The Embodiment of Privacy Regulation within Domestic

Legislation
This section of the study analyses the viability of an approach that takes into
account the efficacy of domestic legislation in regulating practices pertaining to the
privacy of individuals in the healthcare sector. This approach perceives the letter
and spirit of the law as the foundational structure upon which internal practices, self
regulation and the effective implementation of policy considerations that aim to
create an atmosphere of effective privacy regulation take shape, within institutions
that offer healthcare services. To this effect, domestic legislationthat provides for
the protection of a patient’s privacy has been examined. The law has been further
studied with respect to its tendency to percolate into the everyday practices,
regulations and guidelines that private and government hospitals adhere to. The
extent of its permeation into actual practice; in light of its efficacy in fulfilling the
perambulatory objectives of ensuring safe and unobtrusive practices,within the
construct of which a patient is allowed to recover and seek treatment, has also been
examined.
The term ‘Privacy’ is used in a multitude of domestic legislations primarily in
the context of the foundation of the fiduciary relationship between a doctor
and a patient.This fiduciary relationship emanates from a reasonable expectation
of mutual trust between the doctor and his patients and is established through the
Indian Medical Council Act of 1952, specifically section 20(A) of the Act which lays
down the code of ethics which a doctor must adhere to at all times. Privacy within
the healthcare sector includes a number of aspects including but not limited
to informational privacy (e.g., confidentiality, anonymity, secrecy and data
security); physical privacy (e.g., modesty and bodily integrity); associational
privacy (e.g. intimate sharing of death, illness and recovery); proprietary
privacy (e.g., self-ownership and control over personal identifiers, genetic data, and
body tissues); and decisional privacy (e.g., autonomy and choice in medical
decision-making).
Privacy Violations stem from policy and information gaps: Violations in the
healthcare sector that stem from policy formulation as well and implementation
gaps[2] include the disclosure of personal health information to third parties without
consent, inadequate notification to a patient of a data breach, unlimited or
unnecessary collection of personal health data, collection of personal health data
that is not accurate or relevant, the purpose of collecting data is not specified,
refusal to provide medical records upon request by client, provision of personal
health data to public health, research, and commercial uses without de-identification
of data and improper security standards, storage and disposal. The disclosure of
personal health information has the potential to be embarrassing, stigmatizing or
discriminatory.[3] Furthermore, various goods such as employment, life, and
medical insurance, could be placed at risk [4]if the flow of medical information were
not restricted. 
[5]

Disclosure of personal health information is permitted and does not amount to a

violation of privacy in the following situations: 1) during referral, 2) when demanded
by the court or by the police on a written requisition, 3) when demanded by
insurance companies as provided by the Insurance Act when the patient has
relinquished his rights on taking the insurance, and 4) when required for specific
provisions of workmen's compensation cases, consumer protection cases, or for
income tax authorities,  5) disease registration, 6) communicable disease
[6]

investigations, 7) vaccination studies, or 8) drug adverse event reporting. [7]

The following domestic legislations have been studied and relevant provisions of
the Act have been accentuated in order to analyse their compliance with the basic
principles of privacy as laid out in the A.P Shah Committee report on Privacy.
Mental Health Act, 1987[8]
The Provisions under the Act pertaining to the protection of privacy of the patient
have been examined. The principles embodied within the Act include aspects of the
Law that determine the nature and extent of oversight exercised by the relevant
authorities over the collection of information, the limitation on the collection of data
and the restrictions on the disclosure of the data collected. The principle of
oversight is embodied under the legislation within the provisions that allow for the
inspection of records in psychiatric hospitals and nursing homes only by officers
authorized by the State Government.  The limitation on the Collection of information
[9]

is imposed by the Inspection of living conditionsby a psychiatrist and two social

workers are on a monthly basis. This would include analyzing the living condition of
every patient and the administrative processes of the psychiatric hospital and/or
psychiatric nursing home.  Additionally, Visitors must maintain a book regarding
[10]

their observations and remarks.  Medical certificates may be issued by a doctor,

[11]

containing information regarding the nature and degree of the mental disorder as
reasons for the detention of a person in a psychiatric hospital or psychiatric nursing
home.  Lastly, the disclosure of personal records of any facility under this Act by
[12]

inspecting officers is prohibited [13]

Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex

Selection) Act, 1994  [14]

The Act was instituted in light of a prevalent public interest consideration of

preventing female foeticide. However, it is imperative that the provision of the Act
remain just shy of unnecessarily intrusive techniques and do not violate the basic
human requirement of privacy in an inherently personal sphere. The procedure that
a mother has to follow in order to avail of pre-natal diagnostic testing is mandatory
consent of age, abortion history and family history. These conditions require a
woman to reveal sensitive information concerning family history of mental
retardation or physical deformities.[15] Aspecial concern for privacy and
confidentiality should be exercised with regards to disclosure of genetic
information. [16]
Medical Termination of Pregnancy Act, 1971  [17]

Although, the right to an abortion is afforded to a woman within the construct of her
inherent right to bodily privacy, decisional privacy (for e.g., autonomy and choice in
medical decision-making) is not afforded to patients and their families with regards
to determining the sex of the baby. The sections of the Act that have been
examined lay down the provisions available within the Act to facilitate the protection
of a woman’s right to privacy during the possible termination of a pregnancy. These
include the principles pertaining to the choice and consent of the patient to undergo
the procedure, a limit on the amount of information that can be collected from the
patient, the prevention of disclosure of sensitive information and the security
measures in place to prevent the unauthorized access to this information. The
Medical Termination of Pregnancy Regulations, 2003 supplement the Act and
provide relevant restrictions within every day practices of data collection use and
storage in order to protect the privacy of patients. The Act mandates Written
Consent of the patient in order to facilitate an abortion .Consent implies that the
patient is aware of all her options, has been counselled about the procedure, the
risks and post-abortion care.[18]. The Act prohibits the disclosure of matters relating
to treatment for termination of pregnancy to anyone other than the Chief Medical
Officer of the State. [19]The Register of women who have terminated their
pregnancy, as maintained by the hospital, must be destroyed on the expiry of a
period of five years from the date of the last entry.[20] The Act also emphasizes
upon the security of information collected. The medical practitioner assigns a serial
number for the woman terminating her pregnancy.[21]Additionally, the admission
register is stored in safe custody of the head of the hospital. [22]
Indian Medical Council (Professional conduct, Etiquette and Ethics)
Regulations, 2002 (Code of Ethics Regulations, 2002)
The Medical Council of India (MCI) Code of Ethics Regulations  sets the [23]

professional standards for medical practice. These provisions regulate the nature
and extent of doctor patient confidentiality. It also establishes universally recognized
norms pertaining to consent to a particular medical procedure and sets the
institutionally acceptable limit for intrusive procedure or gathering excessively
personal information when it is not mandatorily required for the said procedure. The
provisions addressed under these regulations pertain to the Security of the
information collected by medical practitioners and the nature of doctor patient
confidentiality.
Physicians are obliged to protect the confidentiality of patients  5during all stages of
the procedure and with regard to all aspects of the information provided by the
patient to the doctor, includinginformation relating to their personal and domestic
lives.  The only exception to this mandate of confidentiality is if the law requires the
[24]

revelation of certain information, or if there is a serious and identifiable risk to a

specific person and / or community ofa notifiable disease.
Ethical Guidelines for Biomedical Research on Human Subjects [25]
The provisions for the regulation of privacy pertaining to biomedical research
include aspects of consent as well as a limitation on the information that may be
collected and its subsequent use. The provisions of this act aim to regulate the
protection of privacy during clinical trials and during other methods of research. The
principal of informed consent is an integral part of this set of guidelines. ThePrivacy
related information included in the participant/ patient information sheet includes:
the choice to prevent the use of their biological sample, the extent to which
confidentiality of records could be maintained and the consequences of breach of
confidentiality, possible current and future uses of the biological material and of the
data to be generated from the research and if the material is likely to be used for
secondary purposes or would be shared with others, the risk of discovery of
biologically sensitive information and publications, including photographs and
pedigree charts.[26] The Guidelines require special concern for privacy and
confidentiality when conducting genetic family studies. [27]The protection of privacy
and maintenance of confidentiality, specifically surrounding the identity and records,
is maintained whenusing the information or genetic material provided by
participants for research purposes.  The Guidelines require investigators to
[28]

maintain confidentiality of epidemiological data due to the particular concern that

some population based data may also have implications on issues like national
security or public safety.[29]All documentation and communication of the
Institutional Ethics Committee (IEC) must be dated, filed and preserved according
to the written procedures.Data of individual participants can be disclosed in a court
of law under the orders of the presiding judge, if there is a threat to a person’s life,
communication to the drug registration authority regarding cases of severe adverse
reaction and communication to the health authority if there is risk to public health.
[30]
Insurance Regulatory and Development Authority (Third Party
Administrators) Health Services Regulations, 2001
The provisions of the Act that have been addressed within the scope of the study
regulate the practices of third party administrators within the healthcare sector so as
to ensure their compliance with the basic principles of privacy.An exception to the
maintenance and confidentiality of information confidentiality clause in the code of
conduct, requires TPAs to provide relevant information to any Court of
Law/Tribunal, the Government, or the Authority in the case of any investigation
carried out or proposed to be carried out by the Authority against the insurance
company, TPA or any other person or for any other reason.[31]In July 2010, the
IRDA notified theInsurance Regulatory and Development Authority (Sharing of
Database for Distribution of Insurance Products) Regulations [32]. These
regulations restrict referral companies from providing details of their customers
without their prior consent.[33]TPAs must maintain the confidentiality of the data
collected by it in the course of its agreement and maintain proper records of all
transactions carried out by it on behalf of an insurance company and are also
required to refrain from trading information and the records of its
business[34].TPA’s must keep records for a period of not less than three years.[35]
IDRA Guidelines on Outsourcing of Activities by Insurance Companies [36]
These guidelines require the insurer to take appropriate steps that require third
party service providers protect confidential information of both the Insurer and its
clients from intentional or inadvertent disclosure to unauthorized persons.[37]
Exceptions to the Protection of Privacy
The legal provisions with regard to privacy, confidentiality and secrecy are often
superseded by Public Interest Considerations. The right to privacy, although
recognized in the course of Indian jurisprudence and embodied within domestic
legislation is often overruled prima facie when faced with situations or instances that
involve a larger interest of a greater number of people. This policy is in keeping with
India’s policy goals as a social welfare state to aid in the effectuation of its utilitarian
ideals. This does not allow individual interest to at any point surpass the interest of
the masses.
Epidemic Diseases Act, 1897 [38]
Implicit within this formulation of this Act is the assumption that in the case of
infectious diseases, the right to privacy, of infected individuals must give way to the
overriding interest of protecting public health.[39] This can be ascertained not only
from the black letter of the Law but also from its spirit. Thus, in the absolute
positivist as well as a more liberal interpretation, at the crux of the legislation lies the
undeniable fundamental covenant of the preservation of public health, even at the
cost of the privacy of a select few individuals [40].

Policy and Regulations

National Policy for Persons with Disabilities, 2006[41]
The following provisions of the Act provide for the incorporation of privacy
considerations in prevalent practices with regard to persons with disabilities. The
National Sample Survey Organization collects thefollowing information on
persons with disabilities: the socio- economic and cultural context, cause of
disabilities, early childhood education methodologies and all matters connected with
disabilities, at least once in five years.[42]This data is collected by non-medical
investigators. [43]There is thus an inherent limit on the information collected.
Additionally, this information is used only for the purpose for which it has been
collected.
The Special Employment Exchange, as established under The Persons with
Disabilities (Equal Opportunities, Protection of Rights and Full Participation) Act,
1995 Act, collects and furnishes information in registers, regarding provisions for
employment. Access to such data is limited to any person who is authorized by
the Special Employment Exchange as well as persons authorized by general or
special order by the Government, to access, inspect, question and copy any
relevant record, document or information in the possession of any
establishment. [44] When conducting research on persons with disabilities consent
is required from the individual or their family members or caregivers.[45]
HIV Interventions
In 1992, the Government of India instituted the National AIDS Control Organization
(NACO) for the prevention and control of AIDS. NACO aims to control the spread of
HIV in India through the implementation of Targeted Interventions (TIs) for most at
risk populations (MARPs) primarily, sex workers, men having sex with men and
people who inject drugs.[46]The Targeted Interventions (TIs) system of testing
under this organization has however raised numerous concerns about relevant
policy gaps in the maintenance of the confidentiality and privacy of persons living
with HIV/ AIDS. The shortcomings in the existing policy framework include: The
Lack of a limitation and subsequent confidentiality in the amount of Information
collected. Project staff inTIsrecordthe name, address and other contact information
of MARPs and share this data with Technical Support Unit and State AIDS Control
Societies.[47] Proof of address and identity documents are required to get enrolled
in government ART programs.[48]Peer-educators operate under a system known
as line-listing, used to make referrals and conduct follow-ups. Peer-educators have
to follow-up with those who have not gone at regular intervals for testing. [49] This
practice can result in peer-educators noticing and concluding that the names
missing are those who have tested positive. [50] Although voluntary in nature, the
policy encourage the fulfillment of fulfilling of numerical targets, and in doing so
supports unethical ways of testing.[51]
The right to privacy is an essential requirement for persons living with HIV/AIDS due
to the potential stigmatizing and discriminatory impact of the revelation of this
sensitive information, in any form.[52] The lack of privacy rights often fuels the
spread of the disease and exacerbates its impact on high risk communities of
individuals. Fears emanating from a privacy breach or a disclosure of data often
deter people from getting tested and seeking medical care. The impact of such
disclosure of sensitive information including the revelation of tests results to
individuals other than the person being tested include low self esteem, fear of loss
of support from family/peers, loss of earnings especially for female and transgender
sex workers, fear of incrimination for illicit sex/drug use and the insensitivity of
counselors. [53]HIV positive individualslive in constant fear of their positive status
being leaked. They also shy away from treatment as they fear people might see
them taking their medicines and thereby guess their status. Thus breaches in
confidentiality and policy gaps in privacy regulation, especially with respect to
diseases such as HIV also prevents people from seeking out treatment. [54]

