HEALTH LAW (SEM-09/PAPER-XX)

LW 5017

SELF – NOTES

Anish Mahapatra

BBA LLB “A”

Roll No. - 1782019

MODULE 1: INTRODUCTION

Universal Declaration of Human Rights, 1948 & Right to Health

Universal Declaration of Human Rights (UDHR) is a foundational document of international

human rights law. It has been referred to as humanity’s Magna Carta by Eleanor Roosevelt,
who chaired the UN Commission on Human Rights that was responsible for the drafting the
document. After minor changes, it was adopted unanimously – though with abstentions from the
Belorussian Soviet Socialist Republic (SSR), Czechoslovakia, Poland, Saudi Arabia, South
Africa, the Soviet Union, the Ukrainian SSR, and Yugoslavia – by the UN General Assembly on
December 10, 1948(now celebrated annually as Human Rights Day), as a “common standard
of achievement for all peoples and all nations.”

World Health Day is celebrated on 7th April.

It laid the foundation for the human rights protections that we have in the UK today. It formed
the basis of the European Convention on Human Rights, which in turn was incorporated in
UK law by the Human Rights Act 1998. It has been the catalyst for improving human rights
protections for groups such as disabled people, indigenous people and women. Two key ethical
considerations underscored the main tenets of the UDHR:

 A commitment to the inherent dignity of every human being; and

 A commitment to non-discrimination

Right to Health w.r.t. Non-Discrimination

It is wide in nature as many factors are stated and even state must ensure that there must be non
discrimination like AIDS, leprosy patients suffer from these diseases are getting discriminated.
Even COVID-19 patients get’s discriminated. Discrimination include following grounds:
Distinction, exclusion, restriction that results in suffering from malnutrition to children living
in streets and even indigenous people also not get proper health care facilities.

Right to Health is a basic human right as there’s a link with human rights such as right to
food, right to water, right to adequate standard of living, right to adequate housing, right to
freedom from discrimination, right to privacy, right to access to information, right to
participation and right to benefit from scientific progress and its applications.

The UDHR comprises 30 articles that contain a comprehensive listing of key civil, political,
economic, social, and cultural rights. Articles 3 through 21 outlines civil and political rights,
which include the right against torture, the right to an effective remedy for human rights
violations and the right to take part in government. Articles 22 through 27 detail economic,
social, and cultural rights, such as the right to work, the right to form and to join trade unions,
and the right to participate freely in the cultural life of the community. The latter right relates to
everyone’s entitlement to be directly involved in and appreciative of the arts, and it is clearly
linked to the full development of one’s own personality (which, in accordance with article 26,
constitutes one of the goals of the right to education). Because of the ideological fissures caused
by the Cold War and the concomitant failure to develop a legally binding international human
rights instrument, it became common to view civil and political rights independently of
economic, social, and cultural rights, though this is a misinterpretation of both the letter and the
spirit of the document. For example, it is impossible for a society to fulfill its commitment to the
right to education (Article 26) without taking seriously its commitment to the right to seek,
receive, and impart information (Article 19). Likewise, it is difficult to envisage the realization
of the right to form and to join trade unions (Article 23) without a commensurate realization of
the right to peaceful assembly and association (Article 20). Yet, these obvious linkages were
obscured by the selective use of human rights norms by the main adversaries in the Cold War.

The indivisibility of human rights in Article 28—which many consider the most forward-looking
article of the UDHR, though it has been one of the least-studied—links all the enumerated rights
and freedoms by entitling everyone to “a social and international order in which the rights and
freedoms set forth in this Declaration can be fully realized.”

One factor contributing to the UDHR’s moral authority is precisely that it transcends positive
international law. Indeed, it enunciates general moral principles applicable to everyone, thus
universalizing the notion of a fundamental baseline of human well-being. Despite its
shortcomings, including a preoccupation with the state as the main perpetrator of human rights
violations—which has marginalized human rights problems stemming from socially and
culturally sanctioned abusive behaviour and violence, whose perpetrators are often non-state
actors such as individuals, families, communities, and other private institutions—the UDHR was
and remains the key reference point for international human rights discourse. For example,
during the 1960s and ’70s, several organs of the United Nations system used the declaration’s
provisions to condemn racial discrimination in South Africa and Southern Rhodesia (now
Zimbabwe). More than any other instrument, the UDHR is responsible for making the notion of
human rights nearly universally accepted.

Definition of Health by WHO

According to WHO, World Health Organization, health is defined as “a state of complete

physical, mental and social well-being and not merely the absence of disease or infirmity.”

Right to Health under UDHR

The right to health was first articulated in the WHO Constitution (1946) which states that, “the
enjoyment of the highest attainable standard of health is one of the fundamental rights of every
human being...” The preamble of the Constitution defines health as, a state of complete physical,
mental and social well-being and not merely the absence of disease or infirmity”.

The 1948 Universal Declaration of Human Rights mentioned health as part of the right to an
adequate standard of living (Article 25). It was again recognized as a human right in 1966 in the
International Covenant on Economic, Social and Cultural Rights, as: The right to health is
an inclusive right, extending not only to timely and appropriate health care, but also to the
underlying determinants of health, such as access to safe and potable water and adequate
sanitation, healthy occupational and environmental conditions, and access to health-related
education and information, including on sexual and reproductive health.

Constitutional mandate including healthcare as a Fundamental Right (Article 21)

Right to Health refers to and mean the most attainable levels of health that every human being is
entitled to. Health has been regarded as the basic and fundamental human right by the
international community under international human rights law. In contrast to all other human
rights, the right to health creates an obligation upon the states to ensure that the right to health is
respected, protected and fulfilled, and is duly entitled to all its citizens. According to Salmond,
every right has a corresponding duty to be fulfilled and there can be no right without a parallel
element of duty.

According to Article 25(1) of Universal Declaration of Human Rights “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”. The generally satisfactory meaning of health is
that given by the WHO in the introduction of its constitution, as indicated by the World Health
Organization, “Health is a condition of complete physical, mental and social prosperity and not
only the nonappearance of disease”. As of late, this announcement has been intensified to
incorporate the capacity to lead a ‘socially and economically productive life’.

Earlier the Right to Health was a part of Directive Principles of State Policy (DPSP). Article
38 of Indian Constitution imposes an obligation on the State that states will make sure about a
social request for the advancement of government assistance of the individuals however without
general health we can’t accomplish it. It implies without general health government assistance of
individuals is unthinkable. In India the Directive Principle of State Policy under Article 47
thinks of it as the essential obligation of the state to improve general health, making sure about
equity, human state of works, expansion of disorder, mature age, disablement and maternity
benefits and furthermore thought about. However, the Supreme Court has carried the right to
health under Article 21. The extent of this arrangement is extremely wide. It endorses the right
of life and individual freedom. The idea of individual freedom fathomed numerous rights,
identified with by implication to life or freedom of an individual. Furthermore, presently an
individual can guarantee his right of health. Consequently, the right to health, alongside various
other common, political and monetary rights, is managed insurance under the Indian
Constitution.

For the very reason of Direct Principles holding only persuasive value, the state used this as a
weapon to escape its duty, responsibility and liabilities in providing and protecting health of the
common public. Therefore, the Hon’ble Supreme came to the rescue and brought the right under
the purview of Article 21 of the Constitution of India. The scope of Article 21 has, thus, been
widened. Article 21 ensures the right of life and liberty to each individual, citizens or non-
citizens. The concept of personal liberty is meant to include rights that may or may not be
directly linked to the life and liberty of a person; which now includes right to health as well.

According to Article 21 of the Constitution – “No person shall be deprived of his/her life or
personal liberty except according to the procedure established by law. ‘Life’ in Article 21 of the
Constitution isn’t just the physical demonstration of breathing. It doesn’t imply insignificant
creature presence or proceeded with drudgery through life. It has a lot more extensive
importance which incorporates the right to live with human nobility, the right to livelihood, right
to health, right to pollution free air, and so forth. In the State of Punjab v. M.S. Chawla, it has
been held that-the right to life ensured under Article 21 incorporates inside its ambit the right to
health and clinical consideration.

The Supreme Court in Vincent v. Union of India, accentuated that a healthy body is the very
establishment of all human activities. Article 47, a Directive Principle of State Policy in such
manner lays pressure on the improvement of general health and denial of medications harmful to
health as one of the essential obligations of the state. In Consumer Education and Research
Center v. Association of India, the Supreme Court set out that: “Social equity which is a device
to guarantee life to be significant and decent with human nobility requires the State to give to
labourer’s offices and chances to reach at any rate least standard of health, monetary security and
edified living. The health and quality of labourers, the court stated, was a significant feature of
right to life. Disavowal thereof bares the labourers the better aspects of life damaging Art. 21.”

Right to life under Article 21 of the Constitution has been liberally interpreted to mean
something more than merely human existence and includes the right to live with dignity and
decency. In 1995, the Hon’ble Supreme Court of India in the case of Parmanand Katra held
that those who are indulged into the profession of medical are in charge of public health and
have an inherent obligation to protect the same so that those who are innocent can be protected
and the guilty be punished.

In yet another case of Spring Meadow Hospital, the court held that there is need for
sensitization of relevant law pertaining to the content of the right to health. An act to deal with
legal prohibition of commercialized transplantation has further animated the right to health.
Therefore, the recognition of dignity and fundamental right to life led to recognizing of the
importance of health. In another case of Bandhua Mukti Morcha v. Union of India, the court
held that although the Directive Principles of State Policy hold persuasive value, yet they should
be duly implemented by the state; and it was in this case also that the court had interpreted the
dignity and health within the ambit of life and liberty under Article 21 of the Constitution of
India.

In the Ram Lubhaya case, while looking at the spinning around the issue of right to health
under Article 21, 41 and 47 of the Constitution of India, the court saw that the right of one
associates with the obligation of another. Consequently, the right endowed under Article 21
forces an equal obligation on the state which is additionally strengthened as under Article 47.
Despite the fact that few schools and emergency clinics are set up by the administration however,
the obligation isn’t satisfied until they can be in reach of the overall population. It is relevant to
take note of that the Hon’ble Court for this situation respected health to be a consecrated, holy
and important right.

Further, in Paschim Banga Khet Mazdoor Samity case, the extent of Article 21 was
additionally broadened; thus the court held that it is the duty of the legislature to give sufficient
clinical guidance to each individual and to work in the government assistance of the overall
population. In addition, Article 21 forces commitment on the express, the state is required to
ensure and shield the rights of each individual.

In the T. Ramakrishna Rao case, the Hon’ble High Court gave the perception that ensuring
condition is the obligation of the two residents and the state. Article 21 likewise grasps the
security and conservation of the earth for the explanation that the natural contamination is a
moderate demise and along these lines, it is infringement of Article 21 of the Constitution of
India. In the popular instance of Ratlam Municipal Corporation, the court held that it is the
essential obligation of the state under Article 47 of the Constitution to guarantee the everyday
environments of the individuals are healthy and uphold this obligation against any legislative
body or authority who defaults in doing so independent of the money related assets it has.

Indian Judiciary recognizing International conventions for upholding Right to Health

Good health pertains to clean and safe drinking water, sanitation, adequate housing, education
and humane working conditions, nutritious foods etc. Health has in one way been linked to the
right to privacy wherein everyone is entitled to their respect and dignity. Therefore, every person
is entitled to control his/her own body and health which also includes various other elements. In
India, judiciary has played a major role in recognizing the right to health as a part of Article 21
of Chapter III which deals with the fundamental rights guaranteed under the Constitution of
India. State has been directed to provide the highest attainable health standards to its citizens
towards the fulfilment of International standards.

In 2011, the Delhi High Court issued a landmark joint decision in the cases of Laxmi Mandal v.
Deen Dayal Harinagar Hospital & Ors. and Jaitun v. Maternity Home, MCD, Jangpura &
Ors. concerning denials of maternal health care to two women living below the poverty line. The
Court stated that “these petitions focus on two inalienable survival rights that form part of the
right to life: the right to health (which would include the right to access and receive a minimum
standard of treatment and care in public health facilities) and in particular the reproductive rights
of the mother.” Citing CEDAW and ICESCR, the decision held that “no woman, more so a
pregnant woman should be denied the facility of treatment at any stage irrespective of her social
and economic background…This is where the inalienable right to health which is so inherent in
the right to life gets enforced.”

International Covenant on Economic, Social and Cultural Rights, Article 2

1. Each State Party to the present Covenant undertakes to take steps, individually and
through international assistance and cooperation, especially economic and technical, to
the maximum of its available resources, with a view to achieving progressively the full
realization of the rights recognized in the present Covenant by all appropriate means,
including particularly the adoption of legislative measures.
2. The States Parties to the present Covenant undertake to guarantee that the rights
enunciated in the present Covenant will be exercised without discrimination of any kind
as to race, colour, sex, language, religion, political or other opinion, national or social
origin, property, birth or other status.
A proposed framework for indicators

Report on indicators for monitoring compliance with international human rights instruments

 Structural indicators: number of international treaties ratified, effort of state obligation

 Process indicators: method of implementation
 Outcome indicators: mortality ratio, outcome- state implementation document number
of deaths

Case Laws

Mohd Abrar vs Dr. Ashok Desai

The appellants case before the State Commission was that he sustained fracture of left leg due to
accident on 24.04.1997. The accident occurred in the proximity of Dewas town. The appellant
was initially admitted to Karim Nursing Home, Dewas on the same day. The x-ray examination
indicated comminuted fracture. Though, there was no external injury found, he was advised to
get further treatment at Greater Kailash Nursing Home, Indore. He went to Indore on the same
day. He was admitted as indoor patient at Greater Kailash Nursing Home, Indore in the same
evening. His left leg was hung upwards. The respondent no. 1 Dr. Ashok Desai decided to fix an
external fixator. The measurement was taken on 30.04.97 for such purpose. On 5.05.1997, the
external fixator was fixed by the treating medical practitioner, i.e., Dr. Ashok Desai. The
appellant was hospitalized for further treatment after the installation of safety shoes on
8.05.97.he appellant alleged that on 17.05.1997 he got himself discharged from the hospital on
being assured of the successful operation and further assurance that no further medical treatment
was required. He further alleged that the quality of external fixator was inferior. The rings and
the steel rods were rusted. The rod fixed during the course of operation was defective. The
respondent no. 1 Dr. Ashok Desai, did not pay any attention to the fact that there was occult
blood.The infected blood had started oozing out of the drilled holes. No care was taken to drain
out the infected blood. The appellant further alleged that after four days of discharge he again
approached the respondent no. 1 Dr. Ashok Desai but the latter was not available. He was
advised to visit the Hospital on 25.05.97. He accordingly went to the respondent no. 2 – hospital
where he was told that the rod fixed in the left leg was defective and therefore, another operation
was needed.
In between 29.05.97 till 21.06.97, the respondent no. 1 Dr. Ashok Desai performed four
operations including sequestrectomy and sloughectomy. Besides, plastic surgery was also
performed. According to the appellant, the respondent no. 1 Dr. Ashok Desai ought to have
gathered knowledge that there was onset of gangrene, yet instead of removal of the infected
blood and giving treatment for gangrene the plastic surgery was performed along with four
operations in order to gloss over the patent and negligent error committed by him. The appellant
alleged that when there was no improvement noticed, he shifted himself to Gita Bhawan
Hospital, Indore on 21.06.97. He was duly informed at that medical centre about the prognosis of
gangrene. He was advised to undergo amputation of the left leg below the knee in order to arrest
progression of the gangrene and to save his life. His left leg below the knee was amputated on
26.06.97. He took further treatment in Gita Bhawan Hospital till 31.07.1997. The appellant came
out with a case that the amputation of his left leg was result of medical negligence committed by
the respondent no. 1 Dr. Ashok Desai. He, therefore, claimed compensation of Rs.20 lakh on
account of loss of livelihood, medical expenditure and mental as well as physical agony.The
complaint was dismissed by the State Commission on 29.05.2003. The appellant preferred an
appeal to this Commission. By order dated 09.02.2004, the matter was remanded to the State
Commission for giving opportunity to the parties to conduct cross-examination of the witnesses
by each other on the affidavits which were placed on record. The cross-examination of the
respondent no. 1 Dr. Ashok Desai was conducted by the appellant whereas the respondents
cross-examined Dr. Shakir Ali, whose affidavit was relied upon by the appellant. On evaluation
of the material placed before it, the State Commission reached the same conclusion, namely, that
the appellant failed to establish medical negligence committed by the respondent no. 1 Dr. Ashok
Desai in providing necessary medical treatment and conducting the operations. The complaint
was accordingly dismissed. respondent no. 1 Dr. Ashok Desai stated that after the comminuted
fracture was treated by binding of the external fixator. The fixator is used in order to prevent
early movements at the place of the fracture, thus, inhibiting callus formation. It goes without
saying, therefore, that if after the operation the patient does not take due care to keep his
movements restricted, after applying of the external fixator, there is possibility of movements at
the site of the fracture that would cause complications. The fact that the appellant got himself
discharged on his own, is indicative of his own negligence. In any case, it is difficult to find out
whether he contributed to the causation of the gangrene.
CESC V Subhash Chandra Bose

SC stated that health isn’t merely absence of sickness. Health is something more than sickness.
Access to health care facilities for economic man power to get the workers most; attainable, a
complete well being.

Paschim Banga Khet Mazdoor Samity V State of West Bengal

The case concerns the question whether denial of emergency medical aid to a patient at a
government hospital amounts to violation of that person's constitutional right to life. It also gives
an insight as to how far the court can go in giving directions that have budgetary implications on
the state.

In the case a persons fell off a train and suffered serious head injuries and brain haemorrhage. He
was taken to a Primary Health Centre but since the centre did not have the necessary facilities he
only got first aid and was referred to government hospitals that were well equipped. At the first
hospital even after examination had revealed that the patient needed emergency medical
treatment, admission was denied on the ground that there were no available beds. He was then
taken to several other hospitals but could not get admission either because of lack of beds or
facilities to handle his case. He ended in a private hospital where he was treated at his cost.

In his petition he claimed that by being denied emergency medical treatment, his right to life was
violated. He claimed damages for this purpose.

The Decision

It was held by S.C. Agrawal, J. that: “The India Constitution envisages the establishment of a
welfare state in which the primary responsibility of the state is to secure the welfare of the
people. That the government discharges this obligation by running hospitals and health centers
which provide medical care to persons seeking to avail those facilities. The Constitution imposes
an obligation on the state to safeguard the right to life of every person and preservation of life is
of paramount importance. The government hospitals and the medical officers in them are duty
bound in this respect. Failure on their part amounts to violation of the individual right to life, that
the obligation on the state stands irrespective of constraints in financial resources.” The state
said, it should have a time bound plan for providing these services.

The Court approved of the recommendations that were made by a Committee that had been
appointed to inquire into this incident. Directions were given which required the Government to
do a number of things to ensure that facilities existed for emergency medical treatment; keeping
of proper records of all patients, increasing the number of beds, setting up a central bureau to
ensure proper coordinated treatment by all hospital among others. Reference was made to the
position in the United States of America where by virtue of the Consolidated Omnibus
Budget Reconciliation Act 1986 all private hospitals that receive medical care benefits and
maintain emergency rooms are required to perform two tasks even when a patient is indigent.
First the hospital must perform medical screening examination of all prospective patients and
second, if the hospital determines that the patient suffers from an emergency condition, to
stabilize that condition and cannot transfer or discharge such patient unless this is appropriate.
The Petitioner was awarded Rs 25,000/-

Mr X v. Hospital Z 1998 (6) SCALE 230; 1998 (8) SCC 296

The facts of the case in brief were as follows:

1. The Appellants blood was to be transfused to another and therefore a sample thereof was
taken at the Respondents Hospital.
2. The Appellant was found to be H.I.V.(+).
3. On account of disclosure of the fact that the Appellant was H.I.V.(+) by the Hospital
authorities without the express consent of the Appellant, the Appellants proposed
marriage to Ms A which had earlier been accepted, was called off.
4. Moreover, the Appellant was severely criticized and was also ostracized by the
community to such an extent that he had to leave is place of work and residence and shift
to a new city.
5. The Appellant approached the National Consumer Dispute Redressal Commission for
damages against the Respondents on account of injury and damages suffered to him
because of disclosure of information required to be kept secret under medical ethics by
the Hospital authorities.
 6. The Commission however dismissed the complaint on the ground that the Appellant
could seek his remedy in the Civil Court.
7. The Appellant thus appeared before the Supreme Court contending that the principle of
Duty of care applicable to persons in medical profession included the Duty to maintain
confidentiality and the said duty had a correlative right vested in the patient that whatever
came to the knowledge of the doctor would not be divulged.
8. The Appellant contended that for violating the above duty as well as the Appellants right
to privacy, the Respondents were liable to pay damages.

Issues before The Supreme Court:

1. Whether the Respondents were guilty of violating the Appellants right to privacy
guaranteed under Article 21 of the constitution?
2. Whether the Respondents were guilty of violating their duty to maintain secrecy under
medical ethics?

Every human being is capable of making mistakes. The degree of mistake made by one as
compared to another may vary. But mistakes we all make. The Supreme Court of India – an
embodiment of justice, the highest court of the land is no exception.

