs permissible after proper consent. The first few
hundred such cadaver transplants have been performed mainly in the metros in the last two to
three years but the activity in the field is well below what was expected or what is needed. On
the other hand, the Act also seeks to regulate non-related live donation of organs and makes
commercial trading an offense. It makes it mandatory for institutions conducting transplants to
register with an authority appointed by the state government. This authority will also enforce
standards, investigate complaints and inspect the hospitals regularly to monitor quality. All
persons associated in any way with hospitals conducting transplants without the proper
registration are liable for punishment. 

 The Transplantation of Human Organs Act, 1994 is meant to provide for the regulation of
removal, storage, and transplantation of human organs for therapeutic purposes and for
the prevention of commercial dealings in human organs. The Central Act illegalises the
buying and selling of human organs and makes cash-for-kidney transactions a criminal
offence.
 The law establishes an institutional structure to authorise and regulate human organ
transplants and to register and regulate, through regular checks, hospitals that are
permitted to perform transplants.
 It recognises, for the first time in India, the concept of brain-stem death, paving the way
for a cadaver-based kidney transplant programme.
 The Act details actions that amount to direct participation in or abetment of the organ
trade; these offences are punishable under Section 19 of the Act.
 The Act defines two categories of donors:-
i. First, it permits a near relative, defined as a patient's spouse, parents, siblings, and
children, to donate a kidney to the patient.
ii. Secondly, in Section 9(3) of the Act, live donors who are not near relatives but are
willing to donate kidneys to the recipients by reason of affection or attachment towards
the recipient or for any other special reasons, are permitted to do so, provided that the
 transplantations have the approval of the Authorisation Committee, established under the
Act.
 The Act makes the offence of kidney trading non-cognisable. In other words, the police
cannot look into complaints of kidney trading independently but must wait for a
complaint to be made by the Appropriate Authority set up under the Act or by an officer
authorised by it or by an individual who has given prior notice of not less than 60 days to
the Appropriate Authority.

 It is not clear whether Section 9(3) was deliberately meant - under pressure from special
interests - to provide a loophole that could be exploited in practice, or whether the law-makers
thought they were sympathetically making provision for donations from second-degree relatives
and others who might act out of genuine love and affection or altruism. But whatever be the
reasoning and motivation behind the provision of a loophole, the practical operation of Section
9(3), combining with the non-cognisability of the offences to be prosecuted, has rendered the
1994 Act virtually unenforceable.

The Act very sensibly provides for registration of hospitals claiming to have the necessary
competence and facilities to perform particular organ transplantation. This is a regulatory
measure intended to protect the interests of patients. It is with the Appropriate Authority, set up
by the State government under the Act, that hospitals intending to do transplants must register.
Approvals are granted only after the institutions fulfill certain technical, infrastructural and
medical requirements.

Indian law permits live donation from non-relatives; this is mostly misused for commercial
interests. The lacuna in the law was that the screening committee had no mechanism to find out
the whereabouts of the donor and whether the donor was truly altruistic. In most cases, the
donors were well coached by the middle man before the screening procedure. There is no system
in place that can effectively monitor the transplantations. If the organ trade is not controlled,
disappearances, especially among street children, violences and baby kidnapping rackets may
flourish along with the theft of organs of executed criminals in future. The people may lose trust
in the medical community and may suspect their involvement in premature declaration of death
on seeing a signed donor card.
 Donation of an organ is most altruistic, meaning an act in life to help another human being and
reliably change the situation of the latter. Even in the UK, 70% of the people favour organ
donation, but only 25% hold donor cards. Data from the Arab world shows that all the 81 renal
transplantations conducted during 2001 were cadaveric donations. Selling organs demean human
beings; there is always 'the rich who receive and the poor who give'. In India, it is estimated that
there are 80,000 people with severe renal failure and 650 dialysis units are available. Our
resources are scarce and the needs outstrip these.
Describe the legal control of PC-PNDT

The PC-PNDT Act was enacted on 20 September 1994 with the intent to prohibit prenatal
diagnostic techniques for determination of the sex of the fetus leading to female feticide. That is
to say the preliminary object was to put a check on female feticide. No doubt the bare perusal of
the Act indicates that it is a draconic act from the point of its effect on radiologists/sonologists.
The Act does not offer any escape to the erring radiologist/sonologist.

But at the same time it is very simple to fulfill and abide by the requisitions of the Act. The few
basic requirements of the Act are:

1. Registration under Section (18) of the PC-PNDT Act.

2. Written consent of the pregnant woman and prohibition of communicating the sex of fetus under
Section 5 of the Act.
3. Maintenance of records as provided under Section 29 of the Act.
4. Creating awareness among the public at large by placing the board of prohibition on sex
determination.

A look at the basic requirement of the Act shows the simplicity of the Act, but non-compliance
of the Act in any manner, be it the smallest of an error brings wrath upon the errant. The Act
penalizes all the errants, either involved in sex determination or non-maintenance of records.