Case Law
The following cases have been used to deliberate upon important points of
contention within the ambit of the implementation and impact of Privacy
Regulationsin the healthcare sector. This includes the nature and extent of privacy
enjoyed by the patient and instances where in the privacy of the patient can be
compromised in light of public interest considerations.
Mr. Surupsingh Hrya Naik vs. State of Maharashtra ,[55] (2007)
The decision in this case held that The RTI Act 2005 would supersede The Medical
Council Code of Ethics. The health records of an individual in judicial custody should
be made available under the Act and can only be denied in exceptional cases, for
valid reasons.
Since the Code of Ethics Regulations are only delegated legislation, it was held in
the case of Mr. SurupsinghHrya Naik v.State Of Maharashtra[56] that these would
not prevail over the Right to Information Act, 2005 (RTI Act) unless the information
sought falls under the exceptions contained in Section 8 of the RTI Act. This case
dealt with the important point of contention of whether making the health records
public under the RTI Act would constitute a violation of the right to privacy. These
health records were required to determine why the convict in question was allowed
to stay in a hospital as opposed to prison. In this context the Bombay High Court
held thatThe Right to Information Act supersedes the regulation that mandate the
confidentiality od a person, or in this case a convict’s medical records. It was held
that the medical records of a a person sentenced or convicted or remanded to
police or judicial custody, if during that period such person is admitted in hospital
and nursing home, should be made available to the person asking the information
provided such hospital nursing home is maintained by the State or Public Authority
or any other Public Body. It is only in rare and in exceptional cases and for good
and valid reasons recorded in writing can the information may be denied.
Radiological & Imaging Association v. Union of India ,  (2011)
[57]

On 14 January 2011 a circular was issued by the Collector and District Magistrate,
Kolhapur requiring the Radiologists and Sonologists to submit an on-line form “F”
under the PNDT Rules. This was challenged by the Radiological and Imaging
Association, inter alia, on the ground that it violates the privacy of their patients.
Deciding the above issue the Bombay High Court held that .The images stored in
the silent observer are not transmitted on-line to any server and thus remain
embedded in the ultra-sound machine. Further, the silent observer is to be opened
only on request of the Collector/ the civil surgeonin the presence of the concerned
radiologist/sonologist/doctor incharge of the Ultra-sound Clinic. In light of these
considerations and the fact that the `F' form submitted on-line is submitted only to
the Collector and District Magistrate is no violation of the doctor's duty of
confidentiality or the patient's right to privacy. It was further observed that The
contours of the right to privacy must be circumscribed by the compelling public
interest flowing through each and every provision of the PC&PNDT Act, when read
in the background of the following figures of declining sex ratio in the last five
decades.
The use of a Silent Observer system on a sonograph has requisite safeguards and
doesn’t violate privacy rights. The declining sex ratio of the country was considered
a compelling public Interest that could supersede the right to privacy.
Smt. Selvi and Ors. v.State of Karnataka (2010)
The Supreme Court held that involuntary subjection of a person to narco analysis,
polygraph test and brain-mapping violates the ‘right against self-incrimination' which
finds its place in Article 20(3)[58] of the Constitution. [59] The court also found that
narco analysis violated individuals’ right to privacy by intruding into a “subject’s
mental privacy,” denying an opportunity to choose whether to speak or remain
silent, and physically restraining a subject to the location of the tests and amounted
to cruel, inhuman or degrading treatment.[60]
The Supreme Court found that Narco-analysis violated an individuals’ right to
privacy by intruding into a “subject’s mental privacy,” denying an opportunity to
choose whether to speak or remain silent.
Neera Mathur v. Life Insurance Corporation (LIC),[61] (1991)
In this casethe plaintiff contested a wrongful termination after she availed of
maternity leave. LIC required women applicants to furnish personal details like their
menstrual cycles, conceptions, pregnancies, etc. at the time of appointment. Such a
requirement was held to go against the modesty and self respect of women. The
Court held that termination was only because of disclosures in application, which
was held to be intrusive, embarrassing and humiliating. LIC was directed to delete
such questions.
The Court did not refer to the term privacy however it used the term personal details
as well as modesty and self respect, but did not specifically link them to the right to
life or any other fundamental right. These terms (modesty and self respect) are
usually not connected to privacy but although they may be the harm which comes
from an intrusion of one’s privacy.
The Supreme Court held that Questions related to an individual’s reproductive
issues are personal details and should not be asked in the service application forms.
Ms. X vs. Mr. Z &Anr ,[62] (2001)
In this case, the Delhi High Court held that an aborted foetus was not a part of the
body of a woman and allowed the DNA test of the aborted foetus at the instance of
the husband. The application for a DNA test of the foetus was contested by the wife
on the ground of “Right to Privacy”.7In this regard the court held that The Supreme
Court had previously decided that a party may be directed to provide blood as a
DNA sample but cannot be compelled to do so. The Court may only draw an
adverse interference against such party who refuses to follow the direction of the
Court in this respect.The position of the court in this case was that the claim that the
preservation of a foetus in the laboratory of the All India Institute of Medical
Science, violates the petitioner’s right to privacy, cannot be entertained as the
foetus had been voluntarily discharges from her body previously, with her consent.
The foetus, that she herself has dischargedis claimed to be subjected to DNA test.
Thus, in light of the particular facts and the context of the case, it was held that
petitioner does not have any right of privacy.
A woman’s right to privacy does not extend to a foetus, which is no longer a part of
her body. The right to privacy may arise from a contract as well as a specific
relationship, including a marital relationship. The principle in this case has been laid
down in broad enough terms that it may be applied to other body parts which have
been disassociated from the body of the individual.
It is important to note here that the fact that the Court is relying upon the principles
laid down in the case ofR. Rajagopal seems to suggest that the Court is treating
organic tissue preserved in a public hospital in the same manner as it would treat a
public document, insofar as the exception to the right to privacy is concerned.
B.K Parthasarthi vs. Government of Andhra Pradesh ,[63] (1999)
In this case, the Andhra Pradesh High Court was to decide the validity of a
provision in the Andhra Pradesh Panchayat Raj Act, 1994 which stipulated that any
person having more than two children should be disqualified from contesting
elections. This clause was challenged on a number of grounds including the ground
that it violated the right to privacy. The Court, in deciding upon the right to privacy
and the right to reproductive autonomy, held thatThe impugned provision, i.eSection
19(3) of the said Act does not compel directly anyone to stop procreation, but only
disqualifies any person who is otherwise eligible to seek election to various public
offices coming within the ambit of the Andhra Pradesh Panchayat Raj Act, 1994 or
declares such persons who have already been holding such offices to be
disqualified from continuing in such offices if they procreate more than two
children.Therefore, the submission made on behalf of the petitioners 'right to
privacy' is infringed, is untenable and must be rejected.”
Mr. X v. Hospital Z, Supreme Court of India ,[64] (1998 and 2002)
The petitioner was engaged to be married and thereafter during tests for some
other illness in the hospital it was found that the petitioner was HIV positive. This
information was released by the doctor to the petitioner’s family and through them
to the family of the girl to whom the petitioner was engaged, all without the consent
of the petitioner. The Court held that:
“The Right to privacy is not treated as absolute and is subject to such action as may
be lawfully taken for the prevention of crime or disorder or protection of health or
morals or protection of rights and freedoms of others.”
Right to privacy and is subject to such action as may be lawfully taken for the
prevention of crime or disorder or protection of health or morals or protection of
rights and freedoms of others.
This decision of this case could be interpreted to extend the principle, of disclosure
to the person at risk, to other communicable and life threatening diseases as well.
However, a positivist interpretation would render these principle applicable to only
to HIV+ cases.
M. Vijaya v. Chairman and Managing Director, Singareni Collieries Co.
Ltd. [65] (2001)
The petitioner alleged that she had contracted the HIV virus due to the negligence
of the authorities of Maternity and Family Welfare Hospital, Godavarikhani, a
hospital under the control of Singareni Collieries Company Ltd., (SCCL), in
conducting relevant precautionary blood tests before transfusion of blood of her
brother (donor) into her body when she was operated for hysterectomy (Chronic
Cervicitis) at the hospital. The petition was initially filed as a Public Interest
Litigation,which the court duly expanded in order to address the problem of the lack
of adequate precautionary measures in hospitals, thereby also dealing with issues
of medical confidentiality and privacy of HIV patients. The court thus deliberated
upon the conflict between the right to privacy of an HIV infected person and the duty
of the state to prevent further transmission and held:
In the interests of the general public, it is necessary for the State to identify HIV
positive cases and any action taken in that regard cannot be termed as
unconstitutional. As under Article 47 of the Constitution, the State was under an
obligation to take all steps for the improvement of the public health. A law designed
to achieve this object, if fair and reasonable, in our opinion, will not be in breach of
Article 21 of the Constitution of India
The right of reproductive autonomy is a component of the right to privacy .A
provision disqualifying a person from standing for elections due to the number of
children had, does not violate the right to privacy as the object of the legislation is
not to violate the autonomy of an individual but to mitigate the population growth in
the country. Measures to control population growth shall be considered legal unless
they impermissibly violate a fundamental right.
However, another aspect of the matter is whether compelling a person to take HIV
test amounts to denying the right to privacy? The Court analyzed the existing
domestic legislation to arrive at the conclusion that there is no general law that can
compel a person to undergo an HIV-AIDS test. However, specific provisions under
the Prison Laws[66]
provide that as soon as a prisoner is admitted to prison, he is required to be
examined medically and the record of prisoner's health is to be maintained in a
register. Further, Under the ITP Act, the sex workers can also be compelled to
undergo HIV/ AIDS test.[67]
Additionally, under Sections 269 and 270 of the Indian Penal Code, 1860, a person
can be punished for negligent act of spreading infectious diseases.
The right to privacy of a person suspected to be HIV+ would be subordinate to the
power and duty of the state to identify HIV+ patients in order to protect public
interest and improve public health. However any law designed to achieve this object
must be fair and reasonable. In a conflict between the individual’s privacy right and
the public’s right in dealing with the cases of HIV-AIDS, the Roman Law principle
'SalusPopuliestSuprema' (regard for the public wealth is the highest law) applies
when there is a necessity.
After mapping legislation that permit the invasion of bodily privacy, the Court
concluded that they are not comprehensive enough to enable the State to collect
information regarding patients of HIV/AIDS and devise appropriate strategies and
therefore the State should draft a new legislation in this regard. Further the Court
gave certain directions to the state regarding how to handle the epidemic of
HIV/AIDS and one of those directions was that the “Identity of patients who come
for treatment of HIV+/AIDS should not be disclosed so that other patients will also
come forward for taking treatment.”
Sharda v. Dharmpal ,[68] (2003)
The basic question in this case was whether a party to a divorce proceeding can be
compelled to a medical examination. The wife in the divorce proceeding refused to
submit herself to medical examination to determine whether she was of unsound
mind on the ground that such an act would violate her right to personal liberty.
Discussing the balance between protecting the right to privacy and other principles
that may be involved in matrimonial cases such as the ‘best interest of the child’ in
case child custody is also in issue, the Court held:
If the best interest of a child is in issue in the case then the patient’s right to privacy
and confidentiality would get limited. The right to privacy of an individual would be
subordinate to the power of a court to arrive at a conclusion in a matrimonial dispute
and the right of a party to protect his/her rights in a Court of law would trump the
right to privacy of the other.
"Privacy" is defined as "the state of being free from intrusion or disturbance in one's
private life or affairs". However, the right to privacy in India, is only conferred
through an extensive interpretation of Article 21 and cannot therefore in any
circumstance be considered an absolute right. Mental health treatment involves
disclosure of one's most private feelings However, like any other privilege the
psychotherapist-patient privilege is not absolute and may only be recognized if the
benefit to society outweighs the costs of keeping the information private. Thus if a
child's best interest is jeopardized by maintaining confidentiality the privilege may
be limited.” Thus, the power of a court to direct medical examination of a party to a
matrimonial litigation in a case of this nature cannot beheld to violate the petitioner’s
right to privacy.

THOA -1994/2011

Trends in Litigation
An analysis of the cases identified above also demonstrate some patterns that shed
light on the litigation taking place under the Act. Some of these are as follows:

(i) Jurisdictional Issues

There has been a degree of uncertainty with respect to the jurisdiction that is
exercised by the Authorisation Committees. Disputes arising out of this area have
found their way to the courts, and the Courts have clarified some of these issues.

In Kuldeep Singh v. State of Tamil Nadu, (2005) 11 SCC 122 the donor and
recipient were from the state of Punjab, but the transplant was sought to be
conducted in Tamil Nadu. The Authorisation Committee in Tamil Nadu refused to
issue a No-Objection Certificate, stating that the Authorisation Committee in
Punjab was the competent authority for this purpose. The Supreme Court agreed
with this contention, and held that since both the donor and recipient were from
Punjab, they were required to seek the approval of the Authorisation Committee in
Punjab. This was because since the legislative intention under the Act was to
determine the “true intent” behind the donor’s willingness to donate his or her
organs, the Authorisation Committee where he or she resides would be best placed
to do this.

Following this judgment, rule 6(b) was inserted in the Rules through the
Transplantation of Human Organ Rules, 2008. This rule stated that the legal and
residential status of the donor and recipient shall be established by state-level
committees through no-objection certificates (“NOCs”). Thus, if the domicile of the
donor, recipient and state of transplantation are different, NOCs would have to be
sought from each state, and the approval of the Authorisation Committee is to be
taken from the institution where the transplant is to take place.

