Environmental Jurisprudence in India and Healthcare Wastes

1. Prof. (Dr.) Prashant Mehta
M.Sc, Ph.D. (Chemistry), MBA, Ph.D. (Management)
National Law University, Jodhpur
DECODING THE INDIAN HEALTHCARE SYSTEM
Waste Trail

2. • Residential
• Commercial
• Institutional
• Construction Waste
• Municipal services
• Treatment plant sites
• Industrial
• Agricultural
• Healthcare Waste
Municipal Solid Waste (MSW)
Industrial Solid Waste
Bio-Medical / Hospital Waste
Agricultural Waste

3. International Imperatives
WHO preamble defines Health as “a state of complete physical, mental and social wellbeing and not merely the absence of disease”
International Treaties, Conventions, Conferences, and Protocols resulted in regulatory legislation to
protect and improve environment in several countries. It included framing policies to protect and improve
environment, preventing pollution of all kinds, punishing environmental crimes, and compensating those
affected environmental crimes or by breach of protective provisions.
• UN International Conference on the Human Environment, Stockholm 1972 - It is the duty of every person
to protect the environment and prevent its pollution. Domestic laws and international treaties impose this
duty on individuals and states.
• Brundtland Report, 'Our Common Future' was presented to UN General Assembly. It stimulated a debate
on development policies and practices in developing as well as industrialized countries.
• The UN General Assembly adopted World Charter for Nature in 1982. It explicitly states that the
governments have a duty to pass on their natural heritage to future generations.
• "Earth Charter” / "Rio Declaration” made a strong pitch for: maintenance of ecological balance,
prevention, and control of environmental pollution, preservation of our natural resources, disaster
mitigation and sustainable development .
• It was followed by review meeting at World Summit on Sustainable development in Johannesburg, 2002.

4. Constitutional Provisions: India
• The Constitution of India indirectly provides right to health as a fundamental right.
• The power of Supreme Court to issue directions under Article 32 and that of High Courts under Article 226 have
attained greater significance in environmental litigation where in they relaxed Locus Standi norms in
environmental cases where third party could directly petition through Public Interest Litigation.
• Part III (Fundamental Rights) and Part IV (Directive Principles of State Policy) of Indian Constitution provides a
a framework for regulating relation between the state and its citizens and between citizens inter-se.
• The achievement of the objectives laid down in the preamble has been amplified and elaborated in Part IV of
the Constitution (Directive Principles of State Policy), which contains provisions from Article 36 to Article 51.
• The Constituent Assembly included Directive Principles of State Policy as goals or aspirations to embody the
concept of a Welfare State. These principles are fundamental in the governance of the country and they
supplement the fundamental rights for achieving welfare state. It shall be duty of the State to apply these
principles while enacting laws.
Keshavananda Bharati vs. State of Kerala (AIR 1973 SC 1461)
• Parliament can amend the fundamental rights for implementing these directives, so long as the amendment
does not touch the basic features of the constitution.
Chandra Bhavan vs. State of Mysore (AIR 1970 SC 2042)

5. Directive Principle of State Policy
• Article 38 impose liability on State to secure a social order for the promotion of welfare of the people which
cannot be achieved without good public health.
• Article 39(e) is related with protecting the health of workers.
• Article 41 imposed duty on State to provide public assistance basically for those who are sick and disable.
• Article 42 makes provision to protect the health of infant and mother by way of maternity benefits.
• Article 47 considers that it the primary duty of the state to secure the improvement in public health (sickness,
old age, disablement, and maternity benefits) and the prohibition of intoxicating drinks and drugs.
• Article 21 guarantees the right to life and personal liberty in accordance with the procedure established by law
of the Indian Constitution. This right is available to both citizens and non-citizens.
• The scope of Article 21 have been expanded through judicial pronouncements which expressed ‘Personal
Liberty’ in the widest amplitude.
• The Supreme Court has brought the ‘Right to Health’ and ‘Right to Education’ under the preview of Article 21 in
Paschim Banga Khet Mazdoor Samity and Others vs. State of West Bengal and Others, (1996 SCC (4)37)

