UNIT I

Good health, free from disease, is not only the very foundation for a healthy
life, but equally recognized as a human right and a constitutional
fundamental. Health, being one of the essential components of an adequate
standard of living is always accompanied by the legal regulations.
a. What is right to health:
The right to health includes healthy environment to live or work in, and
access to adequate health care facilities including medical, preventative, and
mental, nutrition, sanitation, and to clean water and air.
While the availability, accessibility, acceptability and quality of these is
important, the question of access to drugs stands out in the context of the
TRIPs Agreement.
b. Constitutional Provisions:
The humbler the Indian human, the higher the state's duty to protect the
person
The obligation on the State to ensure the creation and the sustaining of
conditions congenial to good health is cast by the Constitutional directives
contained in various articles viz: .
The Preamble to the Constitution which gives a broad direction for the
Indian Republic, refers to social, economic and political justice and also
equality of status and of opportunity. Under the term Social Justice, one can
bring in the question of access to health care facilities and the principle of
justice involved in the equality of access to these facilities
Article 21 of the Constitution guarantees protection of life and personal
liberty by providing that, No person shall be deprived of his life or
personal liberty except according to the procedure established by
law.
As a result of liberal interpretation of the words life and liberty, Article 21
has now come to be invoked almost as a residuary right. Public interest
petitions have been founded on this provision for providing special treatment
to children in jail; against health hazards due to pollution; against health
hazards from harmful drugs; for redress against failure to provide immediate
medical aid to injured persons; against starvation deaths; against inhuman
conditions in after-care home and on scores of other aspects which make life

meaningful and not a mere vegetative existence. A positive thrust is given to

the nature and content of this right by the Apex Court imposing a positive
obligation upon the State to take effective steps for ensuring to the
individual a better enjoyment of his life. The Supreme Court has held that the
right to live with human dignity enshrined in Article 21 derives its life and
breath from the directive principles of State. Few of the landmark cases are
as under:
Parmananda Katara v. Union of India AIR 1989 SC 2039
Article 21 of the Constitution casts the obligation on the State to preserve
life.
Paschim Bang Khet Mazdoor Samiti v. State of W.B. (1996) 4 SCC 37
The Supreme Court held that Art. 21 imposes an obligation on the State to
provide medical assistance to every injured person. Preservation of human
life is of paramount importance.
Consumer Education and Research Centre v. Union of India (1995) 3
SCC 42
Right to Life in Art. 21 does not connote mere animal existence. It has a
much wider meaning which includes right to livelihood, better standard
of life, hygienic conditions in workplace and leisure.
Kirloskar Brothers Ltd. v. Employees State Insurance Corporation
(1996) 2 SCC 682.
The Supreme Court, following the above case, held that right to health is a
fundamental right. The Court further held that it is a right not only
available against the State and its instrumentalities but even
private industries
State of Punjab v. Mohinder Singh Chawla AIR 1997 SC 1225
right to health has been declared a fundamental right under the Constitution
of India and State is obliged to provide adequate condition for healthy life.

Article 39(e)
- health and strength of workers, men and women, and the
tender age of children are not abused and that citizens are not forced by
economic necessity to enter avocations unsuited to their age or strength

Article 39(f)
- children are given opportunities and facilities to develop
in a healthy manner and in conditions of freedom and dignity and that
childhood and youth are protected against exploitation and against moral
and material abandonment.
Article 42 - The State is required to make provision for just and humane
conditions of work and for maternity benefit.
Article 47
- It is the primary duty of the State to endeavor the raising
of the level of nutrition and standard of living of its people and improvement
of public health and to bring about prohibition of the consumption, except for
medicinal purposes of intoxicating drinks and of drugs which are injurious to
health.
ARTILCE 51A(a)It shall be the duty of every citizen to protect and improve
the natural environment including forests, lakes, rivers and wild life, and to
have compassion for living creatures
Article 243G and 243W empowers panchayats and municipalities
respectively , with such powers and authority and may be necessary to
enable them to function appropiatley for the preparation of plans for
economic development and social justice;

VII Schedule:
State List- Entry 6 : State legislature is empowered to make laws with
respect to public health and sanitation, hospitals and dispensaries.
Concurrent List Entries 23, 26 and 29 : Both the Centre and the States
have power to legislate in the matters of social security and social insurance,
medical professions, and, prevention of the extension from one State to
another of infections or contagious diseases or pests affecting man, animals
or plants, by entries 23, 26 and 29 respectively contained in the concurrent
list of the Seventh Schedule.
International Scenario on Right to health
Right to health has also been a concern at the international community and
the same can be seen from the various declarations and conventions.