This gave rise to further confusion, with some state-level committees refusing to
grant these NOCs on different grounds. In Sadhna Bhardwaj v. The Department
of Health and Family Welfare, 184 (2011) DLT 510

the petitioner’s application for the grant of an NOC from the Delhi authority to
undergo a transplant in Kolkata was rejected by the authority on the grounds that
there was no proven relationship between the potential donor and recipient. The
Delhi High Court clarified, on a plain reading of Rule 6(b), that approval is
mandatory only at the place of the intended transplant, and not at the state of
domicile of the donor or recipient. The Punjab & Haryana High Court, in a case
where an Authorisation Committee in Kolkata rejected an application on the
grounds that the potential recipient’s domicile was in Punjab, re-iterated this
position (Vinay Kumar v. State of Haryana AIR 2012 P&H 160)

A provision similar to Rule 6(b) has now been incorporated in Rule 14 of the 2014
Rules. However, this provision now states that if the donor or recipient belongs to a
state different from the state where the transplant is to take place, the residential
status shall be verified by the Tehsildar or any other officer authorised for this
purpose in the format under Form 20.

Another issue with respect to jurisdiction arose in Mukesh Gandhi v. Deputy

Secretary (Health), (AIR 2009 Guj 7) where the potential recipient was a resident of
Ahmedabad. She sought a transplant in Delhi or Hyderabad due to higher success
rates in these cities. However, her application to procure the organ in Ahmedabad
and transplant it in Delhi was rejected by the State Government. This order was
struck down by the Gujarat High Court, reasoning that the Act does not explicitly
prohibit an organ being procured in one state and transplanted in another.

(ii) Burden of Proof to Approve Transplants

Another recurring issue in litigation under the Act has been a lack of clarity with
respect to the basis for approval or rejection of transplants by Authorisation
Committees. In Kuldeep Singh v. State of Tamil Nadu, {(2005) 11 SCC 122, at 127}
the Court stated that the burden to prove that the donation is happening for reasons
of love and affection lies on the applicants:

“The burden is on the applicants to establish the real intent by placing relevant
materials for consideration of the Authorisation Committee. Whether there exists
any affection or attachment or special reason is within the special knowledge of the
applicants, and a heavy burden lies on them to establish it. Several relevant factors
like relationship if any (need not be near relationship for which different
considerations have been provided for), period of acquaintance, degree of
association, reciprocity of feelings, gratitude and similar human factors and bonds
can throw light on the issue.”

Some guidance for Authorisation Committees to make decisions with respect to

grant of approval for transplants is provided under rule 7(3) of the 2014 Rules,
which states that in cases where the potential donor and recipient are not near
relatives, the Authorisation Committee must:

(i)  “evaluate that there is no commercial transaction between the recipient and the
donor and that no payment has been made to the donor or promised to be made to
the donor or any other person;

(ii)  prepare an explanation of the link between them and the circumstances which
led to the offer being made;

(iii)  examine the reasons why the donor wishes to donate;

(iv)  examine the documentary evidence of the link, e.g. proof that they have lived
together, etc.;

(v)  examine old photographs showing the donor and the recipient together;

(vi)  evaluate that there is no middleman or tout involved;

(vii)  evaluate that financial status of the donor and the recipient by asking them to
give appropriate evidence of their vocation and income for the previous three
financial years and any gross disparity between the status of the two must be
evaluated in the backdrop of the objective of preventing commercial dealing;

(viii)  ensure that the donor is not a drug addict;

(ix)  ensure that the near relative or if near relative is not available, any adult person
related to donor by blood or marriage of the proposed unrelated donor is
interviewed regarding awareness about his or her intention to donate an organ or
tissue, the authenticity of the link between the donor and the recipient, and the
reasons for donation, and any strong views or disagreement or objection of such kin
shall also be recorded and taken note of.”

Before this provision was incorporated through the 2014 Rules, the parameters on
which the Authorisation Committees were expected to base their decisions to
approve or reject transplant requests were not very clear. Even after some guidance
has now been provided, several facets of the approval process remain unclear.

For example, the High Courts have taken different approaches to whether the
Authorisation Committees are required to conclusively establish that a commercial
transaction has taken place with respect to the organ transplantation, or if a
reasonable apprehension as to the involvement of a commercial element is enough.
In Anees Ahmed v. State of U.P., (2012 SCC OnLine All 4427) for example, the
Allahabad High Court stated that the Authorisation Committee must give an
explicit finding to the effect that there was a commercial transaction or there was a
likelihood of a commercial dealing. The High Courts have ruled in a similar manner
on at least five other occasions. {Belson Baby v. State of Kerala W.P.(C) No. 23868 of 2015
(Ker HC)(Unreported); Latheefa E. v. State of Kerala W.P.(C) No. 8339 of 2013 (Ker HC)
(Unreported); S. Samson v Authorisation Committee AIR 2008 Mad 227; Jaswinder Singh v. State
of Punjab 2008 SCC OnLine P&H 576; Rajinder Kumar v. State of Punjab AIR 2005 P&H 172}.

In other cases, the courts have adopted a lower evidentiary standard. For example,
in the case of Mohammad Sulaiman v. Union of India, (2016 SCC OnLine Del
5197) the Delhi High Court, in rejecting the petition to grant approval for an organ
transplant, noted that the donor and recipient had only met eleven days ago, and
therefore there was a high likelihood that a commercial element was involved.
Similarly, in Poonam Gupta v. State of Punjab, (2009 SCC OnLine P&H 4572) in
hearing an appeal against orders of the Authorisation Committee and Appellate
Authority, the Punjab & Haryana High Court noted that since the family members
of the potential organ recipient hadn’t come forward to offer their organs, and a
clear relationship between the donor and recipient could not be established, there
was a possibility of a commercial element to the transaction. In Pawan Anand v.
Director General of Health Services, (2012 SCC OnLine Del 4145) the financial
 disparity between the donor and recipient was the ground for the rejection of the
application to approve a transplant. In these cases, therefore, a mere apprehension
of the involvement of a commercial element in the transplant was sufficient
grounds to reject the application.

In the last category of cases, on the other hand, the courts have been very liberal in
approving organ transplants. They have thus not considered discrepancies in the
evidence presented to establish a relationship between the donor and recipient as
sufficient ground to reject applications to approve transplants. {S Malligamma v. State
of Karnataka ILR 2004 Kar 5078; Noushad KK v. Chairman W.P.(C) No. 31925 of 2010(M);
Mohammed Sali v. State of Kerala 2012 SCC OnLine Ker 30178}

While the law is sufficiently lucid about the documentary and evidentiary
requirements that must be met by applicants seeking approval for an organ
transplant, it does not clearly specify the grounds on which an Authorisation
Committee ought to approve or reject an application for an organ transplant. The
result is a diversity of judicial opinion, as set out above.

Mohammed   Sali , S/o Rayin, Pottachola House, Ezhur, Post Tirur, Malappuram District.

2. Suni T., S/o Thankachan, Kaniyantayyath House, Poruvzhi North, Chathakulam Po., Kollam
District .…. Petitioner(s)
 By Adv. Sri. C.M  Mohammed  Iquabal

v.

1.  State   of   Kerala , Rep. by The Secretary to Health Department, Government Secretariat,
Thiruvananthapuram - 695 001.

2. The Principal Secretary, Department  of  Health, Government  of   Kerala , Government

Secretariat, Thiruvananthapuram - 695 001.

3. The District Level Authorization Committee for Transplantation  of  Human Organs, Rep. by
its Chairman .…. Respondent(s)

By Sr. Government Pleader Sri. S. Abdul Salam

W.P (C) No. 28417  of   2012

Decided on December 11,  2012

JUDGMENT

This Writ Petition is filed by the petitioners aggrieved by Exhibit P10 order passed in
appeal by the Government. Therein it is informed that under Rule 4A and Sub-rule
4(ii)  of  the Transplantation  of  Human Organs Act, the application cannot be
considered.

2. The 1st petitioner is a kidney patient who is undergoing treatment in the Medical

Trust Hospital. Both his kidneys have been spoiled and it requires urgent
transplantation and he was advised so from the Hospital. The donor is the
2nd petitioner herein. It is stated that the 2 nd petitioner has been working in the
house  of  the 1st petitioner for the last six years. It is also stated that he is ready to
donate kidney to the 1st petitioner without any hesitation. Approval was sought under
Section 9(3)  of  the Act and the Hospital submitted a request to the Authorisation
Committee  of  Human Organs Transplantation as per Exhibit P2.

3. The communication Exhibit P8 is by the District Level Authorisaction Committee

for Transplantation and their findings read as follows:

“Grounds for rejection:

Donor claimed that he had worked with recipient's family for 6 years but he could
not trace out the exact place  of  work hence the committee concluded that
statements given by donor it false regarding the place  of  work. Rule 4A subsection
4(ii)(c)  of the Transplantation  of  Human Organs Act, 1994 not complied with. (c)
Documentary evidence  of  the link.”

4. It is submitted by the learned counsel for the petitioners that there was no proper
consideration  of  the matter by the District Level Authorisation Committee and the
1st petitioner filed an appeal as per Exhibit P9 dated 3.8. 2012 , which was
disposed  of  by Exhibit P10 by a cryptic order.
5. The learned Government Pleader submitted that it is only in the light  of  sub-rule
(ii)  of  Rule 4A  of  the Act that such a decision was taken as per Exhibit P10.

6. I have considered the rival submissions. A reading  of  the order will show that it is
not supported by reasons and the contentions are not adverted to. In a matter like
this, wherein a person is requiring kidney transplantation, the authorities will have to
apply their mind on various aspects and take into consideration the grievances
raised in the appeal also. Herein there is no elaborate consideration going by
Exhibit P10.
7. In the light  of  the above, the learned counsel for the petitioners submitted that
the appeal may be directed to be reconsidered, as otherwise the first petitioner will
be put into greater prejudice and the health  of  the first petitioner is deteriorating day
by day.

The Writ Petition is therefore allowed. Exhibit P10 is quashed. There will be a
direction to the Government to reconsider the matter. The appeal will be heard and
disposed  of  expeditiously and within a time limit. The learned Government Pleader
submitted after getting instructions that the appeal can be reconsidered within ten
days. The parties will appear before the 1strespondent accordingly. No costs.

2012 SCC OnLine Del 5155 : (2012) 195 DLT 79 : (2013) 123 AIC J1
(Sum 19) 11

Delhi High Court

 (BEFORE RAJIV SHAKDHER, J.)

Pawan   Anand  & Anr. .…. Petitioners

v.

Director   General   of   Health  Services and Others .…. Respondents

For the Petitioners: Mr. Mukesh  Anand , Advocate

For the Respondents: Mr. Rajeeve Mehra, ASG with Mr. M. Sumeet Pushkarna, CGSC

Mr. Gaurav Sharma and Mr. Ashish Virmani, Advocates for R-1 & 3

WP (C) No. 5960/2012

Decided on October 1, 2012

The Judgment  of  the Court was delivered by

RAJIV SHAKDHER, J.:— There are few decisions which challenge the intrinsic
attributes  of  a human being, which is, to tilt in favour  of  life and equity, as and
when equity coalesces with law. At times, similar challenges are faced by Judges.
This is one such case. Much  of  the initial dilemma faced by me was resolved on
coming across the reply that Justice Holmes gave to his friend Judge learned Hand
who while parting his company, exhorted him:— “Do justice, Sir, do justice”. Justice
Holmes in his inimitable style turned back and replied:— “that is not my job. It is my
job to apply the law”. The takeaway for me is: for a judge it is always about justice
according to law.

2. With this preface, let me first pen down, the facts obtaining in the present
case. By and large, the facts are not in dispute.
3. There are two petitioners before me. Petitioner no. 1 is the son  of  one, Mrs.
Urmila  Anand , who is suffering from a chronic liver disease accompanied with
cirrhosis  of  liver and is therefore, in urgent need  of  liver transplantation (hereinafter
referred to as the recipient). Petitioner no. 2, is one, Smt. Gulab Devi (hereinafter
referred to as donor), who is the potential donor  of  a part  of  her liver, in
respect  of  which, permission is sought under the Transplantation  of  Human
Organs and Tissues Act, 1994 (in short the Transplantation Act). The recipient is
approximately 62 years  of  age, while the donor is 43 years of  age; is married and
has five children,  of  which three are unmarried, while the other two being a son and
a daughter are married. The unmarried children are aged: twenty (20), eighteen
(18) and sixteen (16) years. The married son stays separately and is not financially
supporting the donor's family.

4. It appears that in and around April, 2012, the recipient discovered that she
was suffering from a chronic liver disease and hence, required a liver transplant.
The recipient's family appears to have approached Indraprastha Apollo Hospital,
Delhi (in short Apollo Hospital) for advice and treatment.

5. The treating doctor, one, Dr. Subash Gupta vide communication dated
16.04.2012, wrote to the Authorisation Committee, in the State  of  U.P, for
issuance  of  a No Objection Certificate (NOC), under the Transplantation Act, to
enable the necessary medical procedure to be undertaken for effecting the
transplant.

6. A certificate was also issued by the Centre for Liver and Biliary Surgery, on
08.06.2012, certifying thereby, the necessity of  a requirement  of  a liver transplant
by the recipient.
7. The recipient has also obtained NOC from the office  of  the District
Magistrate, Agra dated 21.05.2012 Recommendations have also been obtained by
the recipient from the Mayor  of  Agra and a Member  of  Parliament from Agra dated
22.05.2012 and 23.05.2012 respectively.

