UNIT – 2

FOOD SAFETY AND STANDARDS ACT (FSS ACT) 2006:

SALIENT FEATURES

Introduction to the Food Safety and Standards Act (FSS Act)

On the 23rd of August, 2006 the government of India passed the FSS Act or the food safety and standards act
which changed the way food safety and food handling practices are being monitored in India. The FSS Act also
empowered the establishment of FSSAI, the Food Safety and Standards Authority of India which carries out
operations related to setting the standards of food articles. The standards set by FSSAI, empowered under the
Food Safety and Standards Act are based on scientific research and help regulate the manufacture, storage,
distribution, sale as well as import-export of all types of food articles being made available to the general
population. The FSS Act endows powers to the FSSAI to certify organizations involved in any type of food-
related activities that they are involved with food articles safe for consumption of human beings. This
certification is known as a FSSAI license.

Chapters of the Food Safety and Standards Act

The Act empowered by the government of India has been divided into 12 Chapters which discuss in detail the
impact, regulations, authorities that the Act carries with it to empower the safety of food products. The
Chapters of the Food Standards and Safety Act are as follows

Chapter I: Preliminary
Preliminary basically gives the introduction to the Act what it stands for, what are the definitions related to the
act and also declared that the Union is taking the food industry under its control for the purpose of public
interest. This chapter also declared that the applicability of the FSS Act will be throughout India.

Chapter II: FSSAI

Chapter two basically entails setting up the Food Safety and Standards Authority of India (FSSAI) in order to
fully exercise the powers and carry out the responsibilities and functions assigned to it by the FSS Act. One of
the main functions of FSSAI include is checking the food standards of all consumable items and providing them
with

Chapter 2 also tells about the composition of the members of the food authority and hierarchical structure of the
authority. FSSAI will contain a Chairperson and 22 other members in it. At the very least, One-Third of those
22 members have to be women. The tenure of the chairperson is 3 years to which they can be further re-appointed
for another term of 3 years

In addition to this, the headquarters of FSSAI will be in the capital city of New Delhi. With 6 other regional
offices based on the various zones that the jurisdiction of the act has been divided up into.

Headquarter Address: FDA Bhawan near Bal Bhavan, Kotla Road, New Delhi
Chapter III: General Principles of Food Safety
Chapter 3 of the Food Safety and Standards Act focuses on food safety, the purpose for which the act and the
body under its guidance FSSAI have been established. The basic principles f food safety outline in the FSS act
are as follows.

 Endeavor to achieve an appropriate level of protection of human life and health along with protection
of the customer’s interests including fair practices in any and all kinds of food trade with reference to
food safety standards and practices.
 Perform Risk Management which will take into account the results of risk assessment and other factors
which help the regulatory authorities
 In specific circumstances where on the basis of assessment of available information, the possibility of
ill effects on health have been detected but scientific uncertainty still persists, provisional risk
management measures for appropriate safety should be deployed till the time concrete scientific
evidence and proper risk assessment hasn’t been conducted.
 In cases where there are reasonable grounds to suspect that a food may present a risk for human health,
then, depending on the nature, seriousness and extent of that risk, the Food Authority and the
Commissioner of Food Safety shall take appropriate steps to inform the general public of the nature of
the risk to health, identifying to the fullest extent possible the food or type of food, the risk that it may
present, and the measures which are taken or about to be taken to prevent, reduce or eliminate that risk
 Where any food which fails to comply with food safety requirements is part of a batch, lot or
consignment of food of the same class or description, it shall be presumed until the contrary is proved,
that all of the food in that batch, lot or consignment fails to comply with those requirements.

Chapter IV: General Provisions as to Articles of Food

 Use of Food Additive or Processing Aid

No article of food shall contain any food additive or processing aid unless it is in accordance with the
provisions of this Act and regulations made thereunder
 Contaminants, Toxic Substances Heavy Metals
No article of food shall contain any contaminant, naturally occurring toxic substances or toxins or
hormone or heavy metals in excess of such quantities as may be specified by regulations.
 Pesticides, Veterinary Drugs, Antibiotic Residue, Microbiological Counts
No article of food shall contain insecticides or pesticides residues, veterinary drugs residues, antibiotic
residues, solvent residues, pharmacologically active substances and microbiological counts in excess
of such tolerance limit as may be specified by regulations
 Genetically Modified Foods, Organic Foods Functional Foods, Propreitory Foods
o No person shall manufacture, distribute, sell or import any novel food, genetically modified
articles of food, irradiated food, organic foods, foods for special dietary uses, functional foods,
nutraceuticals, health supplements, proprietary foods and such other articles of food which the
Central Government may notify in this behalf.

 Packaging and Labelling of Foods

o Every food business operator shall ensure that the labeling and presentation of food, including
their shape, appearance or packaging, the packaging materials used, the manner in which they
are arranged and the setting in which they are displayed, and the information which is made
available about them through whatever medium, does not mislead consumers.
 o No person shall manufacture, distribute, sell or expose for sale or despatch or deliver to any
agent or broker for the purpose of sale, any packaged food products which are not marked and
labeled in the manner as may be specified by regulations

 Restrictions on Advertisment and Prohibition as to unfair trade practices

o No advertisement shall be made of any food which is misleading or deceiving or contravenes

the provisions of this Act, the rules and regulations made thereunder.
o No person shall engage himself in any unfair trade practice for purpose of promoting the sale,
supply, use, and consumption of articles of food or adopt any unfair or deceptive practice
including the practice of making any statement, whether orally or in writing or by visible
representation which falsely represents that the foods are of a particular standard, quality,
quantity or grade-composition or makes a false or misleading representation concerning the
need for, or the usefulness.

Chapter V: Provisions Related to Import

 No person shall import into India any unsafe or misbranded or sub-standard food or food containing
extraneous matter or any article of food for the import of which a license is required under any Act or
rules or regulations, except in accordance with the conditions of the license and any article of food in
contravention of any other provision of this Act or of any rule or regulation made thereunder or any
other Act.
 The Central Government shall, while prohibiting, restricting or otherwise regulating the import of
article of food under the Foreign Trade (Development and Regulation) Act, 1992 (22 of 1992), follow
the standards laid down by the Food Authority under the provisions of this Act and the Rules and
regulations made thereunder.

Chapter VI: Special Responsibility to as to Food Safety

The chapter VI of the Food Safety and Standards Act basically dictates the responsibilities of the people involved
in the food business and how this translates into ensuring the delivery of safe food products to the consumers.
These are divided into three broad categories in the FSS Act. These are as follows.:

 Responsibilities of the Food Business Operator

 Liability of Manufacturers, packers, wholesalers, distributors, and sellers
 Food Recall Procedures

Chapter VII: Enforcement of the Act

Chapter 7 entails in great detail the powers and efficient enforcement and compliance with the safety rules for
food items being made available to the general population. It also describes the authorities and the officers
responsible for enforcing the same via the provisions of the Food Safety and Standards Act. The enforcement of
the act via regulatory bodies and officers allocate towards food safety have been divided up by the central
government as follows.

