Assignment on Health Law

Title: Bio Ethics and Law: Issues and Challenges

Name: Dathranghok Robert Sean Pajat

Roll No. : 19
Semester: Ninth (9th) Semester of August 2023- December 2023
Name of institution: Department of Law, North Eastern Hill University,
Shillong.
Submitted to: Prof. Naveen Kumar

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 Table of Contents
Sl No. Contents Pg No.

1 Introduction 2

2 Definition and Development 3

3 Four Principles of Bio Ethics 4-5

4 Bio Ethics in India 6

5 Issues in Bio Ethics 7-10

6 Challenges faced by India in Bio Ethics 11-14

7 Position of Medical Laws and Ethics in India 15-16

8 Specific Laws Governing the Medical Profession in India 17

9 Landmark Cases Regarding Bio Ethics in India 18-19

10 Conclusion 20

11 Bibliography 21

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 Introduction
The bioethics law, which was passed in July 2021, has been much talked about because of its
broad scope. However, its content remains largely unknown, except to the scientific community.
Admittedly, the very notion of bioethics seems incomprehensible, almost cryptic, to anyone not
involved in medical and biological issues. To simplify matters, bioethics can be described as the
set of practices and research aimed at studying the main moral problems raised by advances in
medical and scientific disciplines.

Bioethics or medical ethics advocates respect for the human person. This multidisciplinary
questioning reflects on the possible consequences of scientific progress on society and sets, if
necessary, moral limits to prevent abuses. The main themes of bioethics are genetics,
procreation, and the end of life and the modification of cellular organisms for purposes other
than the good of humanity.

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 Definition and Development

The range of issues considered to fall within the purview of bioethics varies depending on how
broadly the field is defined. In one common usage, bioethics is more or less equivalent to
medical ethics, or biomedical ethics. The term medical ethics itself has been challenged,
however, in light of the growing interest in issues dealing with health care professions other than
medicine, in particular nursing. The professionalization of nursing and the perception of nurses
as ethically accountable in their own right have led to the development of a distinct field known
as nursing ethics. Accordingly, health care ethics has come into use as a more inclusive term.
Bioethics, however, is broader than this, because some of the issues it encompasses concern not
so much the practice of health care as the conduct and results of research in the life sciences,
especially in areas such as cloning and gene therapy (see clone and genetic engineering), stem
cell research, xenotransplantation (animal-to-human transplantation), and human longevity.

Although bioethics—and indeed the whole field of applied ethics as currently understood—is a
fairly recent phenomenon, there have been discussions of moral issues in medicine since ancient
times. Examples include the corpus of the Greek physician Hippocrates (460–377 BC), after
whom the Hippocratic oath is named (though Hippocrates himself was not its author);
the Republic of Plato (428/27–348/47 BC), which advocates selective human breeding in
anticipation of later programs of eugenics; the Summa contra gentiles of St. Thomas
Aquinas (1224/25–1274), which briefly discusses the permissibility of abortion; and the Lectures
on Ethics of the German Enlightenment philosopher Immanuel Kant (1724-1804), which
contains arguments against the sale of human body parts.

Bioethics emerged as a distinct field of study in the early 1960s. It was influenced not only by
advances in the life sciences, particularly medicine, but also by the significant cultural and
societal changes taking place at the time, primarily in the West. The perfection of certain
lifesaving procedures and technologies, such as organ transplantation and kidney dialysis,
required medical officials to make difficult decisions about which patients would
receive treatment and which would be allowed to die. At the same time, the increasing
importance placed on individual well-being contributed to changes in conventional attitudes
toward marriage and sexuality, reproduction and child rearing, and civil rights. The ultimate
result was widespread dissatisfaction with traditional medical paternalism and the gradual
recognition of a patient’s right to be fully informed about his condition and to retain some
measure of control over what happens to his body.

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 Four Principles of Bioethics

Regardless of the differences between the medical and scientific rules applicable in each country,
all bioethics laws in India and in the rest of the world are based on four founding principles.