8. With these certificates and recommendations in hand, petitioner no. 1

approached the Authorization Committee in the State  of  Delhi as the medical
procedure was required to be conducted at Delhi. Vide a communication dated
07.06.2012, the request for effecting liver transplant was rejected. The said
communication very cryptically informed the consultant (i.e, treating doctor  of  the
recipient), that permission for transplant could not be granted for the following
reasons:—

(i). there was no reciprocal relationship between the recipient and the donor;
(ii). there appears to be an “association”  of  “Master” and “Care Taker” between
the two; and

(iii). there was a gross financial disparity between the donor and the recipient.
9. Aggrieved by the same, petitioner no. 1 approached this court by way  of  a
writ petition, bearing no. 3734/2012. Simultaneously, an appeal under section
17  of  the Transplantation Act, was also filed. The said writ petition came up for
hearing before this court on 15.06.2012 On the said date, the writ petition was
disposed  of  with a direction to respondent no. 1, to dispose  of  the appeal within a
period  of  one week from the date  of  the order. Respondent no. 1, was also,
directed to consider the judgment  of  this court passed in WP (C) 2574/2012,
titled Parveen Begum  v . Appellate Authority, decided on 15.05.2012

10. The appeal was disposed  of  by respondent no. 1 vide order dated
21.06.2012 Respondent no. 1, dismissed the appeal briefly on the ground that
based on the evidence on record, petitioner no. 1 had failed to establish “love and
affection” or “affection and attachment” as between the donor and the recipient. In
sum and substance, respondent no. 1 agreed with the decision taken by the
Authorization Committee  of  the Apollo Hospital.

11. This order  of  the respondent no. 1 was assailed before me in WP (C)

3848/2012. By order dated 09.08.2012, I allowed the writ petition and set aside the
order  of  the respondent no. 1, primarily on the ground that while passing the order
dated 21.06.2012, no personal hearing had been given to petitioner no. 1. I had
also observed that on account  of  my interaction with petitioner no. 2, I had come to
a conclusion that the apparent consent  of  respondent no. 1, was not an informed
consent. It is in these circumstances that I remanded the matter to respondent no. 1
for a de novo hearing. I had also directed respondent no. 1 to inform petitioner no. 2
with regard to all possible outcomes  of  such an operation.

12. Pursuant to the above, the respondent no. 1 undeniably granted a personal

hearing to petitioner no. 1. As directed, petitioner no. 2 was also informed, it
appears, about the possible outcomes  of  such a transplant surgery, including the
fact that, it could lead to mortality. Respondent no. 1, pursuant to its
reconsideration  of  the matter, has come to a conclusion vide the impugned order
dated 24.08.2012 that, the request  of  the petitioner no. 1, could not be accepted.
The appeal was accordingly dismissed.
SUBMISSIONS  OF  COUNSELS

13. It is against this order  of  the respondent no. 1, that the present writ petition
has been preferred. Mr. Mukesh  Anand , appeared on behalf  of  the petitioners,
while the respondents were represented by Mr. Rajeeve Mehra, learned ASG,
instructed by Mr. Sumeet Pushkarna, CGSC, Mr. Gaurav Sharma and Mr. Ashish
Virmani, Advocates.
14. Briefly, Mr. Mukesh  Anand , submitted that the impugned order would have
to be set aside in view  of  the following:—

15. The impugned order lacks cogent reasons. In this regard, it was submitted
that, the reference in the impugned order to the fact that the recipient and the donor
families did not participate in marriage functions  of  their children, was incorrect.

16. No opportunity  of  hearing was granted to the petitioners and that the order
had been passed in breach  of  the principles  of  the Natural Justice;

17. Petitioner no. 2, is cognizant  of  the consequences  of  a transplant surgery,

which is borne out from, not only the psychiatric report, but also, the advice
rendered to her by the concerned doctors i.e, Dr. Subash Gupta and Dr. Manav
Wadhawan. It was contended in this regard that, petitioner no. 2 was advised even
by respondent no. 1 pursuant to the order of  this court; a fact which is recorded
even in the impugned order  of  respondent no. 1.
 18. On merits, it was contended by learned counsel for the petitioner that there
was no financial disparity between petitioner no. 1 and his family and that  of  the
respondents family. In this regard, a reference was made to the Income Tax
returns  of  petitioner no. 1 to demonstrate that the gross income  of  petitioner no. 1,
for the Assessment Year 2011–2012 was Rs. 4,34,595/-, which after statutory
deductions, was equivalent to Rs. 3,19,600/-

19. The position for the assessment year prior to the one referred above was
even less rosy, according to the learned counsel, in as much as, the gross total
income  of  petitioner no. 1, for the assessment year 2010–2011, was Rs. 3,84,449/-
while the taxable income, after statutory deductions, was Rs. 2,71,550/-. The
position in Assessment Year 2009–2010 was more or less the same. The petitioner
no. 1, had the gross total income  of  Rs. 5,04,254/-, while the taxable income was
Rs. 3,91,360/-.
20. As against this, the husband  of  petitioner no. 2, operated two auto rikshaws;
one  of  which was owned by him and the other rented out by him; from which he
earned an annual income  of  Rs. 1,80,000/-. The donor i.e, Petitioner no. 2, ran a
tiffin service  from her house, and had, almost the same annual income i.e, Rs.
1,80,000/-. For this purpose, reliance was placed by Mr. Mukesh  Anand  on
certificates  of  Chartered Accountants dated 22.05.2012 and 01.06.2012

21. It was also contended that that even though the recipient had three children,
that is, two daughters and a son (i.e, petitioner no. 1), they were not in a position to
donate a part  of  their liver as their blood group did not match with that  of the
recipient. While, the blood group  of  the recipient, the mother, was, ‘O(-) negative’,
the blood group  of  her children i.e, petitioner no. 1 and one daughter was ‘A(+)
positive’ and that  of  the other daughter was ‘B(+) positive’. It is, for this reason, that
the family members  of  the recipient were unable to donate a part  of  their liver to
the recipient.
22. In order to demonstrate, the subsistence  of  a long relationship between the
recipient's family and that  of  the donor's family, reliance was placed by
Mr.  Anand  on the School Leaving Certificates  of  the three children  of  the donor
which, evidently bore the address  of  the house owned by the petitioner. Reliance in
this regard was also placed on photographs and a guarantee card issued by a
Refrigerator company in the name  of  the husband  of  the petitioner, which showed
the address of  the house owned by petitioner no. 1's family. The purpose was to
show that there was a long association by virtue  of which, it was stressed, intense
intimacy had developed between the recipient and the donor - which, was the
sentiment, according to the learned counsel, which propelled the donor, to offer a
part  of  her liver to the recipient.
 23. In addition to the above, reliance was also placed on the affidavit  of  the
donor wherein, she has deposed to the effect that, she has known the recipient
family since 1983, as she resided in the recipient house situate at E-319, Kamla
Nagar, Agra, U.P The donor in the said affidavit has gone on to state that she
stayed in the recipient's house till 2002. It is averred by the donor that on
account  of  this long association and the affection which the recipient showed to the
donor and her children, the donor and the recipient developed a mother and
daughter relationship. The donor further avers that on becoming aware of  the
ailment suffered by the recipient, she voluntarily offered to donate a part  of  her liver
which, as it turned out had the same blood group, as that  of  the recipient. The
donor has denied exertion  of  any coercion or undue influence on her or that her
offer to donate a part  of  her liver is motivated by commerce.

24. In support  of  his contentions, Mr.  Anand  strenuously relied upon the
judgment  of  a Single Judge  of  this court in the case  of  Praveen
Begum  v . Appellate Authority.

25. On the other hand, the learned ASG relied upon the impugned order to
contend that this was a clear case  of  financial disparity. The impugned order is
based on the evidence on record placed before respondent no. 1 and therefore, the
court ought to sustain the view taken in the impugned order.

26. Reliance was placed by the learned ASG on the following

judgments: Kuldeep Singh  v . State  of  Tamil Nadu, (2005) 11 SCC 122; Poonam
Gupta  v . State  of  Punjab. AIR 2009 P&H 162;

REASONS

27. I have heard the learned counsels for the parties and perused the record. On
perusal  of  the record, which was furnished in the first round  of  writ petition i.e, WP
(C) 3848/2012 and the record filed in the captioned writ petition, the following has
emerged:—

28. when the matter was taken up by the Authorisation Committee on

07.06.2012, which incidently was the Authorisation Committee  of  the treating
hospital i.e, the Apollo Hospital, both the recipient and the donor were personally
interviewed. The Authorization Committee comprised  of  six persons, out  of  which
four were doctors. The Authorization Committee had before it the entire record
which included the assessment  of  the treating doctor i.e, Dr. Subash Gupta and the
Centre for Liver and Biliary Surgery. The committee also had before it, the various
NOCs and recommendations issued in favour  of  the recipient. This apart, in its
record, it also had before it the psychiatric assessment  of  the donor. Apart from
other documents, there is also a donor proforma available in the record, which
shows, the total income  of  the donor as “nil”. To be noted, that alongwith this
information, there is also available on record the certificates  of  the Chartered
Accountants certifying the income  of  the donor and her husband, to which I have
already made a reference above. The transcript  of  the interview that the
Authorization Committee had with the recipient, petitioner no. 1, the donor and her
husband is also on record. The photographs filed by the recipient's family are also
found on record.
29. The Authorisation Committee after due consideration  of  this entire
body  of  evidence concluded that there was a “Master” and a “Caretaker”
relationship between the recipient's family and that  of  the donor. It was the
Authorisation Committee's assessment that there was gross financial disparity
between the donor and the recipient. Respondent no. 1, in first appeal, vide its
order dated 21.06.2012 more or less came to the same conclusion when it stated
that the relationship between the donor and recipient was not based on the love and
affection. Since, petitioner no. 1 had not been given a personal hearing, I had
remanded the matter to respondent no. 1 for a de novo hearing.
30. On remand, contrary to what has been submitted before me by Mr.  Anand ,
the impugned order clearly shows that a personal hearing was accorded to the
petitioners on 21.08.2012 under the chairmanship  of  Dr. N.K Mohanty. Therefore,
the suggestion to the contrary in the writ petition is wholly untenable. It appears that
this ground has crept in as the petitioner appears to have lifted the
ground  of  challenge which they have formulated in the petition filed in the first
round.
31. A perusal  of  the impugned order would show that the donor's husband
came in contact with the recipient's husband in early 1980's when he would
transport the recipient's husband to and fro from his home to office and back. It
appears that in and around 1983, the recipient's house which is located at E-319,
Kamla Nagar, Agra was under construction and required a caretaker. This is where,
the donor's husband stepped in and was thus tasked with the job  of  looking after
the house, in return, the donor's family was housed therein.

32. The donor has deposed before the Authorisation Committee that her family
continued to stay in the recipient house in Kamla Nagar, Agra between 1983 to
2002. After 2002, the donor's family moved to Ishwar Nagar in Agra, as the
tiffin  service which the donor ran from Kamla Nagar, Agra, did not do well. What is
also come through in the statements  of  the donor is that she has a large family,
comprising  of  five children, out  of  which two are married. The
certificates  of  Chartered Accountants submitted on behalf  of  the donor's family
shows that the donor family annually earns an income  of  Rs. 3,60,000/- with which
they are required to take care  of  rent, food, clothing, fee for three children as also
expenses which may have to incur from time to time for medical care.
 33. As against this, petitioner no. 1 has income from salary and other sources.
Petitioner no. 1's family also has assets in the form  of  their own house, with large
accommodation comprising  of  seven rooms. The recipient's husband, evidently,
retired from State Trading Corporation Ltd. as an Assistant Manager. The recipient's
two daughters are married. The assessment  of  the Authorisation Committee that
the recipient and the donor belonged to a different social milieu, is demonstrable by
the following answers to the questions raised by one  of  the Members  of  the said
Authorisation Committee.

“..Member: Kaise, aap kaise inke contact me aaye? Kaise dhoonda aapne inko?

Donor: Nahin dhunda, nahin, hamare auto chalte the na to inka jo baau ji hai na
baau ji ko le jaane lane karte the, hamare pati school ke bachhe vachhe chodte
the.

Member: Auto chalate the?

Donor: Ji abhi bhi chalate hai

Member: Abhi bhi chalate hai, vo jo teen pahiye wala hota hai?

Donor: Ji wahi chalate hai…”

34. Furthermore, a careful perusal  of  the following extracts  of  the interview had
with the donor would cast doubt about the assertion that there has been a long
association between the families  of  the recipient and the donor or that there is
financial parity between the two families. With respect to the first aspect, questions
were asked  of  the donor to the effect that having contended that her family had
stayed in the Kamla Nagar house for 16 years, she would have got herself a ration
card issued. The answer  of  the donor was as follows:—

“..Member: Kitne din rahi?

Donor: Yeh 16 saal tak

Member: 16 saal rahi uska koi ration card hai koi?

Donor: Ration crad wahan nahi banwayi thi

Member: Kyun?

Donor: Ration cad wahan nahi banwayi thi.

Member: Kyon?

Donor: Ration card yahan aakar banwai.

Member: Wahan par ration card kyun nahi banwaya?

Donor: Iss liye kyuki yahan rahne ka mann nahi tha

 Member: 16 saal aap wahan rahi scooter khareda inn 16 saal mein uske kagaz
toh bane honge na, ration card ke bina thodi hoga

Donor: Auto jo kharida thi who kisi ke naam par nhi, kisht mein kharidi thi.

Member: Apne naam par nahi kharida????

Donor: Nahi, kisht pure hoga tabhi to humara…..

Member: Abhi kaha rehte ho????

Donor: Abhi main reh rhi hu kakreta, Ishwar Nagar Kakreta.

Member: Kiraye ka makan hai aapka

Donor: Ji

Member: Kitna kiraya dete hai?

Donor: 1500, 2000

Member: 1500 dete ho 2000?

Donor: 2000 deti hu

Member: 2000 deti hai, aap kaam kya karti hai?…”

35. As to the donor's present vocation and the amount she earned, her
responses were as follows:—

“…Member: Tiffin ka matlab?

Donor: Student wagarah, jaise office wagarah khana iss type ka

Member: Ghar par banati hai aur tiffin bhejti hai

Donor: Haan ji, bache school se aate hai unhe kahti hu tiffin chodh aao.

Member: Kite tiffin hote hai roj ka?

Donor: 15, 20, 40 aise ho jata hai

Member: Kite paise leti ho

Donor: Ek ka 40 rupay leti hu. Aur meetha kuch rakh deti hu to 50 ho jata hai.