6. Constitution 42nd Amendment
• Taking note of the mandate of the Stockholm Declaration of 1972 the Indian parliament passed historic
amendment – 42nd Constitution Amendment Act, 1976.
• The amendment introduced principles of environmental protection in an explicit manner into the Constitution
through Article 48A and 51A(g).
• Article 48A obligated the State to protect and improve the environment, safeguarding forests including wildlife,
and impose the pollution free environment for good health. Under Directive Principles of State Policy and state
needs to enact legislation to realize these rights.
• Article 51A(g) obligated the Citizens to protect and improve the environment.
• The 42nd Amendment also moved the subjects of ‘forests’ and protection of ‘wild animals’ and ‘birds’ from state
list to concurrent list.
M.C. Mehta vs. State of Orissa (AIR 1992 ORI 225) laid the foundation for jurisprudence of environmental
protection.
Sachidanand Pandey vs. State of West Bengal (AIR 1997 SC 1109) courts recognized DPSP in deciding
environmental cases in light of Article 48A and 51A(g).

7. Directive Principle of State Policy
• It is established law laid down by the Supreme Court of India that this Directive Principle is to be read along with
Article 21 and Article 51A(g) as mentioned in Subhash Kumar vs. State of Bihar (AIR 1991 SC 420)
• Our constitution framers were much aware about the public health or right to health. As such they they
imposed liability on State by different provision like (Article 38, 39(e) 41, 42, 47, 48A).
• Thus the Constitutional mandate is very clear for the State to protect the environment.
• Part XI of the Constitution of India deals with relations between Union and States (Article 245-263).
• On the subject of Public health and sanitation; hospitals and dispensaries, the State Legislature has legislative
competence under Article 246(3) in enacting legislation in matters enumerated in List II (State List) in the 7th
Schedule of the Constitution of India including management of Bio-Medical Waste generated from any
establishment within its territorial limits.

8. Land Mark Judgments
Environmental Jurisprudence
• The Supreme Court in Rural Litigation and Entitlement Kendra vs. State of Uttar Pradesh (AIR 1987 SC 359)
took note of consciousness for environment protection, which is of recent origin.
• In M.C. Mehta vs. Union of India and Others (1991, 2 SCC 353) the court observed, “Man has the fundamental
right to freedom, equality, and adequate conditions of life, in an environment of a quality that permits a life of
dignity and well-being, and he bears a solemn responsibility to protect and improve the environment for
present and future generations”.
• In Virender Gaur vs. State of Haryana (1995, 2 SCC 577 (at 580)), the Supreme Court held that environmental,
ecological, air, and water pollution should be regarded as amounting to violation of right to health guaranteed
by Article 21 of the Constitution.
• In T. Ramakrishna Rao vs. Hyderabad Development Authority (2002 (2) ALT 193), the Andhra Pradesh High
Court observed: Protection of the environment is not only the duty of the citizens but also the obligation of
the State and it’s all other organs including the Courts.
• The enjoyment of life and its attainment and fulfillment guaranteed by Article 21 of the Constitution embraces
the protection and preservation of nature’s gift without which life cannot be enjoyed fruitfully.

9. Land Mark Judgments
Environmental Jurisprudence
• The most important judgment which reflects the modern environmental jurisprudence is the Karnataka
Industrial Areas Development Board vs. Sri. C. Kenchappa and Ors (AIR 2006 SC 2038, [para 13]).
• This judgment try to bring consonance with the principle of 'Sustainable Development', where a serious
endeavour has been made to strike a balance between the industrial development and ecological
preservation. While exploring its model for environmental jurisprudence, court has resorted to its famous
judgment and expressed:
“While economic development should not be allowed to take place at the cost of ecology or by causing
widespread environment destruction and violation; at the same time the necessity to preserve ecology and
environment should not hamper economic and other developments. Both development and environment must go
hand in hand, in other words, there should not be development at the cost of environment and vice versa, but
there should be development while taking, due care and ensuring the protection of environment”.
• The “Polluter Pays Principle” implies that all producers of waste are legally and financially responsible for the
safe and environmentally sound disposal of the waste they produce and it also assigns liability to the party that
causes damage.