Universal Declaration of Human Rights, 1948: Article 25

guarantees a right to adequate standard of living for the health and well-

being of a person and his family including food, clothing, housing and
medical care and necessary social services, and the right to security in the
event of unemployment, sickness, disability, widowhood, old age or other
lack of livelihood in circumstances beyond his control.

International Convention on the Elimination of All Forms of

Racial Discrimination 1965: Under article 5 (e) (iv) the right to health is
recognized.

International Convention on the Elimination of All Forms of

Racial Discrimination, 1969: Article 5 in compliance with the
fundamental obligations laid down in article 2 of this Convention, requires
the States Parties to prohibit and to eliminate racial discrimination in all its
forms; guarantees social, economic and cultural right of everyone, without
distinction as to race, colour, or national or ethnic origin Article 7, 11 and
12 recognize the right of everyone to ... just and favourable conditions of
work.

International Covenant on Economic, Social & Cultural Rights,

1976: Article 12 recognizes the right of everyone to the enjoyment of the
highest attainable standard of physical and mental health... and also requires
the State to take necessary steps for the reduction of the stillbirth-rate and
of infant mortality and for the healthy development of the child; for the
improvement of environmental and industrial hygiene; for the prevention,
treatment and control of epidemic, endemic, occupational and other
diseases, etc.

Committee on Economic, Social & Cultural Rights : General

Comment 14: Article 12 guarantees the highest attainable standard of
health.

Convention on the Elimination of All Forms of Discrimination

against Women, 1979: Article 11, 12 and 14 assures the safety in
working conditions, appropriate measures to eliminate discrimination against
women and providing special attention and care to women.

Convention on the Rights of the Child, 1989: Article 24 requires

the State to ensure that no child is deprived of his/ her right of highest
attainable standard of health and access to such health care services set
forth in the present Convention and in other international human rights or
humanitarian instruments to which the said States are Parties.


African [Banjul] Charter on Human and Peoples' Rights: Article
16 recognises the right of everyone to enjoy the best attainable state of
physical and mental health.
Similarly the entire Constitution of the World Health Organization is relevant
to the right to health without distinction of race, religion, political belief,
economic or social condition."
Several regional human rights instruments also recognize the right to health,
such as the European Social Charter of 1961 as revised (art. 11), the African
Charter on Human and Peoples' Rights of 1981 (art. 16) and the Additional
Protocol to the American Convention on Human Rights in the Area of
Economic, Social and Cultural Rights of 1988 (art. 10). Similarly, the right to
health has been proclaimed by the Commission on Human Rights as well as
in the Vienna Declaration and Programme of Action of 1993 and other
international instruments.
Thus, various Conferences, Treaties, Declarations, Conventions, etc have
been made at the international era to recognize the right to health and a
duty has been caste upon the state to provide such adequate means and
conditions for the enjoyment of such right. India is also a member of most of
the above.
Thus, on the one hand, it is the duty of the Government to provide adequate
facilities for a healthy life, while on the other hand, TRIPS requires the states
to provide for the product patent resulting in the hike of the drug prices and
ultimately posing a severe question of affordability. Thus, it is difficult to
determine, whether right to health is a myth or reality?
UNIT II
(Narcotic Drugs & Psychotropic Substances Act,1985)
Narcotic Drugs and Psychotropic Substances have several medical and
scientific uses. However, they can be and are also abused and trafficked.
India's approach towards Narcotic Drugs and Psychotropic Substances is
enshrined in Article 47 of the Constitution of India which mandates that the
State shall endeavour to bring about prohibition of the consumption except
for
medicinal purposes of intoxicating drinks and of drugs which are injurious to
health. The system of control of Narcotic Drugs in India has been put in
place considering the requirement of narcotic drugs and psychotropic
substances for medical use and the countrys obligations towards the UN