Member: Aur aapke husband tiffin le jate hai

Donor: Ji main aur 2 rakh liya jaisa helper hota hai no kam krne k liye use aur
badhti ja rahi hai…”.

36. Having regard to the above, it is quite clear that the Authorisation

Committee's assessment with regard to the glaring gap in the social and financial
status  of  the recipient's family and that  of  the donor's family, is not incorrect. This
very body of  evidence has also been examined by respondent no. 1. Having regard
to the above, one cannot find fault with the conclusion  of  the authorities below that
the offer  of  donation  of  a part  of  her liver by petitioner no. 2 i.e, the donor is not
propelled by “love and affection”.
37. It would, not be out  of  place to mention that, both the preamble  of  the
Transplantation Act as well as the provision of  section 9  of  the said Act, proclaim
and therefore, prohibit “commercial dealings” in human organs. There will rarely be
direct evidence with regard to “commercial dealings”. Commercial dealings
necessarily have to be inferred from facts and circumstances, obtaining in each
case.
38. While section 9(3)  of  the Transplantation Act, permits donation by a person
other than a “near relative”, for reasons of  affection or attachment towards a
recipient or for any other special reason - such a donation, which involves
removal  of an organ from the donor, prior to his death, and its transplantation in the
body  of  the recipient requires prior approval  of the Authorization Committee.

39. Therefore, the assessment  of  the authorities below which includes the

Authorization Committee and respondent no. 1 attains significance. I found nothing
on record which would have me come to a conclusion different from one which has
been arrived at by the authorities below. In these circumstances, I am  of  the view
that the writ petition will have to be dismissed, and consequently, the orders  of  the
authorities below sustained. It is ordered accordingly.
40. Before I conclude, I must also deal with the judgment  of  a Single
Judge  of  this court in the case  of  Parveen Begum v . Appellate Authority, which
was cited by Mr.  Anand  in support  of  his contention. A careful perusal  of  the
judgment would show that the court overturned the order  of  Authorization
Committee rejecting the application, on the ground that the Authorization
Committee had misdirected itself by carrying out its enquiry on aspects which were
not germane, i.e, to the provisions  of  the Transplantation Act and the rules framed
thereunder. The Authorization Committee sought to direct its enquiry substantially
to seek answers from the recipient as to why her relatives had not come forth to
make the donation; disregarding the fact that the donor was infact a relative (the
donor's mother and recipient were sisters) and that the Transplantation Act did not
prohibit receipt  of  donation from a person other than a near relative, as long as, it
was made on account  of  love and affection or for other special reasons. The
special reasons, would necessarily not include commerce. In my view, the judgment
ultimately turned on its own facts; as would be the case in most such cases.

41. Having come to the conclusion which I have above, I make it clear that the
dismissal  of  the writ petition will not come in the way  of  the petitioner no. 1 and/or
 the recipient attempting to enter into a swapping transaction with
relatives  of similarly circumstanced families  of  patients who are willing to donate a
part  of  their liver which matches the blood group  of the recipient in the present
case. A perusal  of  the statement  of  the petitioner no. 1 made before the
Authorization Committee is indicative  of  the fact that the recipient's family have
enlisted themselves for a swapping arrangement with the concerned hospital.

42. This apart, I also deem it fit to issue directions to the respondents to file an
affidavit before this court as to the policy which is been put in place by the
Government  of  India, Ministry  of   Health  and Family Welfare with regard to organs
harvested from cadavers. The affidavit will also disclose as to whether information
with regard to swapping requests and donation  of  organs from cadavers are
uploaded on official website. More than any other area  of  human concern, there is
an urgent need to inculcate complete transparency, accountability
and  general  awareness in the citizenary at large, in this area, by the State. This
affidavit be filed within one week from today.
43. With the aforesaid directions, the writ petition is disposed  of .

44. List for directions on 08.10.2012

45. Dasti to both parties, under the signatures  of  the Court Master.

2016 SCC OnLine Del 5197 : (2016) 233 DLT 620 : AIR 2017 Del J1
9 : (2017) 1 RCR (Cri) 83 : (2017) 169 AIC 798 : (2017) 1 RCR
(Civil) 248

In the High Court  of  Delhi at New Delhi

(BEFORE SANJEEV SACHDEVA, J.)

Mohammad  Sulaiman  (Pakistani National) & Anr. .…. Petitioners

v.

Union   of   India  & Ors. .…. Respondents

For the Petitioner: Mr. Manmohan and Mr. Prakash Verma, Advocates For the Respondents:Mr.
Kirtiman Singh, CGSC with Mr. Pranav Agrawal, Mr. Prateek Dhanda, Mr. Waize Ali Noor and
Mr. Karan Jain, Advocates for Respondent No. 1
Mr. Mudit Sharma and Ms. Bhavna Dhami, Advocates for R-2 & 3

W.P(C) 7742/2016

Decided on September 16, 2016

Drugs, Cosmetics, Medical Practice & Practitioners and Public Health —

Organ Transplant — Trafficking/Commercial Transaction — Prohibition on
Transplantation  of  Human Organs and Tissues Act, 1994 — Order passed by
authorization committee — Challenged — Authorisation Committee as well as
Appellate Authority had held that they could not rule out possibility  of  a
commercial transaction — Petitioner has not been able to establish any link
or connection or any affection or attachment or special reason as to Donor
has consented to donate liver tissue to Recipient — Statute has to be strictly
complied with to ensure that there is no trafficking or commercial angle
involved in transplantation  of  human organs or tissue — No error or infirmity
in orders  of Authorisation Committee

(Para 25)
The Judgment  of  the Court was delivered by

SANJEEV SACHDEVA, J. (Oral):— The petitioners have filed the present petition
impugning the order dated 24.08.2016 passed by the Authorisation Committee
under the Transplantation  of  Human Organs and Tissues Act, 1994 (hereinafter
referred to as the Act) rejecting the application  of  the petitioners.

2. Both the petitioners are Pakistani Nationals. Petitioner no. 1 is the proposed
Recipient and Petitioner no. 2 is proposed Donor. As per the petitioners, the
petitioner No. 1 immediately requires transplantation  of  liver tissue and may also
require transplantation  of  kidney. Whether the petitioner would require
transplantation  of  a kidney would be dependent on the condition  of  the petitioner
after the transplantation  of  liver tissue.

3. The petitioners filed an application before the Authorisation Committee on

17.08.2016 The Authorisation Committee has rejected the application on the ground
that there is no relationship between the Donor and the Recipient and no
connection could be established between the two. The rejection is also on the
ground that there is great financial disparity between the income  of  the proposed
Donor and the proposed Recipient.

4. Pending the present petition, the petitioner filed an appeal before the
Appellate Authority under the Act. The Appellate Authority by its order dated
09.09.2016 has rejected the appeal  of  the petitioner primarily on the same grounds.
Copy  of  the order  of  the Appellate Authority has been filed by the counsel for the
Respondents.
 5. Since the matter required an urgent hearing, on the request  of  the petitioners,
the petitioners were permitted to impugn the order  of  the Appellate Authority
without moving any formal application for amendment.
6. Arguments  of  both the parties have been heard.

7. Learned counsel for the respondents submits that both the Authorisation
Committee as also the Appellate Authority could not find any link between the
Donor and the Recipient. Both are admittedly foreign nationals. The Authorisation
Committee examined the Donor as well as the Donor's husband, who stated that for
the first time the Donor and her husband met the Recipient on 06.08.2016 i.e just
11 days before filing  of  the application. The Authorisation Committee did not find
any good reason for the Donor to agree to donate her liver tissue. The Authorisation
Committee was also  of  the view that because there is no connection or link
between the Donor and the Recipient, the possibility  of  commercial transaction
could not be ruled out. The Appellate Authority has rejected the appeal  of  the
Petitioners on the same grounds.
8. Section 2 sub-section (1)  of  the Act defines ‘near relatives’ as under:-

2. Definitions.—In this Act, unless the context otherwise requires,—

(i) “near relative” means spouse, son, daughter, father, mother, brother,
sister, grandfather, grandmother, grandson or granddaughter;

9. Admittedly, the Donor and the Recipient are not related to each other.
10. Section 9  of  the Act reads as under:-

9. Restrictions on removal and transplantation  of  human organs or

tissues or both.—(1) Save as otherwise provided in sub-section (3), no human
organ or tissue or both removed from the body  of  a Donor before his death
shall be transplanted into a Recipient unless the Donor is a near relative  of  the
Recipient.

(1A) Where the Donor or the Recipient being near relative is a foreign
national, prior approval  of  the Authorisation Committee shall be required before
removing or transplanting human organ or tissue or both:

Provided that the Authorisation Committee shall not approve such

removal or transplantation if the Recipient is a foreign national and the Donor
is an Indian national unless they are near relatives.

***** ***** *****

(3) If any Donor authorises the removal  of  any  of  his human organs or
tissues or both before his death under sub-section (1)  of  section 3 for
 transplantation into the body  of  such Recipient, not being a near relative, as is
specified by the Donor by reason  of  affection or attachment towards the
Recipient or for any other special reasons, such human organ or tissue or both
shall not be removed and transplanted without the prior approval  of  the
Authorisation Committee.
11. As per section 9  of  the Act, no human organ or tissue or both removed from
the body  of  the Donor before his death can be transplanted into a Recipient unless
the Donor is a near relative  of  the Recipient. In case the Donor and the Recipient
are not near relative no such transplantation can take place without prior
approval  of  the Authorisation Committee constituted under the Act.

12. Rule 7  of  the Transplantation  of  Human Organs and Tissues Rules, 2014

(hereinafter referred to as the Rules) reads as under:-

7. Authorisation Committee.—(1) The medical practitioner who will be

part  of  the organ transplantation team for carrying out transplantation operation
shall not be a member  of  the Authorisation Committee constituted under the
provisions  of  clauses (a) and (b)  of  sub-section (4)  of  section 9  of  the Act.

(2) When the proposed Donor or Recipient or both are not Indian nationals
or citizens whether near relatives or otherwise, the Authorisation Committee
shall consider all such requests and the transplantation shall not be permitted if
the Recipient is a foreign national and Donor is an Indian national unless they
are near relatives.

(3) When the proposed Donor and the Recipient are not near relatives, the
Authorisation Committee shall,—

(i) evaluate that there is no commercial transaction between the Recipient

and the Donor and that no payment has been made to the Donor or
promised to be made to the Donor or any other person;
(ii) prepare an explanation  of  the link between them and the circumstances
which led to the offer being made;

(iii) examine the reasons why the Donor wishes to donate;

(iv) examine the documentary evidence  of  the link, e.g proof that they have
lived together, etc.;
( v ) examine old photographs showing the Donor and the Recipient together;

(vi) evaluate that there is no middleman or tout involved;

(vii) evaluate that financial status  of  the Donor and the Recipient by asking
them to give appropriate evidence  of  their vocation and income for the
 previous three financial years and any gross disparity between the
status  of  the two must be evaluated in the backdrop  of  the
objective  of  preventing commercial dealing;

(viii) ensure that the Donor is not a drug addict;

(ix) ensure that the near relative or if near relative is not available, any adult
person related to Donor by blood or marriage  of  the proposed unrelated
Donor is interviewed regarding awareness about his or her intention to
donate an organ or tissue, the authenticity  of  the link between the Donor
and the Recipient, and the reasons for donation, and any strong views or
disagreement or objection  of  such kin shall also be recorded and taken
note  of .

13. Sub-rule 3  of  Rule 7  of  the Rules stipulate that when the proposed Donor
and the Recipient are not near relatives, the Authorisation Committee shall, inter-
alia take into account the parameters mentioned therein. The Authorisation
Committee is to evaluate that there is no commercial transaction between the
Recipient and the Donor and that no payment has been made to the Donor or
promised to be made to the Donor or any other person. The Authorisation
Committee has to prepare an explanation  of  the link between them and the
circumstances which led to the offer being made. The documentary evidence of  the
link has to be examined. The financial status  of  the Donor and the Recipient has
also to be examined by the Authorisation Committee.

14. In the present case, the Authorisation Committee examined the Donor, her
husband as also the submissions made on behalf  of  the Recipient who was
represented through a doctor.
15. The Authorisation Committee on examination  of  the above, has given to the
following grounds for rejection:

“1. There is no relationship between Donor and the Recipient. As per

information given in various forms the Donor claims to be a family
friend  of  the Recipient and they are not related with each other in any
way.
2. As per the prescribed procedure in case  of  foreign nationals given under
rule 20 THOA rules, a senior embassy official  of  the country  of  origin
has to certify the relationship between the Donor and the Recipient as
per form 21 and in case a country does not have an embassy in  India ,
the certificate  of  relationship, in the same format, shall be issued by the
Government  of  that country. As per rule 20 there is no provision to
permit donation  of  a foreigner to another foreigner, if the Donor and
Recipient are not relatives.
 3. The Recipient is telecom engineer and his annual income is rupees 24
lakh. The Donor is teacher (Online Islamic study) and her annual income
is rupees 5 lakh. This shows there is great financial disparity between the
Donor and the Recipient.

4. As per the information provided by the Donor and Donor husband they
met the Recipient and his wife for the first time on 06.08.2016 i.e just two
week back only in New Delhi,  India  when they came for transplant. As
per the details given in the Family Tree  of  the Recipients wife is O +ve
and Recipient is also O+ve. There appears to be no good reason for wife
not to donate to her husband.
5. As per rule 7, 3(i)  of  THOA, commercial transaction cannot be ruled out
in this case, as such present case violates rule 7.3(i)  of  THOA.

6. As per rule 7.3(iii)  of  THOA the committee has not been able to find any
good reason for the Donor to donate her liver.

7. There is no document/evidence to show that the Donor and the Recipient

ever lived together. This violates rule 7.3(iv) of  THOA.