10. Polluters Pay Principle
Indian Judgments
• The principles was partly adopted in Bhopal Gas case in which the Supreme Court overruled to accept any of the
defence of Rylands vs. Fletcher case, and while deciding the case it enunciated the principles of Polluter Pays
Principle.
• In Indian Council for Enviro-Legal Action vs. Union of India, AIR 1996 SC 1466, the Court observed that: “The
Polluter Pays principle demands that the financial costs of preventing or remedying damage caused by pollution
should lie with the undertakings which cause the pollution, or producer of the goods which cause the pollution.
Under the principle it is not the role of Government to meet the costs involved in either prevention of such
damage, or in carrying out remedial action, because the effect of this would be to shift the financial burden of
the pollution incident to the taxpayer”.
• In Vellore Citizens Welfare Forum vs. Union of India 1996(5) SCC 647, (at 659), the court observed that: the
“Polluter Pays Principle” and the “Precautionary Principle” are essential features of sustainable development
and have been accepted as part of the law of the land on the basis of provisions under Articles 47, 48A, and
51A(g) of the Constitution of India.
• The Supreme Court interpreted the Polluter Pays Principle as the absolute liability for harm to the environment,
extends to the principle of compensating the victim, and restoring the environmental degradation. It is laid
down in Sec. 3 of the National Environment Tribunal Act, 1995.

11. Precautionary Principle
Indian Judgments
• The precautionary principle came to be included as a general principle of environmental policy and it was also
extended to protection of coastal areas, marine pollution, and fisheries sector.
• In Vellore Citizens’ Welfare Forum v. Union of India (1996(5) SCC 64731), Supreme Court referred to the
precautionary principle and declared it to be part of the customary law in our country.
• The Principle is contained in Principle 11 of the principles laid down in the UN General Assembly Resolution on
World Charter for Nature, 1982 and was reiterated in the Rio Conference of 1992 in its Principle No. 15. The
same principle was reiterated in the case of A.P. Pollution Control Board (1999(2) SCC 718).
• The Prevention Principle takes care of reckless polluters who would continue polluting the environment in as
much as paying for pollution is a small fraction of the benefits they earn from their harmful acts or omissions.
Environment Impact Assessment is the crucial procedure which seeks toward off prevention. This is reiterated in
Principle 17 of the Rio Declaration.
• In Vellore Case (1996(5) SC 647) p 658 para 11, the court observed that: “The ‘onus of proof’ is on the actor or
the developer/industrialist to show that his action is environmentally benign.”

12. Hazardous Substances - Absolute Liability
Indian Judgments
• Absolute or strict liability is one where fault need not be established.
• In M.C. Mehta vs. Union of India (AIR 1987 SC 1086), the Supreme Court laid down that an enterprise which is
engaged in a hazardous or inherently dangerous industry which poses a potential threat to the health and
safety of persons working in the factory and to those residing in the surrounding areas, owes an absolute and
non-delegable duty to the community to ensure that no harm results to any one on account of hazardous or
inherently dangerous nature of the activity which it has undertaken.
• The enterprise must be absolutely liable to compensate for such harm and it should be no answer to the
enterprise to say that it had taken all reasonable care and that the harm occurred without negligence on its part.
• The larger and more prosperous the enterprise, greater must be the amount of the compensation payable for
the harm caused on account of an accident in the carrying on of the hazardous or inherently dangerous activity
by the enterprise.

13. Principle of New Burden of Proof
Indian Judgments
• The `Uncertainty' of scientific proof and its changing frontiers from time to time has led to great changes in
environment concepts during the period between the Stockholm Conference of 1972 and the Rio Conference of
1992.
• In Vellore Citizens' Welfare Forum v. Union of India and others, 1995(5) SCC 647, a three Judges Bench of this
Court referred to these changes, to the `precautionary principle' and the new concept of `burden of proof' in
environmental matters.
• In A.P. Pollution Control Board (1999 (2) SCC 718 (at p 734)) case, it was explained that the ‘precautionary
principle’ has led to the ‘ new burden of proof’ principle.
• In environmental cases where burden as to the absence of injurious effect of the actions proposed, is placed on
those who want to change the status quo. This is often termed as a reversal of the burden of proof, because
otherwise, in environmental cases, those opposing the change could be compelled to shoulder the evidentiary
burden, a procedure which is not fair. Therefore, it is necessary that the party attempting to preserve the status
quo by maintaining a less polluted state should not carry the burden and the party who wants to alter it, must
bear this burden.