conventions. India is a signatory to The UN Single Convention on Narcotics

Drugs 1961, The Convention on Psychotropic Substances, 1971 and The
Convention on Illicit Traffic in Narcotic Drugs and Psychotropic Substances,
1988 which prescribe various forms of control aimed to achieve the dual
objective of limiting the use of narcotics drugs and psychotropic substances
for medical and scientific purposes as well as preventing the abuse of the
same.
The administrative and legislative setup in the field of Narcotics has been put
in place in the country in accordance with the aforesaid spirit of the UN
Conventions. The basic legislative instrument of the Government of India in
the regard is the Narcotics Drugs and Psychotropic Substances (NDPS) Act,
1985. Various Ministries and Departments under the Government of India as
well as the State Governments exercise various functions pertaining to drug
demand and supply reduction. The aspect of drug supply reduction is looked
after by various enforcement agencies under the Ministry of Finance, Ministry
of Home Affairs and State Governments. The aspect of drug demand
reduction is handled by the Ministry of Social Justice & Empowerment and
that of treatment of drug addicts and their rehabilitation falls under the
domain of the Ministry of Health. The NDPS Act defines offences, prescribes
the procedure for investigation including searches, seizure, and arrests, and
provides for punishments for each offence
Hence aim and objective is to
1. to consolidate and amend the lawrelating to narcotic drugs &

psychotropic substances
.
2. to make stringent provisionsfor control, forfeiture of property,derived
from or used in illicit traffic
3. to implement the provisions of the international conventions nds&pss.
4. all the matters related there to.
Drugs that are abused can be classified into:
1. Natural drugs{Opium poppy, Cannabis and Coca)
1. Semi-synthetic drugs; and
2. Synthetic drugs.
Effects of drugs
When abused, drugs produce a variety of effects depending upon the drug:

1. Stimulants increase the activity of the abuser and make him more
lively and active. Some stimulants such as amphetamines were used in
wars to make the soldiers more active.
2. Sedatives make the person feel sleepy and reduce his activity. Opium
and opiates are good examples of sedatives.
3. Hallucinogens create hallucinations in the abuser. LSD is one of the
well known hallucinogens.
4. Tranquilisers calm the nerves of the addict without making him feel
sleepy.
5. Drugs of abuse are smoked, snorted, consumed orally or injected.
Injecting drug users (IDUs) often share needles and syringes and
infections spread through them. If a member of the group of addicts is
HIV positive, the infection spreads to others through needles and
syringes
Relevant provision prohibiting,controlling and preventing use of
drug(sec8-14)
Section 10 of the NDPS Act empowers the State Government to permit and
regulate, transport, sale, use, etc. of poppy straw. This power of the State
Governments is subject to the restriction under Section 8 by which no
narcotic drug or psychotropic substance can be used except for medical or
scientific purposes . Section 9 of the NDPS Act empowers the Central
Government to licence cultivation of coca bush for medical and scientific
purposes.
Amendment in 2014
The amendments 2014 make important, path breaking changes for medical
access to narcotic drugs by removing barriers that date back to 1985, when
the Act was first introduced. The amendments also include provisions to
improve treatment and care for people dependent on drugs, moving away
from abstinence oriented services to treating drug dependence as a chronic,
yet manageable condition. The amendments broaden the object of the NDPS
Act from containing illicit use to also promoting the medical and scientific use
of narcotic drugs and psychotropic substances. The language incorporated in
section 4, which is an overarching provision, reflects the principle of
balance between control and availability of narcotic drugs, which is at the
heart of international drug control Parliament has adopted a new category of
essential narcotic drugs in section 2(viiia) of the Act a list, which the
Central Government can notify on the basis of expediency in medical
practice