8. There is no old photograph to show the Donor and Recipient together.

This violates rule 7.3( v )  of  THOA.

9. The present case also violate rule 7.3(vii)  of  THOA.”

16. The Authorisation Committee referring to rule 20 has held that there is no

provision to permit the donation  of  a foreigner to another foreigner if the Donor and
Recipient are not relatives. Even if assuming Rule 20 has no application, the other
grounds which led to the rejection  of  the application  of  the petitioner are material.

17. The Authorisation Committee has noted that the Recipient is a Telecom

Engineer having an annual income  of  Rs. 24 lakhs whereas the Donor claims to be
a Teacher with an annual income  of  Rs. 5 lakhs. The Authorisation Committee has
noted that there is great financial disparity between the Donor and the Recipient.
The Authorisation Committee has noted that Donor and the Donor's husband met
the Recipient and his wife for the first time on 06.08.2016 i.e 11 days before the
application was filed. There is no link between the Donor and the Recipient. The
committee could not find any good reason for the Donor to agree donate her liver
tissue to the Recipient. No document/evidence was produced before the
Authorisation Committee to establish a link between the Donor and the Recipient.
The Authorisation Committee could not rule out the possibility  of  a commercial
transaction between the Donor and the Recipient.

18. The Appellate Authority by its order dated 09.09.2016, rejecting the appeal,
has held as under:-
 i. The immediate requirement is liver transplantation and if required kidney
transplant at a later date.
ii. As per the statements  of  appellants, doctors have recommended
transplantation  of  kidney and liver in one surgery on urgent basis. Being a
foreigner case, the kidney Donor, which is claimed to be wife is also required
to be approved by the Authorisation Committee as per Rule 19  of  the
Transplantation  of  Human Organs and Tissue Rules. No information has
been received regarding approval  of  Donor for kidney transplant. However,
it was confirmed from Chairperson  of  the Authorisation Committee that the
case for kidney transplantation has not been presented before the
Authorisation Committee. Obviously, the appellants have not disclosed the
full facts in their appeal.

iii. Donor is unrelated to the Recipient, nor there has been an association
between the two to consider from the point  of affection and attachment.
There is no relation and no past association between Donor and Recipient
and the Donor has met the Recipient family first time in  India  in August,
2016. The claimed association  of  family friend (as also mentioned in Form
21 received from Embassy) is based o the online teaching group connection
with sisters  of Recipient's wife  of  maximum claimed duration  of  one year
where also as per her own statement she has never met the sisters or her
children in person or even face to face on skype. There is even no
documentary proof  of  this online claimed association with
sisters  of  Recipient's wife. Clearly affection and attachment between the
Donor and Recipient is not established in this case.

iv. The association that exists is between Donor and Recipient's sister and that
too online contents  of  which are not in record. The financial disparity does
exist between Donor and Recipient as stated in their own affidavits.
v . The Donor wants to donate in the name  of  religion. There is no provision
under the Transplantation  of  Human Organs and Tissues Act 1994 to allow
donation from other than near related Donor on the grounds  of  religious
belief/traditions.”

19. It may be noted that Appellate Authority gave personal hearing to the
Recipient's wife as well as the Donor and the Donor's husband. Personal
hearing  of  the Recipient could not be held as he was admitted in hospital and could
not appear before the Appellate Authority.

20. Though the Appellate Authority has opined that there is recommendation for
requirement  of  transplantation  of kidney and liver but no information has been
received regarding approval  of  Donor for liver and kidney transplantation. In my
view, this would not be relevant as the submissions  of  the petitioner is that
requirement  of  kidney transplant can only be assessed after the
transplantation  of  liver tissue.

21. The Appellate Authority has also found that there is no association between
the Donor and the Recipient to establish any point  of  affection or attachment. No
relation or past association between the Donor and Recipient could be established.
They claimed association  of  the family friend based on online teaching connection
with the sister  of  Recipient's wife which also was claimed for about one year. This
claim was also not accepted. No documentary proof for such online association
could be produced before the Appellate Authority. The Appellate Authority also
noted the financial disparity between the two. The contention that the Donor wanted
to donate in the name  of  religion was not accepted since the Act does not make
such a provision.
22. The Supreme Court in Kuldeep Singh  v . State  of  Tamil Nadu (2005) 11
SCC 122 may be referred to, wherein the Supreme court has held as under:

“12. Where the Donor is not “near relative” as defined under the Act, the
situation is covered by Sub-Section (3)  of Section 9. As the Form I in
terms  of  Rule 3 itself shows the same has to be filed in both the cases where
the Donor is a near relative and where he is not, so far as the Recipient is
concerned. In case the Donor is not a near relative the requirement is that he
must establish that removal  of  the organ was being authorized for
transplantation into the body of  the Recipient because  of  affection or
attachment or for any special reasons to make donation  of  his organ. As the
purpose  of  enactment  of  the Statute itself shows, there cannot be any
commercial element involved in the donation. The object  of  the Statute is
crystal clear that it intends to prevent commercial dealings in human organs.
The Authorisation Committee is, therefore, required to satisfy that the real
purpose  of  the Donor authorizing removal  of  the organ is by
reason  of  affection or attachment towards the Recipient or for any other special
reason. Such special reasons can by no stretch  of  imagination encompass
commercial elements. Above being the intent, the inevitable conclusion is that
the Authorisation Committees  of  the State to which the Donor and the
Recipient belong have to take the exercise to find out whether approval is to be
accorded. Such Committee shall be in a better position to ascertain the true
intent and the purpose for the authorisation to remove the organ and whether
any commercial element is involved or not. They would be in a better position to
lift the veil  of  projected affection or attachment and the so called special
reasons and focus on the true intent. The burden is on the applicants to
establish the real intent by placing relevant materials for consideration  of the
Authorisation Committee. Whether there exists any affection or attachment or
special reason is within the special knowledge  of  the applicants, and a heavy
burden lies on them to establish it. Several relevant factors like relationship if
any (need not be near relationship for which different considerations have been
provided for), period  of  acquaintance, degree  of  association,
reciprocity  of  feelings, gratitude and similar human factors and bonds can
throw light on the issue. It is always open to the Authorisation Committee
considering the application to seek information/materials from Authorisation
Committees  of  other States/State Governments as the case may be for
effective decision in the matter. In case any State is not covered by the
operation  of  the Act or the Rules, the operative executive
instructions/Government orders will hold the field. As the object is to find out the
true intent behind the Donor's willingness to donate the organ, it would not be in
line with the legislative intent to require the Authorisation Committee  of  the
State where the Recipient is undergoing medical treatment to decide the issue
whether approval is to be accorded. Form I in terms requires the applicants to
indicate the residential details. This indication is required to prima facie
determine as to which is the appropriate Authorisation Committee. In the instant
case, therefore, it was the Authorisation Committee  of  the State  of Punjab
which is required to examine the claim  of  the petitioners.

13. We may note here that there is a provision for appeal in

terms  of  Section 17  of  the Act in case  of  refusal by the Authorisation
Committee. But taking into account the urgency involved and the grey area
projected by the two States regarding the proper Authorisation Committee, we
have entertained the Writ Petition and decided the issues involved. In the
normal course, it would be for the Appellate Authority constituted in
terms  of  Section 17 who has to consider the appeal to be preferred by the
aggrieved party.
14. Since the object  of  the Statute is to rule out commercial dealings, it
would be desirable to require the Donor and Recipient to give details  of  their
financial positions and vocations. It would be appropriate for the Legislature to
accordingly amend the Rules and the Form I, so that requirement for disclosing
incomes and vocations for some previous financial years (say 3 years) gets
statutorily incorporated. This would help the Authorisation Committees to assess
whether any commercial dealing is involved or not. Until Legislative steps are
taken, all Authorisation Committees shall, in terms  of this judgment require the
applicants to furnish their income particulars for the previous three financial
years and the vocations. The petitioners are directed to furnish the aforesaid
details within ten days from today before the Authorisation Committee.”
 23. In cases where Donor and Recipient not near relatives, the Supreme Court
in Kuldeep Singh (Supra) has laid down that it has to be established that
removal  of  organ was being authorized for transplantation into the body  of  the
Recipient because  of  affection or attachment or for any special reason to make
donation  of  his organ. There could not be any commercial element involved in the
donation. The Supreme Court has noted that the object  of  the statute is to prevent
commercial dealings in human organs. The Authorisation Committee has been
mandated to satisfy itself that the real purpose of  Donor authorizing removal  of  the
organ is by reason  of  affection or attachment towards the Recipient or for any other
special reasons. Such reason cannot encompass commercial element. The
Supreme Court has also held that whether there exists any affection or attachment
or special reason would be within the special knowledge  of  the applicants, and a
heavy burden lies on them to establish it. Relevant factors like relationship if any
(need not be near relationship for which different considerations have been
provided for), period  of  acquaintance, degree  of  association,
reciprocity  of  feelings, gratitude and similar human factors and bonds would throw
light on the issue.
24. It is clear that the object  of  the Act is to prevent any commercial dealings.
The strict parameters laid down by the statute have to be strictly complied with. The
Supreme Court in Kuldeep Singh (Supra) has categorically laid down that the
Authorisation Committee shall strictly comply with the requirement  of  establishing a
link between the Donor and Recipient where they are not related. This has been
laid down to ensure that there are no commercial angles or motives involved in the
Donor agreeing to donate an organ or tissue.

25. The Authorisation Committee as well as the Appellate Authority had held

that they could not rule out the possibility  of a commercial transaction between the
two. The petitioner has not been able to establish any link or connection or any
affection or attachment or special reason as to why the Donor has consented to
donate the liver tissue to the Recipient. Though it may be a hard case from the
point  of  view  of  the petitioner no. 1 but the statute has to be strictly complied with
to ensure that there is no trafficking or commercial angle involved in the
transplantation  of  human organs or tissue.

26. In my view there is no error or infirmity in the orders  of  the Authorisation

Committee dated 24.08.2016 and the Appellate Authority dated 09.09.2016

27. The writ petition is dismissed with no orders as to costs.

28. The Authorisation Committee as well as the Appellate Authority have noted

that wife  of  the petitioner no. 1 is  of  the same blood group (O +ve) and they have
rather noted that the wife could have but has not come forward to donate her liver
tissue to the petitioner no. 1. It is clarified that, in case any application is filed by the
wife  of  the Petitioner No. 1 seeking to donate her liver tissue to the petitioner, such
application would be considered by the respondents in accordance with law without
being influenced by anything stated in this order.
29. Dasti under signatures  of  Court master.

7.16 Before performing an operation the physician should

obtain in writing the consent from the husband or wife, parent
or guardian in the case of minor, or the patient himself as the
case may be. In an operation which may result in sterility the
consent of both husband and wife is needed.
7.17 A registered medical practitioner shall not publish
photographs or case reports of his / her patients without their
permission, in any medical or other journal in a manner by
which their identity could be made out. If the identity is not to
be disclosed, the consent is not needed.
7.18 In the case of running of a nursing home by a physician
and employing assistants to help him / her, the ultimate
responsibility rests on the physician.
7.19 A Physician shall not use touts or agents for procuring
patients.7.20 A Physician shall not claim to be specialist
unless he has a special qualification in that branch.
7.21 No act of invitro fertilization or artificial insemination shall
be undertaken without the informed consent of the female
patient and her spouse as well as the donor. Such consent
shall be obtained in writing only after the patient is provided, at
her own level of comprehension, with sufficient information
about the purpose, methods, risks, inconveniences,
disappointments of the procedure and possible risks and
hazards.
7.22 Research: Clinical drug trials or other research involving
patients or volunteers as per the guidelines of ICMR can be
undertaken, provided ethical considerations are borne in mind.
Violation of existing ICMR guidelines in this regard shall
constitute misconduct. Consent taken from the patient for trial
of drug or therapy which is not as per the guidelines shall also
be construed as misconduct.
CAPACITY AND INFORMATION WHILE SEEKING CONSENT
There are two more additional aspects to be borne in mind: first, valid consent can be
obtained only from a patient who is competent to consent and secondly, such consent must
also be informed consent. To be competent to give a legally effective consent, the patient
must be endowed with the ability to weigh the risks and benefits of the treatment that is
being proposed to him. The law presumes that such an ability is generally acquired with the
attainment of the age of maturity. A person who has attained the competent age and who has
sound mind can give valid consent to the medical practitioner for any treatment. Persons
who have attained the age of 18 are generally considered to have attained the age of maturity
and are competent to give consent. The law thus presumes capacity, rationality, autonomy,
and freedom if the person has attained the age of so called maturity. On the other hand,
where there is reason to believe that a patient is unable to understand the nature of the
treatment and its benefits or side effects before making the decision, it is necessary to
consider whether an adult presumption of capacity is rebutted in that particular case. If the
patient is incompetent to give consent, then the consent may be obtained from the attendant
of the patient.[4] In the UK, there are several ethical issues raised regarding the proxy
consent on behalf of such persons. Even the Law Commission Report (Mental Incapacity,
1995) suggests few reforms. Irrespective of the age, for a person who is incompetent due to
unsoundness of mind, consent will be obtained from the guardian of the patient. In India, the
court has not come across borderline cases of an adult refusing treatment leading to
emergency and leaving the doctor in a dilemma, unlike in the west.[5]

The law also presumes that the medical practitioner is in a dominating position vis-à-vis the
patient; hence, it is his duty to obtain proper consent by providing all the necessary
information. Consent without necessary information is no consent at all. Unfortunately, the
expression ‘informed consent’ is often used without precision. The “informed consent”
doctrine is American in origin and relates to the amount of information that a patient should
be provided with to avoid any probable action in negligence. Rarely, a medical practitioner
or a hospital administrator can rely upon the consent form signed by the patient, when the
contention is that he was made to sign on the dotted lines of such format without proving
necessary information. This practice is also developed by the practice of treating the consent
form as a one of standard forms of contracts and eliminating all such unfair and sweeping
clauses, which will only benefit the medical practitioner. It is rather necessary as the pro-
forma is prepared by the medical practitioner/hospital administration, and the patient is left
with the choice of either accepting it as whole or rejecting it. Therefore, it is absolute
imperative that a medical practitioner provide all relevant information relating to the
proposed treatment to the patient in a language understandable to him, while obtaining the
much needed consent for the treatment.