The Act is legislated in a manner that it should be a deterrent for those indulging in sex
determination. The unfortunate decline in the male-female sex ratio has brought in stringent
measures, there is suspension of registration, filing of criminal cases and sealing of machines.
Besides, criminal prosecution will also bring in suspension and cancellation of registration
granted by the State Medical Council.

Conditions in which the act allows sex determination

Listed below are the few exceptions where pre-natal diagnostic techniques shall be conducted for
detection of the following abnormalities:

 chromosomal abnormalities

 genetic metabolic diseases

 Family history of diseases

 sex-linked genetic diseases

 congenital anomalies

 any other abnormalities or diseases as may be specified by the Central supervisory

board
No pre-natal diagnostic techniques shall be used or conducted unless the person qualified to do
so is satisfied that all of the following conditions are fulfilled, which are:

 age of the pregnant woman is above thirty-five years

 the pregnant woman has undergone two or more spontaneous abortions or fetal loss

 the pregnant woman had been exposed to potentially teratogenic agents such as drugs,
radiation, infection, or chemicals

 the pregnant woman has a family history of mental retardation or physical deformities
such as spasticity or any other genetic disease

 any other condition as may be specified by the Central Supervisory Board

  no person, being a relative or the husband of the pregnant woman shall seek or
encourage the conduct of any pre-natal diagnostic techniques on her except for the
purpose specified in Section 5(2) of the PC-PNDT Act. 

Loopholes in the law

The Pre-Natal Diagnostic Techniques (Regulation and bar of Misuse) Bill, 1991, introduced in

the Parliament in 1994, awaits implementation. The most offensive and misguided feature of the
law is its penalization for women to act as a deterrent for them. Such a clause can solely increase
the misery of women in a context where the social system leaves very little space for women to
make autonomous decisions and women are forced to create ‘choices’. Penalization of women
can solely facilitate the protection of the interests of those liable for providing such a facility.

Future technologies being developed for sex-determination, like testing of craniate cells in
maternal blood, subtle techniques for sex-pre-selection, like electrolysis, Ericsson’s
methodology, etc are presently not coated underneath the law. Unless future technologies bring
at intervals the scope of the law, it’ll shortly become digressive to the terrible problems that are
to be self-addressed by it.

Suggestions

 Strengthening the implementation of the PNDT Act

 Monitoring and evaluation
 Capacity building

Salient features of National Health policy in India

National Health Policy was launched in 2017 by the Central Government to replace the existing
health policy. This policy has introduced four significant goals:

1. Changing health priorities

This policy aims to tackle the increasing non-communicable and infectious diseases in
India.
 2. Growth of the health care industry

National Health Policy plans to strengthen the health care industry by introducing newer
and more advanced technologies.

3. Lower the expenditure

This policy also aims to reduce medical expenses and other health-related costs. They
aim to provide superior services to poor and backward communities.

4. Economic growth

It aims to enhance fiscal capacity by boosting economic growth.

The National Health Policy aims to achieve the following goals:

 It aims to offer superior health services to every age group and gender.

 The policy focuses on providing universal access to excellent quality health care services
at a reasonable cost.

 Promoting health care orientation in every developmental policy.

 Offering access to better treatment, lowering expenses related to health care services and
improving quality.

 It aims to reduce premature mortality from cancer, cardiovascular diseases, chronic

respiratory diseases and diabetes by 25% within 2025.

 This policy recognises the importance of sustainable development and time-bound

quantitative goals.

 National Health Policy in India improves overall health status through promotive,
palliative, and rehabilitative services.

 It aims to raise public healthcare expenditure to 2.5% of GDP from current 1.4%, with more than
two-thirds of those resources going towards primary healthcare.

 It envisages providing a larger package of assured comprehensive primary healthcare through

the ‘Health and Wellness Centers’.
 It is a comprehensive package that will include care for major non-communicable diseases
(NCDs), geriatric healthcare, mental health, palliative care and rehabilitative care services.

 It proposes free diagnostics, free drugs and free emergency and essential healthcare services in
all public hospitals in order to provide healthcare access and financial protection.

 It seeks to establish regular tracking of disability adjusted life years (DALY) Index as a measure
of burden of disease and its major categories trends by 2022.

 It aims to improve and strengthen the regulatory environment by putting in place systems for
setting standards and ensuring quality of healthcare.

 It also looks at reforms in the existing regulatory systems both for easing drugs and devices
manufacturing to promote Make in India and also reforming medical education.

 It advocates development of mid-level service providers, public health cadre, nurse practitioners
to improve availability of appropriate health human resource.

 It aims to ensure availability of 2 beds per 1000 population to enable access within golden hour.
It proposes to increase life expectancy from 67.5 to 70 years by 2025.

 It aims to reduce total fertility rate (TFR) to 2.1 at sub-national and national level by 2025.

 It also aims to reduce mortality rate (MR) of children under 5 years of age to 23 per 1000 by
2025 and maternal mortality rate (MMR) to 100 by 2020.

 It also aims to reduce infant mortality rate to 28 by 2019 and reduce neo-natal mortality to 16
and still birth rate to ‘single digit’ by 2025.