S. 71 of the amended Act, it is concluded that there is a move to protect the

interests of drug addicts affirmatively.
Unit III
Doctor patient relationship and duty to take care and duty to treat
Physicians and surgeons are medical practitioners who treat illness and
injury by prescribing medication, performing diagnostic tests and
evaluations, performing surgery, and providing other medical services and
advice. Physicians and surgeons are highly trained and duly authorized by
law to practice medicine.
A physician stands in a fiduciary relationship to her patients,
meaning that the physician must always exercise the utmost Good Faith
and trust when dealing with patients. A confidential relationship exists
between the parties: because a patient must feel free to disclose any
information that might pertain to treatment and diagnosis, the physician has
the professional obligation to keep information confidential absent a patient's
consent. But a physician cannot attempt to shield his own incompetence by
refusing to disclose information. Moreover, a physician may have a
statutory duty to reveal information concerning a patient. Doctors are
required to provide authorities with information regarding birth and death,
Child Abuse, and contagious or infectious diseases. A physician may also
have a duty to disclose confidential information to third parties in other
circumstances.
Physicians and their patients have a contractual relationship. The
relationship continues until treatment is completed or upon agreement by
the parties. The physician agrees to treat the patient but rarely promises a
specific outcome or cure. If a doctor promises a specific outcome but fails to
deliver it, the doctor may be liable for breach of contract. One example
would be a surgeon who promises that cosmetic surgery will produce certain
results.
A physician's conduct must always meet the standard of care set by the
profession, or he may be liable for Malpractice. Physicians and surgeons
must possess and exercise the same level of skill and learning ordinarily
possessed and exercised by other members of their profession under similar
circumstances.
Although not absolute in every instance, some of the responsibilities a
physician or surgeon has toward a patient include a duty to

Fully inform a patient of her condition;

Notify a patient of the results of a diagnosis or test;

Inform the patient of the need for different treatment or refer the
patient to a specialist or other qualified practitioner;

Continue medical care until proper termination of the relationship;

Give proper notice before withdrawal from treatment;

Not abandon a patient, including making arrangements for treatment

during absences;

Treat nonpaying patients the same as those who pay;

Use diligence in treatment in providing all necessary care;

Obtain a patient's informed consent before performing a medical

procedure;

Instruct others as to the care and treatment of a patient;

Warn others of exposure to communicable and infectious diseases.

A patient has a duty to cooperate with a physician and participate in

treatment and diagnosis. For example, a patient does not have a general
duty to volunteer unsolicited information but is required to disclose a
complete and accurate medical history upon questioning by a physician. A
patient also must return for further treatment when required. Failure to
cooperate or participate in treatment may result in a limited recovery for a
physician's malpractice or completely bar recovery, depending upon the
circumstances of the case.
Medical negligence and malpractice
Negligence is the event in which an individual does not do something in a
situation in which a helpful action is needed. Medical negligence, however, is
slightly different, due to the fact that these situations involve medical
professionals, who have been trained in their field. Medical negligence is the
event in which a medical professional fails to take an action that otherwise
would have prevented harm upon their patient. Some examples of medical
negligence are ignoring the individual, avoiding answering questions of the
patient or those of their family, operating on the wrong limb, or even not
performing enough tests to determine a correct diagnosis.

Medical negligence most often gets confused with medical malpractice. The
two are very much related, but they are not the same entity. Both consist of
the same four elements of the duty, the breach, the damage, and the injury,
but the difference between the two is an unfortunate accident that could
have been prevented, and information that was kept from the patient who
needs to know their condition. Medical malpractice is also the event in which
the patient experiences unnecessary procedures or trauma. While medical
negligence is negligence in the medical field by a professional who should
have known better, medical malpractice is a foolish action that could have
been corrected with knowledge of their actions and their field.
Duty: A medical professional owes a duty to his or her patient. That duty is
to perform with reasonable care, as per the medical standards, to prevent
injuries.
Breach: Once duty is established, it needs to be determined whether there
was a breach of that duty.
Causation: For a negligence claim, it is not enough that a duty was
breached. The injured party must also show that the breach of duty was the
cause of the injuries sustained.
Damages: The damages were talking about are pecuniary damages,
placing a value on the harm done to the patient. The damages might include
lost wages and medical bills. They could include general damages, such as
pain and suffering. Punitive damages, which are intended to punish the
negligent party for his or her actions, could be included as well.
Medical Malpractice
Medical malpractice is the illegal event in which the bond of trust between
medical professional and client has in some form been breached with
intention. It is under the umbrella of negligence, as it is the occurrence in
which the malign negligence is committed by a health care provider. Health
care providers refer to most professionals in the medical field, such as
physicians, doctors, dentists, nurses, and therapists. The malpractice exists
when treatment is not provided as is standard and safe procedure, which
thus results in injury or even death to the patient.
Medical negligence can lead to a medical malpractice claim if the even of
malpractice is proven to be involved in four areas with intent: a duty was
owed and was never followed through; a professional responsibility was
breached and the care was not standard; the breach caused an injury or
death; and the patient was negatively affected in some form by the damage.
In shorter terms, medical malpractice occurs when any medical professional
does not provide the standard legal care to their patient in regards to their