In my humble opinion, the above judgment was a mistake. My reason for holding such an
opinion is based on the following details discussed broadly below:

i. The issue before the Supreme Court was whether or not a breach of confidentiality and
privacy by the Hospital authorities had indeed taken place. However the judgment makes
out that the complainant was contesting his right to marry, which is factually incorrect. It
is an elementary principle of Jurisprudence that the Court will not decide on issue not
raised before it. Thus by deciding on an issue not before the court such as the Appellants
right to marry, such decision is in fact no decision in law.
ii. Furthermore it may be noted that for the first time in the judicial history anywhere in the
world a Court has taken away the fundamental right of an individual to marry.
iii. Even for the sake of argument if one was to believe that right to marry was an issue
before the Court in the present case, it cannot be take away as it is an absolute right. The
reason for the same is that the right to marry of an individual flows directly from his right
 to life guaranteed under article 21 of the constitution of India. Article 21 extends to
citizens and aliens alike and a person suffering from AIDS is no exception. Prior to the
44th Amendment the constitution provided for the suspension of this right under article
359 on the Presidents order to that effect. However after the 44th Amendment things
have changed and now article 21 cannot be suspended at any point of time even on such
order of the President, thus making rights flowing under it absolute With reference to the
Courts decision regarding the issue of conflict of the Appellants right to privacy against
Ms As right to be informed and that whose right would override who's right. The Court
failed to take notice of the following points:

The Court overlooked the fact that the Appellant in the present case was himself a Doctor who
could be reasonably expected to be aware of the dangers of the disease and hence his consent
should have at least been taken by the hospital authorities before publicly declaring his disease
which had the effect of making him a victim of gross discrimination, and led him to being
ostracized from the community.

Furthermore, the Court also failed to hear out one of the essential parties to the case- Ms A who's
right was in question if at all, or was made out to be by the Court.

Murli Deora vs Union of India and Ors 2001, 8 SCC 765, Murli S. Deora was a famous
politician. He was also a social activist who is very much concerned about the society.

Ill effects of tobacco –Tobacco related diseases caused an estimated eight hundred thousand
deaths in India per year with treatment of tobacco caused diseases resulting in a loss of Rupees
13,500 crores annually. The World Health Organization estimated that up to seven million
deaths, worldwide per year were attributable to tobacco related diseases, of which sixty million
deaths occurred in developing countries during the previous fifty years.

Lack of legislation – During those time only one act was in force called Cigarettes (Regulation
of production, supply and distribution) Act, 1975. The Tobacco Products (prohibition of
advertisement and regulation of trade and commerce, production, supply and distribution)
bill, 2001 was pending. The objects of both Acts detailed the concern of tobacco smoking on
public health, but did not establish a ban.
Petitioner Approached Hon’ble Supreme Court – The Petitioner, Murli S. Deora has
approached the Supreme Court by filing a Public Interest Litigation on the basis of the right to
life, and liberty espoused in Article 21 of the Indian Constitution.

VERDICT: The Supreme Court held that smoking in public places deprives the Right to life of
the passive smokers. Upon Realizing the gravity of the situation and considering the adverse
effect of smoking on smokers and passive smokers, the Supreme Court directed and prohibited
smoking in public places. And it also issued directions to the Union of India, State Governments
as well as the Union Territories to take effective steps to ensure prohibiting smoking in public
places namely:

 Auditoriums
 Hospital Buildings
 Health Institutions
 Educational Institutions
 Libraries
 Court Buildings
 Public conveyances including railways

Naz Foundation v. Government of NCT of Delhi and Others WP(C) No.7455/2001

This case concerned a writ petition (a public interest action taken before the court) brought by an
Indian NGO working with HIV/AIDS sufferers which argued that Section 377 of the Indian
Penal Code was unconstitutional. Section 377 entitled “Of Unnatural Offences” has effectively
been interpreted as criminalizing consensual sexual acts between persons of the same sex.
Section 377 states: “Whoever voluntarily has carnal intercourse against the order of nature with
any man, woman or animal, shall be punished with [imprisonment for life], or with
imprisonment of either description for term which may extend to ten years, and shall also be
liable to fine.” The Naz Foundation and others submitted that this interpretation of Section 377
violated the fundamental rights guaranteed under Articles 14, 15, 19 and 21 of the Constitution
of India. The Foundation brought the action in the public interest on the grounds that its work on
combating the spread of HIV/AIDS was being hampered by discrimination against the gay
community. This discrimination, the petitioners submitted, resulted in the denial of fundamental
human rights, abuse, harassment and assault by public authorities, thus driving the gay
community underground and subjecting them to greater vulnerability in violation of their
fundamental rights.

Bandhua Mukti Morcha v. Union of India (1997) 10 SCC 549

 The Supreme Court of India, in this public interest litigation case, directed the State of
Uttar Pradesh to eliminate the carpet industry’s use of child labor, issue welfare directives
prohibiting child labor under the age of 14 and provide children access to education and
health facilities in an effort to abolish child labor.
 This public interest litigation case (PIL) was filed via Article 32 of the Indian
Constitution directly before the Supreme Court of India and petitioned the Court to direct
the State of Uttar Pradesh (UP) to take steps to end child labor. Thereafter a Court-
appointed committee reported the enormity of child exploitation in UP’s carpet industry,
finding that many children were kidnapped from Bihar, that the industry largely
employed minor children under 14 years, and that many experienced physical abuse. 
 In its judgment, the Court discussed the importance of protecting children’s rights to
education, health, and development in ensuring India’s progress as a democracy.  While
recognizing that child labor could not be abolished immediately due to economic
necessity, the Court found that pragmatic steps could be taken to protect and promote the
rights of children in the poverty-stricken and vulnerable populations of Indian society.
  In support of its conclusion, the Court referred to various fundamental rights and
directive principles of the Indian Constitution including, Article 21 (the right to life and
personal liberty), Article 24 (prohibits employment of children younger than 14 in
factories, mines, or other hazardous industries), Article 39 (e) (prohibits forcing citizens
into vocations unsuited for their age or strength), Article 39(f) (describes the State’s
duties to protect children from exploitation and to ensure children the opportunities and
facilities to develop in a healthy manner), and Article 45 (mandates the State to provide
free compulsory education for all children below 14 years).
 The Court also noted India’s obligations under the Universal Declaration of Human
Rights (UDHR) and the Convention on the Rights of the Child to provide free primary
education for all children in the country, and to protect children against economic
 exploitation.  The measures ordered to abolish child labor set out in an earlier case, M.C.
Mehta v. State of Tamil Nadu & Ors. [[(1996) 6 SCC 756] were referenced by the Court
and incorporated in orders to the States of Uttar Pradesh and Bihar. 
 The orders included, directing the States to take steps to frame policies to progressively
eliminate the employment of children below the age of 14; provide compulsory education
to all children employed in factories, mining, and other industries; ensure that the
children receive nutrient-rich foods; and administer periodic health check-ups.

Enforcement of the decision and outcomes

In its judgment, the Court required that periodic reports of progress regarding the implementation
of the decision be submitted to the Registry of the Court. In addition, as regards enforcement, a
supplemental, if not consequential outcome of this case, along with other relevant public interest
litigation cases, was that that National Commission for Protection of Child Rights (NCPCR) in
2006 framed the NCPCR rules constituting the National Child Rights Commission. This
Commission was entrusted with assessing compliance with the Convention on the Rights of the
child and thus by extension monitoring the provision of free primary education for all children in
the country and the protection of children against economic exploitation.

Significance of the case

This case along with other public interest litigation cases on the issue of child labor, and a range
of child labor eradication campaigns have been successful in raising awareness about the issue of
child labor and placing the issue prominently on the government’s agenda. Law and policy is
moving in the direction of formal abolition of child labor and different initiatives especially in
the area of education are being undertaken towards eradicating child labor. One effect has been
that the use of child labor in the carpet industry has been reduced. However, millions of
children still continue to be exploited in the labor market in India and there is an urgent need for
stronger and more effective protections for the rights of children.
MODULE 2: ROLE OF WHO & GOVERNMENT IN PANDEMICS

Role of World Health Organization (WHO)

The World Health Organization describes its job as "the global guardian of health." It is now
possibly facing the most devastating global health threat in its 72-year history: the coronavirus
pandemic. WHO is devoting hundreds of millions of dollars and an all-hands-on-deck approach
to the effort to vanquish the virus.

The World Health Organization (WHO) is a specialized agency of the United Nations
responsible for international public health. The WHO Constitution states its main objective as
"the attainment by all peoples of the highest possible level of health". The WHO's mandate
includes advocating for universal health care, monitoring public health risks, coordinating
responses to health emergencies, and promoting health and well-being. It provides technical
assistance to countries, sets international health standards, and collects data on global health
issues. The WHO has played a leading role in several public health achievements, most notably
the eradication of smallpox, the near-eradication of polio, and the development of an Ebola
vaccine. Its current priorities include communicable diseases, particularly HIV/AIDS, Ebola,
COVID-19, malaria and tuberculosis; non-communicable diseases such as heart disease and
cancer; healthy diet, nutrition, and food security; occupational health; and substance abuse.

During the pandemic, WHO continuously monitored the evolution of the pandemic, and
developed guidance for Member States to put in place appropriate measures including enhanced
surveillance and active monitoring, assessment of the pandemic characteristics, and
recommendations on appropriate measures including medical and non-medical interventions.

WHO’s risk assessments were balanced, independent and transparent. Daily updates, weekly
surveillance overviews and guidance from WHO provided the basis for evidence-based decisions
by the Member States, especially those with fewer resources to perform their own risk
assessments. There was regular interaction between risk assessors and risk managers in the EU
system. During the pandemic frequent teleconferences were held with risk managers in the
Member States. There was general good collaboration between WHO, EU, ECDC, the European
Medicines Agency (EMA) and the European Food Safety Authority (EFSA), especially
considering this was the first major health crisis since founding of WHO.
With the emergence of the pandemic WHO assumed its full responsibilities as mandated by the
International Health Regulations (2005) to coordinate public health emergencies of international
concern. WHO counted on governments’ support and collaboration to meet the rapidly emerging
challenge.

International Health Regulations (2005)

The purpose and scope of the International Health Regulations (2005) are “to prevent, protect
against, control and provide a public health response to the international spread of disease in
ways that are commensurate with and restricted to public health risks, and which avoid
unnecessary interference with international traffic and trade”. Because the IHR (2005) are not
limited to specific diseases but apply to new and ever- changing public health risks, they are
intended to have long-lasting relevance in the international response to the emergence and spread
of disease. The IHR (2005) also provide the legal basis for important health documents
applicable to international travel and transport and sanitary protections for the users of
international airports, ports, and ground crossings.

The IHR are an instrument of international law that is legally-binding on 196 countries,
including the 194 WHO Member States. The IHR grew out of the response to deadly epidemics
that once overran Europe. They create rights and obligations for countries, including the
requirement to report public health events. The Regulations also outline the criteria to determine
whether or not a particular event constitutes a “public health emergency of international
concern”.

At the same time, the IHR require countries to designate a National IHR Focal Point for
communications with WHO, to establish and maintain core capacities for surveillance and
response, including at designated points of entry. Additional provisions address the areas of
international travel and transport such as the health documents required for international traffic.

Finally, the IHR introduce important safeguards to protect the rights of travellers and other
persons in relation to the treatment of personal data, informed consent and non-discrimination in
the application of health measures under the Regulations.
The seven areas of work for IHR (2005) implementation:

 Foster global partnerships

 Strengthen national disease prevention, surveillance, control and response systems
 Strengthen public health security in travel and transport
 Strengthen WHO global alert and response systems
 Strengthen the management of specific risks
 Sustain rights, obligations and procedures
 Conduct studies and monitor progress

Pandemic Influenza Preparedness Framework (PIP Framework)

The Pandemic Influenza Preparedness (PIP) Framework aims to improve the sharing of influenza
viruses with pandemic potential and increase access of developing countries to vaccines and
other life-saving products during a pandemic. Under the Framework, countries have been
supported to enhance their capacities to detect, prepare for and respond to pandemic influenza.

The PIP Framework brings together Member States, industry, other stakeholders and WHO to
implement a global approach to pandemic influenza preparedness and response. Its key goals
include: to improve and strengthen the sharing of influenza viruses with human pandemic
potential; and to increase the access of developing countries to vaccines and other pandemic
related supplies.

The objective of the Pandemic Influenza Preparedness Framework is to improve pandemic

influenza preparedness and response, and strengthen the protection against the pandemic
influenza by improving and strengthening the WHO global influenza surveillance and response
system (“WHO GISRS”), with the objective of a fair, transparent, equitable, efficient, effective
system for, on an equal footing:

 The sharing of H5N1 and other influenza viruses with human pandemic potential; and
 Access to vaccines and sharing of other benefits.

This Framework applies to the sharing of H5N1 and other influenza viruses with human
pandemic potential and the sharing of benefits.
This Framework does not apply to seasonal influenza viruses or other non-influenza pathogens
or biological substances that may be contained in clinical specimens shared under this
Framework.

National Centre for Disease Control (NCDC)

The institute was established to function as a national centre of excellence for control of
communicable diseases. The function of the institute also included various areas of training and
research using multi-disciplinary integrated approach. The institute was, in addition, expected to
provide expertise to the States and Union Territories (UTs) on rapid health assessment and
laboratory based diagnostic services. Surveillance of communicable diseases and outbreak
investigation also formed an indispensable part of its activities.

The activities at the national level include the designation of the National IHR Focal Point,
initially assigned to the National Institute of Communicable Diseases (NICD) under the Ministry
of Health and Family Welfare. In 2009, NICD transformed into the National Centre for Disease
Control (NCDC), with a larger mandate for controlling emerging and re-emerging diseases.
NCDC, headed by a Director, has the following departments:

a) Centre for AIDS and related diseases

b) Integrated Disease Surveillance Project
c) Division of Epidemiology
d) Division of Biochemistry and Biotechnology
e) Centre for Medical Entomology and Vector Management
f) Division of Zoonosis
g) Division of Microbiology
h) Division of Malaria and Coordination
i) Division of Parasitic Diseases
j) Division of Planning, Budget and Administration.

Apart from conducting training and research using a multidisciplinary integrated approach,
NCDC is also expected to provide expertise to the states and UT on rapid health assessment and
laboratory-based diagnostic services, surveillance of communicable diseases and outbreak
investigation. The mandate of NCDC is also to notify public health emergencies of international
concern (PHEIC) to WHO, to respond to requests for verification of information of such events,
support field investigations for early diagnosis and technical guidance to the States for the timely
and effective response to PHEIC. The notification of an outbreak to WHO is based on the
identification of any two of the four point criteria of determination of PHEIC:

i. unusual or unexpected event

ii. an event that seriously impacts public health
iii. event with a significant risk of international spread and
iv. event with a significant risk of international spread requiring travel and trade restrictions.

National Health Bill 2009

The Government of India took a landmark decision when it decided to introduce the National
Health Bill, 2009. The bill recognizes health as a fundamental human right and states that every
citizen has a right to the highest attainable standard of health and well-being. The constitution of
India, under Articles 14, 15, and 21, recognizes the right to life as a fundamental right and places
obligations on the Government to ensure protection and fulfillment of the right to health for all,
without any inequality or discrimination.

The basic tenets of the Bill include the peoples' right to health and healthcare, the obligations of
the governments and private institutions, core principles/norms/standards on rights and
obligations, the institutional structure for implementation and monitoring, and the judicial
machinery for ensuring health rights for all. The bill provides itemized lists of the obligations of
the central and state governments. Chapter III of this bill provides elaborate rights to health care,
including terminal care, for everyone. A heartening point is that the bill guarantees that no
person shall be denied care under any circumstances, including the inability to pay the requisite
fee or charges. Prompt and necessary emergency medical treatment and critical care must be
given by the concerned health care provider, including private providers.

As per the bill, the health care provider, including the clinician, would be obligated to provide all
information to the patients regarding the proposed treatment (risks, benefits, costs, etc.) and any
alternate treatments that may be available for the particular condition/disease. There is a clause
in this chapter that demands that the user (i.e., the patient) respect the rights of the health care
providers by treating them with respect, courtesy, and dignity and refrain from any abuse or
violent or abusive behavior towards them or to the rights provided to them. The bill envisages
the establishment of National- and State-level Public Health Boards to formulate national
policies on health, review strategies, and ensure minimum standards for food, water, sanitation,
and housing.

These boards would also lay down minimum standards and draw up protocols, norms, and
guidelines for diverse aspects of health care and treatment. The bill provides for elaborate
mechanisms for monitoring at the government and community levels. There is a need to have
wider discussion on the scope and activities of these monitoring agencies and regarding dispute
resolution and redressal mechanisms listed in chapter V of the Bill.

A comprehensive Act that covers the various aspects of health care rights, delivery and related
matters has been a pressing need in this country for long. Several international and national
agencies, as well as the Honorable Supreme Court of India, have drawn the attention of the
Government to this issue.

The Bill, once enacted, would have far-reaching consequences on the Indian health scenario. It
would demand greater levels of professionalism, standards of care, accountability, from the care
providers and, besides, ensure protection for them. The Bill calls for greater official involvement
of professional bodies like the Indian Academy of Neurology in the health care management in
this country. It is hoped that professional bodies will carefully study this Bill and come out with
suggestions and recommendations as soon as possible.

Important Features

 Right to Healthcare - The recently drafted health bill 2009 seeks to legalize the 'right to
healthcare', along with other issues associated with health rights
 Good treatment - It will strive to ensure that good treatment be made available to the
vastly neglected groups such as those affected by HIV/AIDS.
 Collaborations between the Center and the State - The bill demands a broad legal
framework (that involves cooperation/ collaborations between the Center and the State)
for providing essential public health services and to monitor its functions, such as
responding to public health emergencies.
  Emergency Care - According to the National Health Bill 2009 'Patient's Right' includes
emergency care. No individual should be denied emergency treatment because of his
inability to pay fees or due to the requirement for police clearance
 Patient Complaints - The new bill also seeks to make it mandatory for the hospitals to
address patient complaints, on a 24 x 7 basis.
 Name of doctor involved in treatment- Every patient has the right to know name of
doctor / nurse involved in his treatment.
 Summary & Second Opinion - Each patient has the right to avail of a summary of their
condition and also to seek a second opinion.
 Cost of Treatment- A patient may protest against overbilling, transferring elsewhere
without valid reasons and for denying medical records
 Rights of healthcare providers - The rights of healthcare providers is also likely to get
legal recognition.

The basic tenets of the Bill include -

 People's rights relating to health and healthcare,

 Obligations of governments and private actors,
 Core principles / norms / standards on rights and obligations,
 Institutional structure for implementation and monitoring
 Judicial machinery for health rights.

However, the bill does not interfere with the regulatory tasks and administrative decisions to be
taken by governments and local bodies, on the specific measures to be adopted to achieve the
target.

The bill also empowers the government to review the existing laws and systems and to make new
subordinate legislations and regulations and, overall, ensure the right to health of all people.
Role of National Disaster Management

Disaster Management Act, 2005

It came into effect in the aftermath of the 2004 tsunami, when the country lost thousands of lives.
It was passed by the government for efficient management of disasters, including preparation of
mitigation strategies, capacity-building and related matters.

The Act aims to manage disasters, including preparation of mitigation strategies, capacity-
building and a lot more.

The Act also designates the Ministry of Home Affairs as the nodal ministry responsible for
looking after the overall national disaster management in the country. The Act also contains
provisions for financial mechanisms including creation of funds for emergency response like the
National Disaster Response Fund.

Governing bodies that were established under the Act include –

1. The National Disaster Management Authority or NDMA:

It is the nodal central body for disaster management coordination, with the Prime Minister as its
Chairperson. It is responsible for framing the policies, plans and guidelines for disaster
management to ensure an effective & strong response during any disaster.

2. Second is the National Executive Committee or NEC which assists NDMA & prepares
National Disaster Management Plan for the whole country.
3. On the state and district level, we have SDMA & NDMA responsible for drawing the
disaster plan for states & districts respectively.
4. Then, there is NDRF or National Disaster Response Force which directly responds to a
threatening disasters and calamities. The NDRF has been playing a major role in rescuing
people from disasters for years.

Punishment clause

The DM Act immensely empowers the NDMA and the central government. So much so that
regardless of any law in effect, the Central Govt can issue instructions to any authority anywhere
in India to assist and contribute in disaster management. Failure to follow such directions leads
to violation of the act.

The Act comprises 79 sections and 11 chapters. And Chapter 10 of the Act deals with ‘Offences
and Penalties’.

Under Section 51, anyone refusing or failing to follow orders is liable for punishment with
imprisonment up to one year, or fine, or both.

Article 52 guarantees imprisonment for almost two years and a fine on any person making false
claims to gain relief benefits. Article 54 enforces imprisonment of one year or a fine on anyone
circulating false alarms about the severity of a disaster.

These two articles of the act, i.e. Article 52 and 54 have gained importance in the recent times.
This is because, lately, a lot of news and updates about COVID have been flooding social media
platforms which fail to check the credibility of the news.

COVID-19 and the ambit of DM Act

Though the Act came into effect 16 years ago, it got popular and made headlines with the onset
of COVID-19 and PM Modi’s call for a nationwide lockdown last year in May 2020. The
lockdown was imposed under the same Disaster Management Act, 2005.

Sec 2(d):- “Disaster” means a catastrophe, mishap, calamity or grave occurrence in any area,
arising from natural or man-made causes, or by accident or negligence which results in
substantial loss of life or human suffering or damage to, and destruction of, property, or damage
to, or degradation of, environment, and is of such a nature or magnitude as to be beyond the
coping capacity of the community of the affected area.