 Authorities responsible for enforcement of the Act

 Commisioner of Food Safety of the State
 Licensing and Registration of Food Business
 Improvement Notices
  Emergency Prohibition Notice and Orders
 Notification of Food Poisoning
 Designated Officers
 Food Safety Officer
 Powers of the Food Safety Officer
 Liability of the Food Safet Officer
 Food Analysis from Purchaser
 Power of search, seizure, investigation, prosecution and procedure thereof
 Procedure for launching Prosecution

Chapter VIII: Analysis of Food

The Analysis of food chapter 8 in the Food Safety and Standards Act , lays down the procedures and the
intricacies involved with checking and analyxing the food products which have been shipped for consumption
by the masses. The detailed procedure for the analysis of food has the following provisions :

 Recognition and accreditation of laboratories, research instiutions as well as referral food laboratory
 Recognition of Organisation or agency of food safety audit
 Food Analysts
 Functions of Food Analyst
 Sampling and Analysis

Chapter IX: Offences and Penalties

The Chapter 9 of the Food Safety and Standards Act lays down the foundation for and the provisiions for the
non-compliance of the food businesses to deliver safe food to consumers and hence list down a comprehensive
list of offences and penalties imposed thereof on the violators of the regulations. The offences and penalties
under the act are classified under the following provisions.

 General Provisions relting to offences

 General Provisions relating to Penalties
 Penalty for selling food not of the nature or substance or quality demanded
 Penalty for sub-standard food.
 Penalty for misbranded food.
 Penalty for misleading advertisement
 Penalty for food containing extraneous matter
 Penalty for failure to comply with the directions of Food Safety Officer
 Penalty for unhygienic or unsanitary processing or manufacturing of food
 Penalty for possessing adulterant
 Penalty for contraventions for which no specific penalty is provided
 Punishment for unsafe food
 Punishment for interfering with seized items.
 Punishment for false information
 Punishment for obstructing or impersonating a Food Safety Officer
 Penalty for contravention of provisions of this Act in case of import of articles offood to be in addition
to penalties provided under any other Act
 Offences by companies
 Compensation in case injury of death of consumer
 Punishment for carrying out a business without licence
 Punishment for subsequent offences.
Chapter X: Adjudication and Food Safety Appellate Tribunal
The Food Safety Appelleate Tribunal handls matters relaed to the offenses commited under violation of any of
the regulations directd and laid down by the Food Safety and Standards Act of 206. Let’s take a look at what
entails the functions of the Food Safety Appelleate tribunal and how adjudication is made on the matters related
to negligence of Food Safet and it’s practises.

 Adjudication
 Power to compound offences
 Establishment of Food Safety Appellate Tribunal
 Procedure and powers of the Tribunal
 Power of court to try cases summarily
 Civil court not to have jurisdiction.
 Power of court to try cases summarily
 Special courts and Public Prosecutor
 Power to transfer cases to regular courts
 Appeal
 Time limit for prosecutions
 Power of court to implead manufacturer etc
 Magistrate’s power to impose enhanced punishment
 Defences which may or may not be allowed in prosecution under this Act

Chapter XI: FINANCE, ACCOUNTS, AUDIT AND REPORTS

This section of the Food Safety and Standards Act basically deals with financing, mainitainince of books, audits
and audit reports of entities involved in the food business activities as well as the food authority. Provisions
listed out in this chapter of the FSS Act have the following stipulations:

 Budget of the Food Authority

 Finances of the Food Authority
 Accounts and Audit of Food Authority
 Annual Report of Food Authority
 Provisions relating to Public Health under Criminal Law

IPC-
268. Public nuisance.—A person is guilty of a public nuisance who does any
act or is guilty of an illegal omission which causes any common injury,
danger or annoyance to the public or to the people in general who dwell or
occupy property in the vicinity, or which must necessarily cause injury,
obstruction, danger or annoyance to persons who may have occasion to use
any public right. A common nuisance is not excused on the ground that it
causes some convenience or advantage.

269. Negligent act likely to spread infection of disease dangerous to

life.—Whoever unlawfully or negligently does any act which is, and which
he knows or has reason to believe to be, likely to spread the infection of any
disease dangerous to life, shall be punished with imprisonment of either
description for a term which may extend to six months, or with fine, or with
both.
270. Malignant act likely to spread infection of disease dangerous to
life.—Whoever malignantly does any act which is, and which he knows or
has reason to believe to be, likely to spread the infection of any disease
dangerous to life, shall be punished with imprisonment of either description
for a term which may extend to two years, or with fine, or with both.

271. Disobedience to quarantine rule.—Whoever knowingly disobeys any

rule made and promulgated 1[by the 2[***] Government 3[***] for putting
any vessel into a state of quarantine, or for regulating the intercourse of
vessels in a state of quarantine with the shore or with other vessels, or for
regulating the intercourse between places where an infectious disease prevails
and other places, shall be punished with imprisonment of either description
for a term which may extend to six months, or with fine, or with both.

272. Adulteration of food or drink intended for sale.—Whoever

adulterates any article of food or drink, so as to make such article noxious as
food or drink, intending to sell such article as food or drink, or knowing it to
be likely that the same will be sold as food or drink, shall be punished with
imprisonment of either description for a term which may extend to six
months, or with fine which may extend to one thousand rupees, or with both.

273. Sale of noxious food or drink.—Whoever sells, or offers or exposes for

sale, as food or drink, any article which has been rendered or has become
noxious, or is in a state unfit for food or drink, knowing or having reason to
believe that the same is noxious as food or drink, shall be punished with
imprisonment of either description for a term which may extend to six
months, or with fine which may extend to one thousand rupees, or with both.

274. Adulteration of drugs.—Whoever adulterates any drug or medical

preparation in such a manner as to lessen the efficacy or change the operation
of such drug or medical preparation, or to make it noxious, intending that it
shall be sold or used for, or knowing it to be likely that it will be sold or used
for, any medicinal purpose, as if it had not undergone such adulteration, shall
be punished with imprisonment of either description for a term which may
extend to six months, or with fine which may extend to one thousand rupees,
or with both.

275. Sale of adulterated drugs.—Whoever, knowing any drug or medical

preparation to have been adulterated in such a manner as to lessen its
efficacy, to change its operation, or to render it noxious, sells the same, or
offers or exposes it for sale, or issues it from any dispensary for medicinal
purposes as unadulterated, or causes it to be used for medicinal purposes by
any person not knowing of the adulteration, shall be punished with
imprisonment of either description for a term which may extend to six
months, or with fine which may extend to one thousand rupees, or with both.

276. Sale of drug as a different drug or preparation.—Whoever

knowingly sells, or offers or exposes for sale, or issues from a dispensary for
medicinal purposes, any drug or medical preparation, as a different drug or
medical preparation, shall be punished with imprisonment of either
description for a term which may extend to six months, or with fine which
may extend to one thousand rupees, or with both.

277. Fouling water of public spring or reservoir.—Whoever voluntarily

corrupts or fouls the water of any public spring or reservoir, so as to render it
less fit for the purpose for which it is ordinarily used, shall be punished with
imprisonment of either description for a term which may extend to three
months, or with fine which may extend to five hundred rupees, or with both.

278. Making atmosphere noxious to health.—Whoever voluntarily vitiates

the atmosphere in any place so as to make it noxious to the health of persons
in general dwelling or carrying on business in the neighbourhood or passing
along a public way, shall be punished with fine which may extend to five
hundred rupees.

279. Rash driving or riding on a public way.—Whoever drives any

vehicle, or rides, on any public way in a manner so rash or negligent as to
endanger human life, or to be likely to cause hurt or injury to any other
person, shall be punished with imprisonment of either description for a term
which may extend to six months, or with fine which may extend to one
thousand rupees, or with both.

284. Negligent conduct with respect to poisonous substance.—Whoever

does, with any poisonous substance, any act in a manner so rash or negligent
as to endanger human life, or to be likely to cause hurt or injury to any
person, or knowingly or negligently omits to take such order with any
poisonous substance in his possession as is sufficient to guard against any
probable danger to human life from such poisonous substance, shall be
punished with imprisonment of either description for a term which may
extend to six months, or with fine which may extend to one thousand rupees,
or with both.