14. Sustainable Development
Indian Judgement
• Environment is a NATIONAL ASSET.
• It is also to be remembered that most of the environmental cases have come before the court through PIL
(public interest litigation) either under Article 32 or under 226 of the constitution.
• In Vellore Citizens Welfare Forum v. Union of India (AIR1996 SC 2715), Supreme Court acknowledged that the
traditional concept that development and ecology are opposed to each other, is no longer acceptable. It said
that Sustainable development is the answer.
• Some of the salient principles of "Sustainable Development" as taken out from Brundtland Report and other
international documents. It refer to Inter-Generational Equity (better quality of life for present and future
generations).
• In Karnataka Industrial Areas Development Board v Sri. C. Kenchappa and Ors. (AIR 2006 SC 2038, [para 29]),
the Court observed that “Precautionary Principle" and “ Polluter Pays Principle" are essential features of
"Sustainable Development”
• In Narmada Bacho Andolan vs. Union of India (2000 (10)SCC 664), Sustainable development means a type of
development which can be sustained by nature/ecology with or without mitigation.

15. Principle of Public Trust and Balance
Indian Judgment
• In M.C. Mehta vs. Kamal Nath (1997(1) SCC 388), Supreme Court referred to the concept of ‘Public Trust’
doctrine.
• The Public Trust Doctrine primarily rests on the principle that certain resources like air, sea, waters, and forests
have such a great importance to the people as a whole that it would be wholly unjustified to make them a
subject of private ownership. The said resources being a gift of nature, they should be made freely available to
everyone irrespective of the status in life.
• The doctrine enjoins upon the Government to protect the resources for the enjoyment of the general public
rather than to permit their use for private ownership or commercial purposes. The State is holding the natural
resources as a trustee and cannot commit breach of trust.
• In T.N. Godavarman Thirumalpad vs. Union of India and Ors., ((2002) 10 SCC 606, 2003 AIR SCW23,[Para 40]),
The concept of "balance" under the principle of proportionality applicable in the case of sustainable
development is lucidly explained. The court observed that we have to balance the priorities of development on
one hand and environmental protection on the other hand.

16. Article 21
Indian Judgement
• Environment is a national asset and the object is to protect “nature” on whom our survival depends.
• Natural resources are brought into Article 21 by invoking the doctrine of Public Trust.
• In Subhas Kumar v. State of Bihar (1991 AIR 420, 1991 SCR (1) 5), the Court has given directions that, under
Article 21 of the Constitution, pollution free water and air are the fundamental rights of the people.
• In the case of A.P. Pollution Control Board II vs. M.V. Nayudu ((2001) 2 SCC 62)) the Court observed that the
right to have access to drinking water is fundamental to life and it is the duty of the State under Article 21 to
provide clean drinking water to its citizens.

17. Land Mark Judgment
Healthcare Waste
• In Dr. B. L. Wadehra vs. Union of India and Others (1996 SCC (2) 594), Supreme Court in its judgment in
connection with safe disposal of hospital waste ordered that:
• All hospitals with 50 beds and above should install either their own incinerator or an equally effective
alternative method of safe disposal before 30th November 1996.
• The incinerator or the alternative method should be installed with a necessary pollution control
mechanism conforming to the standard laid down by Central Pollution Control Board (CPCB).
• Hazardous medical waste should be segregated as source and disinfected before final disposal.
• Health as a human right has a wider community orientation. The human rights continuum, as conceived in
the constitution of India and in several international covenants, is perennially progressive and life rises to
higher forms and fuller manifestations. Environmental protection therefore has now become a matter of
grave concern for human existence.
• Promotion of environmental protection implies that is duty of every citizen to maintain, to conserve, to
protect, and to preserve the purity and sanctity of the environment. Following these landmark judgments,
India enacted various laws to protect its citizens and environment.