Sec 2(e):- “Disaster Management” means a continuous and integrated process of planning,
organising, coordinating and implementing measures which are necessary or expedient for—

i. prevention of danger or threat of any disaster;

ii. mitigation or reduction of risk of any disaster or its severity or consequences;
iii. capacity-building;
iv. preparedness to deal with any disaster;
 v. prompt response to any threatening disaster situation or disaster;
vi. assessing the severity or magnitude of effects of any disaster;
vii. evacuation, rescue and relief;
viii. Rehabilitation and reconstruction.

Sec 12: Guidelines for minimum standards of relief — The National Authority shall
recommend guidelines for the minimum standards of relief to be provided to persons affected by
disaster, which shall include,—

i. the minimum requirements to be provided in the relief camps in relation to shelter, food,
drinking water, medical cover and sanitation;
ii. the special provisions to be made for widows and orphans;
iii. ex gratia assistance on account of loss of life as also assistance on account of damage to
houses and for restoration of means of livelihood;
iv. such other relief as may be necessary.

Sec 36: Responsibilities of Ministries or Departments of Government of India — It shall be

the responsibility of every Ministry or Department of the Government of India to— (a) take
measures necessary for prevention of disasters, mitigation, preparedness and capacity building in
accordance with the guidelines laid down by the National Authority; (b) integrate into its
development plans and projects, the measures for prevention or mitigation of disasters in
accordance with the guidelines laid down by the National Authority; (c) respond effectively and
promptly to any threatening disaster situation or disaster in accordance with the guidelines of the
National Authority or the directions of the National Executive Committee in this behalf; (d)
review the enactments administered by it, its policies, rules and regulations, with a view to
incorporate therein the provisions necessary for prevention of disasters, mitigation or
preparedness; (e) allocate funds for measures for prevention of disaster, mitigation, capacity-
building and preparedness; (f) provide assistance to the National Authority and State
Governments for— (i) drawing up mitigation, preparedness and response plans, capacity-
building, data collection and identification and training of personnel in relation to disaster
management; (ii) carrying out rescue and relief operations in the affected area; (iii) assessing the
damage from any disaster; (iv) carrying out rehabilitation and reconstruction; (g) make available
its resources to the National Executive Committee or a State Executive Committee for the
purposes of responding promptly and effectively to any threatening disaster situation or disaster,
including measures for— (i) providing emergency communication in a vulnerable or affected
area; (ii) transporting personnel and relief goods to and from the affected area; (iii) providing
evacuation, rescue, temporary shelter or other immediate relief; (iv) setting up temporary
bridges, jetties and landing places; (v) providing, drinking water, essential provisions, healthcare,
and services in an affected area; (h) take such other actions as it may consider necessary for
disaster management.

Sec 38. State Government to take measures.—(1) Subject to the provisions of this Act, each State
Government shall take all measures specified in the guidelines laid down by the National
Authority and such further measures as it deems necessary or expedient, for the purpose of
disaster management. (2) The measures which the State Government may take under sub-section
(1) include measures with respect to all or any of the following matters, namely:— (a)
coordination of actions of different departments of the Government of the State, the State
Authority, District Authorities, local authority and other non-governmental organisations; (b)
cooperation and assistance in the disaster management to the National Authority and National
Executive Committee, the State Authority and the State Executive Committee, and the District
Authorities;

Sec 39: Responsibilities of departments of the State Government — It shall be the

responsibility of every department of the Government of a State to— (a) take measures necessary
for prevention of disasters, mitigation, preparedness and capacity building in accordance with the
guidelines laid down by the National Authority and the State Authority; (d) respond effectively
and promptly to any threatening disaster situation or disaster in accordance with the State Plan,
and in accordance with the guidelines or directions of the National Executive Committee and the
State Executive Committee

Sec 41: Functions of the local authority — (1) Subject to the directions of the District
Authority, a local authority shall— (a) ensure that its officers and employees are trained for
disaster management; (b) ensure that resources relating to disaster management are so
maintained as to be readily available for use in the event of any threatening disaster situation or
disaster; (c) ensure all construction projects under it or within its jurisdiction conform to the
standards and specifications laid down for prevention of disasters and mitigation by the National
Authority, State Authority and the District Authority; (d) carry out relief, rehabilitation and
reconstruction activities in the affected area in accordance with the State Plan and the District
Plan. (2) The local authority may take such other measures as may be necessary for the disaster
management.

Sec 51: Punishment for obstruction, etc — Whoever, without reasonable cause— (a) obstructs
any officer or employee of the Central Government or the State Government, or a person
authorised by the National Authority or State Authority or District Authority in the discharge of
his functions under this Act; or (b) refuses to comply with any direction given by or on behalf of
the Central Government or the State Government or the National Executive Committee or the
State Executive Committee or the District Authority under this Act, shall on conviction be
punishable with imprisonment for a term which may extend to one year or with fine, or with
both, and if such obstruction or refusal to comply with directions results in loss of lives or
imminent danger thereof, shall on conviction be punishable with imprisonment for a term which
may extend to two years.

The Epidemic Diseases Act, 1897

The Epidemic Diseases Act (hereafter referred to as the act) was enacted in 1897 to control the
outbreak of the deadly bubonic plague in Bombay. As the plague assumed epidemic proportions,
the colonial response was typical—one driven by panic, high handedness, ill planning and
extreme measures. The Epidemic Diseases Act was a result of “stringent measures,” which
Queen Victoria had directed her government to take, in order to tackle the plague outbreak
(Kumbhar 2020).

Legal frameworks are important during crisis situations as they augment a government’s
response to public health emergencies and also the rights and duties of citizens. It is thus
important to review the act with reference to its current relevance, its adequacy to tackle deadly
virus outbreaks, surveillance and privacy issues and, most importantly, its limitations.

The act is one of the shortest legislations in the country, containing four sections only. Section 2
of the act empowers the state governments to take such measures and prescribe temporary
regulations as may be required to control an epidemic disease. Section 2A empowers the central
government to inspect any ship leaving or arriving in port and for the detention of any person
sailing or arriving therein. Section 3 provides for punishment under Section 188 of the Indian
Penal Code (IPC) for any person disobeying the act. If any disobedience by a person causes or
tends to cause danger to human life, health or safety, then they may be punished with
imprisonment upto six months and/or fine upto Rs 1,000. Section 4 provides legal protection to
persons for anything done under the act (Ministry of Law and Justice 2020).

The Act during the Pandemic

As the corona virus pandemic engulfed the country, this 123-year-old act was invoked, along
with provisions of the Disaster Management Act, to control the spread of the virus. Most Indian
states, such as Delhi, Uttar Pradesh, Maharashtra and Bihar, notified regulations under the act
authorising government officials to admit, isolate and quarantine people in certain situations.
Drawing from the act, many states took measures, such as the closing of schools, malls, gyms,
institutional and home quarantine, in order to mitigate the crisis.

The act was amended by way of an ordinance in April 2020. The amendment aimed primarily at
protecting healthcare personnel engaged in combating the coronavirus and expanded powers of
the central government to prevent the spread of such diseases. It made acts of violence against
healthcare personnel and damage to property, including a clinical establishment, quarantine
facility or a mobile medical unit, during an epidemic punishable with imprisonment upto five
years and fine upto Rs 2 lakh. Persons convicted of such offences will also be required to pay
compensation to the victims. The ordinance was introduced as a bill in the recently concluded
session of Parliament. It was passed by both houses of Parliament and received the assent of the
President on 28 September 2020, thereby bringing into effect the Epidemic Diseases
(Amendment) Act, 2020, which incorporates the afore-discussed changes.

Limitation of the EDA

Despite recent amendments, the act has major limitations in this era of changing dynamics in
public health emergency management. Communicable diseases and their spread have changed
over the years. Novel viral diseases, which are more virulent and potent in form, pose constant
challenges for us. There is increased international travel, global connectivity, greater migration,
closed urban spaces, climate and ecological changes and more pressure on natural resources. The
act is not in consonance with the changing requirements of modern-day epidemic disease
prevention and control.

The act fails to define a “dangerous epidemic disease.” There is no clarity on the criteria that
need to be applied for declaring a disease as “dangerous” or “epidemic.” It is silent on variables
such as the magnitude of the problem, the severity of the disease, distribution of affected
population across age groups, possible international spread, or the absence of a known cure.
Further, the act contains no provision on the dissemination of drugs/vaccines and quarantine
measures to be taken. The act was formulated at a time when concepts like constitutional
principles, fundamental rights and basic human rights did not exist. There is no underlying
dissemination of fundamental human rights that need to be observed during the implementation
of emergency measures during an epidemic (Tewari 2020). The act focuses on government’s
powers during an epidemic, but does not specify its duties in controlling/preventing an epidemic,
nor does it enunciate any rights available to the citizens in the event of an outbreak.

There are concerns about disease surveillance and risk of privacy breach under the current
epidemic disease response regime. Under the Integrated Disease Surveillance Programme, each
district has a surveillance unit and a rapid response team to manage the outbreak of a disease. To
augment surveillance activities and response mechanisms, a wide network of health professionals
and state functionaries has been put in place, further bolstered by an information technology (IT)
based dissemination of data. When there is already a system in place for disease surveillance, the
provision in the act for devolution of power to “any” person makes little sense.

In a landmark judgment of the Supreme Court, Justice K S Puttaswamy (Retd) and Anr v
Union of India and Ors (2017), the right to privacy was held to be an intrinsic part of the right
to life under Article 21 of the Constitution. The Court laid down a few tests for limiting the
discretion of the state while impinging on the right of privacy, which included procedural
guarantees against abuse of interference that may be necessary for a legitimate aim. It is to be
noted that the Epidemic Diseases Act does not provide for procedural guarantees against any
abuse of state power regarding privacy infringement. There is a fear of the law being misused for
profiling, mass quarantine and targeting of individuals. There is blanket legal protection to public
servants who function under it. Therefore, the act does not pass the tests of reasonable
restrictions on privacy infringement and is, thus, grossly inadequate when weighed against the
scales of privacy rights.

The Epidemic Diseases (Amendment) Ordinance, 2020

The Epidemic Diseases (Amendment) Ordinance, 2020 was promulgated on April 22, 2020. The
Ordinance amends the Epidemic Diseases Act, 1897. The Act provides for the prevention of the
spread of dangerous epidemic diseases. The Ordinance amends the Act to include protections
for healthcare personnel combatting epidemic diseases and expands the powers of the central
government to prevent the spread of such diseases.

Key features are:

 Definitions: The Ordinance defines healthcare service personnel as a person who is at

risk of contracting the epidemic disease while carrying out duties related to the epidemic.
They include: (i) public and clinical healthcare providers such as doctors and nurses, (ii)
any person empowered under the Act to take measures to prevent the outbreak of the
disease, and (iii) other persons designated as such by the state government.
o An ‘act of violence’ includes any of the following acts committed against a
healthcare service personnel: (i) harassment impacting living or working
conditions, (ii) harm, injury, hurt, or danger to life, (iii) obstruction in discharge
of his duties, and (iv) loss or damage to the property or documents of the
healthcare service personnel. Property is defined to include a: (i) clinical
establishment, (ii) quarantine facility, (iii) mobile medical unit, and (iv) other
property in which a healthcare service personnel has direct interest, in relation to
the epidemic.
 Powers of the Central Government: The Act specifies that the central government may
regulate: (i) the inspection of any ship or vessel leaving or arriving at any port, and (ii)
the detention of any person intending to travel from the port, during an outbreak. The
Ordinance expands the powers of the central government to regulate the inspection of any
bus, train, goods vehicle, ship, vessel, or aircraft leaving or arriving at any land port, port
or aerodrome. Further, the central government may regulate the detention of any person
intending to travel by these means.
  Protection for healthcare personnel and damage to property: The Ordinance specifies
that no person can: (i) commit or abet the commission of an act of violence against a
healthcare service personnel, or (ii) abet or cause damage or loss to any property during
an epidemic. Contravention of this provision is punishable with imprisonment between
three months and five years, and a fine between Rs 50,000 and two lakh rupees. This
offence may be compounded by the victim with the permission of the Court. If an act of
violence against a healthcare service personnel causes grievous harm, the person
committing the offence will be punishable with imprisonment between six months and
seven years, and a fine between one lakh rupees and five lakh rupees. These offences are
cognizable and non-bailable.
 Compensation: Persons convicted of offences under the Ordinance will also be liable to
pay a compensation to the healthcare service personnel whom they have hurt. Such
compensation will be determined by the Court. In the case of damage or loss of property,
the compensation payable to the victim will be twice the amount of the fair market value
of the damaged or lost property, as determined by the Court. If the convicted person fails
to pay the compensation, the amount will be recovered as an arrear of land revenue under
the Revenue Recovery Act, 1890.
 Investigation: Cases registered under the Ordinance will be investigated by a police
officer not below the rank of Inspector. The investigation must be completed within 30
days from the date of registration of the First Information Report.
 Trial: The inquiry or trial should be concluded within one year. If it is not concluded
within this time period, the Judge must record the reasons for the delay and extend the
time period. However, the time period may not be extended for more than six months at
a time.
o When prosecuting a person for causing grievous harm to a healthcare service
personnel, the Court will presume that person is guilty of the offence, unless the
contrary is proved.

https://www.mondaq.com/india/employment-and-workforce-wellbeing/941818/epidemic-
diseases-amendment-ordinance-2020-receives-presidential-assent-
MODULE 3: REGULATION OF MEDICAL AND PARAMEDICAL PROFESSION

Medical Negligence

Medical negligence is simply defined as “the improper or unskilled treatment of a patient by a

medical practitioner such as a nurse, surgeon, pharmacist, or any other medical practitioner.”
Medical negligence forwards to medical malpractice where the victim suffers some kind of
injury from the treatment provided by the doctor or any other medical professional. The most
common categories of medical negligence are wrong diagnosis, delay in diagnosis, error in
surgery, unnecessary surgery, errors in administration of anesthesia, etc.

The commissioning of mistakes in this profession can bring about minor injuries or result to
serious injuries and the result of these mistakes can lead to death. Nobody is perfect in this
world; even the most skilled person can commit mistakes. “To err is human but to replicate the
same mistake due to one’s carelessness is negligence.”

The negligence generally involves a medical error. This could occur during diagnosis of a
patient, medicine dosage, treatment of patient, or aftercare. Medical malpractice law is made a
reality possible for patients to recover compensation from any harm that results from treatment
that is not of proper standard. The most essential reason for medical negligence is that the
remissness of the specialists or clinical experts is frequently found out in different situations
where sensitive consideration isn't taken during the conclusion, during activities, while infusing
sedation, and so on.

Example: After a patient has undergone a major operation, he is quite prone to infections and
diseases because of certain reasons such as blood loss, weakness, greater dosage of medicines
etc. The standard of care is that the doctor must provide the patient with some premedication to
prevent and avoid certain infectious diseases. If a doctor fails to do it and it results in an infection
on the patient or death of patient, then it is said that the doctor has committed medical
negligence.
ESSENTIALS OF MEDICAL NEGLIGENCE

The term ‘Medical negligence’ consists of two parts – “medical” and “negligence”. Negligence
occurs only because of the failure to avail reasonable care. Medical negligence is the same. In the
case of medical negligence, the defendant is the doctor or medical practitioner.

To prove negligent action, the following essentials are required:

 The defendant was under an obligation to provide duty of care to the plaintiff.
 A breach of duty was committed by the defendant.
 As a result of such breach of duty, the plaintiff suffered injury/damage.

A doctor is bound to certain duties of care for his patients. His duties are as follows:

 It is his duty to decide whether he wants to take up the case or not,

 It is his duty to decide which appropriate treatment needs to be given;
 It is his duty to decide the direction in which the treatment has to start.

If a doctor fails to abide by the duties (as shown above), it leads to breach of duty and the patient
the ‘right of action’. If a doctor does not perform the degree of care like a reasonable doctor, then
it is said that the doctor has committed breach of duty.

In the case of Kusum Sharma v. Batra Hospital1, the Supreme Court held that a doctor
sometimes decides to take up a procedure which involves a greater risk, but also believes that in
doing so, he can increase the success rate of the surgery. If a doctor adopts such a high risk
procedure to recover the patient of their suffering and it does not the result in a desired
conclusion, it cannot amount to medical negligence.

In the case of Jasbir Kaur v. State of Punjab2, a newborn child was found missing from their
bed in a hospital. The newborn was later found bleeding in a bathroom. The hospital authorities
argued that the child was abducted by a cat which caused the damage to the newborn. The court
in its judgment held that it is a result of negligence on the part of the hospital authorities as they

1
2010
2
1995 ACJ 1048
did not take reasonable amount of care and precaution. The victim was awarded Rs. 1 lakh as
compensation.

DIFFERENT FORMS OF MEDICAL NEGLIGENCE

Medical negligence can occur in many different ways. Usually, it happens when a medical
professional strays from the required standard of care.

Therefore, it can be said that that any kind of straying from the acceptable standards of
medication and care is considered to be medical negligence and if such straying causes injury to
a patient then the doctor who operated on him, other staff and/or hospital may be held liable for
such negligence.

Some common forms of medical negligence are as follows:

Incorrect diagnosis – When a person visits a clinic or hospital, the first step is to diagnose the
problem. Identifying the symptoms is very critical and crucial to provide medical care to any
patient. But, if that patient is not given proper treatment due to an incorrect diagnosis, then the
doctor can be held liable for the injuries/damages caused as a result of the incorrect diagnosis.

Delayed diagnosis – Delay in diagnosis is also considered as negligence if some other doctor
could have adequately diagnosed the condition of the patient in a timely manner. Delayed
diagnosis can cause unwanted injuries to the patient if such injury or illness is left to aggravate
over time instead of giving treatment to it. It is natural that any delay in identification of the
injury or symptom of the patient can drastly reduce the chances of recovery.

Surgical Errors – All surgeries require a great amount of skill and it should be done with due
care & caution as even the minor of mistakes can have extreme effects on the patient. Opening
the patient from the wrong point, injuries of an internal organ, failure to identify & stop internal
bleeding, or a foreign object left in the body, all this come under surgical errors.

Unwanted surgery – Unnecessary surgery is usually associated with the misdiagnosis of patient
symptoms or a medical decision without proper consideration of other options or risks.
Alternatively, sometimes surgery is chosen over conventional treatments for their expediency
and ease compared to other alternatives.
Errors in inducing anesthesia – Anesthesia is a perilous part of any surgery and requires an
anesthesiologist to induce it in the patient and monitor the effects. Before any surgery or
procedure, this person has to review patient's medical history to ascertain if any medicines are
required to be provided before the surgery. Negligence occurs during the pre-surgery review or
during the procedure/surgery of the patient.

Negligence during childbirth and labor – Childbirth is a strenous event for a woman and it can
sometimes becomes difficult if not given proper care and attention by the doctors and nurses
present. There are various situations of medical negligence in the case of childbirths such as
bungling a difficult birth, labour complications, wrongly diagnosing the medical condition of a
newborn etc.

Long-Term negligent treatment – Medical negligence can also occur in elusive ways during
the course of a long treatment. Such negligence usually happens when there is a failure on behalf
of the doctor to follow-up with the treatment, or the failure of a doctor to keep track of the effects
of the treatment timely.

Clinical Negligence – The Bolam Test

Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 is a case that lays down
the typical rule for assessing the appropriate standard of reasonable care in negligence cases
involving skilled professionals (e.g. doctors): the Bolam test. Where the defendant has
represented him or herself as having more than average skills and abilities, this test expects
standards which must be in accordance with a responsible body of opinion, even if others differ
in opinion. In other words, the Bolam test states that “If a doctor reaches the standard of a
responsible body of medical opinion, he is not negligent”.

Mr Bolam was a voluntary patient at mental health institution run by the Friern Hospital
Management Committee. He agreed to undergo electro-convulsive therapy. He was not given
any muscle relaxant, and his body was not restrained during the procedure. He flailed about
violently before the procedure was stopped, and he suffered some serious injuries, including
fractures of the acetabula. He sued the Committee for compensation. He argued they were
negligent for (1) not issuing relaxants (2) not restraining him (3) not warning him about the risks
involved.
McNair J at the first instance noted that expert witnesses had confirmed, much medical opinion
was opposed to the use of relaxant drugs, and that manual restraints could sometimes increase
the risk of fracture. Moreover, it was the common practice of the profession to not warn patients
of the risk of treatment (when it is small) unless they are asked. He held that what was common
practice in a particular profession was highly relevant to the standard of care required. A person
falls below the appropriate standard, and is negligent, if he fails to do what a reasonable person
would in the circumstances. But when a person professes to have professional skills, as doctors
do, the standard of care must be higher. “It is just a question of expression,” said McNair J.

In this case, the verdict was in favour of the defendant hospital. Given the general medical
opinions about what was acceptable electro-shock practice, they had not been negligent in the
way they carried out the treatment.

BOLAM’s rule has been adopted by the Supreme Court in the case of Jacob Mathew vs. State
of Punjab 2005, as the benchmark to assess the Medical Negligence. In case of Bolam Vs.
Friern Hospital Management Committee (1957), the house of lords formulated the Bolam’s
rule as: “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 men skilled in that particular art. Putting it
another way round, a doctor is not negligent if he is acting in accordance with such a practice,
merely because there is a body of opinion that takes a contrary view.”