285. Negligent conduct with respect to fire or combustible matter.—

Whoever does, with fire or any combustible matter, any act so rashly or
negligently as to endanger human life, or to be likely to cause hurt or injury
to any other person, or knowingly or negligently omits to take such order
with any fire or any combustible matter in his possession as is sufficient to
guard against any probable danger to human life from such fire or
combustible matter, shall be punished with imprisonment of either
description for a term which may extend to six months, or with fine which
may extend to one thousand rupees, or with both.
286. Negligent conduct with respect to explosive substance.—Whoever
does, with any explosive substance, any act so rashly or negligently as to
endanger human life, or to be likely to cause hurt or injury to any other
person, or knowingly or negligently omits to take such order with any
explosive substance in his possession as is sufficient to guard against any
probable danger to human life from that substance, shall be punished with
imprisonment of either description for a term which may extend to six
months, or with fine which may extend to one thousand rupees, or with both.
 The Pre-Natal Diagnostic Techniques (Regulation and Prevention of
Misuse) Act, 1994
The Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994, which
was passed on 20.09.1994. The Central Act which is an improvement on the Maharashtra
Regulation of the Use of Pre-Natal Diagnostic Techniques Act, 1988 was passed on the 20th
September 1994.

The following are the salient features of the Act:

1. A woman may avail herself of the facility only if she is (a) above the age of 35, or (b) has had
two or more ‘spontaneous abortions’, or (c) if she has a family history of genetic disease, or (d)
has been exposed to agents that are potentially harmful to the unborn child.

2. It can only be conducted to detect: genetic abnormalities; (b) genetic metabolic diseases; (c)
haemoglobinopathies; (d) sex-linked genetic diseases; (e) congenital abnormalities.

3. The test shall not be used for the purpose of sex determination.

4. The test can be conducted only at duly registered ‘genetic counselling centres, laboratories and
clinics.

5. The test cannot be performed without the written and ‘informed consent’ of the mother.

6. Advertising of the availability of facilities for sex-determination is banned. A violation of this

provision results in a maximum of 3 years, imprisonment and /or fine.

7. Pre-Conception Pre-natal Diagnostic Techniques Act (Prohibition of the Sex Selection) Act,
1994 provides for following instruction to stop the pre-selection of the sex. The PNDT Act has
been amended with the amendment Act which came into force w.e.f. January-2003.

 It prohibits sex selection, before and after conception.

 It regulates of Pre-natal Diagnostic Techniques (e.g. amniocentesis and
ultrasonography) for detection of genetic abnormalities, by restricting their use to
registered institutions. The Act allows the use of these techniques only at a
registered place for a specified purpose and by a qualified person, registered for
this purpose.
 It prohibited the sale of ultrasound machines to persons not registered under this
Act.
 It provides punishment for violation of provisions of the Act.
 It further provides that the name of the registered medical practitioner shall be
reported by the Appropriate Authority to the State Medical Council concerned for
taking necessary action including suspension of the registration if the charges are
framed by the court and till the case is disposed of and on conviction for removal
of his name from the register of the Council for a period of five years for the first
offence and permanently for the subsequent offence.
 It provides that any person who seeks the aid of any Genetic Counselling Centre,
Genetic Laboratory, Genetic Clinic or ultrasound clinic or imaging clinic or of a
medical geneticist, gynaecologist, sonologist or imaging specialist or registered
medical practitioner or any other person for sex selection or for conducting pre-
natal diagnostic techniques on any pregnant women for the purposes other than
those specified in sub-section (2) of section 4, he shall, be punishable with
imprisonment for a term which may extend to three years and with fine which may
extend to fifty thousand rupees for the first offence and for any subsequent offence
with imprisonment which may extend to five years and with fine which may extend
to one lakh rupees.
 It provides that the Court shall presume unless the contrary is provided that the
pregnant women have been compelled by her husband or relative to undergo the
test.
 It provides that there shall be an Appropriate Authority consisting of an appointed
officer, who shall be advised by an Advisory Committee, consisting of, three
medical experts, one legal expert, three imminent social workers and one
government officer. The function of the Appropriate Authority is namely to grant,
 suspend, cancel registration; to enforce standards, to investigate complaints of
breach, to search and seize records etc.
 It provides that all records etc. are required to be maintained and preserved by the
concerned institution/person.
 It provides that the Court shall take cognizance of a complaint only if it is made by
the Appropriate Authority or by a person who has given more than 30 days’ notice
the Appropriate Authority.

In Vinod Soni and Anr. v. Union of India 2005, the constitutionality of the Preconception and Prenatal
Diagnostic Techniques Act, 1994 was challenged on the grounds; first, that it violates Article 14 of the
Constitution; secondly, it violates Article 21 of the Constitution of India. However, at the time of
arguments the petitioner did not press his petition on the ground of Article 14. Therefore, the Court
deliberated on the challenge on the ground of Article 21 of the Constitution. Reliance was placed on
several judgments of Supreme Court to elaborate the submission regarding expansion of right to life and
personal liberty embodied under Article 21. It was submitted that in so far as protection of life is
concerned, it must of necessity include the question of terminating a life. This enactment basically
prohibits termination of life which has come into existence. It also prohibits sex selection at preconception
stage.

The court held that apart from that such cases are permitted as mentioned in sub clause 3 of section 4
where certain dangers to the pregnant woman are noticed. A perusal of those conditions which are five
and which can be added to the four, existence on which is provided by the Act. It will therefore be seen
that the enactment does not bring about total prohibition of any such tests. It intends to thus prohibit user
and indiscriminate user of such tests to determine the sex at preconception stage or post conception stage.
The right to life or personal liberty cannot be expanded to mean that the right of personal liberty includes
the personal liberty to determine the sex of a child which may come into existence.

In Vijai Sharma and Mrs. Kirti v. Union of India 2008 The Bombay HC held that sex selective abortion is
the violation of right to life and personal liberty of the female foetus. Since female feticide is the violation
of article 14 on the ground of sex of the foetus.
UNIT – III
 Euthanasia

When a person terminates his life by his own act, it is referred to as “suicide”. To end the life of a
person by a request of others or on the request of the deceased is known as “euthanasia” or in
a simpler form, “mercy killing.”

When the patient explicitly requests for euthanasia, it is referred to as voluntary euthanasia.
Governments of many countries have rendered this form as legal, and if not legal, they have
decriminalized it. It is considered as homicide by few countries, but if the doctor fulfills some legal
requirements, it is not regarded as a criminal homicide, and such a person won’t be prosecuted.

When a person is incapable of giving consent as to the procedure of euthanasia, in such cases
where he/she is unconscious, legally incompetent, or comatose, then in such a case, it is referred
to as non-voluntary euthanasia. Non-voluntary euthanasia can even be in the cases where
previously a patient has declared his will t die but, presently he/she is unable to do so. Euthanasia
is internationally illegal in the case of children, as they are not competent to contracts. It might be
accepted in certain exceptional circumstances.

Passive Euthanasia

Passive euthanasia means the withdrawal of life support to patients in a vegetative state. Euthanasia
cannot be justified with the common word i.e. killing because there is a difference between
deliberately carrying out an act in order to get the desired result and simply omitting an act. Killing
includes an action which is intended in order to get the consequences so desired whereas euthanasia
refers to withdrawal of life support in case of patients who are in a complete vegetative state.

Acts amounting to passive euthanasia are:

 Switching off life support systems.

 Disconnecting feeding tubes.
 Not carrying out a life-extending surgery.
 Not providing life-extending drugs.
Aruna’s Case– A New Dimension in the Indian Legal Context

In a recent judgment, the Supreme Court in the case of Aruna Ramchandra Shanbaug v. Union of
India, unlocked the gateway for validation of passive euthanasia.