– The law of benevolence

Medical practices that are permitted and deemed to be in accordance with bioethics are always
for the benefit of the individual. Decisions governed by bioethical rules must never cause
physical or psychological harm to third parties who will be involved, directly or indirectly, in a
human action that raises bioethical issues. Such action or decision is deemed to be medically or
scientifically ethical if its benefits to humans do not come at the expense of destruction,
degradation or any other negative impact on other individuals.

– The principle of maleficence

The principle of maleficence in bioethics is closely related to the principle of benevolence. One
cannot exist without the other. Simply put, bioethics refutes any action that may cause more or
less serious negative effects in the political, biological, philosophical and environmental fields,
among others.

– The principle of freedom and autonomy

In bioethical issues, each individual is the master of his or her own choice. Bioethics considers
each person as a limitless entity, free to make all decisions regarding his or her health and any
other matter related to biology, politics, environmental science and genetics. According to the
principle of freedom, no organisation, no external entity can impose on the individual a choice
that affects his or her physical health and well-being.

– The principle of justice

The fourth principle of bioethics establishes the sharing of responsibility for the benefits, risks
and costs of a bioethical action or decision. The principle of equality and equity also applies to
materials and rights relating to the ethical values of a biological factor.

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In French law, these four main principles of bioethics are complemented by two other important
notions, including the principle of solidarity and the principle of dignity.

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 Bioethics in India
The Indian Council of Medical Research (ICMR), is important in the region and in our country,
mainly because it funds research in India. Set up in 1911 by the British as the Indian Research
Fund Association, it was renamed in 1949 the Indian Council of Medical Research. Its main
function is to formulate, coordinate and promote biomedical research in India through intramural
as well as extramural research programmes. It has 27 permanent institutions spanning the
country and 6 regional medical research centres at Dibrugarh, Assam;, Port Blair, Anadaman and
Nicobar; Bhuvaneshwar, Orissa; Jabalpur, Madhya Pradesh; Belgaum, Karnataka; and Jodhpur,
Rajasthan. The regional research centres concentrate on research pertaining to the diseases of
their particular region, where there is often a lack of proper government infrastructure for health
care delivery. Consequently, the ICMR also functions as a service provider in those regions.
Its mandate is to undertake and support research, not only basic, applied or epidemiological
research but also operational research in the area of public health using a variety of tools,
including those of modern biology. The ICMR fosters a research culture by improving funding,
mainly for developing infrastructure. It also advocates and lobbies for certain methodologies
which need to be used to carry out high-quality research; creates awareness about research, from
the medical student stage to the highest level; and concentrates on methods of applying the
research for the benefit of the community. Sometimes the association also works to foster
community support and promote an environment conducive to innovative research.

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 Issues in Bio Ethics

The health care context

The issues studied in bioethics can be grouped into several categories. One category concerns the
relationship between doctor and patient, including issues that arise from conflicts between a
doctor’s duty to promote the health of his patient and the patient’s right to self-determination
or autonomy, a right that in the medical context is usually taken to encompass a right to be
fully informed about one’s condition and a right to be consulted about the course of one’s
treatment. Is a doctor obliged to tell a patient that he is terminally ill if there is good reason to
believe that doing so would hasten the patient’s death? If a patient with a life-threatening
illness refuses treatment, should his wishes be respected? Should patients always be permitted
to refuse the use of extraordinary life-support measures? These questions become more
complicated when the patient is incapable of making rational decisions in his own interest, as in
the case of infants and children, patients suffering from disabling psychiatric disorders such
as schizophrenia or degenerative brain diseases such as Alzheimer disease, and patients who
are in a vegetative state.

Traditional philosophical questions

Another category of issues concerns a host of philosophical questions about the definition and
significance of life and death, the nature of personhood and identity, and the extent of human
freedom and individual responsibility. At what point should a fatally injured or terminally ill
patient be considered dead? When his vital functions—e.g., heartbeat and breathing—have
ceased? When the brain stem has ceased to function? Should the presence of deep coma be
sufficient to establish death? These and similar questions were given new urgency in the 1960s,
when the increased demand for human organs and tissues for use in transplant operations forced
medical ethicists to establish guidelines for determining when it is permissible to remove organs
from a potential donor.