Bolam test is one of the fourfold stage in determining the medical negligence. There are other 3
essentials which need to proven by the plaintiff to constitute an offence of medical negligence.

1. The doctor owed a duty of care to the patient

2. Breach in performance duty of care
3. Injury or harm caused due to breach of duty and resulted in significant damages

Liability of doctors for Medical Negligence – Civil Liability under law of Tort

A tort is a residuary civil wrong. Duties in tort are fixed by the law and such duties are owed in
rem or to the people at large generally. Such wrongs can be remedied by filing for unliquidated
damages. There may also be cases where concurrent liability may exist under tort and contract.
For instance, if there is a contract existing between a patient and a doctor, then the doctor, for his
negligence, will be liable under contract.

A contract may have express or implied terms. There are situations where there is a contract
between medical practitioners and patients. Even in the absence of an express stipulation to the
effect that the practitioner will exercise reasonable skill and care in treatment of a patient, it is
taken as an implied duty arising out of the contract. Breach of this duty thus results in violation
of the contract.

In King v. Phillips, it was observed that the question of negligence arises only when there is a
direct harm to the plaintiff by the misconduct and the harm should be foreseeable. Damage is an
important ingredient to bring negligence under tort.

In the case of Dr. Laxman Balkrishna Joshi vs. Dr. Trimbark Babu Godbole and Anr., AIR
1969 SC 128 and A.S.Mittal v. State of U.P., AIR 1989 SC 1570, it was laid down that when a
doctor is consulted by a patient, the doctor owes to his patient certain duties which are: (a) duty
of care in deciding whether to undertake the case, (b) duty of care in deciding what treatment to
give, and (c) duty of care in the administration of that treatment. A breach of any of the above
duties may give a cause of action for negligence and the patient may on that basis recover
damages from his doctor. In the aforementioned case, the apex court interalia observed that
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, willful or reckless negligence,
or negligence per se.

Liability of doctors for Medical Negligence under Consumer Protection Act, 2019

Ever since professions have been included under the purview of consumer protection laws;
medical practitioners too have felt the heat. It is on a footing different from any other kind of
negligence.

Under consumer protection laws, medical negligence is another form of deficiency in service. It
is most akin to the liability under the law of torts. But there is stricter and broader liability in this
situation as failure to exercise skill and care as is ordinarily expected of a medical practitioner is
the test under consumer protection laws.

Admittedly, doctors have an extremely difficult duty to perform. They are the ones in whose
hands a patient places what is most valuable to each human – their lives. It is for this reason that
doctors are expected to exercise a very high degree of skill and care, but this is also the precise
reason why they should not be inhibited in the exercise of their duty. Therefore the laws
imposing liability on medical practitioners have been tailored to accord to practitioners
maximum possible protection.

Consumer protection act intends to better protect the interest by providing easy dispute
resolution tribunals at district and nationals levels. It promotes and protects the rights of the
consumers by providing provisions for establishment Consumer Councils for settlement of
consumer disputes. Sec 14 (1) (d) of the Act provides for the compensation to the consumer who
has suffered any loss or injury due to negligent behaviour of the opposite party. This section
includes medical practitioner, doctors and hospitals in its ambit.

Indian Medical Association Vs. P.V. Shantha & ors. is one of the landmark cases where
Supreme Court brought the medical profession within the ambit of Consumer Protection Act.
Court declared that the services rendered by medical professional shall now be treated as
“service” under Sec 2(1)(o) of the Consumer Protection Act and it will be a “contract for
service” unlike “contract of service” which constitutes Master-servant relationship. This defined
the relationship between a doctor and patient as a contractual one. Patient if suffered any injury
in due course of treatment can now sue doctors for compensation in consumer protection courts.

Liability of doctors for Medical Negligence – Criminal Liability under IPC

Negligence as a crime has a different yardstick. Negligence under tort is determined on the
extent of the loss caused whereas negligence under criminal law is dependent on the degree or
amount of negligence. Courts have repeatedly held that the burden of proving criminal
negligence rests heavily on the person claiming it. Criminal law requires a guilty mind. If there is
a guilty mind, a practitioner will be liable in any case.
But if, under the criminal law, rashness and recklessness amount to crime, then also a very high
degree of rashness would be required to prove charges of criminal negligence against a medical
practitioner. In other words, the element of criminality is introduced not only by a guilty mind,
but by the practitioner having run the risk of doing something with recklessness and indifference
to the consequences. It should be added that this negligence or rashness or must be ‘gross’ in
nature.

In order to attract criminal liability, the degree of negligence has to be higher in comparison to
degree of negligence enough to fasten liability under civil laws. Mens rea is one of the requisite
ingredients in criminal law. It is important to prove the guilty mind or an evil intention to hold a
person liable. In case of medical negligence of a doctor, whether slight or gross, it is difficult to
prove the guilty mind and intentionally negligent behaviour of a doctor.

Sec 304-A of Indian Penal Code, 1860 states that “whoever causes the death of any person by
doing any rash or negligent act not amounting to culpable homicide shall be punished with
imprisonment for a term which may extend to two years, or with a fine or with both.”

Sec 80 of IPC (accident in doing a lawful act) – Nothing is an offense which is done by
accident or misfortune, and without any criminal intention or knowledge in the doing of a lawful
act in a lawful manner by lawful means and with proper care and caution.

Sec 88 of IPC (act not unintended to cause death, done by consent in good faith for
person’s benefit) – A person cannot be held accused of an offense if she/ he discharges an act in
good faith for the other’s benefit, does not intend to cause harm even if there is a danger, and the
patient has explicitly or implicitly given consent to suffer or take the risk of that harm.

In Dr. Suresh Gupta case3, Supreme Court held that the legal position was quite clear and well
settled that whenever a patient died due to medical negligence, the doctor was held liable under
civil law for paying the compensation. Negligence has to be a ‘gross negligence’ or
‘recklessness’ for fixing a criminal liability on a doctor. Where a patient’s death occurs merely
from error of judgement or an accident no criminal liability should be attached to it. The moral
culpability of recklessness is not located in a desire to cause harm. It resides in the proximity of
the reckless state of mind to the state of mind present when there is an intention to cause harm. In
3
Dr. Suresh Gupta vs Govt. of N.C.T. of Delhi, 2004 6 SCC 422
Bolam’s cases doctors or the hospital did not want to do something wrong intentionally. At no
point of time they had guilty mind. In Jacob Mathew case neither the doctor nor the hospital
staff intentionally connected empty cylinder. For civil liability, only damages can be imposed by
the Court but for criminal liability the Doctor can also be sent to jail (apart from damages).
However, what is simple negligence and what is gross negligence may be a matter of controversy
even among experts.

The Importance of obtaining Informed Consent

In the case of Samira Kohli vs. Dr. Prabha Manchanda and Ors. I (2008) CPJ 56 (SC), the
apex court held that consent given for diagnostic and operative laparoscopy and “laporotomy if
needed” does not amount to consent for a total hysterectomy with bilateral salpingo
opherectomy. The appellant was neither a minor nor mentally challenged or incapacitated. As the
patient was a competent adult, there was no question of someone else giving consent on her
behalf. The appellant was temporarily unconscious under anesthesia, and as there was no
emergency. The respondent should have waited until the appellant regained consciousness and
gave proper consent. The question of taking the patient's mother's consent does not arise in the
absence of emergency. Consent given by her mother is not a valid or real consent. The question
was not about the correctness of the decision to remove reproductive organs but failure to obtain
consent for removal of the reproductive organs as performance of surgery without taking consent
amounts to an unauthorized invasion and interference with the appellant's body. The respondent
was denied the entire fee charged for the surgery and was directed to pay Rs. 25000/- as
compensation for the unauthorized surgery.

MCI Act and regulations on negligence in clinical practice

The Indian Medical Council Act, 1956 provides for the constitution of the Medical Council of
India (MCI). The MCI regulates standards of medical education, permission to start colleges,
courses or increase the number of seats, registration of doctors, standards of professional conduct
of medical practitioners.

In the year 2020, the National Medical Commission (NMC) replaced the Medical Council of
India (MCI) as the new regulator for medical education and medical professionals in the country.
The main functions of the Medical Council of India are as follows:

 Establishment and maintenance of uniform standards for undergraduate medical

education.
 Regulation of postgraduate medical education in medical colleges accredited by it. (The
National Board of Examinations is another statutory body for postgraduate medical
education in India).
 Recognition of medical qualifications granted by University or UGC in medical
institutions in India.
 Recognition of foreign medical qualifications in India.
 Accreditation of medical colleges.
 Registration of doctors with recognized medical qualifications. The state medical
councils maintains the register of doctors registered in each state which is then forward to
the Medical council each quarter for updation in the national register. However, Foreign
medical graduates have the option to directly register at the MCI.
 Keeping a directory of all registered doctors (called the Indian Medical Register).
 Making necessary amendments in the regulation related to medical education and
practices.

If there is any professional misconduct by any medical practitioner then the MCI reserves the
right to punish any medical practitioner as it may deem fit and in the rarest of the rarest
circumstances, the MCI suspends the license of the medical practitioner.

The State Medical Councils conduct inquiries and investigate the case with the help of a panel of
expert doctors. The order of the State Medical Councils can be appealed in the MCI by the
patient or the doctors. The punishment awarded by the MCI ranges from warning the doctor who
is found guilty to removing the name of the doctor from the Indian Medical Register/ State
Medical Register for a specified period. The MCI order can also be appealed in a court of law by
the aggrieved party.

MCI drafted the The Medical Code of Ethics, 2002 ("the Code") to govern medical practitioners.
By using the term ‘ethics', it appeals to a moral principle. However, all aspects of the MCI
constitute a legal system under the authority of the Parliamentary law (the Medical Council of
India Act, 1956). An analysis of a few provisions of the Code shows that while the MCI seems to
claim moral authority: it drafts standards in the moral style. Even if it had systems and
procedures in place to enforce these standards; the language of the standards would prevent them
from being enforced in a legal system.

The code does not specify how MCI will identify and enforce against non-compliance. Neither
through legal instruments associated with the MCI, nor through any other enactments, is there an
enforcement apparatus which involves issues such as accepting complaints, carrying out
inspections, requiring the submission of operational data, etc. Section 1.3.4 of the code reads:
Efforts shall be made to computerize (sic) medical records for quick retrieval. This is an
exhortation and cannot be enforced.

Role of Quality Council of India in maintaining quality of hospitals and diagnostic centre

Quality Council of India is a non-profit autonomous society, under the Department of Promotion
of Industry and Internal Trade (DPIIT), with the mandate to establish an accreditation structure
in the country and to spread quality movement in India by undertaking a National Quality
Campaign. The Mission of QCI is to lead nationwide quality movement in India by involving all
stakeholders for emphasis on adherence to quality standards in all spheres of activities primarily
for promoting and protecting interests of the nation and its citizens.

QCI’s role is to establish and operate a national accreditation structure and to promote quality
through the National Quality Campaign. It functions through its own resources and through fees
from accreditations and investments in quality promotion. It plays the role of the National
Accreditation Body (NAB) as per the eco-system of quality around the world with the task of
creating a mechanism for third-party assessment of products, services and processes.

Role of Quality in Healthcare

The quality in healthcare system implies that the patients receive high level of care, have access
to a qualified and competent medical staff and to a quality-focused organization, receive
understandable education and communication and that their feedback (satisfaction) is evaluated
continuously. It also benefits patient through appropriate healthcare decisions and
standardization of healthcare processes, focus on patient safety, vulnerable patient, safe
transport, and continuity of care, which is paramount.

Role of the Quality System in a Healthcare Facility

The primary role of any quality system is to provide effective means to assuring that the
customer (patient) requirements are met fully.(1) Some of the key elements/components of
quality that accomplish the patient requirements are patient's safety, staff behavior toward the
patients, correct and timely treatment, compliance to treatment protocols, seeking patient
feedback, and adequate response to it, complete record keeping, acceptable quality care at
affordable prices, clear communication to the patients with respect to the services, best practices
for fixing appointment and service delivery, reliable diagnostic and laboratory support, reliable
support services like canteen, ambulance, pharmacy, etc. safe and pleasant environment,
technical competence, courtesy, and attitude of staff.

The establishment of a quality system in a healthcare organization facilitates the standardization

of the systems and processes (both clinical and administrative). This standardization further
ensures improving the performance of the hospital with respect to above-stated key
elements/components of quality. The quality system thus acts as a vehicle for healthcare
organizations to focus on patient and provider needs and expectations.

Effective implementation of the QMS will address the major quality issues such as the staff
deficit; implementation of the health management information system, interpersonal
communication, and other important unaddressed areas such as regular patient feedback and its
evaluation, standardization of care processes, patient safety, safe transport, and continuity of care
and will thus facilitate improvement in public sector hospital as envisaged under NRHM. Once
the hospital is certified, it is important that it focuses on maintaining the quality and that the
hospital staff is continuously motivated for continual and ongoing quality enhancement to higher
levels of quality of healthcare.
ICMR Guidelines on bio medical waste management

According to Biomedical Waste Management and Handling Rules, 1998: “Any waste which is
generated during the diagnosis, treatment or immunization of human beings or animals or in
research activities pertaining thereto or in the production or testing of biological.” The
Government of India specifies that Hospital Waste Management is a part of hospital hygiene and
maintenance activities.

Major Sources of Biomedical Waste

 Govt. hospitals/private hospitals/nursing homes/dispensaries

 Primary health centres
 Medical colleges and research centres/ paramedic services
 Veterinary colleges and animal research centres
 Blood banks/mortuaries/autopsy centres
 Biotechnology institutions
 Production units.

Minor Sources of Biomedical Waste

 Physicians/dentists' clinics
 Animal houses/slaughter houses
 Blood donation camps
 Vaccination centres
 Acupuncturists/psychiatric clinics/cosmetic piercing
 Funeral services
 Institutions for disabled person

Need of biomedical waste management in hospitals

The reasons due to which there is great need of management of hospitals waste such as:

1. Injuries from sharps leading to infection to all categories of hospital personnel and waste
handler.
 2. Hospital acquired infections in patients from poor infection control practices and poor
waste management.
3. Risk of infection outside hospital for waste handlers and scavengers and at time general
public living in the vicinity of hospitals.
4. Risk associated with hazardous chemicals, drugs to persons handling wastes at all levels.
5. “Disposable” being repacked and sold by unscrupulous elements without even being
washed.
6. Drugs which have been disposed of, being repacked and sold off to unsuspecting buyers.
7. Risk of air, water and soil pollution directly due to waste, or due to defective incineration
emissions and ash.

Benefits of Biomedical Waste Management

 Cleaner and healthier surroundings.

 Reduction in the incidence of hospital acquired and general infections.
 Reduction in the cost of infection control within the hospital.
 Reduction in the possibility of disease and death due to reuse and repackaging of
infectious disposables.
 Low incidence of community and occupational health hazards.
 Reduction in the cost of waste management and generation of revenue through
appropriate treatment and disposal of waste.
 Improved image of the healthcare establishment and increase the quality of life.

Incineration Technology – This is a high temperature thermal process employing combustion of

the waste under controlled condition for converting them to into inert material and gases.
Incinerators can be oil fired or electrically powered or a combination thereof. Broadly, three
types of incinerators are used for hospital waste: multiple hearth type, rotary kiln and controlled
air types. All the types can have primary and secondary combustion chambers to ensure optimal
combustion. These are refractory lined.

Non-Incineration Technology – Non-incineration treatment includes four basic processes:

thermal, chemical, irradiative, and biological. The majority of non-incineration technologies
employ the thermal and chemical processes.
Autoclaving – The autoclave operates on the principle of the standard pressure cooker. The
process involves using steam at high temperatures. The steam generated at high temperatures
penetrates waste material and kills all the microorganisms.

Microwave Irradiation – The microwave is based on the principle of generation of high

frequency waves. These waves cause the particles within the waste material to vibrate,
generating heat. This heat generated from within kills all pathogens.

Plasma Pyrolysis – It is a state-of-the-art technology for safe disposal of medical waste. It is an

environment friendly technology, which converts organic waste into commercially useful
byproducts. The intense heat generated enables it to dispose all types of waste including
municipal solid waste, biomedical waste and hazardous waste in a safe and reliable manner.

MODULE 4: WOMEN HEALTHCARE

Technological Developments in Women Healthcare

Maternal Health and Newborn Development

Although maternal mortality rates in India have declined substantially in the last decade, the
number of recorded deaths related to pregnancy complications in the country is still remarkably
high. A report by UNICEF estimates that 44,000 women die due to preventable pregnancy-
complications in India yearly. These complications often stem from a lack of knowledge and
inherently the inability to understand that their baby isn’t developing correctly. This lack of
knowledge results in fewer women seeking treatment that could save their lives. To combat this,
organizations are developing innovative mobile apps to help women stay proactive and educated
about the health of their babies and the status of their pregnancies.

For example, in 2014, MAMA (Mobile Alliance for Maternal Action), an organization dedicated
to women’s maternal health in developing countries, developed a digital service called mMitra.
The service sends recordings and SMS messages to new and expectant mothers with crucial
information about the early stages of pregnancy and child development within the first year of
life. The app, which collected 50,000 subscribers within months of its launch, sends educational
content to women in their native languages and at times of their choosing. The app, mMitra
ultimately aims to help women pick up on pregnancy and child development issues early and
seek treatment before symptoms escalate or endanger the mother and child.

Breast Exams and Preventative Care

Mammograms are an essential part of preventative care for women globally. Despite this, it is
estimated that over 90 percent of women in the developing world go without this essential
screening examination. Particularly, in India, high-costs, unsustainable electricity and lack of
properly trained radiologists are major causes for the inaccessibility to mammograms and other
procedures like it. More women die of breast cancer in the country than anywhere else in the
world (around 70,000 women annually). While these high death rates due to inaccessibility to
preventive care are tragic, they’ve inspired innovative medical devices that have revolutionized
women’s health in India.

One such device, known as iBreastExam was invented by computer engineer Mihir Shah. Shah
invented the device to ensure that women in even the most rural parts of India could get
affordable, accurate breast exams and seek treatments as needed. The battery-operated wireless
machine is designed to record variations in breast elasticity and performs full examinations in
five minutes, posting and recording results through a mobile app. The exams are painless,
radiation-free and are extremely affordable.

Family Planning and Contraceptive Options

Lack of family planning and knowledge of contraceptive options is another challenge in

improving women’s health in India. Many Indian women shy away from modern family
planning and contraception due to things like familial expectations, cultural influence and a
general fear stemming from misinformation from disreputable resources. Family planning and
the use of contraception could reduce India’s high maternal mortality rates. However, without
proper education on these matters, it is difficult for young Indian women to make informed
decisions about what options are best for them. But, in the midst of India’s technological
revolution, an increase in accessibility to mobile devices is steadily transforming the way women
are gaining health awareness in India.
There is a particular mobile app that is playing a huge role in improving women’s health
awareness in India. Known as Gyan Jyoti, the mobile app provides credible information through
educational films, TV advertisements and expert testimonials from doctors. It also acts as a
counseling tool for ASHAS (appointed health counselors). The app allows ASHAS to expand
their knowledge of family planning through an e-learning feature, customize their counseling
plan according to the needs of clients and monitor and store client activity in order to provide the
best information possible.

The Embrace Neonatal MRI is among the first MRIs (approved by the FDA) made specifically
for the brain and head imaging of neonates. This technology is used on neonates with a head
circumference up to 38cm, weighing between 1 and 4.5 kg. This neonatal MRI device comes
equipped with a temperature-controlled incubator, built into this system. Among its advantages is
that this incubator prevents any excess infant movement. In case of an emergency, the new-born
can be taken out within 30 seconds. Another major plus is that the Embrace Neonatal MRI is
used in a NICU and not within a radiofrequency shielded room, typically a requirement for a
regular MRI.Of course, as with everything, the Embrace Neonatal MRI does have limitations.
This system should not be used on neonates weighing over 4.5 kg or with a head circumference
more than 38cm. It also should not be used on infants with metallic or electronically active
implants. The MRI is likely to cause tissue near the implant to heat up or malfunction.

Remote Monitoring and Telemedicine

Remote monitoring has the potential to remodel prenatal care by enabling more frequent contact
with less inconvenience. Beyond home monitoring, telemedicine has been integrated into the
care of the pregnant patient.

Electronic fetal monitoring—surveillance of a fetus's heart rate with the goal of decreasing
cerebral palsy, neonatal seizures, or intrapartum fetal death—can also be done remotely. Ochsner
Health has implemented a system called TeleStork through which live, beat-to-beat monitoring is
centralized, and heart tracings from laboring patients across the system are monitored. If the
TeleStork monitors, usually trained registered nurses, note an abnormal fetal heart tracing, the
physicians in-house are notified to ensure timely intervention. Although electronic fetal
monitoring is subjective and open to interpretation and therefore difficult to standardize, it is still
the most commonly used method of intrapartum surveillance during labor.

Overall, while there are still many challenges in improving women’s health in India, the country
has proven itself to be a pioneer in technological innovation. Just as well, it’s proven that
transformation is possible by putting its innovations towards women’s health awareness through
mobile apps, life-saving hand-held devices, and educational platforms that can be accessed at the
click of a button.

Surrogate Motherhood, Historical Background, Contractual Aspect and Enforceability

Surrogacy

Surrogate motherhood is a practice in which a woman (the surrogate mother) bears a child for a
couple unable to produce children in the usual way, usually because the wife is infertile or
otherwise unable to undergo pregnancy.