profession. The element of damage refers to any damages that affected the
client in any way, including monetary, physically, or emotionally. The time
frame required from the incident to the case filing varies between locations
and type of medical malpractice.
juggankhan v. The State of Madhya Pradesh
it was a rash and negligent act to prescribe poisonous medicines without
studying their probable effect. The Court also held that though it was true,as
ruled in , John Oni v King [AIR (1943) 30 PC 72], that care should be taken
before imputing criminal negligence to a professional man acting in the
course of his profession, even then it was clear that the appellant was guilty
of a rash and negligent act and hence liable for conviction under s. 304A,
IPC.

Dr. Laxman Balkrishna Joshi v Dr. Trimbak Bapu Godbole & Another
The medical practitioner must bring to his task a reasonable degree of skill
and knowledge and must exercise a reasonable degree of care. Neither the
very highest nor a very low degree of care and competence, judged in the
light of the particular circumstances of each case was what the law required
A.S. Mittal and another V State of UP and Others
the Court went to observe that a mistake by a medical practitioner which no
reasonably competent and careful practitioner would have committed was a
negligent one
Jacob Mathew v. State of Punjab three Judge Bench of Supreme Court by
order quashed prosecution of a medical professional under Section 304-A/34
IPC and disposed of all the interlocutory applications that doctors should not
be held criminally responsible unless there is a prima-facie evidence before
the Court in the form of a credible opinion from another competent doctor,
preferably a Government doctor in the same field of medicine supporting the
charges of rash and negligent act.
Indian Medical Association v V.P. Shanta and Others
state of Rajasthan v Vidhyawati, N Nagendra Rao and Co. v Slate of
A..P , State maharashtra v Kanchanmala Vijaysing Shirke, and in
Bolam v. FeiernHospital Management Committee the Supreme Court
held that running of hospitals by the Government was a welfare activity and
not a function carried out in exercise of its sovereign power.

Spring Meadows Hospital & another v Harjol Ahluwalia through K.S.

Ahluwalia & Another
The Court also indicated thatuse of wrong drug or gas during anesthesia or
delegation of responsibility knowing that the delegatee was incapable of
performing his duties properly were some instances of tortious negligence.

Unit 4
Surrogacy or Surrogate means substitute. In medical parlance, the term surrogacy
means using of a substitute mother in the place of the natural mother.
Commercial surrogacy has been legal in India since 2002.
India is emerging as a leader in international surrogacy and a sought after
destination in surrogacy-related fertility tourism. Indian surrogates have been
increasingly popular with fertile couples in industrialized nations because of
the relatively low cost. Indian clinics are at the same time becoming more
competitive, not just in the pricing, but in the hiring and retention of Indian
females as surrogates. Clinics charge patients roughly a third of the price
compared with going through the procedure in the UK.
Surrogacy in India is relatively low cost and the legal environment is
favorable. In 2008, the Supreme Court of India in the Manji's case (Japanese
Baby) has held that commercial surrogacy is permitted in India with a
direction to the Legislature to pass an appropriate Law governing Surrogacy
in India. At present the Surrogacy Contract between the parties and the
Assisted Reproductive Technique (ART) Clinics guidelines are the guiding
force. Giving due regard to the apex court directions, the Legislature has
enacted ART BILL, 2008 which is still pending and is expected to come in
force somewhere in the next coming year. The law commission of India has
specifically reviewed the Surrogacy Law keeping in mind that in India that
India is an International Surrogacy destination.

International Surrogacy involves bilateral issues, where the laws of both

the nations have to be at par/uniformity else the concerns and interests of
parties involved will remain unresolved and thus, giving due regard to the
concerns and in order to prevent the commercialization of the Human
Reproductive system, exploitation of women and the commodification of

Children, the law commission has submitted its report with the relevant
suggestion:

The Law Commission of India has submitted the 228th Report on NEED
FOR LEGISLATION TO REGULATE ASSISTED REPRODUCTIVE TECHNOLOGY
CLINICS AS WELL AS RIGHTS AND OBLIGATIONS OF PARTIES TO A
SURROGACY. The following observations had been made by the Law
Commission: -