At about the same time, the development of safer techniques of surgical abortion and the
growing acceptability of abortion as a method of birth control prompted increasing debate about
the moral status of the human fetus. In philosophical discussion, this debate was framed in terms
of the notion of a “person,” understood as any being whose interests are deserving of special
moral concern. The central issue was whether—and, if so, at what stage—the fetus is a person in
the moral sense. In slightly different terms, the issue was whether the class of persons is
coextensive with the class of human beings—whether all and only human beings are persons, or
whether instead there can be human beings who are not persons or persons who are not human
beings (the latter category, according to some, includes some of the higher animals
and hypothetical creatures such as intelligent Martians). These questions were raised anew in

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later decades in response to the development of drugs, such as RU-486 (mifepristone), that
induce abortion up to several weeks after conception and to the use of stem cells taken from
human embryos in research on the treatment of conditions such as parkinsonism (Parkinson
disease) and injuries of the central nervous system.

A closely related set of issues concerns the nature of personal identity. Recent advances in
techniques of cloning, which enabled the successful cloning of animals such as sheep and
rabbits, have renewed discussion of the traditional philosophical question of what, if anything,
makes a particular human being the unique person he is. Is a person just the sum of the
information encoded in his genes? If so, is the patient who has undergone gene therapy a
different person from the one he was before—i.e., has he become someone else? If a human
being were to be cloned, in what sense would he be a copy of his “parent”? Would he and his
parent be the same person? If multiple human beings were cloned from the same parent, would
they and their parent all be the same person?

The attempt to understand personal identity in terms of genetic information also raised anew the
philosophical problems of free will and determinism. To what extent, if any, is human
personality or character genetically rather than environmentally determined? Are there genetic
bases for certain types of behaviour, as there seem to be for certain types of diseases (e.g., Tay-
Sachs disease)? If so, what kinds of behaviour are so influenced, and to what extent are they also
influenced by environmental factors? If behaviour is at least partly genetically determined,
should individuals always be held fully responsible for what they do?

Finally, the possibility of developing technologies that would extend the human life span far
beyond its current natural length, if not indefinitely, has led to speculation about the value of life,
the significance of death, and the desirability of immortality. Is life intrinsically valuable? In
cases in which one is not suffering physically or emotionally, is it always better to be alive than
dead? If so, is it rational to desire immortality? What would be the significance of death in a
world in which dying was not biologically inevitable?

Social and legal issues

Many of these philosophical questions, however they are answered, have significant social and
legal dimensions. For example, advances in medical technology have the potential to create
disproportionate disadvantages for some social groups, either by being applied in ways that harm
members of the groups directly or by encouraging the adoption of social policies that
discriminate unfairly against them. Accordingly, questions of discrimination in bioethics have
arisen in a number of areas. In one such area, reproductive medicine, recently developed
techniques have enabled parents to choose the sex of their child. Should this new power be
considered liberating or oppressive? Would it be viewed positively if the vast majority of the
parents who use it choose to have a boy rather than a girl? Similar concerns have been raised
about the increasing use of abortion as a method of birth control in overpopulated countries

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such as India and China, where there is considerable social and legal pressure to limit family size
and where male children are valued more highly than female children.

In the field of genetics, the use of relatively simple tests for determining a patient’s susceptibility
to certain genetically transmitted diseases has led to concerns in the United States and other
countries that the results of such tests, if not properly safeguarded, could be used in unfair ways
by health-insurance companies, employers, and government agencies. In addition, the advent of
so-called “genetic counseling”—in which prospective parents receive advice about the chances
that their offspring will inherit a certain genetic disease or disorder—has allowed couples to
make more-informed decisions about reproduction but also has contributed, in the view of some
bioethicists, to a social atmosphere considerably less tolerant of disability than it ought to be.
The same criticism has been leveled against the practice of diagnosing, and in some cases
treating, congenital defects in unborn children.

Research on the genetic bases of behaviour, though still in its infancy, is controversial, and it has
even been criticized as scientifically invalid. Whatever its scientific merits, however, it has the
potential, according to some bioethicists, to encourage the adoption of crude models of genetic
determinism in the development of social policies, especially in the areas of education and crime
prevention. Such policies, it is claimed, could result in unfair discrimination against large
numbers of people judged to be genetically disposed to “undesirable” forms of behaviour, such
as aggression or violence.