The practice of surrogate motherhood, though not unknown in previous times, came to
international attention in the mid-1970s when a reduction in the number of children available for
adoption and the increasing specialization of techniques in human embryology made such
methods a viable alternative to lengthy and uncertain adoption procedures or childlessness.
Surrogate motherhood has raised a number of issues—such as the matter of payment for services
(which, taken to the extreme, has implications of making children a commodity) and the rights of
all of the individuals involved should any aspect of the procedure go awry.

The positive aspect of the surrogacy process brings happiness to the couples who are infertile but
contrary to this the negative aspects is the cause of many legal, social ethical and moral issues in
society of the country like India. Further our union cabinet has approved a draft bill to regulate
and formulate the process of surrogacy to commission in the country.

There are two kinds of surrogate mothers:

 Traditional surrogate: It’s a woman who gets artificially inseminated with the father's
sperm. They then carry the baby and deliver it for you and your partner to raise. A
 traditional surrogate is the baby's biological mother. That's because it was their egg that
was fertilized by the father's sperm. Donor sperm can also be used.
 Gestational surrogates: A technique called “in vitro fertilization” (IVF) now makes it
possible to gather eggs from the mother, fertilize them with sperm from the father, and
place the embryo into the uterus of a gestational surrogate. The surrogate then carries the
baby until birth. They don't have any genetic ties to the child because it wasn't their egg
that was used. A gestational surrogate is called the “birth mother.” The biological mother,
though, is still the woman whose egg was fertilized.

There are two types of Surrogacy:

 Commercial Surrogacy – In this type of surrogacy the surrogate mother remunerated

and above all the required medical expenses during the course of the surrogacy.
 Altruistic Surrogacy– In this particular type of surrogacy the surrogate mother does not
receive any type of financial remuneration for her pregnancy except the essential
requirement for her medical expenses.

History of Surrogacy in India

According to the Hindu mythology it also offers instances of surrogacy shows the secrecy due to
which practise of surrogacy still surround us. In Bhagavata Purana, Vishnu ji heard Vasude’s
prayers begging Kansa not to kill all sons being born. Vishnu heard these prayers and had an
embryo from Devika’s womb transferred to the womb of Rohini, the other wife of the vasudev.
Rohini the give birth to the baby Balaram, brother of Krishna and secretly raised the child while
Vasudev and Devki told Kansa that the child was born dead.

The History of surrogacy also belonged to the Mahabharata, as in Mahabharata Gandhari

delivered a semi solid material on the place of delivering a child, Mahairishi Vyas further
divided that semi solid material into 100 pieces and planted them in different pans. Thus the 100
Kauravas were born.

India’s First IVF baby and world second baby Kanupriya was born 67 days later on 3rd of
October 1978.The baby Kanupriya is the result of the efforts made by Dr. Subhas Mukherjee and
hid two mates in Kolkata. The Birth of this first IVF Indian baby was a part of tremendous
controversy.

Commercialisation of surrogacy arrangement in India

The commerce of a child is a thing that can be hard to imagine as the child is symbol of the love
not of the money and having a child is a perception away from the concept of marketing
activities. But surrogacy has become a part of the commercial business in a country like India.
This commercialisation of surrogacy has now become a political debate for the Indian society.
The market of surrogacy is now becoming very large and growing very rapidly. There are “N”
numbers potential parents in a country like India desire to hire other women to bear their child.

The concept of surrogacy has revolved around an ordinary biotic function of the body of a
woman into a commercial contract and hence the surrogate services are now even publicized.
Surrogates are being enlisted and the operating agencies make huge profits from them. The
commercialization of surrogacy is nothing but the giving rise to the new problem of selling child
and setting up breeding farms which may turn women into baby producers.

The management of the surrogacy process in India is termed as baby booming business by many
experts. Surrogacy in India is now termed as the commercial contract for a normal biological
function in the women. The reason for the booming industry of surrogacy in India is that the
surrogates women are easily available in a country like India and the entire cost for the process
of surrogacy is much less as compare to the other countries. In India at present the business of
the surrogate motherhood involve approx. $445 billion. The only country in the world which
legalised the happening of commercial surrogacy is India in year 2002. On an average the most
of the surrogate’s mothers in India are paid money in Instalments for the period of 9 months in
the process of surrogacy. In past few years there has been a sudden increase in the cases of
surrogacy, the increment is likely to be more than 150%.

Evolution of surrogacy laws in India

In the year 2002 commercial surrogacy was legalised by the India seeing this immense growth of
surrogacy in India leads to the growth of the many commercial surrogacy firm who claims to
have the forte in the surrogacy law and assisting the foreigners who came India in search of
mother womb as a rent. Such marshalling are considered to be very combustible in nature as it
leads the commercialisation of the baby selling and also harm the dignity and the reputation of
the vouchsafed phenomenon of the women reproductive capabilities.

The 228th report of the Law Commission of India has recommended to prohibit the process of
commercial surrogacy and enacted the suitable legislation which allows performing altruistic
surgery which is ethical.

There were certain guidelines issued by the Indian council of medical research for regulating
surrogacy arrangements they are:

 The surrogate mother would be entitled for the monetary compensation, the value of
which would be decided by the couple and the surrogate mother.
 The surrogate mother cannot donate her own egg for the surrogacy and that she must
relinquish all parental rights related to the surrogate child.

Indian law associated with surrogacy

In the world of the diverse jurisdiction the legal approach to the process of surrogacy differs
from one jurisdiction to another jurisdiction. The international motion to the surrogacy has been
differentiated in three major approaches they are:

 Free Market
 Regulated
 Prohibited (forbid)

Many jurisdiction of the world completely interdict the process of surrogacy as they proclaim
commercial surrogacy to be a criminal offence in their respective jurisdiction on the contrary
some jurisdiction permits process of surrogacy but only to the some extent or we can say that
only on the grounds of altruism (selflessness). In the world only country India neither completely
interdicts the surrogacy nor synchronizes the process of surrogacy, the reason behind this is that
In India the surrogacy is not directly proclaimed unenforceable by the law so it is considered to
be valid and enforceable.
The Assisted Reproductive Technology Bill 2008 was drafted by the Indian council of medical
research to sanction and regularize different form of reproductive technologies including the
process of commercial surrogacy. The law commission of India in its 228th report rationalize
that why there is a need of the surrogacy in India.

According to the provision ART (Assisted Reproductive Technology) Bill 2013 no women of
the age less than 21 years and more than 35 years can act as the surrogate mother. This bill leads
to put condition on the foreign couples who are taking womb at rent which was first time by this
ART bill 2013. The compensation for the surrogacy as per the guidelines by the ART bill 2013
draft will be the private negotiation between the surrogate mother and the commissioning
couples. The ART bill 2013 leads to disqualify homosexual couples, foreign single individuals
and the couple in live in relationship from having the child through the surrogate mother in India.

Contractual Aspects

American Law Reports defines surrogacy as a contract in the following lines:

“..a contractual undertaking whereby the natural or surrogate mother, for a fee, agrees to
conceive a child through artificial insemination with sperm of the natural father, to bear and
deliver the child to the natural father, and to terminate all of her parental rights subsequent to the
child’s birth.”

In India, surrogacy transactions are very rampant and foreigners come to India in search of a
surrogate and a surrogate child. As such, it is being considered as the hub of surrogacy in the
world. It is also being considered as a suitable place for the surrogacy industry which is regarded
as the genetic pool banks of India.

Primarily, in case of a surrogacy transaction, difficulty lies in recognizing its exact nature. Some
view it as an industry, some as a service or as a contract for certain purposes. Absence of
uniform regulations but presence of certain regulations which may prohibit such a transaction
adds more complications to the surrogacy transaction. The centre of a surrogacy transaction is
the involvement of a third party. Such a transaction or relationship arising out of it or legitimacy
of the child born out of it is foreign to legal systems across the world. Most of the countries
across the world either deem it partially or completely illegal or make it valid to the extent of
altruistic surrogacy. In some countries, intended parents are recognized as the legal parents of the
child born out of it either statutorily or by recognizing surrogacy agreements.

Legally, a surrogacy arrangement has been defined by the Indian Supreme Court as an agreement
whereby a woman agrees to become pregnant for the purpose of gestating and giving birth to a
child she will not raise, but hand over to a contracted party. Often it is done with intention of
entering into a contract, or sometimes it can be inferred from the very transaction, that it’s an
agreement between the two different parties.

As per the provisions of Indian Contract Act, 1872 legal contracts can be of following types:

1. General contract
2. Special Contracts
3. Specific contracts

Thus, contracts can be classified into different heads depending upon the subject matter or
purpose of the contract. With respect to surrogacy, it is difficult to decide under which type or
under which head it falls. If surrogacy transactions were to be considered legal, then it must fall
in the category of either specific or special contract. However, for them to be legal, it must
satisfy all the requirements of contract law as given under the Indian Contract Act, 1872.

Apart from the contractual point of view, surrogacy can be treated as a statutory transaction also.
However, this requires a particular statute which can govern the statute. In such a scenario, the
question of legality of a surrogacy contract may not arise, as it would then be backed by statute
governing the surrogacy relationship.

In the context of the Indian Contracts Act, 1872, even though surrogacy arrangement fulfills the
preliminary requirements of an agreement, the same may not be converted into a contract since it
may not be an agreement enforceable by law. Hence, it is very difficult to term a surrogacy
agreement as a surrogacy contract, which raises doubts with respect to the enforceability of the
claims, obligations and liabilities of the concerned parties. Since a contract/agreement made by
the parties cannot violate the law of the land, it is necessary that surrogacy be given recognition
and governed by a special statute to protect the parties concerned.
Surrogacy (Regulation) Act, 2020

The Bill forbids commercial surrogacy but permits altruistic surrogacy. Altruistic surrogacy does
not mean any financial benefits to the surrogate mother except the medical costs and insurance
coverage during pregnancy. Commercial surrogacy involves surrogacy or its associated methods
for just a financial gain or incentive beyond the standard medical expenditures and insurance
covers.

Surrogacy is allowed only when the intended couples are suffering from confirmed fertility
issues. It has to be altruistic and not for commercial purposes. It should not be for the
development of children for trafficking, pornography, or other types of exploitation and for any
disorder or disease as defined in legislation. The intending couple will have the ‘certificate of
essentiality’ and the ‘certificate of eligibility’ provided by the relevant authority.

A Certificate of Essentiality shall be given upon fulfilment of the following terms which includes
a certificate of confirmed infertility from a District Medical Board of either or both members of
the intending couple, a declaration of parentage and custody of the surrogate child approved by a
Magistrate’s court and the insurance policy for just a duration of 16 months regulating
postpartum delivery issues of the surrogate.

The eligibility certificate for the intending couple shall be given after compliance with the
following conditions that also include the couple being Indian citizens and married for at least
five years. The age of the wife should be between the ages of 23 and 50 and that of husband
should be between the ages of 26 and 55.

If they have no living child including biological, adopted, or surrogate and that does not include
a child who is mentally or physically disabled or suffers from a life-threatening disability or
deadly disease as well as other circumstances that may be defined in the guidelines.

To get an approval certificate from the relevant authority, the surrogate mother must be a close
relative of the intending couple. The woman should have her own child and must be between the
ages of 25 and 35. The surrogate is only allowed to go through the same process once in her life.
She needs to have a medical and psychological suitability certificate for surrogacy. Furthermore,
the surrogate mother cannot have her own surrogacy gametes.
Within 90 days of the bill becoming an Act, central and state governments shall designate one or
more competent authorities. The relevant authority’s duties include the authorisation, suspension,
or cancellation of surrogacy clinics. The authority must implement requirements for clinics
offering surrogacy. They will examine and take measures against violations of the Bill’s
provisions and propose amendments to the rules and regulations.

Surrogacy centres must not perform processes relating to surrogacy until they are licensed by the
competent authority. Clinics will apply for recognition within 60 days after the date of the
designation of the appropriate authority.

The central and the state governments shall be composed of the National Surrogacy Board and
the State Surrogacy Board respectively. The NSB’s duties involve informing the central
government on policy issues related to surrogacy, setting out the code of conduct for surrogacy
clinics, and overseeing the operation of SSBs.

A child born from a surrogacy method would be regarded as the expecting couple’s biological
child. A surrogate child abortion involves the surrogate mother’s written permission and
authorization from the relevant authority. This authorization must comply with the Medical
Termination of Pregnancy Act, 1971. Further, before the embryo is placed in her womb, the
surrogate mother would have a choice to refrain from the surrogacy.

The offences under the Bill include commercial surrogacy, abuse of the pregnant mother,
abandonment, trafficking or disownment of a pregnant child, and the selling or importation of
human embryos or gametes for surrogacy. The punishment for these offences is up to 10 years in
jail and up to 10 lakh rupees in fine. The Bill sets out a number of violations and punishments
under the Bill’s rules for certain contraventions.

Assisted Reproductive Technology (Regulation) Bill, 2020

The Assisted Reproductive Technology Bill does not allow commercial surrogacy which
involves exchanging money for something other than paying for the mother and child’s medical
expenses. The bill would exclude these from surrogacy: couples who already have one child,
foreigners or Indian Overseas Citizens (OCI), holders and spouses alike, single citizens,
homosexuals, and widows.
The bill extends such rights to the surrogate mothers because they are not aware of their rights
and contractual responsibilities that are granted to them. The bill suggests that it should be made
compulsory for the couple to accept a child from the surrogate mother regardless of the child’s
abnormality or gender.

The contractual arrangement makes it mandatory for couples to send a certificate stating that a
child born via surrogacy is genetically related to them. The other clause stated in the bill is that
anyone can be a surrogate mother which includes a single parent, widow, divorced, or married
woman.

The law seeks to govern the reproductive technology clinics and doctors involved and their
association with potential surrogates. The law supports the commissioning couple’s rights over
those of surrogate mothers. The bill makes it obvious that there will be no protections for women
involved in commercial surrogacy over the child they have contracted to raise. Its regulations
state that most women aged between 21 and 35 years could be surrogates.

In comparison to three in an earlier version, it puts the maximum number of times a woman will
contract her womb for surrogacy at five live births. But it does not discuss the number of assisted
reproductive cycles that a woman may undergo, which is a significant concern for the health of
women.

There are all sorts of legal documents that cover the rights and interests of the commissioning
couple to cover. In the absence of clear legislation, the surrogate mother has no rights or
interests, and the clauses of the ART Bill are possibly not enough. The ART law tries to strike a
distinction between the lawful and the immoral, but unethical practices remain intact.

Since surrogacy is quite a new procedure in many countries, surrogate mothers’ rights have
evoked many discussions and debates. The bill recognizes surrogacy arrangements and their
enforcement under the rule. The surrogacy arrangements are dealt with several other contracts
under the Indian Contract Act 1872 as well as other laws related to these arrangements. Both the
couple/single parent and the surrogate mother must conclude a surrogacy agreement addressing
all matters which will be legally binding.
Some of the aspects of the proposed bill are that an association should be established at state and
national levels to monitor & control the I.V.F. clinics and A.R.T centres, and a forum must be set
up to lodge a complaint against clinics and ART centres for grievances. The surrogate mother
should have been 21-35 years of age and should not have delivered more than five times
including her child.

For the same pair, surrogate mothers wouldn’t be permitted to undertake embryo transfer more
than 3 times. Unless the surrogate is a married lady it will require her husband’s permission so
that she can serve as a surrogate to avoid legal or marital conflict. A surrogate must be tested for
STD, communicable diseases, and blood transfusion shouldn’t have been received during the last
6 months since these can harm the outcome of pregnancy.

All costs including surrogate medical bill benefits or other fair pregnancy and childbirth-related
expenses must be covered by expected parents. A surrogacy policy would provide the provision
for surrogate mother’s life insurance. The surrogate mother could also obtain financial
compensation from the couple or person, as it may be the case for choosing to serve as such
surrogate.

It is believed that banks will communicate directly with surrogate mothers to save vulnerable
surrogate mothers from abuse, and minimum compensation payable to the surrogate mother
should be set by statute. The surrogacy agreement would also provide financial assistance for the
surrogate child if the commissioning couple dies before the child is born, or divorce between the
intended parents and the resulting willingness of both to take delivery of the child to prevent
injustice.

The surrogate mother will have no parental rights over the infant, and the baby’s birth certificates
must bear the names of intended parents as parents to prevent legal issues. Guidelines are
concerned with the status of the infant born through ART state that the infant is considered to be
the legitimate child of the married / unmarried couple / single parent with all the parentage, care
and inheritance rights of the attendant.

The ART clinics must not be permitted to promote their clients for surrogacy, and couples should
try ART Bank’s facilities directly. Regardless of any abnormality in the child/children, planned
parents would be legally obliged to take custody of the child/children. It must always be kept
private, and both the donor’s right to privacy and the surrogate mother must be covered.

If a foreigner or NRI is pursuing surrogacy, they should enter into an arrangement with their
government’s written assurance of the child’s citizenship, and they should also appoint a local
guardian who will be legally responsible for the care of the surrogate during and after pregnancy
until the child is born to the foreign couple or arrives in their nation. Sex-selective surrogacy
should be banned, and the Medical Termination of Pregnancy Act 1971 would regulate
abortions.

Case laws related to surrogacy in India

In Baby Manji Yamada’s case, in this particular case the Japanese couple entered into a
contract with an Indian woman to be the surrogate mother for their child. After this Baby Manji
Yamada’s was born to the Indian surrogate mother. Further the commissioning father
Mr.Yamada tries to take his child to Japan for which he applies for visa to Japan to which the
embassy of Japan in India denied as the Japan civil code did not grant the surrogate child. After
which Mr. Yamada tried to file for Indian visa which requires a birth certificate an on birth
certificate there is need of the name of the Father and Mother of the child, but in this case Mr.
Yamada was the genetic father of the baby Manji but ambiguity arises in the case of the mother
name as there are three mothers for that child- The commissioning mother,the egg donor and the
surrogate mother ; seeing this authorities refuses to give visa to child Manji as the legal mother
was not certain. In the end the Apex court of India had to be interceding and the child Manji was
allowed to leave the country with her grandmother.

After the case of Manji the Supreme Court of India in 2008 held that surrogacy is permissible in
India due to which it subsequently increase the international confidence in going in for the
surrogacy in India.

The German Couple Case in this case a childless German couple has twins through the
surrogate mother with the help of Anand Infertility Clinic Gujarat. Since the German laws did
not recognise the surrogacy as a means of parenthood, due to this twins are not treated to be the
German citizen so the citizen so the German commissioning parents to avoid the foreseeable
hurdle of the Immigration laws they approach to the High court of the Gujarat for authorizing
their surrogate twin with the Indian Passport, on which Gujarat High Court held that the child
who born through the surrogate mother will carry the name of the surrogate mother but not of the
Biological mother and the child should be authorize with the Indian Passport and certifies him as
the Indian citizen and the surrogate mother in turn had to give the child to the German couples in
adoption.

In a another case the Israel gay couple Yonatan and Omer Gher became parents in India in year
2008 through help of a surrogate mother who belonged from Mumbai in a infertility clinic of the
Bandra. After which both the gay couples have vouchsafed with a baby as the Israel laws does
not allows the same sex marriage and the surrogate child so they came India for their child. After
the child was born the gay couple left to the Israel in the year 2008.

Legal Regulation of Abortion in India

The Wikipedia Dictionary defines an abortion as: “An abortion is the removal or expulsion of an
embryo or fetus from the uterus, resulting in, or caused by, its death.”

This can occur spontaneously as a miscarriage, or be artificially induced through chemical,

surgical or other means. Commonly, "abortion" refers to an induced procedure at any point in the
pregnancy; medically, it is defined as a miscarriage or induced termination before twenty weeks
gestation, which is considered nonviable.

A woman has a right to abortion if:

 The continuance of the pregnancy would involve risk to the life of the pregnant woman
greater than if the pregnancy were terminated
 The termination is necessary to prevent grave permanent injury to the physical or mental
health of the pregnant woman
 The continuance of the pregnancy would involve risk, greater than if the pregnancy were
terminated, of injury to the physical or mental health of the pregnant woman
 The continuance of the pregnancy would involve risk, greater than if the pregnancy were
terminated, or injury to the physical or mental health of any existing child of the family
of the pregnant woman
  There is substantial risk that if the child were born it would suffer from such physical or
mental abnormalities as to be seriously handicapped.
 Or in emergency, certified by the operating practitioner as immediately necessary: to save
the life of the pregnant woman or to prevent grave permanent injury to the physical or
mental health of the pregnant woman.

Indian law allows abortion, if the continuance of pregnancy would involve a risk to the life of the
pregnant woman or grave injury to her physical or mental health. Abortion was being practised
earlier by many. Because it was illegal, it was practised in a clandestine manner.

The passing of the Act made medical termination of pregnancy legal, with certain conditions for
safeguarding the health of the mother. Abortion is severely condemned in Vedic, Upanishadic,
the laterpuranic(old) and smriti literature. Paragraph 3 of the Code of Ethics of the Medical
Council of India says: I will maintain the utmost respect for human life from the time of
conception.

The Supreme Court has said that the right to privacy is implicit in Article 21 of the Constitution
and a right to abortion can be read from this right.