However, the nature of the information that a patient must have in order to give informed
consent is a debatable question, as the American and English viewpoints differ to some
extent. Informed consent from the American sense is often described from the viewpoint of
a prudent patient, popularly know as the prudent patient test. In this approach, the highest
respect for the patient's right of self-determination about a particular therapy is recognized.
This will lead to a so-called objective test of disclosure wherein the doctor will keep in mind
the patient and disclose all such information which is required to be given. In other words,
there is a presumption that some standard information is required to be disclosed to every
patient, and the extent of such disclosure is neither left to the discretion of the doctor (of
course leaving out special circumstances where the doctor might have strong reasons for
concealing) nor he can rely upon the defense of disclosure like a reasonable medical practice
or practitioner.[5] In contrast to this, the English approach is doctor centric, which is also
popularly narrated as the prudent doctor test of disclosure. Here, the doctor is taken as a
professional-man endowed with greater prudence to protect the right interest of the patient
and bestowed with the final right to decide what information shall be divulged to the patient
considering the circumstances and how much information is to be divulged. Lord
Templeman in ‘Sidway’ encapsulated this as follows:

“When the doctor himself is considering the possibility of a major operation, the doctor is
able with his medical training, with his knowledge of the patient's medical history, and with
his objective position to make a balanced judgment as to whether the operation should be
performed or not. The duty of the doctor in these circumstances, subject to his overriding
duty to have regard to the best interests of the patient, is to provide the patient with
information which will enable the patient to make a balanced judgment if the patient
chooses to make a balanced judgment”.[6]

Finally, whatever might be the difference of approach it is evident that a medical

practitioner is obligated to provide the necessary information before obtaining consent from
a patient. To account for the Indian position, although we do not have much litigation,
unlike in the West, it may be concluded that the courts have assigned immense significance
to the requirement of informed consent. A medical practitioner in India has a duty to provide
all the necessary information to the patient in a language that is understandable to him.
Regarding the quantum of information, there are no clear parameters laid down by the
courts. Therefore, it is reasonable information which a doctor deems fit considering best
practices. Considering the knowledge gap in this regard, the professional regulatory body for
medicine can play an important role in establishing standards.

Go to:

INDIAN LAW ON CONSENT

The principle of autonomy is enshrined within Art. 21 of the Indian Constitution, which
deals with the right to life and personal liberty. The expression personal liberty under Art.
21 is of the widest amplitude and covers a wide variety of rights, including the right to live
with human dignity and all that goes along with it, and any act which damages, injures, or
interferes with the use of any limb or faculty of a person, either permanently or temporarily.
[7] However, the common law application of consent is not fully developed in India,
although the Indian courts have often referred to these principles. In such situations,
obviously one has to refer to the principles of the Indian Contract Act and the Indian Penal
Code. The relationship between a medical professional and his patient is a contract by
parties competent to contract giving rise to contractual obligations. Parties are generally
competent (in accordance with the Indian Majority Act) (i) if they have attained the age of
18, (ii) are of sound mind, and (iii) are not disqualified by any law to which they are subject
to. Furthermore, there is a stipulation in the contract law stating that consent of any party (in
our case it is the patient) that is obtained by coercion, undue-influence, mistake,
misrepresentation or fraud, will render the agreement invalid. However, in England, the
General Medical Council guidelines state that the consenting age is 16 years old. A young
person can be treated as an adult and can be presumed to have the capacity to decide. If the
child is under the age of 16 he or she may have the capacity to decide, depending on his/her
ability to understand what is involved. Where a competent child refuses treatment, a person
with parental responsibility or the court may authorize investigation or treatment which is in
the child's best interests. Interestingly, the position is different in Scotland where those with
parental responsibility cannot authorize procedures a competent child has refused.

The consent obtained, of course, after getting the relevant information will have its own
parameter of operation to render protection to the medical practitioner. If the doctor goes
beyond these parameters, he would be treating the patient at his risk, as it is deemed that
there is no consent for such treatment at all. A doctor who went ahead in treating a patient,
to protect the patient's own interest, was held liable as he was operating without consent.[8]
The patient was suspected to have appendicitis. After obtaining due consent, she was
subjected to an operation. However, upon incision, it was found that her appendix was
normal and not inflamed. To protect the interest of the patient, the doctor removed her
gangrenous gall bladder. Later, it was discovered that the kidney of the patient was affected.
The doctor was held liable as he was operating without consent. This case law also signifies
the traditional notion of paternalism prevalent among the members of the medical fraternity.
It is a notion where the doctor takes-up the role of a parent of the patient and starts deciding
on behalf of the patient himself. Unfortunately, the law does not accept this notion. The first
priority of law is always the right of autonomy of the patient provided he is endowed with
necessary capacity. A medical practitioner who believes that a medical procedure is
appropriate and necessary for a patient's well being can perhaps be forgiven for believing
that the principle of autonomy should be sacrificed in the best interest of the patient. In the
present case, had the doctor stopped after realizing that the patient's appendix was normal,
he would have been protected as he was working under the valid consent of the patient, and
more importantly, mere error of judgment is not culpable. When he proceeded in removing
her gall bladder, he was acting sans valid consent, which was an extreme case of
professional paternalism and gross disobedience to the right of the patient's autonomy.
Hence, some commentators like Mill, et al. have advocated for minimal level of paternalism
in the interest of the medical profession and the overall inability of humans in taking rational
decisions, during the time of crises.[9]

Regarding proxy consent, when the patient is unable to give consent himself, there are no
clear regulations or principles developed in India. If such a situation exists, the medical
practitioner may proceed with treatment by taking the consent of any relative of the patient
or even an attendant. In one case, the wife of a patient informed the hospital authorities in
unambiguous terms that she had no objection to her husband undergoing bypass surgery, her
consent was deemed sufficient for the purpose of any formalities with which the hospital
was required to comply.[10]

Interestingly, in another case the relationship between the patient and his wife were strained.
A patient was operated on for sterilization. While giving consent he deposed that he is
married and has two baby girls. In fact, he was undergoing an operation only for getting the
money as incentive. After the operation, his father contended that the patient was of unstable
mind and was not competent to give consent. The court held that if there are no
circumstances for a doctor to sense foul play or doubtabout the capacity of the patient, he is
protected.[11] These two cases demonstrate that a doctor acting reasonably under normal
circumstances is always protected and he is never expected to play the role of an
investigative agency.

Recently, the apex court gave an impacting judgment in the area. Wherein the court
observed that “where a surgeon is consulted by a patient and consent of the patient is taken
for diagnostic procedure/surgery, such consent can't be considered as authorization or
permission to perform therapeutic surgery either conservative or radical (except in a life-
threatening emergent situation)”.[12] For the fist time in India, the court ruled that however
broad consent might be for diagnostic procedure, it can not be used for therapeutic surgery.
Furthermore, the court observed that “where the consent by the patient is for a particular
operative surgery it can't be treated as consent for an unauthorized additional procedure
involving removal of an organ only on the ground that it is beneficial to the patient or is
likely to prevent some danger developing in the future, where there is no imminent danger to
the life or health of the patient”. This proposition puts fetter upon the role of a “paternal
doctor” in the Indian scenario. In one case, a 44-year-old unmarried female consulted her
doctor and was advised to undergo a laparoscopy. A few consent forms were taken from her
of which one was for admission and another one was for the surgery. The relevant one
among such consent forms gave the doctor an allowance to carry out a “diagnostic and
operative laparoscopy” and there was an additional endorsement that a “laparotomy may be
needed”. When the patient was in the operation theater (and was unconscious), another
proxy consent was taken from her attending mother for a hysterectomy. Her uterus, ovaries,
and fallopian tubes were removed. Subsequently, when an action was brought, it was held
that the operation was conducted without real consent and the doctors were held liable.

This decision is of very far reaching consequences, pushing the development of consent law
to new heights. It is contended that it is not only informed consent which is imperative now,
but the same shall be “prior informed consent” unless there is imminent threat to the
patient's life. In addition, this decision curtails the scope of proxy consent from the person
having parental authority or an attendant.

Go to:

EMERGENCY SITUATION AND CONSENT

Interestingly, in India, the entire gamut of laws on consent turns into complex propositions if
an emergency medical situation arises. In a few of the milestone decisions, the apex court
ruled that a medical practitioner has a duty to treat a patient in an emergency. Emphasizing
the paramount duty of any “welfare state“, the Supreme Court stated that Art. 21 imposes an
obligation on the State to safeguard the right to life of every person. Preservation of human
life is thus of paramount importance. The government hospitals run by the state are bound
by duty to extend medical assistance for preserving human life. Failure on the part of a
government hospital to provide timely medical treatment to a person in need of such
treatment results in the violation of his right to life guaranteed under Art. 21.[13] Proceeding
in the same direction, the court emphasized further that every doctor whether at a
Government hospital or otherwise has the professional obligation to extend his services with
due expertise for protecting life. No law or state action can intervene to avoid or delay the
discharge of the paramount obligation cast upon members of the medical profession. The
obligation of a doctor is total, absolute, and paramount. Laws of procedure whether in
statutes or otherwise that would interfere with the discharge of this obligation cannot be
sustained and must, therefore, give way.[14] In one case, the apex court laid down some
important guidelines such as (i) The doctor when approached by an injured person, shall
render all such help which is possible for him at that time, including referring him to the
proper experts, (ii) the doctor treating such persons shall be protected by law, as they are not
contravening any procedural laws of the land (regarding jurisdictions etc.), and (iii) all legal
bars (either real or perceived by the doctors) are deemed to have been eliminated by the
verdict. This is in consonance with the hypocratic oath, which a doctor takes when entering
the profession. Hence, a doctor is duty-bound to treat a patient in the case of an emergency,
without waiting for any formalities. There are several statutes (like medical institutions
regulation acts in various states) imposing this duty upon medical establishments to treat
emergency patients, especially accident victims.

The initial proposition (and the attempt of the Supreme Court) is quiet understandable as the
doctor has to do his best to save life in emergency situations. This is irrespective of
complying with any of the formalities, including consent. Hypothetically, if a patient in an
emergency resists taking treatment, what shall be the way out? Indian courts are not very
clear on that. The above decisions are delivered keeping in mind the accident victims who
were denied medical treatment by doctors, terming them as medico-legal cases. Moreover,
in the above instances, the patient would go himself, or be taken by someone (due to an
unconscious state) to the doctor to seek medical treatment.

In Dr. T.T. Thomas vs. Elisa,(15) the patient was admitted into the hospital on March 11,
1974. Upon admission, the patient was diagnosed as a case of perforated appendix with
peritonitis requiring an operation. But, unfortunately no operation was done until his death
on March 13, 1974. The contention of the doctor was that no surgery could be adhered to,
albeit the suggestion, because the patient did not consent for the surgery. Therefore, other
measures were taken to ameliorate the condition of the patient, which grew worse by the
next day. Although the patient was then willing to undergo the operation, his condition did
not permit it. On the other hand, the version of the respondent (i.e., the Plaintiff) was that the
doctor demanded money for performing the surgery. Furthermore, the doctor was attending
to some chores in an outside private nursing home to conduct operations on the other
patients and that the appellant doctor came back only after the death of the patient. The two
versions before the court were: 1) the plaintiff (the deceased patient's wife) said that the
doctors concerned demanded a bribe, hence the operation was delayed until it proved fatal
and 2) the version of denial for consent. Finally, the court delivered a verdict in favor of the
plaintiffs stating that consent under such an emergent situation is not mandatory.[15] It is
interesting to note the following observations:

“The consent factor may be important very often in cases of selective operations, which may
not be imminently necessary to save the patient's life. But there can be instances where a
surgeon is not expected to say that ‘I did not operate on him because, I did not get his
consent’. Such cases very often include emergency operations where a doctor cannot wait
for the consent of his patient or where the patient is not in a fit state of mind to give or not to
give a conscious answer regarding consent. Even if he is in a fit condition to give a
voluntary answer, the surgeon has a duty to inform him of the dangers ahead of the risks
involved by going without an operation at the earliest time possible”.

“When a surgeon or medical man advances a plea that the patient did not give his consent
for the surgery or the course of treatment advised by him, the burden is on him to prove that
the non-performance of the surgery or the non-administration of the treatment was on
account of the refusal of the patient to give consent thereto. This is especially so in a case
where the patient is not alive to give evidence. Consent is implicit in the case of a patient
who submits to the doctor and the absence of consent must be made out by the patient
alleging it”.

Finally, as stated above, before holding the doctor liable, the court said that “we also hold
that the failure to perform an emergency operation on the deceased on 11-3-1974 amounts to
negligence and the death of the deceased was on account of that failure”. This decision
makes the entire discussion of consent law more complex. Although this case law can't be
given more accent (because it is a High Court decision), the viewpoint is an interesting one
to note. In light of all these developments, it may be concluded that there are many grey
areas in this field of consent law in India, which can be eliminated by pro-active intervention
by the concerned professional regulatory body.

Go to:

Footnotes
Source of Support: Nil

Conflict of Interest: None declared.

Go to:

REFERENCES
1. 1947. Neurenberg Code.

2. 1964. Declaration of Helsinki.

3. Regulation 7.16, of Medical Council of India (Professional Conduct, Etiquette and Ethics)
Regulations.2002. [PubMed]
4. Law Commission. Mental Capacity, Law. Com. 1995;231

5. Re C (Adult: Refusal of Treatment) [1944] 1 All ER 819, Re T (Adult: Refusal of

Treatment), [1992] 4 All ER 649, F v West Berkshire Health Authority, [1989] 2 All ER
545, and Gillick v West Norfolk and Wisbech AHA, [1985] 3 All ER 402.