This last point suggests a related set of issues concerning the moral status of scientific inquiry
itself. The notion that there is a clear line between, on the one hand, the discovery and
presentation of scientific facts and, on the other, the discussion of moral issues—the idea that
moral issues arise only after scientific research is concluded—is now widely regarded as
mistaken. Science is not value-neutral. Indeed, there have been ethical debates about whether
certain kinds of research should be undertaken at all, irrespective of their possible applications. It
has been argued, for example, that research on the possible genetic basis of homosexuality is
immoral, because even the assumption that such a basis exists implicitly characterizes
homosexuality as a kind of genetic abnormality. In any case, it is plausible to suggest that
scientific research should always be informed by philosophy—in particular by ethics but also,
arguably, by the philosophy of mind. Consideration of the moral issues related to one particular
branch of medicine, namely psychiatry, makes it clear that such issues arise not only in areas of
treatment but also in matters of diagnosis and classification, where the application of labels
indicating illness or abnormality may create serious disadvantages for the individuals so
designated.

Many of the moral issues that have arisen in the health care context and in the wake of advances
in medical technology have been addressed, in whole or in part, in legislation. It is important to
realize, however, that the content of such legislation is seldom, if ever, dictated by the positions

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one takes on particular moral issues. For example, the view that voluntary euthanasia is morally
permissible in certain circumstances does not by itself settle the question of whether euthanasia
should be legalized. The possibility of legalization carries with it another set of issues, such as
the potential for abuse. Some bioethicists have expressed the concern that the legalization of
euthanasia would create a perception among some elderly patients that society expects them to
request euthanasia, even if they do not desire it, in order not to be a burden to others. Similarly,
even those who believe that abortion is morally permissible in certain circumstances may
consistently object to proposals to relax or eliminate laws against it.

A final class of social and legal questions concerns the allocation of health care resources. The
issue of whether health care should be primarily an individual or a public responsibility remains
deeply controversial. Although systems of health care allocation differ widely, they all face the
problem that resources are scarce and consequently expensive. Debate has focused not only on
the relative cost-effectiveness of different systems but also on the
different conceptions of justice that underlie them. The global allocation of health care
resources, including generic forms of drugs for life-threatening illnesses such as HIV/AIDS, is
an important topic in the field of developing world bioethics.

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 Challenges Faced by India in Bio Ethics
There are several challenges relating to implementing digitization programs, with India’s
healthcare infrastructure being short by almost half of what the WHO recommends as the
optimal number of doctors, nurses, medical technicians, and healthcare facilities required to
serve the population. Under excessive strain for decades and without sufficient budgetary
support, the country’s health system is overburdened by the tackling of infectious diseases
(tuberculosis and neglected tropical diseases), as well as so-called lifestyle disorders (diabetes,
stroke, and heart and neurological problems). Therefore, I have identified two key legal and
ethical challenges, i.e., informed consent and privacy, as a focus of this paper. These will be
discussed in turn.

1. Informed Consent
Consent is the expression of the right to autonomy, granting an individual the freedom to
make decisions and to make active, conscious, affirmative, and voluntary agreements to engage
in an activity or process. Respect for autonomy is considered one of the key grounding principles
underlying consent. It is, however, pertinent to note that although consent may be the best-
recognized way to permit disclosures of private information, consent is often not informed or
given under economic duress and thus does not provide sufficient protection to patients.
Therefore, it is imperative that the consent of the patient be informed to protect their interests.
Further, it is important for consent to be maintained for all medical interactions, whether in-
person or via telemedicine. An individual’s right to autonomy and ability to exercise consent is
mediated by a range of structural, political, legal, socio-cultural, economic, attitudinal, and
capacity-related barriers. The United Nation’s International; Disability Caucus defines the term
“informed consent” as “Informed decisions [that] can be made only with knowledge of the
purpose and nature, the consequences, and the risks of the treatment and rehabilitation supplied
in plain language and other accessible formats.” The definition ensures equal decision-making
powers for persons with disabilities and other marginalized individuals. Informed consent for
treatment is based on the premise that individuals not only have a right to decide what happens to
their bodies but that both medical goals and individual goals must be considered for treatment
choices.