18. Regulatory Framework: India
• Bureau of Indian Standards (BIS), brought out first standard IS 12625:1989, entitled 'Solid Wastes Hospitals
Guidelines for Management' (Annexure 7.1) but it was unable to bring any improvement in the situation.
• The Water (Prevention and Control of Pollution) Act, 1974, Amended 1988 - The introductory provisions of the
Act explain that the legislation was introduced to provide for the prevention and control of water pollution and
the maintaining or restoring of wholesomeness of water.
• The Air (Prevention and Control of Pollution) Act 1981, Amended 1987 and the Air (Prevention and Control of
Pollution) Rules, 1982 - This Act was established to prevent, control and abatement air pollution and for the
establishment of boards with the power to implement the Act.
• The Environmental Protection Act, 1986, aims to establish a sufficient protection system for the environment. It
gives the power to the central government to regulate all forms of waste and to tackle specific problems that
may present themselves in different regions of India. It is the primary legislation that must be considered as it
contains important provisions concerning the environment.

19. Regulatory Framework: India
Environmental Protection Rules, 1986 - This regulations were drawn up by the government under the powers
conferred on it in terms of the Environment Protection Act, 1986.
1. The Municipal Solid Wastes (Management and Handling) Rules 1999
2. The Hazardous Waste (Management and Handling) Rules, 1989
3. The Plastics (Manufacture, Usage and Waste Management Rules), 2009
4. The E-Waste (Management and Handling Rules), 2010
5. National Rural Health Mission (NRHM) under Ministry of Health and Family Welfare, in 2007 developed and
adopted an Infection Management Environment Plan (IMEP) which outlines a comprehensive framework for
implementation of infection control measures and effective healthcare waste management generated by
healthcare facilities.
6. The issue of Bio-Medical Waste Management (BMWM) in India has attracted the attention of the highest judicial
body at the level of Supreme Court of India.
7. It has issued instructions regarding management of Bio-Medical Waste and Government of India was one of the
first countries to frame and implement Bio-Medical Waste Management and Handling Rules, 1998 (later
amended in 2000 and 2003) in the exercise of power conferred by Sections 6, 8, and 25 of the Environment
(Protection) Act, 1986.

20. Bio-Medical Waste Management and Handling Rules
• Definition of biomedical waste - Any waste that is generated during the diagnosis, treatment, or immunization of human beings or animals, or in research activities
pertaining to or in the production or testing of biologicals.
• Application of the Biomedical Waste Rules - The rules apply to all persons who generate, collect, receive, store, transport, treat, dispose, or handle BMW’s in any form.
• Duty of occupier (operator) - of a healthcare facility (hospital, nursing home, clinic, dispensary, veterinary institution, animal house, pathological laboratory, blood bank
etc) to ensure that BMWs are handled without any adverse effect to human health and the environment, and according to the prescribed treatment and disposal
requirements as per the Biomedical Waste Rules.
• Prescribed authority - State Pollution Control Boards (SPCBs) in States and Pollution Control Committees in territories are responsible for permitting and enforcing the
requirements of the Biomedical Waste Rules.
• Permit - Each occupier (operator) handling BMW’s and providing services to 1,000 or more patients per month is required to obtain a permit from the prescribed
authority.
• Recordkeeping - Each occupier (operator) is required to maintain records on the generation, collection, reception, storage, transportation, treatment, and disposal of
BMWs. All records are subject to inspection and verification by the prescribed authority at any time.
• Accident reporting - Each occupier (operator) is required to report any accident related to the management of BMW’s.
• Annual reporting - Each occupier is required to submit an annual report to the prescribed authority to provide information about categories and amounts of wastes
generated and treated, and modes of treatment used.
• Common disposal/ Incineration sites - Local public entities are required to provide common disposal / incineration sites, and the occupiers (operators) of such sites are
required to comply with the Biomedical Waste Rules.
• Segregation, Packaging, Transportation, and Storage - BMWs are not to be mixed with other waste. According to the Rules, BMWs are to be segregated into labelled
bags/containers. Transportation of BMWs is to be conducted in authorized vehicles. No untreated waste is to be stored more than 48 hours, unless special permission is
obtained from the regulatory authorities.
• Standards - Technology and discharge standards for incineration, autoclaving, microwaving, liquid waste discharges, and deep burial are prescribed in the Biomedical
Waste Rules.