5. Canterbury v Spence. 1972. 464 F 2d 772.

6. Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital
and Others [1985] 1 AC 871, HL.

7. Maneka Gandhi v Union of India. AIR 1978 SC 597.

8. Ram Bihari Lal v Dr. J. N. Srivastava. AIR 1985 MP 150.

9. Mill, J.S., ‘On Liberty’ Harmondsworth: Penguin; 1982. p. 68.

10. C A Muthu Krishnan v M. Rajyalakshmi. AIR 1999 AP 311.

11. Chandra Shukla v Union of India. AIR 1987 ACJ 628.

12. Samera Kohli v Dr. Prabha Manchanda and Another. 2008;(1) SCALE 442.

13. Paschim Banga Khet Mazdoor Samity and Ors v State of West Bengal and Another.
1996. 4 SCC 37.

14. Pt. Parmanand Katara v Union of India. AIR 1989 SC 2039.

15. TT Thomas (Dr.) vs Elisa. AIR 1987 Ker. 52.

MCI Professional Conduct, Etiquette and Ethics 2016

 CHAPTER I

1. CODE OF MEDICAL ETHICS

• A. Declaration: Each applicant, at the time of making an application

for registration under the provisions of the Act, shall be provided a copy
of the declaration and shall submit a duly signed.

• Declaration as provided in Appendix 1. The applicant shall also certify

that he/she had read and agreed to abide by the same.

Duties and responsibilities of the Physician in general: 1.1 Character

of Physician

• A physician shall uphold the dignity and honour of his profession.

• The prime object of the medical profession is to render service to
humanity; reward or financial gain is a subordinate consideration.
Who- so-ever chooses his profession, assumes the obligation to
conduct himself in accordance with its ideals.

• A physician should be an upright man, instructed in the art of

healings. He shall keep himself pure in character and be diligent in
caring for the sick; he should be modest, sober, patient, prompt in
discharging his duty without anxiety; conducting himself with
propriety in his profession and in all the actions of his life.

• No person other than a doctor having qualification recognised by

Medical Council of India and registered with Medical Council of
India/State Medical Council (s) is allowed to practice Modern system
of Medicine or Surgery. A person obtaining qualification in any other
system of Medicine is not allowed to practice Modern system of
Medicine in any form.

Maintaining good medical practice:

• The Principal objective of the medical profession is to render service to

humanity with full respect for the dignity of profession and man.
Physicians should merit the confidence of patients entrusted to their care,
rendering to each a full measure of service and devotion.

• Physicians should try continuously to improve medical knowledge and

skills and should make available to their patients and colleagues the
benefits of their professional attainments.

• The physician should practice methods of healing founded on scientific

basis and should not associate professionally with anyone who violates this
principle. The honoured ideals of the medical profession imply that the
responsibilities of the physician extend not only to individuals but also to
society.

Maintenance of medical records:

• Every physician shall maintain the medical records pertaining to his / her
indoor patients for a period of 3 years from the date of commencement of
the treatment in a standard proforma laid down by the Medical Council of
India and attached as Appendix 3.

• If any request is made for medical records either by the patients /

authorised attendant or legal authorities involved, the same may be duly
acknowledged and documents shall be issued within the period of 72
hours.

 Display of registration numbers:

• Every physician shall display the registration number accorded to him by
the State Medical Council / Medical Council of India in his clinic and in all
his prescriptions, certificates, money receipts given to his patients.

• Physicians shall display as suffix to their names only recognized medical

degrees or such certificates/diplomas and memberships /honours which
confer professional knowledge or recognizes any exemplary
qualification/achievements.

Use of Generic names of drugs:

• Every physician should, as far as possible, prescribe drugs with

generic names and he/she shall ensure that there is a rational
prescription and use of drugs.

• Exposure of Unethical Conduct: A Physician should expose, without

fear or favour, incompetent or corrupt, dishonest or unethical
conduct on the part of members of the profession.

Payment of Professional Services:

• The physician, engaged in the practice of medicine shall give priority to

the interests of patients. The personal financial interests of a physician
should not conflict with the medical interests of patients.

• A physician should announce his fees before rendering service and not
after the operation or treatment is under way.

• Remuneration received for such services should be in the form and

amount specifically announced to the patient at the time the service is
rendered. It is unethical to enter into a contract of "no cure no payment".

• Physician rendering service on behalf of the state shall refrain from

anticipating or accepting any consideration.

CHAPTER 2 2. DUTIES OF PHYSICIANS TO THEIR PATIENTS

• Obligations to the Sick • A physician should endeavour to add to the

comfort of the sick by making his visits at the hour indicated to the
patients. A physician advising a patient to seek service of another physician
is acceptable, however, in case of emergency a physician must treat the
patient.

• No physician shall arbitrarily refuse treatment to a patient. However for

good reason, when a patient is suffering from an ailment which is not
within the range of experience of the treating physician, the physician may
refuse treatment and refer the patient to another physician.
• Medical practitioner having any incapacity detrimental to the patient or
which can affect his performance vis-à-vis the patient is not permitted to
practice his profession

Patience, Delicacy and Secrecy: • Patience and delicacy should

characterize the physician. • Confidences concerning individual or domestic
life entrusted by patients to a physician and defects in the disposition or
character of patients observed during medical attendance should never be
revealed unless their revelation is required by the laws of the State. •
Sometimes, however, a physician must determine whether his duty to
society requires him to employ knowledge, obtained through confidence as
a physician, to protect a healthy person against a communicable disease to
which he is about to be exposed. In such instance, the physician should act
as he would wish another to act toward one of his own family in like
circumstances.

 • Prognosis: The physician should neither exaggerate nor minimize the

gravity of a patient’s condition. He should ensure himself that the patient,
his relatives or his responsible friends have such knowledge of the patient’s
condition as will serve the best interests of the patient and the family.

• The Patient must not be neglected: A physician is free to choose whom

he will serve. He should, however, respond to any request for his assistance
in an emergency. Once having undertaken a case, the physician should not
neglect the patient, nor should he withdraw from the case without giving
adequate notice to the patient and his family. Provisionally or fully
registered medical practitioner shall not willfully commit an act of
negligence that may deprive his patient or patients from necessary medical
care.

• Engagement for an Obstetric case: When a physician who has been

engaged to attend an obstetric case is absent and another is sent for and
delivery accomplished, the acting physician is entitled to his professional
fees, but should secure the patient’s consent to resign on the arrival of the
physician engaged.

CHAPTER 3 3. DUTIES OF PHYSICIAN IN CONSULTATION •

Unnecessary consultations should be avoided • Consultation for Patient’s
Benefit • Punctuality in Consultation Statement to Patient after
Consultation: All statements to the patient or his representatives should
take place in the presence of the consulting physicians, except as otherwise
agreed. The disclosure of the opinion to the patient or his relatives or
friends shall rest with the medical attendant

Patients Referred to Specialists: • When a patient is referred to a

specialist by the attending physician, a case summary of the patient should
be given to the specialist, who should communicate his opinion in writing
to the attending physician. • Fees and other charges: A physician shall
clearly display his fees and other charges on the board of his chamber
and/or the hospitals he is visiting. Prescription should also make clear if
the Physician himself dispensed any medicine.

CHAPTER 4 RESPONSIBILITIES OF PHYSICIANS TO EACH OTHER

• Consultant not to take charge of the case: When a physician has been
called for consultation, the Consultant should normally not take charge of
the case, especially on the solicitation of the patient or friends. The
Consultant shall not criticize the referring physician. He / she shall discuss
the diagnosis treatment plan with the referring physician. • Appointment of
Substitute: Whenever a physician requests another physician to attend his
patients during his temporary absence from his practice, professional
courtesy equires the acceptance of such appointment only when he has the
capacity to discharge the additional responsibility along with his / her
other duties. The physician acting under such an appointment should give
the utmost consideration to the interests and reputation of the absent
physician and all such patients should be restored to the care of the latter
upon his/her return.

 • Visiting another Physician’s Case: When it becomes the duty of a

physician occupying an official position to see and report upon an illness or
injury, he should communicate to the physician in attendance so as to give
him an option of being present.

• The medical officer / physician occupying an official position should avoid

remarks upon the diagnosis or the treatment that has been adopted.

CHAPTER 5 DUTIES OF PHYSICIAN TO THE PUBLIC AND TO THE

PARAMEDICAL PROFESSION

• Physicians as Citizens: Physicians, as good citizens, possessed of special

training should disseminate advice on public health issues. They should
play their part in enforcing the laws of the community and in sustaining
the institutions that advance the interests of humanity. They should
particularly co-operate with the authorities in the administration of
sanitary/public health laws and regulations.

• Public and Community Health: Physicians, especially those engaged in

public health work, should enlighten the public concerning quarantine
regulations and measures for the prevention of epidemic and
communicable diseases. At all times the physician should notify the
constituted public health authorities of every case of communicable disease
under his care, in accordance with the laws, rules and regulations of the
health authorities. When an epidemic occurs a physician should not
abandon his duty for fear of contracting the disease himself.
• Pharmacists / Nurses: Physicians should recognize and promote the
practice of different paramedical services such as, pharmacy and nursing
as professions and should seek their cooperation wherever required.

CHAPTER 6 UNETHICAL ACTS: • Advertising: • A physician shall not

make use of him / her (or his / her name) as subject of any form or
manner of advertising or publicity through any mode either alone or in
conjunction with others which is of such a character as to invite attention
to him or to his professional position, skill, qualification, achievements,
attainments, specialities, appointments, associations, affiliations or
honours and/or of such character as would ordinarily result in his self
aggrandizement.

• A medical practitioner is however permitted to make a formal

announcement in press regarding the following: (1) On starting practice. (2)
On change of type of practice. (3) On changing address. (4) On temporary
absence from duty. (5) On resumption of another practice. (6) On
succeeding to another practice. (7) Public declaration of charges.

• Secret Remedies: • The prescribing or dispensing by a physician of

secret remedial agents of which he does not know the composition, or the
manufacture or promotion of their use is unethical and as such prohibited.
All the drugs prescribed by a physician should always carry a proprietary
formula and clear name.

• Euthanasia: • Practicing euthanasia shall constitute unethical

conduct. However on specific occasion, the question of withdrawing
supporting devices to sustain cardio-pulmonary function even after brain
death, shall be decided only by a team of doctors and not merely by the
treating physician alone. A team of doctors shall declare withdrawal of
support system. Such team shall consist of the doctor in charge of the
patient, Chief Medical Officer / Medical Officer in charge of the hospital and
a doctor nominated by the in-charge of the hospital from the hospital staff
or in accordance with the provisions of the Transplantation of Human
Organ Act, 1994.

Code of conduct for doctors and professional association of doctors in

their relationship with pharmaceutical and allied health sector
industry.

• a) Gifts: A medical practitioner shall not receive any gift from any
pharmaceutical or allied health care industry and their sales people or
representatives.

• b) Travel facilities: A medical practitioner shall not accept any travel

facility inside the country or outside, including rail, air, ship , cruise
tickets, paid vacations etc. from any pharmaceutical or allied healthcare
industry or their representatives for self and family members for vacation or
for attending conferences, seminars, workshops, CME programme etc as a
delegate.

• c) Hospitality: A medical practitioner shall not accept individually any

hospitality like hotel accommodation for self and family members under
any pretext.

 • d) Cash or monetary grants: A medical practitioner shall not receive any

cash or monetary grants from any pharmaceutical and allied healthcare
industry for individual purpose in individual capacity under any pretext.
Funding for medical research, study etc. can only be received through
approved institutions by modalities laid down by law / rules / guidelines
adopted by such approved institutions, in a transparent manner. It shall
always be fully disclosed.

• e) Medical Research: A medical practitioner may carry out, participate in,

work in research projects funded by pharmaceutical and allied healthcare
industries.

 CHAPTER 7 • MISCONDUCT: The following acts of commission or

omission on the part of a physician shall constitute professional
misconduct rendering him/her liable for disciplinary action.

• Sex Determination Tests: On no account sex determination test shall be

undertaken with the intent to terminate the life of a female foetus
developing in her mother’s womb, unless there are other absolute
indications for termination of pregnancy as specified in the Medical
Termination of Pregnancy Act, 1971. Any act of termination of pregnancy of
normal female foetus amounting to female foeticide shall be regarded as
professional misconduct on the part of the physician leading to penal
erasure besides rendering him liable to criminal proceedings as per the
provisions of this Act.

• The registered medical practitioner shall not disclose the secrets of a

patient that have been learnt in the exercise of his / her profession
except –

i) in a court of law under orders of the Presiding Judge;

ii) ii) in circumstances where there is a serious and identified risk

to a specific person and / or community; and iii) notifiable
diseases. In case of communicable / notifiable diseases,
concerned public health authorities should be informed
immediately.

• Before performing an operation the physician should obtain in

writing the consent from the husband or wife, parent or guardian in
 the case of minor, or the patient himself as the case may be. In an
operation which may result in sterility the consent of both husband
and wife is needed.

• A registered medical practitioner shall not publish photographs or

case reports of his / her patients without their permission, in any
medical or other journal in a manner by which their identity could be
made out. If the identity is not to be disclosed, the consent is not
needed.

 • A Physician shall not claim to be specialist unless he has a special

qualification in that branch.

• No act of invitro fertilization or artificial insemination shall be undertaken

without the informed consent of the female patient and her spouse as well
as the donor. Such consent shall be obtained in writing only after the
patient is provided, at her own level of comprehension, with sufficient
information about the purpose, methods, risks, inconveniences,
disappointments of the procedure and possible risks and hazards.

CHAPTER 8 PUNISHMENT AND DISCIPLINARY ACTION

• In case the punishment of removal from the register is for a limited

period, the appropriate Council may also direct that the name so removed
shall be restored in the register after the expiry of the period for which the
name was ordered to be removed.