(a)
Surrogacy arrangement will continue to be governed by contract
amongst parties, which will contain all the terms requiring consent of
surrogate mother to bear child, agreement of her husband and other family
members for the same, medical procedures of artificial insemination,
reimbursement of all reasonable expenses for carrying child to full term,
willingness to hand over the child born to the commissioning parent(s), etc.
But such an arrangement should not be for commercial purposes.
(b)
A surrogacy arrangement should provide for financial support for
surrogate child in the event of death of the commissioning couple or
individual before delivery of the child, or divorce between the intended
parents and subsequent willingness of none to take delivery of the child.
(c)
A surrogacy contract should necessarily take care of life insurance
cover for surrogate mother.
(d)
One of the intended parents should be a donor as well, because the
bond of love and affection with a child primarily emanates from biological
relationship. Also, the chances of various kinds of child-abuse, which have
been noticed in cases of adoptions, will be reduced. In case the intended
parent is single, he or she should be a donor to be able to have a surrogate
child. Otherwise, adoption is the way to have a child which is resorted to if
biological (natural) parents and adoptive parents are different.
(e)
Legislation itself should recognize a surrogate child to be the
legitimate child of the commissioning parent(s) without there being any need
for adoption or even declaration of guardian.
(f)
The birth certificate of the surrogate child should contain the name(s)
of the commissioning parent(s) only.

(g)
Right to privacy of donor as well as surrogate mother should be
protected.
(h)

Sex-selective surrogacy should be prohibited.

(i)
Cases of abortions should be governed by the Medical Termination of
Pregnancy Act 1971 only.
In Jan Balaz v Union of India, the Gujarat High Court conferred Indian
citizenship on two twin babies fathered through compensated surrogacy by a
German national in Anand district in Gujarat.
The Report has come largely in support of the Surrogacy in India, highlighting
a proper way of operating surrogacy in Indian conditions. Exploitation of the
women through surrogacy is another worrying factor, which the law has to
address. The Law Commission has strongly recommended against
Commercial Surrogacy. However, this is a great step forward to the present
situation. We can expect a legislation to come by early 2011 with the passing
of the Assisted Reproductive Technology Bill aiming to regulate the surrogacy
business.

Prevalence and success of surrogacy in India

Prevalence in India is hard to predict as there are no exact figures available and prevalence is
also dependent on specialised centres that cater to surrogacy as an option to couples that have no
other way of getting a baby of their own.
However, the success rate of surrogacy is almost 45% with fresh embryos and 25% with frozen
embryos.
The package for surrogacy in India almost costs 50% less as compared to other countries and can
vary between Rs 8,00,000 to 15,00,000 approximately.The surrogacy package price estimate
above, covers doctor fees, legal fees, surrogate work up, antenatal care, delivery charges,
surrogate compensation, egg donor, drugs and consumables, & IVF costs.

Unit V
Treatment and Disposal of Bio-Medical Wastes The methods of
treatment and disposal of Bio-Medical Wastes are the main aspects of these
Rules. Schedule I has laid down the categories of wastes and their methods
of treatment while the scientific standards for operating technical
instruments like incinerators, autoclaves and microwaves are prescribed in

Schedule V.According to Schedule VI of the BWM 2011 Rules, a time-frame

was envisaged for the use of Bio-Medical Waste treatment facilities of
incineration, microwaving and autoclaving system.
India has been a pioneer in the South Asian Region to have a legal control of
Bio-Medical Waste Management, known as the Bio-Medical Waste
(Management and Handling) Rules, 1998 as they are the first of its kind of
national law in the whole of South-East Asian region. However, since national
legislation is the only basis for improving healthcare waste management
practices in any country, there should be a clear foresight of the enforcement
of the provisions, even before the law is enacted. Unfortunately, the Indian
law failed to have such a foresight and it even failed to come up to the
standard prescribed by the WHO, namely for alternatives to incineration. In
common parlance, Bio-Medical Wastes are most often referred to as hospital
waste or healthcare waste and consequently, would not include wastes from
research activities and veterinary care. Therefore these wastes being outside
the strict mainstream of Bio-Medical Waste as commonly understood, the
definition of Bio-Medical Waste ought to have excluded these aspects. A
separate categorization of these wastes could have been done since such
wastes are scientifically bio-medical in nature and their ill-effects can be
harmful.
The Rules are very wide and includes the Occupier of an institution who
generates Bio-Medical Waste(rule 4) .However there is a direction
mentioning that all steps are to be taken to handle such waste without any
adverse effect to health and the environment. As far as the treatment and
disposal of various categories of BioMedical Wastes are concerned, Schedule
I of the rules provide for several modes of treatment and disposal options.
Amongst these rules, there is mention about setting up of incinerator or any
other alternative mechanism in a hospital.320
The Pollution Control Board(rule 5) is not equipped with enough
infrastructures to check each and every incinerator of a hospital in relation to
its operation and emission standards as provided in Schedule V. Strangely,
the rules even imposed deadlines regarding setting up of incinerators
amongst any other methods,(schedule 6) even after they had been
discarded by western countries.323 Besides, in the use of incineration, there
is reportedly emission of dioxins and furans, which are carcinogenic
In a hospital environment, technologies like incineration fail because
untrained janitor staff runs them. The incinerator should be used at its