The Court dismissed the petition filed on behalf of Aruna Shanbaug and observed that passive
euthanasia was permissible under the supervision of law in an extraordinary circumstance but
active euthanasia was still not permitted under the law. The Court also suggested decriminalizing
the attempt to suicide by repealing the punishment provided in Section 309 of the Indian Penal
Code.

[The Court in this connection has laid down the guidelines which will continue to be the law until
Parliament makes a law on this point.

1. A decision has to be taken to discontinue life support either by the parents or the spouse
or other close relatives, or in the absence of any of them, such a decision can be taken
even by a person or a body of persons acting as a next friend. It can also be made by the
doctors attending the patient. However, the decision should be made bona fide in the
best interest of the patient.
2. Even if a decision is taken by the near relatives or doctors or next friend to withdraw
life support, such a decision requires approval from the High Court concerned.
3. When such an application is filled, the Chief Justice of the High Court should forthwith
constitute a Bench of at least two Judges who should decide to grant approval or not. A
committee of three reputed doctors to be nominated by the Bench, who will give a report
regarding the condition of the patient. Before giving the verdict, a notice regarding the
report should be given to the close relatives and the State. After hearing the parties, the
High Court can give its verdict.
Law Commission of India and It’s Recommendations

The Commission has given the following recommendations in its 241st Report:

1. Obviously, the first thing which is to be declared is that each ‘competent patient’, who
has been suffering from deadly illness has a the right to refuse any medical treatment
or the beginning or continuance of such a treatment that has already been initiated. If
such an informed decision is endorsed by the competent patient, it is compulsory for
the doctor. Consequently, the doctor must be content that a competent patient makes
the decision and it is an informed decision. Such informed decision must be the one
taken by a competent patient autonomously.

It must also be cleared that the doctor, notwithstanding the concealment or withdrawal
of treatment, is eligible to manage palliative care for the incompetent patient if only he
is conscious and also to the competent patient who has declined medical treatment.

2. It proposed to provide that the doctor shall not be entitled to withhold or withdraw
treatment except in a case where he has gained opinion of a body of three skilled
medical practitioners from a panel prepared by an Authority of High Status. It
also proposed another significant caution, namely, that the decision to hold back or
withdraw must be grounded on
guidelines issued by the Medical Council of India as to the conditions under
which medical treatment in respect of the specific illness or disease, could be withdrawn
or withheld.

In addition, it is proposed that, a Register shall be maintained by the doctorswho

recommendthe withholding or withdrawing of the treatment, in the case of competent
as well as incompetent patients. The conclusion as well as the decision-making
procedure must be noted in the Register.
A timeline – Passive Euthanasia attaining its legal status

1. In 2006, 196th law commission report proposed`The Medical Treatment of Terminally

ill Patients (Protection of Patients and Medical Practitioners) Bill 2006. However, the
government didn’t choose to formulate any law with respect to euthanasia.
2. In March 2011, while hearing the Aruna Shanbaug’s case, the Supreme Court laid down
guidelines to process pleas for passive euthanasia. It also laid down the differences
between active and passive euthanasia.
3. Again in August 2012, drafting of a legislation on passive euthanasia was proposed by
the law commission making a draft bill called the Medical Treatment of Terminally Ill
Patients (protection of patients and medical practitioners) Bill. It could not go through
because of lack of content regarding active euthanasia.
4. In May 2016 the ministry of health reviewed the bill and asks for a public opinion.

Conclusion

With respect to the subject matter, no proper law has been framed yet. Passive euthanasia is only
guarded by certain guidelines and no proper legislation. Moreover, passive euthanasia is allowed
under special circumstances. Living wills on the other side is a complex subject matter, which
needs a carefully made legislation because it might just be misused. According to my observation
and research, ‘’passive euthanasia’’ and ‘’living wills’’ can only be dealt based upon precedents,
guidelines and law commission reports.
UNIT – IV
 Surrogacy

Surrogacy is the practice whereby one woman carries the child for another with the intention that
the child should be handed over after birth.[1] Such a surrogacy arrangement may be altruistic or
commercial in nature. Altruistic surrogacy involves an arrangement where the couple does not
pay the surrogate mother any compensation other than the medical and insurance expenses related
to the pregnancy. Commercial surrogacy includes compensation (in cash or kind) paid to the
surrogate mother, which exceeds the reasonable medical expenses associated with the
pregnancy. Currently, commercial surrogacy is allowed for Indian citizens.

In 2005, the Indian Council of Medical Research (ICMR) issued guidelines to regulate surrogacy
arrangements.[2] The guidelines stated that the surrogate mother would be entitled to monetary
compensation, the value of which would be decided by the couple and the surrogate mother. The
guidelines also specified that the surrogate mother cannot donate her own egg for the surrogacy
and that she must relinquish all parental rights related to the surrogate child.

In 2008, the Supreme Court of India in the Baby Manji Yamada vs. Union of India case highlighted
the lack of regulation for surrogacy in India.[3] In 2009, the Law Commission of India observed
that surrogacy arrangements in India were being used by foreign nationals, and the lack of a
comprehensive legal framework addressing surrogacy could lead to exploitation of poor women
acting as surrogate mothers.[4] Further, the Law Commission recommended prohibiting
commercial surrogacy, allowing altruistic surrogacy and enacting a law to regulate matters related
to surrogacy. In 2015, a government notification prohibited surrogacy for foreign
nationals.[5] The Surrogacy (Regulation) Bill, 2016 was introduced in Lok Sabha on November
21, 2016.

Types of Surrogacy

Traditional Surrogacy:

 If the surrogate is related to one of the intended parents, traditional surrogacy can provide a genetic link that
would not have been possible with a donated egg. If the intended parents are a same-sex male couple, a single
male or a heterosexual couple where the woman is unable to use her eggs, traditional surrogacy may give them
the genetic link they desire.
 For intended parents who cannot find an egg donor they like, don’t want an anonymous donor or are looking to
reduce the cost of their surrogacy, traditional surrogacy may be best for them.

Gestational Surrogacy:

 Intended parents and surrogates who are wary of the legalities and emotions involved in traditional surrogacy
will want to choose a gestational surrogacy.
 If traditional surrogacy is outlawed in the surrogate’s state, she and the intended parents will need to pursue a
gestational surrogacy.
 Gestational surrogacy allows many intended mothers to be related to their child.
 Intended parents who have remaining embryos from past IVF treatments can use those in a gestational
surrogacy.

Compensated Surrogacy:

 If intended parents feel uncomfortable asking a friend or family member to become an uncompensated
surrogate, a commercial surrogacy may help eliminate the feeling of indebtedness that they could never pay
back.
 For intended parents and surrogates who don’t know each other prior to the matching process, a compensated
surrogacy protects both parties’ interests and rights in the surrogacy process.
 Surrogates may come to feel resentful or taken advantage of during the altruistic surrogacy process, so for
women who are unsure, a compensated surrogacy is usually the way to go.

Altruistic Surrogacy:

 If a surrogate’s state outlaws compensated surrogacy agreements, she and the intended parents will have to
complete their surrogacy altruistically.
 For some intended parents and surrogates who are friends or family members, a compensated surrogacy is
unnecessary; a surrogate will want to carry their baby because of the love between her and the intended parents.
 Because surrogates are unpaid, an altruistic surrogacy might help intended parents reduce the cost of their
surrogacy.

Domestic Surrogacy:

 If your country allows surrogacy and regulates it properly, it’s usually cheaper and safer to complete a domestic
surrogacy.
 This type of surrogacy allows intended parents and surrogates to meet, establish a relationship and more easily
stay in contact during the whole surrogacy process.
 A domestic surrogacy eliminates the legal processes that occur with bringing a baby born abroad back into their
parents’ country.