The concept of informed consent has matured over the years. The term surfaced in the
1950s and, over the ensuing 20 years, revolved around the obligation to disclose information to
the patient. From the 1970s to the present, the obligation of disclosure evolved into the necessity
of the subject understanding and consenting to the treatment course on which they were about to
embark. The key elements of informed consent are disclosure of information, patient
understanding, voluntariness, and authorization. Informed consent can only occur through
autonomy. Informed consent implies the provision of comprehensive information to the
concerned person whose data are being procured in this case, and in the context of healthcare in
particular, informed consent is defined as the right and responsibility of every individual to make

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informed decisions about their health and care together with their healthcare providers. In order
to facilitate this, healthcare providers must provide patients with the information and support that
is evidence-based, culturally appropriate, and personalized.

The principles of self-determination and individual patient autonomy are at the foundation
of informed consent. Autonomy, when defined within the human rights framework, is
understood as the right of an individual to make free and autonomous decisions about their
bodies, sexual and reproductive capacities, functions, and choices, free from any coercion or
violence. The right of autonomy is at the core of the fundamental rights to equality and privacy
and is among the core human rights principles that must be accounted for in ensuring the
realization of the health rights of all persons without any discrimination. Consent is the
expression of the right to autonomy, granting an individual the freedom to make decisions and to
make active, conscious, affirmative, and voluntary agreements to engage in an activity or
process. Individual autonomy encompasses an individual’s right to control their choices, as well
as the right of freedom from unwanted interference in that regard, only achieved if patients are
sufficiently informed of their rights to refuse medical treatments (105 N.E. 92, 93 (N.Y. 1914)).
Individual autonomy was advocated in Schloendorff v. Society of New York Hospital, wherein
Justice Cardozo wrote, “Every human being of adult years and sound mind has a right to
determine what shall be done with his own body.” In the Indian context, the importance of
informed consent can perhaps be most clearly seen in the administration of the human papilloma
virus (HPV) vaccine to Adivasi (Indigenous) girls in Andhra Pradesh and Gujarat in 2007. After
the death of four indigenous girls, the administration of the vaccine immediately stopped. The
girls and their caretakers were not given information to understand the purpose of the vaccine or
its side effects. Kalpana Mehta filed a public interest litigation claiming the vaccines were
approved after 2007 when they were administered. The lawyer Colin Gonsalves argued that these
were human trials that violated adolescent girls. Even if the vaccines were administered with the
good intention of ending the prevalence of HPV amongst indigenous women, doing so without
their informed consent is dehumanizing. Consent and communication are rights-based principles
and must be emphasized when providing healthcare to marginalized persons.

Melinda McCormick identifies the main concern with ‘informed consent’ as being that
“subjects, to the degree that they are capable, be given the opportunity to choose what shall or
shall not happen to them”. For instance, when conducting research, one may provide information
to survey respondents about the research, but it is difficult to confirm if they have adequately
comprehended the implications of the research. Indian ethicist Amar Jesani notes that at an
institution referred to him for ethical consultation, patients who attempted to receive care at the
hospital were asked to give written general consent stating they consented to the hospital using
their medical records, including case papers, X-rays, ultrasound scans, and more for use in any
research. The only compromise provided by the institution was that the patients’ names and
likenesses would not be disclosed. This blanket consent is justified by the fact that it is a cost-
effective way for students to conduct research. It is also argued that the research contributes to

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the good of the public, improving patient care. However, Jesani highlights that speaking for the
public is problematic, as one cannot provide informed consent when they do not have specific
information on what the consent entails. This is particularly salient when patients are in a
vulnerable position and need medical care.

Informed consent is one of the major requirements of the Data Protection Rules. The DPDP
Bill also requires that data are only processed for lawful purposes but adds that the contact
details for a Data Protection Officer must be provided as a resource, the data principal has the
right to request that their data be redacted or erased, and that the data fiduciary cannot monitor or
target advertisements to children. Further, under the NDHB, data are to be collected as per a
consent framework that has been established for the collection and processing of health data. The
blueprint states that the data source is to be considered as the owner of the data, which shall
exercise control over the nature of the data collected, with whom and how the data are shared,
and the purpose and processing of data. Anonymized data may be accessed by the government to
study disease prevalence and for framing policies. However, the blueprint is silent on what the
consent framework would be like at the ground level and has been said to fall short of ensuring
that patients provide informed consent with respect to the way their health data would be used.