optimum level otherwise the waste may not be treated properly. In most of
the surveys carried out, incinerators run at temperatures lower than those
specified in the rules and due to this poor operation and maintenance, these
incinerators do not destroy the waste, need a lot of fuel to run, and are often
out of order. When every hospital uses an incinerator, it is underutilized since
the amount of infectious waste of a single hospital is not sufficient for the
optimum use of the machine, thereby leading improper treatment of
BioMedical Waste. Therefore on the whole, it is not feasible for every hospital
to use an incinerator and it is preferable to have centralized incinerators
instead.
The Rules6(6) provide that treated Bio-Medical Wastes are to be picked up
and transported by municipal bodies as also segregated non bio-medical
solid waste.Rule requires reconsideration to ensure the objectives of
segregation since, as of now, segregation of the BioMedical Waste into
specific categories of Bio-Medical Waste and storage in different colour coded
containers is not being implemented to an appreciable extent, as observed.
rule 6(2)There are no means to distinguish with an absolute precision
between the two types of wastes. A small carelessness of throwing a syringe
or a needle contaminated by infectious waste will pose great danger as the
waste which is assumed to be non bio-medical solid waste could in fact be
infectious waste as a result. Therefore this Rule is not at all feasible as
utmost care is required while segregating and findings reveal that the
required standard of care is not present. Hence this Rule6(5) requires
reconsideration to ensure the objectives of segregation since, as of now,
segregation of the BioMedical Waste into specific categories of Bio-Medical
Waste and storage in different colour coded containers is not being
implemented to an appreciable extent, as observed.There is a specific
direction in the Rules that the maximum permissible period of storage of
untreated Bio-Medical Waste is 48 hours.
At present the Rules are concentrating only upon the hospitals in the
objective of treatment and disposal of Bio-Medical Wastes. This is evident
upon perusal of the Rule that directs all Occupiers of institutions handling
Bio-Medical Wastes in different ways to apply for grant of authorisation, but
excludes specifically Occupier of clinics, dispensaries, pathological
laboratories, blood banks providing treatment/service to less than 1000 (one
thousand) patients per month. Firstly, the prescribed authority has no means
to verify the number of patients provided with services in these apparently
smaller Occupiers. Secondly, while it is true that medical practitioners and

dental clinics generate small quantities of Bio-Medical Waste when compared

to the hospitals, the numbers of such medical practitioners and dental clinics
is getting enormously huge and all these result in huge quantities of
BioMedical Waste being generated.
There is an inherent policy contradiction in these Rules, since on the one
hand, the Rules require all medical practitioners to safely handle Bio-Medical
Wastes;rule 4 on the other hand the Rules keep outside their purview
smaller Occupiers, even though they collectively contribute significantly to
the quantum of Bio-Medical Wastes generated. Therefore, the law is at
present concentrating on medium and large polluters and leaving aside the
marginal polluters, which are great in number and which in effect outweigh
other polluters.
Analysis
The scenario of Bio-Medical Waste demands better management. The
present rules appear ineffective to manage the volumes of Bio-Medical
Waste. Law has stumbled in performing its duty; much of attribute from the
lack of proper implementation mechanism. Although the law relating to
BioMedical Waste Management is in infant stage, the time has come to act
seriously and implement the rules effectively. Greater commitment is
required on the part of the Government looking into the magnitude of the
problem. The regulatory body should be strengthened. There is certainly a
need to re-look at the rules.