International Surrogacy:

 For intended parents who live in a country that restricts or outlaws surrogacy, completing an international
surrogacy in a surrogacy-friendly country like the U.S. is safer and easier.
 Surrogates who carry a child for an international intended parent can receive a base compensation that, due to
exchange rates and different standards of living, can drastically change their life situation.
 Key Features

Purposes for which surrogacy is permitted

 The Bill prohibits commercial surrogacy, and allows altruistic surrogacy. Altruistic
surrogacy does not involve any monetary compensation to the surrogate mother other than
the medical expenses and insurance coverage during the pregnancy. Commercial
surrogacy includes surrogacy or its related procedures undertaken for a monetary benefit
or reward (in cash or kind) exceeding basic medical expenses and insurance coverage.

 The Bill permits surrogacy when it is: (i) for intending couples who suffer from proven
infertility; (ii) altruistic; (iii) not for commercial purposes; (iv) not for producing children
for sale, prostitution or other forms of exploitation; and (v) for any other condition or
disease specified through regulations.

Eligibility criteria for the intending couple and the surrogate mother

 The intending couple should have a ‘certificate of essentiality’ and a ‘certificate of

eligibility’ issued by the appropriate authority. The surrogate mother too needs a
‘certificate of eligibility’.

 A certificate of essentiality will be issued to the intending couple upon fulfilment of the
following conditions: (i) a certificate of proven infertility of either or both of them; (ii) an
order of parentage and custody of the surrogate child passed by a Magistrate’s court; and
(iii) insurance coverage for the surrogate mother.

 The certificate of eligibility to the intending couple is issued upon the fulfilment of the
following conditions: (i) the couple being Indian citizens and married for at least five years;
(ii) between 23 to 50 years old (wife) and 26 to 55 years old (husband); (iii) they do not
have any surviving child (biological, adopted or surrogate), except if the child is mentally
or physically challenged or suffers from a life threatening disorder; and (iv) such other
conditions that may be specified through regulations.
  To obtain a certificate of eligibility from the appropriate authority, the surrogate mother
has to: (i) be a close relative of the intending couple; (ii) be an ever married woman having
a child of her own; (iii) be 25 to 35 years old; (iv) not have been a surrogate mother earlier;
and (iv) have a certificate of medical and psychological fitness.

Parentage and abortion of surrogate child

 A child born out of a surrogacy procedure will be deemed to be the biological child of the
intending couple.

 An abortion of the surrogate child requires the written consent of the surrogate mother and
the authorisation of the appropriate authority. Further, this authorisation will have to be
compliant with the Medical Termination of Pregnancy Act, 1971.

Appropriate authority and registration of surrogacy clinics

 The central and state governments will appoint one or more appropriate authorities. The
functions of the appropriate authority include: (i) granting, suspending or cancelling
registration of surrogacy clinics; (ii) enforcing standards for surrogacy clinics; and (iii)
investigating and taking action against complaints of breach of the Act. The appropriate
authority comprises the Joint Director of the state Health Department, an officer of the state
Law Department, a medical practitioner, and an eminent woman.

 Surrogacy clinics cannot undertake surrogacy or its related procedures unless they are
granted registration by the appropriate authority. Clinics must apply for registration within
a period of 60 days from the date of appointment of the appropriate authority. This
application will be accepted or rejected within 90 days. No human embryo or gamete can
be stored by a surrogacy clinic for the purpose of surrogacy.

National and State Surrogacy Boards

 The central and state governments shall constitute the National Surrogacy Board (NSB)
and the State Surrogacy Boards (SSBs), respectively. Functions of the NSB include: (i)
 advising the central government on surrogacy policy; (ii) laying down the code of conduct
of surrogacy clinics; and (iii) supervising the functioning of SSBs.
 Functions of the SSBs include: (i) monitoring the implementation of the provisions of the
Act; and (ii) reviewing the activities of the appropriate authorities functioning at the
state/union territory level.

Offences and penalties

 The Bill creates certain offences which include: (i) undertaking or advertising commercial
surrogacy; (ii) exploiting the surrogate mother; and (iii) selling or importing human embryo
or gametes for surrogacy. These offences will attract a penalty of 10 years and a fine of up
to 10 lakh rupees.

Critical Analysis of the Bill

1. ‘Close relative’ not defined

The Bill specifies various conditions that need to be fulfilled by a surrogate mother in order to be
eligible for a surrogacy procedure. Upon fulfilling these conditions, the surrogate mother may
obtain an eligibility certificate from the appropriate authority. One of the conditions to be proved
is that the surrogate mother is a ‘close relative’ of the intending couple who commission the
surrogacy. However, the Bill does not specify who will be a ‘close relative’.

2. Definition of ‘infertility’ restricted to failure to conceive

Under the Bill, ‘infertility’ is a condition that has to be proven by an intending couple, in order to
be eligible to commission a surrogacy procedure. The Bill defines infertility as the inability to
conceive after five years of unprotected coitus or other medical condition preventing a couple from
conception. This definition does not cover all cases in which a couple is unable to bear a child.

For example, there may be medical conditions where the woman may conceive but is unable to
carry a child through the period of the pregnancy, i.e., the period of nine months following the
conception. This includes cases where an intending mother may be able to conceive a child, but
may have multiple miscarriages that result in her inability to bear a child. There are also other
medical conditions like multiple fibroids in the uterus, hypertension, and diabetes that affect
successful pregnancies.[6] Such persons will not be covered under the definition of ‘infertility’
proposed in the Bill and therefore will not be eligible to undertake altruistic surrogacy.

3. Review and appeal procedure for surrogacy applications not specified

In order to initiate a surrogacy procedure, the surrogate mother and the intending couple are
required to obtain certificates of eligibility and essentiality upon fulfilling various conditions from
the relevant appropriate authorities. However, the Bill does not specify a time limit by which the
authority will grant these certificates. Further, the Bill does not specify a review or appeal
procedure in case the surrogacy applications are rejected.

4. Intending couple has no say in the consent to abort a surrogate child

An abortion of the surrogate child requires the written consent of the surrogate mother and an
authorisation by the appropriate authority. The Bill further states that no person may force the
surrogate mother to abort the foetus. However, after the birth, the child is considered the biological
child of the intending couple and they are responsible for bringing up the child. If a child being
born out of surrogacy arrangement is at the risk of physical or mental abnormalities, under the Bill
only the surrogate mother’s consent will be required to abort the child. The intending couple will
have no role in this decision. Under the provisions of the MTP Act, 1971, abortion in such cases
is allowed with the consent of the ‘pregnant woman’. The complexity in the case of surrogacy is
that the surrogate mother (who is carrying the child) is different from the intending couple who
has to bring up the child.

5. Storage of embryo or gamete for surrogacy not allowed

The Bill prohibits storage of embryos and gametes (unfertilised egg and sperm) for the purpose of
surrogacy. This differs from the current ICMR guidelines (2005) which allow the storage of
embryos for a period of five years. The prohibition on storage of egg or sperm may have adverse
health implications for the intending mother.
 HIV/AIDS
Rights, relating to people living with HTV The HTV/AIDS problem extend beyond the physical health
ofthe individual and finds its sustenance and impacts in the social, economic and political condition in
which individual lives. Adopting a human rights approach enables states, communities, groups and
organizations to address the problem in a compassed that the effective response to the HTV/AIDS pandemic
should be viewed in the context of the realization and promotion of peoples civil and political rights as well
as their economic, social and cultural rights.