The Medical Termination of Pregnancy Bill was passed by both the Houses of the Parliament
and received the assent of the President of India on 10th August, 1971. It came on the Statute
Book as the "The MTP Act, 1971". This law guarantees the Right of Women in India to
terminate an unintended pregnancy by a registered medical practitioner in a hospital established
or maintained by the Government or a place being approved for the purpose of this Act by the
Government. Not all pregnancies could be terminated.

In a historic move to provide universal access reproductive health services, India amended the
Medical Termination of Pregnancy (MTP) Act 1971 to further empower women by providing
comprehensive abortion care to all.

The new Medical Termination of Pregnancy (Amendment) Act 2021 expands the access to safe
and legal abortion services on therapeutic, eugenic, humanitarian and social grounds to ensure
universal access to comprehensive care. The new law, which came into force from 25 March
2021, will contribute towards ending preventable maternal mortality to help meet the Sustainable
Development Goals (SDGs).

The changes consider the advances in medical technology, simplify requirement of providers,
increase upper gestation limit for termination of pregnancy under specific conditions, and
remove the gestation limit for cases that could burden the health system. The goal is to
strengthen access to comprehensive abortion care without compromising dignity, autonomy,
confidentiality, and justice for women who need safe and quality services.

Key amendments:

 Increasing the upper gestation limit from 20 to 24 weeks for special categories of women,
including survivors of rape, victims of incest and other vulnerable women (differently-
abled women, minors, among others).
 The opinion of one provider needed for the termination of pregnancy up to 20 weeks of
gestation. Requirement of the opinion of two providers for the termination of pregnancy
from 20-24 weeks of gestation.
 Upper gestation limit to not apply in cases of substantial foetal abnormalities diagnosed
by a Medical Board.
 Confidentiality clause: The name and other particulars of a woman whose pregnancy has
been terminated cannot be revealed except to a person authorised by law.
 Extended MTP services under the failure of contraceptive clause to unmarried women to
provide access to safe abortion based on a woman’s choice, irrespective of marital status.

Critics of the law also pointed out that it does not take into account the crisis of healthcare
caused by the ongoing pandemic. Given this and the chronic shortage of doctors in India,
demanding that women seek out the opinion of two practitioners and a medical board for certain
kinds of abortions is unfair, they said.

The law also recognises mental health-related reasons for seeking an abortion that doctors may
not support if it violates their personal belief system – doctors could withhold approval for
abortion due to changed psycho-social circumstances that make a pregnancy unwanted,
unintended pregnancy, and unwillingness in a young, single woman to have a child.
Pre-Contraception and Pre-Natal Diagnostic Techniques Act, 1994 (PC-PNDT Act)

Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act, 1994 is an Act of the
Parliament of India enacted to stop female foeticides and arrest the declining sex ratio in India.

The Pre-Conception and Pre-Natal Diagnostic Techniques Act of 1994 has banned pre-natal sex-
determination. Very genetic counselling centre, genetic laboratory or genetic clinic engaged in
counselling or conducting pre-natal diagnostics techniques, like in vitro fertilisation (IVF) with
the potential of sex selection (Pre-implantation genetic diagnosis) before and after conception
comes under the preview of the PCPNDT Act and are banned. The main objective of the act is
the arrest of the declining sex-ratio in India due to rampant female foeticide.

Need for the Act

 Owing to the patrilineal line of succession regarding property rights as well as cultural
practices, the male child has always been preferred instead of the female child. As such
there was a tendency for families to continue producing children until a male child was
born, which only magnified India’s overpopulated demographics.
 This was the norm until the 1990’s when the availability of ultrasound techniques lead to
the widespread practice of pre-natal sex-determination. This lead to a rise of an Rs.1000
crore industry where medical professionals practise selective abortion for a price.
 Social discrimination against women and a preference for sons have promoted female
foeticide in various forms skewing the sex ratio of the country towards men. Thus
necessitating the passing of the PCPNDT act.

Salient features of the PCPNDT act

As per the PCPNDT act, sex selection is an act of identifying the sex of the foetus and
elimination of the foetus if it is of the unwanted sex.

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
ultrasound machine or any other equipment capable of detecting sex of the foetus. Main
provisions in the act are:

 The Act provides for the prohibition of sex selection, before or after conception.
 It regulates the use of pre-natal diagnostic techniques, like ultrasound and amniocentesis
by allowing them their use only to detect: Genetic abnormalities, metabolic disorders,
chromosomal abnormalities, certain congenital malformations, haemoglobinopathies and
sex-linked disorders.
 No laboratory or centre or clinic will conduct any test including ultrasonography for the
purpose of determining the sex of the foetus.No person, including the one who is
conducting the procedure as per the law, will communicate the sex of the foetus to the
pregnant woman or her relatives by words, signs or any other method.
 Any person who puts an advertisement for pre-natal and pre-conception sex
determination facilities in the form of a notice, circular, label, wrapper or any document,
or advertises through the interior or other media in electronic or print form or engages in
any visible representation made by means of hoarding, wall painting, signal, light, sound,
smoke or gas, can be imprisoned for up to three years and fined Rs. 10,000.

Amendment of PCPNDT Act 2003

Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 (PNDT), was
amended in 2003 to The Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition Of
Sex Selection) Act (PCPNDT Act) to improve the regulation of the technology used in sex
selection.

Implications of the amendment are:

 Amendment of the act mainly covered bringing the technique of preconception sex
selection within the ambit of the act.
 Bringing ultrasound within its ambit.
 Empowering the central supervisory board, the constitution of the state-level supervisory
board
  Provision for more stringent punishments.

Latest Context related to PCPNDT Act

The Supreme Court of India has dismissed the writ petition filed by Federation of Obstetrics and
Gynecological Societies of India (FOGSI), upheld the constitutional validity of Section 23 of the
PCPNDT Act, 1994. Section 23 of the Act, provides for penalties for anomalies in
paperwork/record keeping/clerical errors regarding the provisions of the Act.

 In the writ petition, it was aggrieved that Section 23, what they term as ‘clerical errors’, is
treated on the same footing as the actual offense of sex determination.
 Supreme Court in its judgment opined that:
o Any dilution of the provisions of the Act or the rules would only defeat the
purpose of the Act to prevent female foeticide, and relegate the right to life of a
girl child under Article 21 of the Constitution, to a mere formality.
o Non-maintenance of records is not merely a technical or procedural lapse in the
context of sex determination, it is the most significant piece of evidence for
identifying the accused.
o If a detailed record is not maintained then the violations can never be detected. It
will defeat the purpose of the whole act.

The illegality of sex determination

In the Indian context, abortion is wrongfully out there until twenty weeks of maternity however
solely underneath bound conditions (Medical Termination of Pregnancy Act, 1971). Abortions
within the trimester of maternity, although ridden with ethical positions, a square measure
typically out there to women. The abortions that square measure wanted the primary trimester
square measure usually treated as contentious problems. The trimester abortions square measure
subjected to contention on the bottom that they’re sex-selective abortions.
In Asian countries and most of South Asia, it’s likely that almost all trimester abortions square
measure sex-selective abortions (Gupte, Bandewar and Pisal 1997). Since the sex quantitative
relation has been apace declining, policy manufacturers, service suppliers, and therefore the
society at giant square measure gazing abortions with heap suspicion. during this case, the
controversy has 3 angles: One version spoke communication that “Right to abortion doesn’t
embrace the right to sex-selective abortion”.

The opposite version says “Right to abortion includes sex-selective abortions as well”. The third
read appearance at this whole discussion through a gender discrimination lens. The primary read
is not anti-abortion.

It believes that among the larger procreative health framework, women have the correct to safe
and legal abortion. however considering the very fact that the sex quantitative relation within the
country is massively declining, no discussion on abortion is feasible while not considering the
problem of sex-selective abortion (George and Dhaiya. 1998). For no matter reason, in the Asian
nation, there’s Associate in Nursing exaggerated consolidation of the read that sex-selective
abortions square measure virtuously and ethically unacceptable and it has to be combated in most
imperative terms. consistent with this perception dominant sex-selective abortions square
measure a priority and everyone steps towards ought to be taken to combat the menace.

Loopholes in the law

The Pre-Natal Diagnostic Techniques (Regulation and bar of Misuse) Bill, 1991, introduced
in the Parliament in 1994, awaits implementation. Women’s teams, health teams, and democratic
rights teams approached the President yet again to incorporate recommendations (submitted in
1992), and withhold assent of the 1991 Bill, till these provisions are enclosed. Registration of
Genetic Guidance Centres and Laboratories can solely serve the aim of regularizing personal
clinics that, in sight of the weak mechanisms for deterrence created by the law, can still savor
these activities for the pursuit of profit. Licensing additionally would pave the means for one
more avenue of corruption to avoid the paperwork. We’ve been more aware that these tests ought
to be confined to government hospitals with public responsibility, instead of granting legitimacy
to the personal sector.
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.

Effective implementation of the law appears close to impossibility. Preventing info concerning
the sex of the craniate from being communicated, isn’t sensible, given the very fact that those
obtaining the sex of the fetus, can have an interest in knowing the results. By making a typical
interest among the suppliers and users of the ability to evade detection, the task of checking the
application has become tougher.

There is no provision for the creation of native vigilance committees which might contribute to
effective implementation, and solely central and state-level bodies are nominal. Punishment for
the offenders is nominal, and cannot act as a deterrent given the super-profits generated during
this business.

Thus, initiatives taken to control or regulate the functioning of the non-public medical sector
through associate degree isolated legislation might not be the foremost acceptable manner. The
opposite issue that emerges is that implementation of this Act needs a lot of general involvement
of the State, and the enactment of legislation is merely the primary step in this direction. The
State machinery, in this case, the health department, has got to play a lot of crucial roles, a task
that is usually not recognized as core health performance.
MODULE 5: DIGITAL HEALTHCARE

National Digital Health Authority (“NeHA”)

The Ministry of Health and Family Welfare, in the year 2015, published a note on establishing a
National e-Health Authority (NeHA) to regulate the emerging usage of electronic mediums in
healthcare, especially for maintenance of e-Health records and digital health information across
India. The goal of NeHA was to ensure development and promotion of e-Health ecosystem in
India for enabling, organizing, managing and providing effective people-centred health services
to all in an efficient, cost-effective and transparent manner.

Objectives

 To formulate “National eHealth Policy and Strategy” for coordinated eHealth adoption in
the country
 To oversee orderly evolution of eHealth initiatives (state and nationwide) and to guide
adoption of eHealth at various levels and in different geographical and health system
areas
 To promote setting up of state health records repositories and health information
exchanges (HIEs) to facilitate interoperability
 To formulate and manage all health informatics standards for India
 To lay down data management, privacy and security policies, guidelines and health
records of patients in accordance with statutory provisions
 To enforce the laws and regulations relating to the privacy, confidentiality, and security
of the patient's health information and records
 To coordinate efforts across departments and ministries, and liaise with other related
policy/regulatory groups to ensure consistency and coherence
 To help enable ecosystem that involves stakeholders to improve care delivery and health
outcomes
 To map continuous evolution of the eHealth landscape and take on new functions as
needed
Functions envisaged

1. Policy and promotion

 To work out a vision, strategy and adoption of time plans, with timeframes, priorities, and
a roadmap in respect of e-Health adoption by all stakeholders, both public and private
providers, large-scale hospitals and stand-alone clinics.
 To formulate policies for e-Health adoption that are best suited to the Indian context and
enable accelerated health outcomes in terms of access, affordability, quality and
reduction in disease mortality and morbidity.
 To engage with stakeholders through various means so that e-Health plans are adopted
and other policy, regulatory and legal provisions are implemented by both the public and
private stakeholders.
 To provide thought leadership in the areas of e-Health.
 To effectively promote adoption of e-Health in the country, NeHA would have the
mandate to set up an agency to provide oversight, handholding, capacity building, etc.

2. Standards development, release, and maintenance

 NeHA will oversee and actively work with all relevant stakeholders including SDOs for
formulation and adoption of health informatics standards.
 NeHA will act as a focal agency for participation or engagement with global SDOs in
Health such as IHTSDO. It will undertake all activities leading to adoption and release of
suitable standards and Indian profiles

3. Legal aspects including regulation

 NeHA will act as an enforcement agency with suitable mandate and powers.
 NeHA will be responsible for enforcement of standards and ensuring security,
confidentiality, and privacy of patient’s health information and records.

4. Setting up Electronic Health Exchanges for interoperability

 NeHA will prepare technical and policy documents relating to architecture, standards,
policies, and guidelines for e-Health record repositories and HIEs.
  NeHA may also initiate Proof of Concept (PoCs), in close consultation with governments
– central and states, industry, implementers and users.
 NeHA would lay down operational guidelines and protocols, policies for sharing and
exchange of data, audit guidelines and the like; these shall be guided by experience in
operation and the use of PoC, global best practices and consultations with stakeholders
(MoHFW, state governments and other public and private providers, academia, R&D
labs, and others).

5. Capacity-Building

 NeHA would co-work with academic institutions to spread awareness on Health

Informatics and e-Health to health care delivery professionals. NeHA would provide
inputs in terms of areas of need/requirement of different courses according to the
background of the learners, to academic institutions.

6. Certification framework

 NeHA will collaborate and work with STQC, Department of Electronics and IT (DeitY)
in creating a certification model for certification of HER products where STQC is
envisaged to function as the certification body.

7. Other functions

 Incidental to the discharge of its functions or as assigned to NeHA by the government or

Parliament or as the situation warrants.

Acting on its vision for NeHA, the Ministry had introduced a draft bill for Digital Information
Security in Healthcare Act (DISHA).

The DISHA healthcare law will give complete control of digital health data to the owner of that
data. The owner of digital health data will have the right to:

 allow or refuse the clinical entities to generate and collect his/her data;
 refuse, allow, or withdraw his/her consent for storing and sharing of data;
 refuse entities from accessing or exposing his/her data;
  choose what should be collected and what not, based on the purpose of data;
 know where the data is being transmitted and to whom;
 access his/her data;
 get his/her health information rectified by the related entity if there is any inaccuracy or
incomplete data;
 get notification by the related entity whenever a clinical establishment accesses the data;
 if there is any health emergency, the data will be shared with family members;
 get compensation if any damage is caused because of a data breach.

Ministry of Health and Family Welfare forwarded the draft legislation to Ministry of
Electronics and Information Technology (MeitY) seeking their inputs and guidance. As of
July 2019, MeitY was in process of enacting ‘Data Protection Framework on Digital Information
Privacy, Security & Confidentiality Act’, which would be applicable in all domains including
health. This Act would provide the framework for the Ministry to utilize the patient data in
programmes in a secured manner.

Telemedicine Regulation

Definition – ‘The delivery of health care services, where distance is a critical factor, by all health
care professionals using information and communication technologies for the exchange of valid
information for diagnosis, treatment and prevention of disease and injuries, research and
evaluation, and for the continuing education of health care providers, all in the interests of
advancing the health of individuals and their communities.’

In common parlance, telemedicine refers to the practice of caring for patients remotely when the
provider and patient are not physically present with each other and in such cases,
telecommunications technology is used to evaluate, diagnose and treat the patient.

DIFFERENCE BETWEEN TELEHEALTH & TELEMEDICINE

Both the terms telehealth and telemedicine are used by healthcare industry interchangeably. [->
is a, interface for connecting storage devices with a computer!!! ATA in the context of
telemedicine means "American Telemedicine Association"] But if we get into technicality, the
word telehealth is a much broader term which includes all kind of health information services,
medical education, health care education in addition to health care services provided using
telecommunications technology, whereas telemedicine refers specifically to providing clinical
services using telecommunication technology.

BENEFITS AND DISADVANTAGES OF TELEMEDICINE

Use of technology brings with it not only advantages in the field of providing health care
services, but certain disadvantages also follow. Telemedicine practice is safe and effective but as
any other technology it can be misused there are certain risk, drawback, limitation and these
drawback and limitation can be managed by training, protocols and issuing guidelines. Some of
the advantages and disadvantages are listed below for better understanding:

Advantages:

 Expands access to quality patient care even to remote areas;

 Convenient access to medical care for patients – especially in the present day and time
where are on the go and on the move from the word go;
 Also makes it convenient for a patient/ physician to seek consultation and/or expert
advice from specialists, from anywhere in the world;
 Saves time for the patient;
 Less expense incurred on travel to and fro the clinic – extremely beneficial for patients
living in rural areas;
 Maintains privacy;
 No exposure to other contagious infections/ diseases;
 Increased revenue for the RMP – fewer missed appointments and cancellations and better
utilisation of its time;
 Better quality Patient Care – as it enables RMP's to follow-up with their patients in a
more effective and prompt manner and ensure that everything is going well – thus leading
to better care outcome;
 Hospitals can also expand their access to medical specialists, and thus increase their
revenue.
Disadvantages:

 Requires RMP's to be technology savvy and undergo tech training alongwith investment
on equipments (such as a webcam)/ mobile apps (secure video chat app);
 Electronic glitches may affect the service – caused by harsh weather leading to power
cuts and/or disruption in internet connection, thus affecting transmission of data;
 There is a line of thought in the medical profession which believes that use of such
technology will reduce the in-person interactions with doctors (may result in missing of
non-verbal cues which a doctor in a in-person consultation can see) and also make
consultation a very impersonal affair – it is thus believed that telemedicine can
supplement in-person consultation but not replace it.
 There is also a risk of the information exchanged via telecommunication being accessed
by hackers and possibility of it being misused.

TELEMEDICINE AND INDIA

India being a very vast country which is densely populated, telemedicine plays a very important
role in enabling medical services being made accessible and deliverable to the remote areas as
well, more so since the concentration of medical health care facilities is found more in the cities
than in rural India, which constitutes majority of the national population.

ISRO (Indian Space Research Organization) made a modest beginning in telemedicine in India
with a Telemedicine Pilot Project in 2001, linking Chennai's Apollo Hospital with the Apollo
Rural Hospital at Aragonda village in the Chittoor district of Andhra Pradesh 5. The
development of telemedicine facilities in India has largely been due to a combined effort of
ISRO, Department of Information Technology, Ministry of External Affairs, Ministry of Health
and Family Welfare coupled with the State Governments. This network of telemedicine has
covered and connected 45 remote and rural hospitals (such as islands of Andaman And Nicobar
and Lakshwadeep, hilly regions of Jammu & Kashmir, Medical College Hospitals in Orissa
amongst other rural hospitals) and 15 super specialty hospitals.
Infact, telemedicine is one of the successful fields in India in which private sector has taken
initiatives and has acted actively in for the public health management. Narayana Hrudayalaya,
Apollo Telemedicine Enterprises, Asia Heart Foundation, Escorts Heart Institute, Amrita
Institute of Medical Sciences and Aravind Eye Care are some of the Indian private sector players
in telemedicine.

In India, the telemedicine service comes under the jurisdiction of the Ministry of Health and
Family Welfare and the Department of Information Technology.

Telemedicine has also been extended to traditional medicines in India, such as the National Rural
AYUSH Telemedicine Network which aims to promote the benefit of traditional methods of
healing to the public at large using the medium of telecommunications.

Prior to 2020, were few concerns regarding the practice of telemedicine which were largely due
to lack of guidelines and ambiguity that accordingly existed. . Infact, in the matter of Deepa
Sanjeev Pawaskar & Anr. Vs the State of Maharashtra, the Bombay High Court refused to
grant anticipatory bail to 2 doctors involved in the treatment of a patient who ultimately died and
the husband filed criminal complaints against the doctors accusing them of criminal negligence.
The case also involved use of telecommunication as a medium of consultation. As there existed
no legislation in India which governed the practice of telemedicine consultation, said judgement
led to medical bodies repeatedly petitioning Medical Council of India and the government to
issue clear guidelines to govern Telemedicine.

Due to the prevalent Pandemic caused by widespread COVID-19, which has affected countries
world over, there appeared challenges to provide health care services to people in need –
especially in the wake of social distancing ordered to be maintained by people all over the world
coupled with the high risk of catching the COVID-19 infection. It was the need of the hour to
regulate Telemedicine and promote it as a tool available for patients suffering from other
ailments to consult and seek timely medical advice, at the same time, also help the RMP's to
effectively manage patients and deliver timely consultation as and when desired and required –
without requiring the patient to visit the hospital and/or clinic.

Thus with the lockdown in force all over the country, use of Telemedicine consultation can help
both the patient as well as doctors from preventing the spread of highly contagious COVID-19
disease and reduce the risk of exposing vulnerable patients aa well as health workers to the
COVID-19 virus.

TELEMEDICINE PRACTICE GUIDELINES, 2020

In order to meet with the crisis faced by the country and the need to enforce social distancing and
do away with unnecessary movement of patients to the clinics/ hospitals, on 25th March 2020
Ministry of Health and Family Welfare, Government of India issued Telemedicine Practice
Guidelines, 2020 which were prepared in partnership with NITI Aayog (Also called "The
National Institution for Transforming India" – which is the premier policy 'Think Tank' of the
Government of India, providing both directional and policy inputs).

As stated in the "Background" of the above said guidelines, the purpose of these guidelines is to
give practical advice to doctors to enable them to start using telemedicine as part of its normal
practice as well as to provide them with a sound course of action to provide effective and safe
medical care founded on current information, available resources, and patient needs to ensure
patient and provider safety (to be used in conjunction with national clinical standards, protocols,
policies and procedures).