The lack of a legal framework could impact access to data protection broadly. The rapid
growth of e-commerce in India is proof that a comprehensive framework is needed to regulate
online industries. Online payments have rapidly increased in the country, which necessitates that
the government provides protections against criminals who perform scams, pushing for robust e-
governance and a digitally empowered society. This includes digital health. Digital health could
also be impacted by a lack of government protections. For example, frontline health workers in
Karnataka were supported by the assets of digital health, such as engaging, video-based health
education material. However, they were hindered by the lack of infrastructure, as digital
initiatives have overlooked broader socio-cultural practices that influence the way frontline
workers operate, and the digital framework has not adapted to their needs. For instance,
community healthcare workers must combat persisting issues, such as language barriers, social
stigmas associated with HIV status, and inter-personal power dynamics within communities,
which continue to battle embedded hierarchies of caste and gender, among other issues.

A common problem with obtaining user consent for processing their data is the difficulty in
explaining to the user in simple terms what data are being collected, how it is being processed,
and whom it may be shared with. Therefore, in addition to obtaining user consent for collecting
and processing data, a robust regulatory framework governing health records should be put in
place. India’s ASHA workers, who are often residents of the poor and rural villages they serve,
should be more highly valued parts of the healthcare system and provided training to be
telemedicine coordinators in low technology and low resource areas. For example, users may
consent to websites using their “cookies” without realizing what this means and that it may track
and collect data related to their online behavior, including a record of their website visits and
activity. This information may then be provided to advertisers without their knowledge. This

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problem is compounded in India due to low levels of digital literacy. The concerted push for
large-scale digitization is confronted with the challenges that result from a lack of digital literacy
among almost 90% of India’s population. There is a further disparity when it comes to the level
of digital literacy in urban and rural India, with the digital literacy rate being 61% in urban India
as contrasted with 25% digital literacy in rural areas.

When dealing with marginalized persons particularly, the contours of informed consent
become even more challenging to navigate. For example, in research focusing on adolescent girls
with anorexia, it has been noted that the assumption that parents know what is in the best interest
of their children does not always hold true. Similarly, in the case of abortion laws in India, the
requirement of parental or guardian consent has proven to be a major barrier to access to abortion
and other reproductive healthcare services. Further, given the lack of digital literacy in India, the
process of obtaining informed consent may further entrench the asymmetries of power and social
hierarchies that define the relationship between a medical practitioner and a patient. For instance,
there is a widespread stigma against transgender and gender-variant persons in India receiving
gender-affirming surgery or hormone therapy. Transgender persons must provide a certification
from a psychiatrist affirming their dysphoria in addition to informed consent, indicating
skepticism around a transgender person’s ability to determine whether they want to pursue
gender-affirming treatments, thus taking away from their right of autonomy. It also provides the
additional barrier of a psychiatrist’s referral, which many persons cannot afford. One of the
alternatives proposed is that of ‘ongoing consensual decision making’ where “the respondent is
kept informed as to their vulnerability to potential dangers and the decisions regarding the
research are made as a team”. Digital health may be more widely accessible, but the model for
informed consent is currently underdeveloped. Thus, it is essential to establish a comprehensive
legal framework with set rules around obtaining informed consent within a rights-based
framework, which would entail taking note of the structural inequalities that can determine the
extent to which an individual can have autonomous decision-making power over their personal
data.

This means that organizations must have standard measures ensuring that patients
understand what data are being collected and why. With consideration for the unique needs of
marginalized communities, including sensitivity towards their socioeconomic conditions and
privacy rights, a rights-based framework can be implemented, which not only ensures that
informed consent can be actualized in a manner that secures the rights of autonomy and protects
the privacy and confidentiality of the person concerned. The challenges concerning privacy are
discussed in the next section.