Rights of persons suffering from AIDS under International Law

The 2nd International Consultation on HIV/AIDS and Human Rights in September 1996, identified some
ofthe key human rights8. Provisions from international human rights treaties have significant implications
for the effectiveness ofthe response to the HIV epidemic.

(a) Right to health. Access to humane, non-discriminatory and high-quality health services and essential
medications is the sine qua non ofsociety’s health obligations to PLHIV. In practical terms it means that
health systems should be responsive to specific needs associated with HTV - both of people infected as
well as ofthe general population so that the risk ofinfection is diminished.

(b) Right to life. The United Nations International Covenant on Civil and Political Rights (ICCPR)
recognizes that “every human being has the inherent right to life”. In practical terms PLHTV warrant every
effort to protect and prolong their lives.

(c) Right equality ICCPR Articles 14 and 26 together guarantee the rights to equal protection before the
law and to be free from discrimination on many grounds. The United Nations Commission on Human
Rights has confirmed that ‘other status’ in nondiscrimination provisions in international human rights
treaties is to be interpreted to include health status, including HTV status150.

(d) Rights of women. The United Nations Convention on the Elimination of All Forms of Discrimination
against Women (CEDAW) obliges states parties to address all aspects of gender-based discrimination in
law, policy and practice. Equal protection of the rights of women and girls is critical to preventing HIV
transmission and to lessening the impact ofthe epidemic on women.

(e) Rights of children. Under the United Nations Convention on the Rights of the Child (CRC), children
are confirmed to have many of the rights of adults, in addition to specific rights for children. Children have
the right to freedom from trafficking, prostitution, sexual exploitation and sexual abuse; the right to seek,
receive and impart HTV information; and the right to special protection and assistance, if deprived of their
family environment. They also have the right to education, the right to health and the right to inherit
property. The right to special protection and assistance, if deprived of his or her family environment,
protects children ifthey are orphaned by the death of parents from AIDS. Children also have the right to be
actors in their own development, to express their opinions and to be involved in the design and
implementation ofchild-focused HIV-related programs.

(f) Right to marriage and family. ICCPR Article 23 recognizes the right to marry and found a family.
Mandatory pre-marital HTV testing as a precondition for marriage, or forced abortions or sterilization
ofwomen living with HTV, violate these (and other) rights.

(g) Right to privacy. This right, set out in the ICCPR Article 17, encompasses obligations to
respect physical privacy (e.g. the obligation to seek informed consent to HTV testing) and the need
to respect confidentiality of personal information (e.g. information relating to a person’s HTV
status).

(h) Right to education and freedom of expression and information. The implications of these
rights in the context of the HIV epidemic are explained above, in the section on ‘Education and
information.’ Freedom of assembly and association. The right to peaceful assembly and
association, provided by Article 20 of the United Nations Universal Declaration on Human Rights
(UDHR) and by Article 22 in the ICCPR, has frequently been denied to civil society organizations
working on human rights and HTV.

(i) Right to work. This right, enshrined in Article 23 of the UDHR and Articles 6 and 7 of the
International Covenant on Economic, Social and Cultural Rights (ICESCR), entails the right of
every person to access employment without any precondition except the necessary occupational
conditions. This right is violated when an applicant or employee is required to undergo mandatory
testing for HIV and is dismissed or refused employment on the ground of a positive result. The
right to work further guarantees the right to safe and healthy working conditions. Where a
possibility of HIV transmission exists, states should take measures to minimize these risks, rather
than deny PLHIV the right to work.
(j) Right to enjoy the benefits ofscientific progress and its applications. This right, set forth in
Article 27 ofthe UDHR and Article 15 ofthe ICESCR, obliges the state to ensure that treatment
and participation in clinical trials are made available equally to marginalized and vulnerable
populations. This right is particularly relevant in view of scientific and pharmaceutical advances
made in diagnosis and treatment, as well as in the development of a vaccine and new prevention
tools such as microbicides.

(k) Right to freedom of movement. This right, found in Article 12 of the ICCPR and Article 13
of the UDHR, encompasses the right of everyone to freely choose his/her place ofresidence within
a country, as well as the rights of nationals to enter and leave their own country. Restricting liberty
of movement or choice of residence for PLHIV, as well as restricting travel, are discriminatory
and violate this right. (l) Right to an adequate standard ofliving and social security services. This
right, found in Article 25 of the UDHR and in Articles 9 and 11 of the ICESCR, stipulates that
states should ensure that PLHIV are not diseriminatorily denied an adequate standard ofliving or
social security services. Families, caregivers and children affected by HTV should be protected
from food insecurity and impoverishment resulting from living with HTV infection.

(m) Right to participation in political and cultural life. This right, found in Article 25 ofthe
ICCPR and Article 15 ofthe ICESCR, is essential for ensuring the participation ofthose most
affected by HIV in all aspects of HIV-related policies and programs. (n) Right to liberty and
security ofperson. This right, found in Article 9 ofthe ICCPR, means that the right to liberty and
security should not be mitigated based on a person’s HIV-status (e.g. by placing an HTV-positive
individual in quarantine or isolation). Compulsory HIV testing can also constitute a deprivation of
liberty and a violation of the right to security of person. Respect for the right to physical integrity
requires that testing be voluntary and undertaken with the informed consent ofthe person.

(o) Freedom from cruel, inhuman or degrading treatment or punishment. This right, found
in Article 5 of the UDHR and Article 7 of the ICCPR, provides for the state to ensure that prisoners
have access to HIV-related information, education and means of protection (such as condoms and
clean injection equipment) as well as voluntary counseling, testing and treatment. All these
provisions from international human rights treaties have direct implications for people affected by
the epidemics - both those living with HIV and their families.

Rights of persons suffering from AIDS under Indian Law

Indian Constitution

In general, all the rights in Indian Constitution are available to the persons living with HIV-AIDS who are
Indian Citizens. The legal rights of HIV-AIDS persons are not affected only because of the disease The basic
rights guaranteed in Indian Constitution can fully be enjoy by the HIV-AIDS persons. Not only that but
when the rights of such persons rights were violated the Indian Constitution stands besides the HIV-AIDS
persons.

The HIV-AIDS persons are normally vested with all fundamental rights guaranteed in Indian Constitution.

a) Art.14. - Equality before law

b) Art.15. - Prohibition of discrimination on grounds of religion, race, caste, sex or place of birth

c) Art.19.- Protection of certain rights regarding freedom of speech, etc

d) Art.21.- Protection of life and personal liberty

e) Art. 32. Remedies for enforcement of Fundamental right

Indian Medical Council Act, 1956-

The Medical Council Act lays down certain duties that have to be observed by the doctors towards the
HIV/AIDS patients. These are enumerated below- 

 Duty to take care and to take informed consent from the patient. 
 Disclosure of information and risks to the patient Provide information of options available and
benefits. Duty to warnTo admit patient in emergency without consent. 

 The physician should not abandon his duty for fear of contracting the disease himself.
The Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome (Prevention and
Control) Act, 2017

Recently the Indian Parliament has passed the The Human Immunodeficiency Virus and Acquired
Immunodeficiency Syndrome (Prevention and Control) Act,2017 which recognises the rights of HIV/AIDS
persons. This Act makes anti-retroviral therapy a legal right of HIV/AIDS patients and states that “every
person in the care and custody of the state shall have right to HIV prevention, testing, treatment and
counselling services. It also asks the central and state governments to provide such treatment along with
infection management. This Act also asks the state and central governments to facilitate access for the
HIV/AIDS community to welfare schemes.

Right to Treatment- This Act provides a special right of HIV/AIDS persons regarding treatment. While
providing the treatment, this Act especially mentions regarding treatment of Anti Retroviral Therapy (ART)
and makes the governments responsible for providing such treatment. The following provisions are very
important in this regard.