LAWS IN INDIA RELATED TO PRACTISE OF TELEMEDICINE IN INDIA

Hon'ble Supreme Court in the matter of Mr. 'X' Vs Hospital 'Z' 10held that in a doctor–patient
relationship, the most important aspect in doctor's duty is to maintain secrecy – a doctor cannot
disclose to any other person any information regarding his patient which he has gathered in the
course of treatment nor can the doctor disclose to anyone else the mode of treatment or the
advice given by him to the patient – doctors were held morally and ethically bound to maintain
confidentiality – the only exception to the said rule being when the disclosure is necessary under
public interest which would then override the duty of confidentiality, particularly where there is
an immediate of future health risk to others.

A perusal of various provisions of the Guidelines makes it clear that the RMP's and
Telemedicine are required to comply with various laws applicable to medical practitioners in
India such as – Indian Medical Council (Professional Conduct, Etiquette and Ethics)
Regulations, 2002; Drugs and Cosmetics Act and Rules, IT Act, Indian Medical Council Act and
other prevailing laws, including provisions related to Data Protection and Privacy Laws. Thus,
laws applicable to telemedicine are the laws applicable to practice of medicine in India coupled
with laws governing Information Technology. Various laws related to practice of medicine in
India are:

 Drug And Cosmetics Act, 1940 – governs the permissible and/or prohibited drugs which
can be prescribed in telemedicine consultation – such as Anti-Cancer drugs which have
been prohibited from being prescribed in telemedicine consultation; A "Drug" has been
defined under Section 3 (b) of the Drugs and Cosmetics Act, 1940.
Prescriptions made against medical consultation and diagnosis services under
telemedicine formats should satisfy legal requirements. The term "prescribed" as per
Section 3 [(i)] of the Drugs and Cosmetics Act, 1940 means prescribed by rules made
under the Act.
Section 8 of Drugs Act, “Standards of quality” ―standard quality means— (a) in relation
to a drug, that the drug complies with the standard set out in the Second Schedule, and (b)
in relation to a cosmetic, that the cosmetic compiles with such standard as may be
prescribed.
 Drugs and Cosmetics Rules,1945 – governs the permissible drugs which can be
prescribed in telemedicine consultation; Prescription only drugs" are defined under
Section 65(9) of the Drugs and Cosmetics Rules, 1945.
o Substances specified in Schedule H or Schedule X shall not be sold by retail
except on and in accordance with the prescription of a Registered Medical
Practitioner only.
o Further, in the case of substances specified in schedule X, the prescriptions shall
be in duplicate, one copy of which shall be retained by the licensee for a period of
two years.
o The supply of drugs specified in Schedule H or Schedule X to Registered Medical
Practitioners, Hospitals, Dispensaries and Nursing Homes shall be made only
against the signed order in writing which shall be preserved by the licensee for a
period of two years;
Regulation for Self Monitoring Healthcare Devices

Commercial self-monitoring devices are becoming increasingly popular, and over the last
decade, the use of self-monitoring technology has spread widely in both consumer and medical
markets.

Medical devices in India were clubbed with regulations for new drugs, biologicals and vaccines.
Medical devices are widely used by healthcare professionals across the globe. Keeping in view
the broad objectives for ensuring protection of the health and safety of patients and healthcare
professionals, CDSCO an agency of Ministry of Health & Family Welfare, Government of India
has released the Medical Device Rules, 2017, effective from January 1, 2018 for regulating
Medical Devices, including in vitro diagnostic kits.

Government regulations are tools used to achieve social, political, environmental and economic
outcomes that would otherwise not be achieved within the market. Laws can often have adverse
consequences, but it is still necessary to protect consumers. Not all biopharmaceutical companies
are good corporate citizens. Many regulations, including most of those involving human health
protections by way of safe drugs and medical devices, are a result of industries failing to regulate
themselves.

Pharmaceutical industries could monitor their “own adherence to legal, ethical, or safety
standards, rather than have government monitor and enforce those standards.” But history is
filled with examples of corporations that put social responsibility far down their priority lists, if it
is on their agenda at all. Their priorities of course are profit, shareholder returns and competitive
advantage. But in pursuit of those goals, some companies engage in practices that are socially
irresponsible, if not dangerous.

Medical Devices Rules, 2017

In the past, medical devices were regulated under Schedule Y of the Drugs and Cosmetics Rules,
1945. Under these, 14 medical devices were notified as ‘Drugs’. These ranged from disposable
hypodermic syringe and needle, perfusion sets, cardiac and drug eluting stents, catheters,
intraocular lens, intravenous cannulae, bone cement, heart valve, scalp vein, orthopaedic implant,
internal prosthetic replacement and in vitro diagnostic kits for human immunodefeciency virus
(HIV), Hepatitis B surface antigen (HBsAg) and Hepatitis C virus (HCV). For those which
required import, the medical devices had to be registered in Form 41 and imported in Form 10.
Approval of new medical devices were through Form 44. The Medical Device Advisory
Committee (MDAC) evaluated the clinical trial protocol and study data, published reports,
literature, and package insert. Based on the recommendations of MDAC, the medical device was
registered for marketing in Form 10 under rule 122A.

The Medical Devices Rules, 2017 of the Drugs and Cosmetics Act, 1940 came into force with
effect from January 1, 2018. The rules are applicable for i) substances used for in vitro diagnosis
and sterile surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures,
blood and blood component collection bag with or without anticoagulant, ii) substances
including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants
and insecticides; and iii) devices notified from time to time.

Medical Device Classification

The medical devices are classified mainly on intended purpose of the device, how invasive they
are, how long they will be implanted.

 Non-invasive medical device that comes in contact with injured skin but not breached the
dermis is class A, and if it is used in breached dermis or connected to an active medical
device which is in class B, C, or D; it is classified as class B; or class C is if it is a blood
bag or that modifies the biological or chemical composition of blood or other body
liquids or other liquids intended for infusion into the body.
 Invasive (body orifice) medical devices for transient use (intended for continuous use for
<60 minutes) is classified as class A, however if used on the external surface of an
eyeball, oral cavity as far as the pharynx or in an ear canal up to the ear drum or in a nasal
cavity it is class B.
 Reusable surgically invasive medical devices for transient use is assigned as class A. If
they are not reused, then they are class B or class C if they are intended for passing
ionising radiation. A transient or short term use surgically invasive medical device is
assigned to class C, if it is intended for the administration of any medicinal product by
means of a delivery system. A transient or short term (intended for continuous use for
 >60 minutes to 30 days) use surgically invasive medical device is assigned to class D, if
it is intended to be used specifically in direct contact with the central nervous system or
for the diagnosis, monitoring or correction of a defect of the heart or of the central
circulatory system through direct contact.
 Surgically invasive medical device intended for short term use shall be assigned to Class
B.
 An implantable medical device or a surgically invasive medical device intended for long
term use is assigned to class C. A long-term use (intended for continuous use for > 30
days) medical device shall be assigned to Class B, if it is intended to be placed into any
tooth. A long term use medical device shall be assigned to Class D, if it is intended to be
used in direct contact with the heart, the central circulatory system or the central nervous
system; is life supporting or life sustaining; is an active medical device; wholly or mainly
absorbed by the body; for administration of any medicinal product; or is a breast implant.
 Medical devices incorporating animal or human cells, tissues or derivatives is assigned to
Class D, if it is manufactured from or incorporates cells, tissues or derivatives of cells or
tissues, or any combination thereof, of animal or human origin, microbial or recombinant
origin.which are or have been rendered non-viable.
 Medical devices intended to be used for contraception or the prevention of the
transmission of any sexually transmitted disease is assigned to class C or D, if it is an
implantable medical device or an invasive medical device intended for long term use,
respectively.

National Accreditation Body – National Accreditation Board for Certification Bodies

(NABCB) under the Quality Council of India set up by the Ministry of Commerce and Industry,
Government of India act as the national accreditation body for the purposes of accrediting
Notified Bodies. NAB lays down the conformity assessment activities for accreditation of
Notified Bodies and standards for such accreditation; prepare norms and procedures for
accreditation of Notified Body; and audit a Notified Body periodically for assessing
conformance with the Medical Devices Rules.
Criminal Liability under Robot Assisted Surgery

Robotic assisted surgeries (RAS) seem to be gaining some acceptance among surgeons and
patients in India.

While it offers to help doctors perform complex operations with ease, it reduces the size of
surgical incisions, minimises blood loss, cuts pain and shortens patient's post-procedure recovery
time, claim surgical robotic systems manufacturers and surgeons who conduct operations on
these machines.

In addition, it facilitates better visualisation (of the body part under surgery), enhanced dexterity
and greater precision and thereby delivers better clinical outcomes especially for patients who
are undergoing procedures for oncology, thyroid, liver, gynecologic cancers (cervical, uterine,
ovarian, vaginal and vulvar) and urology, according to medical professionals.

Whether it relates to the lawsuits concerning the civil or criminal court, classically malpractice
requires demonstration of four main components.

1. Within the frame of standard criteria of care, the surgeon should have the task of
providing medical care for this patient in question,
2. The surgeon has a negligence in his/her task of because of inadvertency,
3. The patient should suffer from this outcome,
4. A cause-effect relationship should exist between the harmful outcome, and erroneous
practice of the surgeon.

Naturally, these principles are also valid for robotic surgery, and in case of dispute each
parameter should be evaluated based on individual case.

In robotic surgery, the doctor operating the device is still obligated to provide the best standard
of care and thus has the responsibility to correctly use the instrument. If he or she incorrectly
operates the device, then the patient must prove that the robotic malfunction risk would have
been lower had the procedure been performed at a different hospital or with a different surgeon.
This alone would be difficult to prove since each robotic device, by nature, has a potential risk of
malfunctioning. Therefore, it is especially important for doctors to take all reasonable
precautions prior to and during robotic surgery given the inherent risk and uncertainty associated
with the procedure.

Those doctors who perform robotic surgery to have special training, experience, and high-quality
assessment. This means they must have specific training in laparoscopic techniques and must be
versatile with use of the robotic system. There also must be at least one other surgeon at the
operating table who is equally as trained as the surgeon operating the device. Interestingly, the
FDA requires the manufacturer of the device to provide surgeons with hands-on training courses
and to adequately warn them about device hazards.

The manufacturer has the duty to provide warnings to consumers about the risks of their
products, of which the doctors also inform their patients. If the manufacturer provides adequate
educational instructions and warnings to the physician, then the Learned Intermediary (LI)
doctrine “absolves the manufacturer from the obligation of providing further warning to the
patient; and shifts the duty to warn patients about device hazards to the physician.” Thus, if a
doctor fails to provide an adequate warning to the patient about the limitations and risks of the
device, then he or she can be found liable for medical malpractice while the manufacturer would
escape liability. Overall, litigation associated with robotic surgery is extremely complex due to
the intermingled relationship between the manufacturer’s duty and the surgeon’s duty.

Big data in healthcare and privacy issues

Digitization of health and patient data is undergoing a dramatic and fundamental shift in the
clinical, operating and business models and generally in the world of economy for the
foreseeable future. This shift is being spurred by aging populations and lifestyle changes; the
proliferation of software applications and mobile devices; innovative treatments; heightened
focus on care quality and value; and evidence-based medicine as opposed to subjective clinical
decisions—all of which are leading to offer significant opportunities for supporting clinical
decision, improving healthcare delivery, management and policy making, surveilling disease,
monitoring adverse events, and optimizing treatment for diseases affecting multiple organ
systems

Big data analytics in healthcare carries many benefits, promises and presents great potential for
transforming healthcare, yet it raises manifold barriers and challenges. Indeed, the concerns over
the big healthcare data security and privacy are increased year-by-year. Additionally, healthcare
organizations found that a reactive, bottom-up, technology-centric approach to determining
security and privacy requirements is not adequate to protect the organization and its patients.

In the domain of mHealth, the World Health Organization has launched the project “Be Healthy
Be mobile” in Senegal and under the mDiabetes initiative it supports countries to set up large-
scale projects that use mobile technology, in particular text messaging and apps, to control,
prevent and manage non-communicable diseases such as diabetes, cancer and heart disease.
mDiabetes is the first initiative to take advantage of the widespread mobile technology to reach
millions of Senegalese people with health information and expand access to expertise and care.

Another example is the UNC Health Care (UNCHC), which is a non-profit integrated healthcare
system in North Carolina that has implemented a new system allowing clinicians to rapidly
access and analyze unstructured patient data using natural-language processing. In fact, UNCHC
has accessed and analyzed huge quantities of unstructured content contained in patient medical
records to extract insights and predictors of readmission risk for timely intervention, providing
safer care for high-risk patients and reducing re-admissions.

Privacy and security concerns in big data

Security and privacy in big data are important issues. Privacy is often defined as having the
ability to protect sensitive information about personally identifiable health care information. It
focuses on the use and governance of individual’s personal data like making policies and
establishing authorization requirements to ensure that patients’ personal information is being
collected, shared and utilized in right ways. While security is typically defined as the protection
against unauthorized access, with some including explicit mention of integrity and availability. It
focuses on protecting data from pernicious attacks and stealing data for profit. Although security
is vital for protecting data but it’s insufficient for addressing privacy.

Security of big healthcare data

While healthcare organizations store, maintain and transmit huge amounts of data to support the
delivery of efficient and proper care, the downsides are the lack of technical support and minimal
security. Complicating matters, the healthcare industry continues to be one of the most
susceptible to publicly disclosed data breaches. In fact, attackers can use data mining methods
and procedures to find out sensitive data and release it to the public and thus data breach
happens. Whereas implementing security measures remains a complex process, the stakes are
continually raised as the ways to defeat security controls become more sophisticated.

Accordingly, it is critical that organizations implement healthcare data security solutions that
will protect important assets while also satisfying healthcare compliance mandates.

The invasion of patient privacy is considered as a growing concern in the domain of big data
analytics due to the emergence of advanced persistent threats and targeted attacks against
information systems. As a result, organizations are in challenge to address these different
complementary and critical issues. An incident reported in the Forbes magazine raises an alarm
over patient privacy. In the report, it mentioned that Target Corporation sent baby care coupons
to a teen-age girl unbeknown to her parents. This incident impels analytics and developers to
consider privacy in big data. They should be able to verify that their applications conform to
privacy agreements and that sensitive information is kept private regardless of changes in
applications and/or privacy regulations. Privacy of medical data is then an important factor
which must be seriously considered.

More than ever it is crucial that healthcare organizations manage and safeguard personal
information and address their risks and legal responsibilities in relation to processing personal
data, to address the growing thicket of applicable data protection legislation. Different countries
have different policies and laws for data privacy.

Privacy preserving methods in big data

De-Identification – It is a traditional method to prohibit the disclosure of confidential

information by rejecting any information that can identify the patient, either by the first method
that requires the removal of specific identifiers of the patient or by the second statistical method
where the patient verifies himself that enough identifiers are deleted. Nonetheless, an attacker
can possibly get more external information assistance for de-identification in big data. As a
result, de-identification is not sufficient for protecting big data privacy. It could be more feasible
through developing efficient privacy-preserving algorithms to help mitigate the risk of re-
identification.
HybrEx – Hybrid execution model is a model for confidentiality and privacy in cloud
computing. It utilizes public clouds only for an organization’s non-sensitive data and
computation classified as public, i.e., when the organization declares that there is no privacy and
confidentiality risk in exporting the data and performing computation on it using public clouds,
whereas for an organization’s sensitive, private data and computation, the model executes their
private cloud. Moreover, when an application requires access to both the private and public data,
the application itself also gets partitioned and runs in both the private and public clouds. It
considers data sensitivity before a job’s execution and provides integration with safety.

Identity based anonymization – It is a type of information sanitization whose intent is privacy

protection. It is the process of either encrypting or removing personally identifiable information
from data sets, so that the people whom the data describe remain anonymous. The main
difficulty with this technique involves combining anonymization, privacy protection, and big
data techniques to analyze usage data while protecting the identities.

MODULE 6: BIOTECHNOLOGICAL ADVANCEMENT IN HEALTHCARE

Legal framework with use of robotics (Artificial Intelligence) in healthcare

Machine learning and artificial intelligence (AI) is making rapid strides in the healthcare sector
in India. Global technology leaders such as Microsoft, Google and Siemens as well as dozens of
new Indian startups are introducing promising AI solutions to address the country’s burgeoning
healthcare needs.

With India’s untenable patient-doctor ratio, global analysts expect that the pressure to improve
healthcare delivery will lead to a faster inclusion of AI and Deep Learning (DL) into the
country’s existing diagnostic and treatment processes.

Microsoft has announced a partnership with Apollo Hospitals to build an AI-centric cardiology
network. Microsoft is also expanding its existing AI network for eye care in India. The
company’s VP for AI & Research, Dr. Peter Lee, said that Microsoft will use AI models for
predicting heart disease risks in patients and support physicians with targeted treatment plans.

Bengaluru-based startup Niramai, which is partly funded by Flipkart co-founder Binny Bansal, is
using AI to create accurate, painless and affordable breast cancer screening tests.
Bengaluru-based startup for AI cervical cancer screening, AIndra, is applying artificial
intelligence to screen samples and identify the ones that indicate cancer risk. Another Bengaluru-
and Singapore-based 3D printing startup Supercraft is developing AI visualization tools that
equip doctors, hospitals and researchers with deeper insights into human anatomy.

According to Chander Shekhar Sibal, VP and Head of Medical Division, Fujifilm India, AI can
make a vital difference to the early diagnosis and prevention of diabetic retinopathy, which is
currently a serious medical challenge. Sibal further says that AI can dramatically improve speed
and accuracy in the area of radiology in India for early detection and containment of diseases,
including malaria and HIV.

Absence of a Legal Framework and Lack of Vision

While advancements in AI are India’s best bet yet to sustain its crumbling healthcare
infrastructure, visionless implementation of AI medical technology and the absence of a robust
legal framework can only compound the crisis, and not mitigate it.

In 2017, the Ministry of Commerce and Industry set up a high-powered “Task Force on Artificial
Intelligence” to explore how AI could be leveraged for India’s economic development across
different sectors.

Although the 18-member task force consists of outstanding civil servants, entrepreneurs,
technocrats and researchers from the fields of engineering, IP, robotics, and artificial
intelligence, it does not include a medico-legal expert to address the issues of law that are likely
to arise with the integration of healthcare and AI.

There is an urgent need for the policy makers, healthcare AI developers, and medical
practitioners in India to consider the legal aspects while designing, implementing, and regulating
artificial intelligence in the healthcare sector.

AI and the Limitations of Existing Legal Concepts

The tort system in the medical arena is founded on the concept that the doctor is the trusted
specialist or the expert. It presumes that the treating doctors are fully responsible for their own
decisions, and consequentially, they are also responsible if the medical care they provide is
proved to be negligent. But who should be held liable when the physician delivers a wrong
treatment at the recommendation of the AI diagnostic tool?

A recently published paper by researchers at NYU argues that medical AI (like IBM’s Watson
for cancer care) should be accorded a special legal status equivalent to personhood in order to
account for its current and future role in the process of medical decision making.[16] (Will this
also mean setting up of separate tribunals to deal with lawsuits against AI medical robots?)

One of the issues is that the traditional tort law concept of ‘foreseeability’ may not work when
AI systems perform a medical diagnosis and treatment. For an individual to be held liable for
negligence, the damage that occurred must be ordinarily ‘foreseeable.’ However, AI or machine
learning systems are supposed to learn from the past data and patterns and may behave in ways
that the AI developers and designers may not be able to foresee reasonably.

The labour laws in India have largely remained stagnant from the days of the socialist era that
began after India’s independence. Some would argue that even IT engineers come within the
purview of “workmen” as defined in the Industrial Disputes Act, 1947. In order to make
transition to an AI-enabled workforce in highly specialized fields such as healthcare, some of the
archaic labour laws may have to be amended.

The limitation of liability as described in the IT Act, 2000 may also be unfit to operate in the era
of artificial intelligence. Section 79 of the Act suggests that intermediary service providers in the
field of information technology are merely the carriers of content. Barring exceptions, under
Section 79, they would not be held liable for the substance of the content. This rule may have to
be re-examined with the implementation of AI systems that are devised by the carriers.

Legal issues with respect to development of embryo banks

Embryos have been successfully frozen for decades for the purposes of fertility preservation and
donation. Embryo freezing and donation is a well-established and successful form of assisted
reproduction treatment when both partners are infertile. The first pregnancy was reported in India
in 2009 after the transfer of embryos generated from frozen– thawed oocytes. The commercial
creation and sale of embryos has raised a chain of ethical-moral questions regarding the rights of
the unborn children – their right to know their biological parent, moral status of embryos, how
embryos should be handled in the event of divorce, etc. Some feminists and others have viewed
the sale of eggs, and presumably embryos, as commodification, arguing that such markets
cheapen human life. The disposition of unused embryos also raises moral and ethical dilemmas
not only for the couples who create them but also for society as a whole. In India there is no law
to regulate commercialization of embryo. The proper guideline should be made immediately to
reduce the nature and extent of commercialization of embryos in India.

The main ethical issues concern the effect on offspring, consent and counselling of donors and
recipients, avoidance of mixing embryos or gametes from different sources, and payment of
donor expenses. The main legal issues concern whether embryo donation is viewed as gamete
donation or adoption; the rearing rights and duties of donors and recipients; liability; and
compensation issues; and the legality of monetary compensation for donors. Use of embryos for
research also raises serious issues.