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 Position of Medical Laws and Ethics in India
The Medical Council Act, 1956 looks over the wrongdoings of medical practitioners in India. In
1933, the Indian Legislative Assembly passed the Indian Medical Council Act, 1933. This Act
was highly criticised resulting in repealing of the entire Act. A new Act called the Indian
Medical Council Act, 1956 was formed and passed which is the current law of the land.

In A.S. Mittal and Another v. State of U.P. and others, 1 the Court had opined that there is a
possibility of criminal convictions by criminal courts for offences including moral turpitude as it
was very clearly observed by the Hon’ble Supreme Court that medicinal profession is one of the
most established callings of the world and is the most philanthropic one in Poonam Varma v.
Ashwin Patel2.

General Medical Council (acting at State level) is the apex body to manage the misconduct of the
medical practitioners. Some additional powers to expel and suspend medical practitioners (if
required) have been given to the State Medical Council. They are also empowered to enlist the
medical practitioners who have faced disciplinary actions.

Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002
(amended upto 8th October, 2016) indicates the duties and responsibilities of the registered
medical practitioners.

These regulations enforce certain standards which medical practitioners are required to follow. If
they fail to do so, legal action can be taken against them and they can be penalized as well. Some
of the duties and responsibilities of the physician are –

1. Maintaining good medical practice

2. Maintenance of medical records
3. Highest quality assurance in patient care
4. Patience, delicacy and secrecy
5. Patient should not be neglected
6. Unnecessary consultations should be avoided
7. Punctuality in Consultation
8. Not to conduct sex determination test
9. Advertising is not allowed
1
1989 AIR 1570
2
AIR 1996 SC 2111

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 10. Contravening cosmetics and drugs act are not allowed
11. Reporting to call for emergency, military situations
12. Reporting of suspected causes of death
13. There should be informed consent of the patient
14. Running an open medical shop is not allowed
15. Ban on practice of euthanasia
Medical Practitioners are required to follow the standards set in the Code. The Code also states
acts of commission or omission on the part of a physician which shall constitute misconduct
rendering him liable for disciplinary action.

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 Specific Laws Governing the Medical Profession in India
There are numerous legislations which have been formed and are currently in implementation in
India. Following are the categories under which the legislations are grouped together –

1. Laws Related to Governing the Commissioning of Hospital

2. Laws Governing the Qualifications / Practice and Conduct of Professionals
3. Laws Governing Storage / Sale of Drugs and Safe Medication
4. Laws Governing Biomedical Research
5. Laws Governing to Management of Patients
6. Laws Governing Medico Legal Aspects
7. Law Governing The Safety of Patients, Public and Staff within the Hospital Premises
and Environmental Protection
8. Laws Governing the Safety of Patients, Public and Staff within the Hospital Premises
9. Laws Governing the Employment of Manpower
10. Laws Governing to Professional Training and Research
11. Regulations Governing the Business Aspects of Hospital

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 Landmark Cases regarding Bio Ethics in India

Dr. Kunal Saha v. Dr. Sukumar Mukherjee, AMRI (Advanced Medicare and Research
Institute Ltd.) and Ors.3

Popularly known as Anuradha Saha Case, this case was filed in 1998 against AMRI Hospital,
namely three doctors – Dr. Sukumar Mukherjee, Dr. Baidyanath Halder and Dr. Balram Prasad.
The petitioner had alleged medical negligence on the part of the doctors resulting in the death of
the patient.

Facts of the case in brief – Petitioner’s wife was suffering from a drug allergy and the doctors
were negligent in prescribing the medicines, which further aggravated the condition of the wife,
resulting in her untimely death.

Supreme Court found the doctors guilty and awarded a compensation of around seven crores to
the petitioner for the loss of his wife.

V. Kishan Rao v. Nikhil Super Speciality Hospital and Anr.,4

Krishan Rao had filed a case against the hospital alleging that his wife was wrongly diagnosed
and treated which resulted in her death.

Facts of the case in brief – Petitioner’s wife was suffering from malaria fever whereas she was
treated for typhoid fever. Due to the wrong medication and treatment given by the hospital, her
condition worsened leading to her death.

Court found the Hospital at fault by applying the principle of “ipsa loquitur” (Latin for “the thing
speaks for itself”) and the Petitioner was awarded a compensation of Rs. two lakhs.