Section 13.- The Central Government and every State Government, as the case may be, shall take all such
measures as it deems necessary and expedient for the prevention of spread of HIV or AIDS in accordance
with the guidelines.

Confidentiality- This Act in Section 8. (1) Notwithstanding anything contained in any other law for the
time being in force,— (i) No person shall be compelled to disclose his HIV status except by an order of the
court that the disclosure of such information is necessary in the interest of justice for the determination
of issues in the matter before it;

3) Right Against Discrimination and Right to Employment- This Act in Section 3. Provides that No person
shall discriminate against the protected person on any ground including any of the following, namely:—

(a) the denial of, or termination from, employment or occupation, unless, in the case of termination, the
person, who is otherwise qualified,

(b) the unfair treatment in, or in relation to, employment or occupation;

(c) the denial or discontinuation of, or, unfair treatment in, healthcare services;
(d) the denial or discontinuation of, or unfair treatment in, educational, establishments and services
thereof;

(e) the denial or discontinuation of, or unfair treatment with regard to, access to, or provision or
enjoyment or use of any goods, accommodation, service, facility, benefit, privilege or opportunity
dedicated to the use of the general public or customarily available to the public, whether or not for
a fee, including shops, public restaurants, hotels and places of public entertainment or the use of
wells, tanks, bathing ghats, roads, burial grounds or funeral ceremonies and places of public resort;

(f) the denial, or, discontinuation of, or unfair treatment with regard to, the right of movement;

(g) the denial or discontinuation of, or, unfair treatment with regard to, the right to reside, purchase,
rent, or otherwise occupy, any property;

(h) the denial or discontinuation of, or, unfair treatment in, the opportunity to stand for, or, hold
public or private office;

(i) the denial of access to, removal from, or unfair treatment in, Government or private
establishment in whose care or custody a person may be;

(j) the denial of, or unfair treatment in, the provision of insurance unless supported by actuarial
studies;

(k) the isolation or segregation of a protected person;

In a public interest litigation brought by Naz (Organisation) India in 2015, India’s Supreme Court
held that children living with or affected by HIV (that is, children who are HIV positive and
children who are HIV negative but whose parents are HIV positive) should be afforded protected
status and included as a ‘child belonging to a disadvantaged group’ under India’s Right of Children
to Free and Compulsory Education (RTE) Act (2009). The extension of protected status to children
living with or affected by HIV means that they are now entitled to special protections and
measures, under the terms of the Right To Education Act.
UNIT – V
 Medical Negligence and liability of Hospitals under Civil and
Criminal law

Medical negligence is known as medical malpractice is improper, unskilled, or negligent treatment

of a patient by a physician, dentist, nurse, pharmacist, or other health care professional. Medical
malpractice occurs when a health-care provider strays from the recognized “standard of care” in
the treatment of a patient.

Liability under Consumer Protection Act

Since 1990’s there is a huge speculation and debate on whether medical services are explicitly or
categorically included in the definition of “Services” as enshrined under Section 2(1)(o) of the
Consumer Protection Act (CPA). Deficiency of service means any fault, imperfection,
shortcoming, or inadequacy in the quality, nature, or manner of performance that is required to be
maintained by or under any law for the time being in force or has been undertaken to be performed
by a person in pursuance of a contract or otherwise about any service.

The question that comes to mind is that where can a complaint be filed; the answer is that, a
complaint can be filed in-:

1) The District Forum if the value of services and compensation claimed is less than 20 lakh rupees,

2) Before the State Commission, if the value of the goods or services and the compensation claimed
does not exceed more than 1 crore rupees, or

3) In the National Commission, if the value of the goods or services and the compensation exceeds
more than 1 crore rupees.

The good positive aspect about this is that there is a minimal fee for filing a complaint before the
District Consumer Redressal Forums.
What Can Be Considered As ‘services’

1. Contract of Service – It connotes a relationship between a master and servant which

involves complete obedience of a just and reasonable order provided by the master to
the servant with respect to the mode and manner of performance of the order. This does
not come within the purview of COPRA.
2. Contract for Service – It refers to a contract in which one party accepts to render
services, for example, professional or technical services to or for some other person in
the discharge or conduct of which, he is not bound by any control or direction but
employs his professional skills and exercises his own knowledge and comprehension.

In order to bring the ‘service’ within the purview of the definition of services provided in Section
2(1)(o) of COPRA following basis needs to be adhered to:

1. Service(s) should not be free of charge

2. Service(s) under a contract of personal service is not covered under the Consumer
Protection Act.

In 1995, the Supreme Court decision in Indian Medical Association v. VP Shantha brought the
medical profession within the ambit of ‘service’ defined In the Consumer Protection Act, 1986.
This defined the relationship between patients and medical professionals by giving contractual
patients the power to sue doctors if they sustained injuries in the course of treatment in ‘procedure
free’ consumer protection courts for compensation.

State of Haryana v. Smt Santra, the Supreme Court held that a doctor can be held liable for
negligence only if one can prove that she/ he is guilty of a failure that no doctor with ordinary
skills would be guilty of if acting with reasonable care.

In a popular case, Achutrao Haribhau khodwa and Ors v. the State of Maharashtra, the Supreme
Court noticed that negligence cannot be attributed to a doctor so long as he is performing his duty
with due care, caution, and attention. Merely because the doctor chooses one course of action over
other, he won’t be liable.
Procedure for Filing a Case

1. Consumer Complaint as is provided under Section 21(a)(i) of COPRA, 1986, is to be

filed with the Registry of this Commission within a time span of two years from the
date on which the cause of action has arisen,where the value of the goods or services
and compensation, claimed, is more than Rs.10,00,000.

1. First Appeal as is provided under Section 19 of COPRA, 1986 – Any person distressed
by an order rendered by the State Commission in application of its powers granted by
Section 17(a)(i) may consider an appeal against such order before this Commission
within a time frame of 30 days, beginning from the date the order was received.
2. Revision Petition as is provided under Section 21(b) of the COPRA, 1986 can be filed
to ask for the records and advance suitable orders in any consumer dispute which is
lying unresolved or has been determined by any State Commission,within a time frame
of 90 days beginning from the date the order was received, be filed with the Registry
of this Commission.
3. Transfer Application as is provided under Section 22(b) of COPRA, 1986 – The
National Commission may, on the application of the aggrieved party or of its own will,
at any juncture of the proceeding, in the best interest of equity, transfer any complaint
lying unresolved before the District Forum of one State to a District Forum of another
State or before one State Commission to another State Commission.

Criminal Liability of Hospitals

There may be an occasion when the patient has died after the treatment and criminal case is filed
under Section 304A of the Indian Penal Code for allegedly causing death by rash or negligent act.
According to S. 304A of the IPC, whoever causes the death of any person by a rash or negligent
act not amounting to culpable homicide shall be punished by imprisonment for up to two years, or
by fine, or both.

Hospitals can be charged with negligence for transmission of infection including HIV,
HBsAg, etc. if any patient develops such infection during the course of treatment in the
 hospital and it is proved that the same has occurred on account of lapse on part of the
hospital then the hospital can be held liable for lack of reasonable duty to care. My very
own grandmother passed away due to the negligence of the doctors. Due to the carelessness
of the doctor that he was in so hurry to rush for his next operation that he forgot to sterilize
the equipments and as a result there was this transmission of some infection into her blood
which infected her entire system and ultimately resulted in her death.