1. Health Issues – Egg donors are hyper-ovulated to stimulate the production of a maximum
number of eggs. Egg harvesting is done under anaesthesia—procedures that could pose
health risks, including ovarian hyper stimulation syndrome. Women donating oocytes
must undergo IVF. Due to the inherent medical risks associated with IVF, including
ovarian hyper stimulation syndrome and surgical risks, informed consent is another major
issue of concern. Additionally, it is considered an ethical prerequisite that oocyte donors
participate voluntarily and without coercion or undue influence. Some have expressed
concern that financial compensation of oocyte donors may lead to exploitation as women
may proceed with oocyte donation against their own best interests, given the inherent
medical risks involved. The “buying or selling” of human gametes is inherently immoral,
as it lead to commodification of embryo.
2. Anonymity of Donor – An issue of great controversy is whether children born using
donated sperm should be able to know the identity of the sperm donor. Indeed, the ability
of human beings to know their genetic roots is universally important, for the sake of self-
identity. Either egg and sperm donors may choose to or not to be anonymous, though the
vast majority in both groups generally chooses anonymity. Recently, however, there is,
increasing consideration of the rights of offspring. Advocates for allowing either gamete
donors or their offspring to break anonymity cite the medical advantages of sharing
 medical information with their genetic offspring, in the case of the donor, or learning
about their genetic history directly, in the case of offspring. Others simply argue that both
donors and offspring have an inherent right to meet and develop a relationship.
Recent court rulings suggest that these rights will become more visible in the coming
future. For example, in the British case Rose v Secretary of State for Health, the court
ruled that children born as a result of assisted reproduction had a right under Article 8 of
the European Convention on Human Rights to discover information about their genetic
parentage. However, a gamete donor who donated with the promise of anonymity also
had a right under Article 8 to protect their anonymity.
3. Surplus Embryos – IVF cycles often result in transferring several embryos and cryo-
preserving other embryos produced by the cycle, presumptively for the purpose of future
pregnancy. However, in many instances, these surplus embryos are never used by the
genetic parents and therefore are stored indefinitely. The number of such embryos stored
internationally is surprisingly high. In the United States alone, it is estimated that over
400,000 embryos are currently cryo-preserved, many of which will not be used by their
genetic parents. The ethical and moral issues surrounding how to deal with these surplus
embryos have been the source of much debate. In general, four possible fates for these
embryos exist:(1)thawing and discarding,(2)donating to research,(3)indefinite storage,
(4)donating the embryos to another couple for the purposes of uterine transfer.
4. Payment for Embryo Donation – There has been debate over whether donors of
gametes should be paid. In UK the HFEA does not prohibit the payment or giving of
benefit in return for gametes, but it is only permitted if authorised by directions issued by
the HFEA. However the EU Tissues and Cells Directive require that gametes should only
be supplied on a non-for-profit basis. Art 12 of the Directive says that ‘donors may
receive compensation which is strictly limited to making good the expenses and
inconveniences related to the donation.’ In India, the ART guidelines say that a woman
can be paid for her oocytes.
5. Moral Status of Human Embryos – The most important ethical question is the moral
status of early embryo. Is it a person? Is it a thing? Or is it something in between? When
during development is personhood established? In USA the Supreme Court held in 1973
in the case of Roe v. Wade that societal protection need not begin until viability, that is,
 late in pregnancy. In Davis v. Davis case, the lower court applied custody laws to the
cryopreserved concepti, implying personhood at this early stage. However this view was
reversed by the appellate court. The court ruled that “pre-embryos” were neither persons
nor property but entitled to “special respect” due to their capacity to become a person,
relying on professional guidelines.
Biologically the human embryo is undoubtedly human; it has human chromosomes
derived from human gametes. It is also undoubtedly alive - a new active individual
human organism from the moment of fertilisation exhibiting respiration, growth,
reproduction, excretion and nutrition. An embryo is a genetically distinct living human
organism in itself, already with a unique genotype and the inherent ability to grow into an
adult.
6. Potential Liability of Donor – What will be the situation of the AID child who suffers
from a genetic defect passed on from the donor? Can the donor be found responsible for a
failure to communicate his knowledge of the defect, or can the law find the donor
negligent for a failure to discover the existence of the defect before becoming a donor, or
the doctor in doing the treatment? Under UK law, Section 1 of the Congenital Disabilities
(Civil Liability) Act, 1976 provides that if a child is born disabled because of an
occurrence which pre-dated birth, and someone is answerable for the existence of the
disability, then that person can be found liable at the suit of the child. In a 2003 case, an
egg donor tested positive as a carrier of the cystic fibrosis gene mutation, but the test
result was not reported to the recipients, who proceeded with the egg donation process
and went on to give birth to a child with the disease. The medical practice did not test the
intended father for carrier status. While the court disallowed the child’s claim or
wrongful life, it permitted the parents to proceed with their malpractice case against the
medical practice. In India, the ART Guidelines state that a third-party donor and a
surrogate mother must relinquish all parental rights in the child.

Transplantation of Human Organs (The Transplantation of Human Organs and Tissues

Act, 1994)

In India there are many health legislations e.g., Drugs and Cosmetics Act,1940, The Prevention
of Food Adulteration Act, 1954, The Medical Termination of Pregnancy Act, 1971, Maternity
Benefit Act,1961, Insecticides Act 1968, Narcotic Drugs and Psychotropic Substances Act and
Rules 1985, The Pre-Natal Diagnostics Techniques Act, 1994, Food Safety and Standards
(Contaminants, Toxins and Residues) Regulations, 2011, Food Safety and Standards (Prohibition
and Restrictions on Sales) Regulations, 2011, amongst others. One disease which captured the
attention of the medical professionals all over the world in early 1900s and throughout the first
half of the 20th century was solid organ failure. With the advent of advanced medical technology
in transplant procedures an end stage organ failure patient got a ray of hope to lead a healthy and
prolonged life by undergoing organ transplant. Human body has certain essential organs like
kidneys, lungs, cornea that are in pairs, making it possible to part away with one of the two
during the lifetime and still be able to lead a healthy life. Whereas other significant organs like
heart, pancreas etc. can be used only after the death of a human being but before the organs
become obsolete on account of discontinuation of blood supply. There are regenerative and non-
regenerative transplantable tissues/organs like liver, blood, bone marrow, stem cells etc.

The THOTA, 1994 was enacted at the time when in India due to absence of any legislation,
rampant sale of human organs was going on. The Act aims to provide for (i) the regulation of
removal, storage and transplantation of human organs for therapeutic purpose and for (ii) the
prevention of commercial dealings in human organs and for matters connected therewith or
incidental thereto. There are two types of organ donations envisaged under the Act viz., (i)
Living Donation and (ii) Cadaver/Deceased Donations. Broadly, the Act for the first time
recognised brain death as the moment of death for facilitating retrieval of organs. Thus owing to
THOTA, 1994, persons in vegetative / brain dead state with beating heart have become a viable
source of organ pool for the purposes of transplantation and the sale of organs is now a
punishable offence. With the acceptance of brain death, it has become possible to undertake solid
organ transplants.

Consent and Organ Donation

In cadaver donation the consent of the deceased before his death is a pre-requisite for removal of
his/her organs upon death. There are three processes through which consent may be given. First
is ‘opt-in’ consent, second is ‘opt-out’ and the third is ‘mandated choice.’ In India we have the
‘opting-in’ form of consent for retrieval of organs from deceased. It is based on the principle of
‘authorisation’, an expression which is intended to convey that people have the right to express,
during their lifetime, their wishes about what should happen to their bodies after death, in the
expectation that those wishes will be respected. It is a positive concept, representing a positive
attitude to the issue, and replaces the lack of objection or ‘presumed consent’. Authorisation to
remove an organ of a deceased reflects the principle of ‘consent’ on which the THOTA,
Trans1994 is based.

Section 3(1) of the Act permits any donor subject to prescribed conditions and the procedure to
donate or authorise the removal of any of his organs or tissues of his body, before his death only
for therapeutic purposes. The consent for the donation of organs can also be given by the kin of
the deceased, under section 3(3) of the Act provided the deceased had not objected to the
donation during his lifetime.

Such consent can be in writing, in presence of two or more witnesses, one of whom has to be a
‘near relative’. And if it is so, then besides the relatives in whose possession the dead body is,
even the person, other than the relatives, can grant all reasonable facilities to a registered medical
practitioner for the removal of the human organ of the deceased person for therapeutic purposes,
provided that such removal can be made only and only by a registered medical practitioner. Here
only embargo being that relative or person in whose possession the body is, should be sure that
deceased had not subsequently revoked that authority or person other than the relative has a
reason to believe that any near relative has no objection to such a removal. This type of consent
is known as opt-in concept, in which the deceased person has already opted for the removal of
the organ before his death.

Emotional, Ethical and Religious Constraints

In India, where the cultural ethos and religious beliefs are stronger than other counties,
generating awareness is the need of the hour for effective implementation of cadaver donation
program. Cultural perception of charity and donation is different in different religions. In India,
religious beliefs generally discourage practices such as stockpiling and collecting organs from
cadavers. It is difficult for a grief stricken family to understand the concept of cadaver donation
when his loved one has been declared dead and to take a decision of permitting doctors to
retrieve organs for which the corpse would be mutilated. Myths and fears dominate their minds.
The very thought of dismemberment of the body of their loved one’s makes them repulsive to the
ides of organ donation. The pre-conceived religious beliefs/myths that in rebirth a person is born
in the same state of body condition as he was at the time of death deters them to give consent for
removal of any of the body parts. They find taking out organs/tissues very repulsive and perceive
it as a kind of disrespect for the dead body of their relative. Though generally all religions permit
donation, people are still unwilling to donate organs. Instead they use religious misconceptions
as excuses for not donating organs Thus permission for cadaver donation by family of the
deceased has still not gained momentum.

Respect for the autonomy of the deceased

THOTA 1994 provides that a person can make a wish to donate his organs/tissues or can also
register his objection for such donation after his death. Indian legislation in this context is
debatable. As per the Act even if the deceased had consented to donation of organs during his
life-time, the wishes of his near ones are given priority over the deceased’ wishes and organ
retrieval cannot be done without the consent of the near relatives.34 In such a situation autonomy
of the deceased is not respected. The wishes of the near relatives of the deceased are given
priority over the wishes of the deceased.

But at the same time, if the person had registered his objection to donate organs after his death or
had revoked his earlier consent to donate, then in that case even the near relative’s authorization
to donate is of no consequence. In Indian law autonomy of deceased is respected in objecting to
donation but not when he agrees to organ donation. In this context provisions of the
THOTA ,1994 seemingly tilt in obstructing rather than facilitating organ donation and are
differentially applicable in respecting the autonomy of the deceased.

Public policy for welfare of the community

In a welfare state, legislations should be in consonance with the needs of the society, for the
collective good of the people. Such needs/interests defined in broad terms as social welfare, are
labelled as public policy for the good of the collective body.

The proposition that enactment and implementation of THOTA, 1994 was in public interest for
curbing human organ trafficking and regulation of transplants cannot be denied. At the same
time it also has to be evaluated on the touch stone of Fundamental Rights, the nature of the right
alleged to have been infringed, the underlying purpose of the restrictions imposed, the extent and
urgency of the evil sought to be remedied, thereby, the disproportion of the imposition , if any,
the prevailing conditions at the time should all be considered for reaching a judicious conclusion.

But the post THOTA ,1994 legal regime is witness to the recurring reports of organ trade rackets
pointing to the hasty passing of THOTA,1994, without developing a well thought out and
functional cadaver organ program, leaving the ESOF patients to die by depriving them to
exercise their ‘right to life’ and also their ‘right to self- preservation’. No one appreciates the
harrowing life experiences of patients in need of donor organs. Patients in need of solid organ
transplant and having no one to donate alive or dead are bound to die and become the victim of
indirect prohibition through this legislation.

The Act should have put restrictions as envisaged under Sec.9 and prohibited sale of organs only
after developing a very effective working cadaver programme. With the changing needs of the
society, progressive laws are welcomed. But having progressive laws alone is not enough, it
should also be ensured that they do not impliedly infringe the Fundamental Rights of the people.

Legal issues pertaining to Clinical Trials in India

Clinical trials are an arrangement of practices performed to confirm and guarantee the security
of a new drug molecule. Compliant with an amendment to the Indian Patents Act 1970 in
January 2005, medications can be made by following both the item and process protecting. This
has encouraged the rise of India as a favored and looked for after goal to direct clinical trials.
The accessibility of exceptionally prepared doctors, attendants and specialized workforce; world
class restorative offices; great IT foundation and a strong Intellectual Property Rights
administration in India have additionally helped the reason. Rule 122 DAA of Drugs &
Cosmetics Rules, 1945 (“D & C Rules”) defines clinical trials as a “systematic study of new
drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical,
pharmacological (including pharmacodynamics and pharmacokinetic) and/or adverse effects
with the objective of determining safety and / or efficacy of the new drug”.

REGULATIONS PERTAINING TO CLINICAL TRIALS IN INDIA

There are number of laws governing clinical research in India. Indian Acts/Orders related to
Clinical Trials is:

 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

Be that as it may, a great deal has changed in the clinical research situation from that point
forward. Today, clinical trials are directed through a controlled approach following certain rules
set around the International Conference on Harmonization (ICH), which is led by U.S.A., Europe
and Japan. There are number of laws representing clinical research in India. Despite the fact that
we have number of enactments the vital one for clinical trials is The Indian Council of Medical
Research (ICMR) – 1947 (amended in the year2002) , which was set up keeping in mind the end
goal to encourage an exploration culture in India, enhance and create foundation and cultivate
group bolster. The Drugs and Cosmetics Act, The Medical Council of India (MCI) Act expresses
that every single clinical trial in India ought to take after the ICMR rules of 2000. The ICMR has
an instrument of audit for its own establishments, thus do other government organizations. Each
specialist is represented by the MCI Act. Any specialist fouling up in a trial or practically
speaking can be arraigned and the doctor’s facility can be shut. The MCI Act is exceptionally
solid; the MCI has the ability to take correctional measures.

The Drugs Controller General of India (DCGI) is in charge of administrative endorsements of

clinical trials in India. The DCGI office relies upon outer specialists and other government
organizations for exhortation. Extra consents are required for the fare of blood tests to remote
focal research centers. The ICMR has a Central Ethics Committee on Human Research
(CECHR). This board of trustees reviews the working of this Institutional Ethics Committee
(IEC). The as of late revised Schedule Y of Drugs and Cosmetic Rules arrange the creation of the
IEC according to the ICMR rules. The DCGI’s office in a joint effort with WHO ICMR and
many submitted look into experts, has been directing preparing programs for individuals from
the Ethics Committees the nation over.

Clinical trials in India are controlled by Schedule Y of the Drugs and Cosmetics Rules. The
Rules are authorized by the workplace of the DCGI who is likewise in charge of observing every
single clinical trial submitted to that office for endorsement. For new medications being
produced in India clinical trials must be directed in India from stage 1. For advertising
endorsement of medications effectively affirmed in different nations, a stage 3 clinical trial is
required on around 100 patients in at least three focuses, with a specific end goal to set up the
medication’s effect on the Indian ethnic populace. An application for another sign of an
effectively endorsed medicate is dealt with as an application for another medication’s
endorsement. New definitions of affirmed medications might be subjected to bioequivalence
thinks about.

The Indian Council of Medical Research (ICMR) first distributed point by point rules for
biomedical research in 2000. These incorporate rules for moral survey. Modified rules
distributed in 2006 express that the morals survey board of trustees is likewise in charge of
observing trials. A draft bill to make the rules legitimately restricting is pending with the service
of wellbeing. Once passed, the law will require that all ECs enroll with a Biomedical Research
Authority. This expert will likewise assess the working of ECs. In any case, morals survey is a
long way from sufficient. Not all ECs are built up according to lawful arrangements; individuals
are not adequately prepared for this work, and support is not given to them to lead exhaustive
audits. An ICMR review found that exclusive 40 of 179 institutional moral boards of trustees
take after the recommended legitimate arrangements and capacity according to different moral
rules. There is no focal enlist of EC choices and if a convention is dismissed by one nearby EC it
might be submitted somewhere else. The support is not obliged to illuminate an EC – or the
DCGI – if the convention being submitted to it has been dismissed somewhere else.

Further, the DCGI is not equipped to monitor existing clinical trials in India. The DCGI’s office
currently has a staff of four or five professionally qualified people and at present does not inspect
clinical trial sites though the government has announced that it is recruiting new staff for this
purpose. Audits of clinical trial data are at present only conducted by contract research
organizations and sponsors. The United States Food and Drug Administration (USFDA) has
recently started auditing trial sites.

Medication organizations direct clinical trials through contract inquire about associations
(CROs), business entities whose occupation it is to complete the exploration and to meet
administrative necessities. Since the mid 2000s, there appears to have been a sharp ascent in the
quantity of agreement inquire about associations working in India; the DCGI has expressed that
the assessed number of agreement look into associations in India enrolled with the USFDA has
gone from 60 to 150. CROs may deal with a few or all parts of a support’s venture including:
administrative endorsements for trials, recognizing selecting destinations and agents, observing
locales, information passage and administration, submitting information for promoting
endorsement and drafting study reports for accommodation to diaries. These exercises may
likewise be part up and dealt with by various associations.

Human Rights Violations

Educated assent is a basic prerequisite of restorative trials, which means that the patient
experiencing treatment as a major aspect of the investigation ought to be made mindful of the
trial being directed, the medications being regulated on him and it’s conceivable reactions. Be
that as it may, the nation has, at a few cases saw net infringement of human rights and moral
esteems while directing trials on volunteers selected in thinks about. In 1999, without getting
assent of the patients who were under treatment in the administration run Regional Cancer
Center in Trivandrum, an exploratory medication tetraglycidyl nor-dihydro-guaiaretic corrosive
was managed on them. In spite of the fact that there was a set up treatment for their condition,
they were not educated that they were partaking in an examination or that they were being denied
a built up treatment.

So also, in 2002, the pharma monster Novo Nordisk directed multi-focus stage III clinical trials
of a diabetes medicate even before accepting the consequences of creature examines. The
examination report found that the medication, ragaglitazar, caused urinary bladder tumors in rats;
and this ought to have been known before the medication went for stage I trials. The trials were
directed on 650 individuals from North America, 200 from Latin America, 100 from
Australia/New Zealand, 800 from the European Union, and 200 from non EU Europe; and 550
from Asia.

In 2003, Mumbai-based Sun Pharmaceutical Industries Ltd. propelled a limited time cum-
explore program by getting private specialists to recommend the counter malignancy tranquilize
Letrozole to more than 400 ladies as a richness sedate for ovulation enlistment. The organization
at that point pitched the specialists’ reports to different specialists as “inquire about”, utilizing
their system of therapeutic agents. The medication was endorsed in spite of the way that it was
known to be harmful to embryos.

Another defect in the Indian human services control is the absence of consistency in the
permitting strategy. At present, the understanding and implementation method shifts starting
with one state then onto the next. This variety in methodology makes little responsibility, in the
event that an issue emerges. In the meantime, endeavors by the Central government to make a
Central Drug Authority is exceptionally calculable. Such a move picks up hugeness in the setting
that the US and European medication goliaths are progressively outsourcing their clinical testing
to the quickly creating economies like China, India and Africa.

Changing Face of Regulations in India

Despite the fact that gradually, India has on numerous occasions been embracing new systems to
control the quick growing restorative research industry. As part, in 2004, India has propelled the
National Pharmacovigilance Program with World Bank Financial help remembering Drug
wellbeing observation. However, tragically, the activity has to a great extent been disregarded till
date.

At introduce, the 21 pharmacovigilance focuses working in India is as of now during the time
spent being interlinked with the new cells. A focal group in the DCGI office would screen and
administer co-appointment of the focuses and cells.

Be that as it may, setting up of such focuses alone won’t address the hidden issues, to be specific
the nonattendance of a strong, workable observation system to report unfavorable occasions and
from which prove based choices are made. This calls for appropriate mechanical and specialized
preparing to work the proposed pharmacovigilance framework.
Presently, the Clinical Research Organizations or the CROs work utilizing an intentional
procedure managed by the Indian Council of Medical Research alongside World Health
Organization. As this procedure has demonstrated inadequate, the DCGI has now concocted
plans for obligatory enrollment of CROs in a focal registry.

The reason for the Clinical Trials Registry-India is to energize every single clinical trial directed
in India to be tentatively enlisted before the enlistment of the primary member and to reveal
points of interest of the 20 obligatory things of the WHO ICTRP dataset. All things considered,
the correct enrollment process and necessities are still in the advancement organize. The Registry
is wanted to be an uninhibitedly accessible and accessible essential enlist. To enlist an
examination, trialists will submit data including the essential information required by the
International Clinical Trials Registry Platform or ICTRP and will get a WHO doled out special
recognizable proof number.

A noteworthy advantage of such enrollment encompasses the trading of fingerprints of clinical

trials volunteers. Fingerprinting of the volunteers is routinely attempted by many organizations
in India to keep individuals from enlisting in numerous trials. Accommodation of this
information as a feature of the focal enlistment process would encourage simple access to the
information by all partners in clinical research.

Another activity from the piece of the Ministry of Health and Family Welfare is its choice to
contribute about Rs. 250 crore in an e-administration activity for the CDSCO to work
productively and straightforwardly. A portion of the e-administration activities mulled over
incorporate online accommodation of all structures, a digitized intuitive entry, digitization of
records and online endorsements with computerized sign.