 Mrs. Arpana Dutta v. Apollo Hospital Enterprises Ltd. and Ors.,5

Facts of the case in brief – A woman had surgery for removal of cysts in her uterus. The doctors
told her that the operation is successful. However, after a couple of days, the woman died
complaining of severe pain in her lower abdomen. After her body was cremated, a pair of
scissors was found in the ashes. It was later found out by the Court that during the operation for
removal of cysts, one of the operators had negligently dropped the pair of scissors in the
abdomen of the woman.
3
III (2006) CPJ 142 NC
4
(2010) 5 SCC 513
5
AIR 2000 Mad 340

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The principle of vicarious liability i.e. “qui facit per alium facit per se” (Latin for “He who acts
through another does the act himself”) was applied in this case and the authorities of the Hospital
were held guilty and a hefty compensation was awarded to the patient’s family.

Pravat Kumar Mukherjee v. Ruby General Hospital and Ors.,6

The National Consumer Disputes Redressal Commission of India gave a landmark judgement on
treating of accident victims.

Facts of the case in brief – A boy named Samanate Mukherjee, a second year student pursuing B.
Tech from Netaji Subhas Chandra Bose Engineering College had met with an accident. The boy
was hit by a Calcutta transport bus and rushed to the hospital which was one kilometer from the
accident spot. He was in conscious state when he was being taken to the hospital and he showed
his medical insurance card, which clearly indicated that he will be given a sum of Rs. 65,000 by
the Insurance Company in case of an accident. Relying on it, the Hospital started his treatment.
However, after initial treatment, the hospital demanded a sum of Rs 15,000 and on the non-
payment of the demanded money, hospital discontinued his treatment. Afterwards, he was rushed
to another hospital however, he died before reaching there.

National Commission held Ruby Hospital liable and a compensation of Rs. 10 lakhs was given to
the grieving parents.

Above mentioned are some of the landmark cases which shows how negligence and unethical
conduct on behalf of the medical practitioners can lead to serious consequences, even resulting in
death of the patients. Hence, it is extremely important for physicians to follow the proper
procedure along with code of conduct keeping in mind the basic morals.

6
2005 CPJ 35 (NC)

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 Conclusion
Medical law is clearly a constantly developing topic, with new developments both complicating
and simplifying the work of medical professionals. Take the new gene-altering method that
scientists have discovered, which enables parents to change their child's genes to generate the
desired progeny. How far is it moral to manipulate the forces of nature? Some might claim that it
will lower the mortality rate while aiding in the treatment of ailments.

Even the dynamics of doctor-patient relationships are evolving, and it is frequently observed that
ethical guidance places greater expectations on physicians than merely following the law.
Although there may be conflicts, inconsistencies, and parallels between a doctor's legal
obligations and his ethical obligations, it is his responsibility to uphold both the law and
professional ethical standards. Compliance with the law is required, even when a doctor finds it
challenging to do so, maybe because it conflicts with his ethical principles.

As a result, a lot of medical professionals today adhere to pragmatism since it aims to create a
methodology that draws on actual experiences to create strategies that are grounded in reality.
The difficulties that patients and medical personnel experience in the real world are what
pragmatists are interested in, not lofty ethical ideals. Rather than using the elegant language of
the philosophers, the focus is on investigating how they see, comprehend, and interpret the
problems.

All things considered, it is clear that the area of medical laws and ethics is indeed complicated
and challenging for everyone to comprehend and formulate because individuals have a variety of
ideas, notions, and interests related to their life. However, it is expected among experts and
thinkers that in the future, a better strategy that is acceptable to all may come into force;
however, until then, we need to be cautious of what practices are being used around the world
because human lives are on the line.

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 Bibliography
 Menon N R Madhava. “Medicine, ethics and the law.” Indian Journal of Medical Ethics
[Online]
 https://www.britannica.com/topic/bioethics
 https://www.mdpi.com/2227-9032/11/6/911
 https://www.sciencedirect.com/topics/agricultural-and-biological-sciences/bioethics
 https://www.emro.who.int/emhj-volume-12-2006/volume-12-supplement-1/bioethics-
activities-in-india
 https://blog.ipleaders.in/medical-laws-conflict-ethics/

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