4. Further In Dr. Suresh Gupta’s Case – Supreme Court of India, 2004 – the court held that
the legal position was quite clear and well settled that whenever a patient died due to
medical negligence, the doctor was liable in civil law for paying the compensation. Only
when the negligence was so gross and his act was as reckless as to endanger the life of the
patient, criminal law for offence under section 304A of Indian Penal Code, 1860 will
apply. Indian Penal Code 1860 sections 52, 80, 81, 83, 88, 90, 91, 92 304-A, 337 and 338
contain the law of medical malpractice in India.

Section 52. “Good faith”.—Nothing is said to be done or believed in “good faith” which is done
or believed without due care and attention.

Section 88. Act not intended to cause death, done by consent in good faith for person’s benefit.—
Nothing which is not intended to cause death, is an offence by reason of any harm which it may
cause, or be intended by the doer to cause, or be known by the doer to be likely to cause, to any
person for whose benefit it is done in good faith, and who has given a consent, whether express or
implied, to suffer that harm, or to take the risk of that harm.

Illustration- A, a surgeon, knowing that a particular operation is likely to cause the death of Z,
who suffers under a painful complaint, but not intending to cause Z’s death and intending in good
faith, Z’s benefit performs that operation on Z, with Z’s consent. A has committed no offence.

Section 92. Act done in good faith for benefit of a person without consent.—Nothing is an offence
by reason of any harm which it may cause to a person for whose benefit it is done in good faith,
even without that person’s consent, if the circumstances are such that it is impossible for that
person to signify consent, or if that person is incapable of giving consent, and has no guardian or
other person in lawful charge of him from whom it is possible to obtain consent in time for the
thing to be done with benefit.

Illustration- A, a surgeon, sees a child suffer an accident which is likely to prove fatal unless an
operation be immediately performed. There is no time to apply to the child’s guardian. A performs
the operation in spite of the entreaties of the child, intending, in good faith, the child’s benefit. A
has committed no offence.

Section 337- Causing hurt by act endangering life or personal safety of others.—Whoever causes
hurt to any person by doing any act so rashly or negligently as to endanger human life, or the
personal safety of others, shall be punished with imprisonment of either description for a term
which may extend to six months, or with fine which may extend to five hundred rupees, or with
both.

Section 338- Causing grievous hurt by act endangering life or personal safety of others.—Whoever
causes grievous hurt to any person by doing any act so rashly or negligently as to endanger human
life, or the personal safety of others, shall be punished with imprisonment of either description for
a term which may extend to two years, or with fine which may extend to one thousand rupees, or
with both.

5. The conduct of medical malpractice was brought under the Consumer Protection Act, 1986,
due to the landmark case of the Indian Medical Association vs. V. P. Shantha &
others[xx], The judgment in this case defined medical care as a “service” that was covered
under the Act, and also clarified that a person seeking medical attention may be considered
a consumer if certain criteria were met.
 BMW Management Rules, 2016

The major salient features of BMW Management Rules, 2016 include the following:-

(a) The ambit of the rules has been expanded to include vaccination camps, blood
donation camps, surgical camps or any other healthcare activity;
(b) Phase-out the use of chlorinated plastic bags, gloves and blood bags within two
years;
(c) Pre-treatment of the laboratory waste, microbiological waste, blood samples and
blood bags throughdisinfection orsterilisation on-site in the manner as prescribed
by WHOor NACO;
(d) Provide training to all its health care workers and immunise all health workers
regularly;
(e) Establish a Bar-Code System for bags or containers containing bio-medical waste
for disposal;
(f) Report major accidents;
(g) Existing incinerators to achieve the standards for retention time in secondary
chamber and Dioxin and Furans within two years;
(h) Bio-medical waste has been classified in to 4 categories instead 10 to improve the
segregation of waste at source;
(i) Procedure to get authorisation simplified. Automatic authorisation for bedded
hospitals. The validity of authorization synchronised with validity of consent
orders for Bedded HCFs. One time Authorisation for Non-bedded HCFs;
(j) The new rules prescribe more stringent standards for incinerator to reduce the
emission of pollutants in environment;
(k) Inclusion of emissions limits for Dioxin and furans;
(l) State Government to provide land for setting up common bio-medical waste
treatment and disposal facility;
(m) No occupier shall establish on-site treatment and disposal facility, if a service of
`common bio-medical waste treatment facility is available at a distance of seventy-
five kilometer.
 (n) Operator of a common bio-medical waste treatment and disposal facility to ensure
the timely collection of bio-medical waste from the HCFs and assist the HCFs in
conduct of training

Steps involved in Bio-medical Waste Management

First five steps (Segregation, Collection, pre-treatment, Intramural Transportation and Storage) is
the exclusive responsibility of Health Care Facility. While Treatment and Disposal is primarily
responsibility of CBWTF operator except for lab and highly infectious waste, which is required to
be pre-treated by the HCF. Following are the responsibility of HCF for management and handling
of bio-medical waste:

1. Biomedical Waste should be segregated at the point of generation by the person who is
generating the waste in designated colour coded bin/ container

2. Biomedical Waste & General Waste shall not be mixed. Biomedical Waste & General Waste
shall not be mixed. Storage time of waste should be as less as possible so that waste storage,
transportation and disposal is done within 48 hours.

3. Phase out use of chlorinated plastic bags (excluding blood bags) and gloves by 27/3/2019.

4. No secondary handling or pilferage of waste shall be done at healthcare facility. If CBWTF

facility is available at a distance of 75 km from the HCF, bio-medical waste should be treated and
disposed only through such CBWTF operator.

5. Only Laboratory and Highly infectious waste shall be pre-treated onsite before sending for final
treatment or disposal through a CBWTF Operator.

6. Provide bar-code labels on all colour coded bags or containers containing segregated bio-
medical waste before such waste goes for final disposal through a CBWTF.

The management of bio-medical waste can overall be summarized in the following steps;

- Waste Segregation in color coded and barcode labeled bags/ containers at source of generation
- Pre-treat Laboratory and Highly infectious waste

- Intra-mural transportation of segregated waste to central storage area

- Temporary storage of biomedical waste in central storage area

- Treatment and Disposal of biomedical waste through CBWTF or Captive facility

Bio-medical waste

i. Biomedical waste comprises human & animal anatomical waste, treatment apparatus
likeneedles, syringes and other materials used in health care facilities in the process of
treatment and research. This waste is generated during diagnosis, treatment or
immunisation in hospitals, nursing homes, pathological laboratories, blood bank, etc. Total
bio-medical waste generation in the country is 484 TPD from 1,68,869 healthcare facilities
(HCF), out of which 447 TPD is treated.

Proper Bio-medical waste management

ii. Scientific disposal of Biomedical Waste through segregation, collection and treatment in
an environmentally sound manner minimises the adverse impact on health workers and on
the environment. The hospitals are required to put in place the mechanisms for effective
disposal either directly or through common biomedical waste treatment and disposal
facilities. The hospitals servicing 1000 patients or more per month are required to obtain
authorisation and segregate biomedical waste in to 10 categories, pack five colour backs
for disposal. There are 198 common bio-medical waste treatment facilities (CBMWF) are
in operation and 28 are under construction. 21,870 HCFs have their own treatment facilities
and 1,31,837 HCFs are using the CBMWFs.

Problems of unscientific Bio-medical waste disposal

iii. The quantum of waste generated in India is estimated to be 1-2 kg per bed per day in a
hospital and 600 gm per day per bed in a clinic. 85% of the hospital waste is non-hazardous,
15% is infectious/hazardous. Mixing of hazardous results in to contamination and makes
the entire waste hazardous. Hence there is necessity to segregate and treat. Improper
disposal increases risk of infection; encourages recycling of prohibited disposables and
disposed drugs; and develops resistant microorganisms