21. Conclusions: Judicial
• Right to health is enforceable in the Indian context. In interpreting right to health, the courts have blurred the
distinction between judicial functions and administrative functions. In a traditional framework, an adjudicating
body is not expected to go into the measures adopted by the executive branch. In the select cases analyzed
previously, the Courts have gone into the micro management issues alternatively referred as JUDICIAL
ACTIVISM.
• Coming specifically to accessibility, the Indian courts have dealt with this issue in all its dimensions viz., Non
discrimination, Physical accessibility, Economic accessibility, and Information accessibility.
• Many a time the governments find it difficult to implement such decisions. Most of the time what is prescribed
as guidelines by the judiciary are in a way directions tending towards policy making which is and should be
confined to the powers of the State.
• It is noted that the Governments (Central and States) brings in policy changes and legal amendments and also
appoints commissions and notify such changes to the satisfaction of the Court.
• ‘Health’ being a State subject in the Constitution, the decision of the Supreme Court and the respective High
Court adds to multitude of other issues. Invariably what is being pleaded by many states is the lack of financial
and manpower resources to undertake massive health schemes.

22. Recommendations: Caring For Billion+
Health is not everything but everything else is nothing without health
• Development of Efficient Delivery Mechanism and Efficient Consumer Response
• Need for Balanced and Equitable Healthcare System at all levels
• Needed Government Initiatives: Taxation, Industry Status, Comprehensive Legislation, Eliminating
multiple clearances, Licenses, Increase Public Finance Expenditure etc.
• Making Healthcare Affordable by Developing Alternative Methods of Financing
• Developing Sustainable Public Private Partnership
• Strong Focus on Research and Development Activities
• Mechanism to Tackle Regulatory Deficiency must be developed
• Extensive Use of Technology: Electronic Health Records, Database, Social Networking Sites etc.
• Develop Value Based Healthcare System
• Develop Healthcare and Bio-waste Awareness
• Waste Management and Disposal should be made mandatory at both urban and rural level

23. References
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24. References
Websites:
• www.technopak.com
• www.kpmg.com/infrastructure
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• www.dbresearch.com
• www.dynamicverticals.com
• www.bostonanalytics.com
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Journals
• JOURNAL OF THE ACADEMY OF HOSPITAL ADMINISTRATION
• INDIAN JOURNAL FOR THE PRACTICING DOCTOR
• JOURNAL OF HEALTHCARE AND MEDICAL TECHNOLOGY AND MANAGEMENT
• INDIAN JOURNAL OF MEDICAL ETHICS
• THE PHARMA REVIEW AND PHARMA TIMES
• JOURNAL OF HOSPITAL PHARMACY
Other Publications:
• MINISTRY OF HEALTH, GOVERNMENT OF INDIA
• INDIAN MEDICAL COUNCIL & INDIAN DENTAL COUNCIL
• EXPRESS HEALTHCARE MANAGEMENT
• INDIAN HEALTHCARE FEDERATION
• MEDICA: PHARMACEUTICAL INDUSTRY PUBLICATIONS
• MEDICA: HEALTHCARE SERVICES PUBLICATIONS
Chapters:
• COMPETITION CONCERNS: THE PHARMACEUTICAL INDUSTRY BY CUTS INTERNATIONAL
• CHAPTER 10: DRUG PRICE DIFFERENTIALS ACROSS DIFFERENT RETAIL MARKET SETTINGS: AN ANALYSIS
OF RETAIL PRICES OF 12 COMMONLY USED DRUGS: BY GODWIN S K AND VARATHARAJAN D., HEALTH
ADMINISTRATOR VOL: XIX NUMBER 1: 41-47
• HEALTHCARE POLICY AND ADMINISTRATION IN INDIA: BY SAPRU R K, STERLING PUBLICATION, II
EDITION, CHAPTER 15, PAGES 228-249.
My Books:
• Indian Health Sector and Healthcare System: A critical Insight, LAP Lambert Academic Publishing,
Germany, 2012, ISBN-10: 3659268895, ISBN-13: 978-3659268892, Prashant Mehta
• Indian Retail Analytics: An In-depth Study of Indian Retail Market, its Dimensions, Opportunities,
Problems, and Prospects, LAP Lambert Academic Publishing, Germany, 2012, ISBN-10: 3659147303,
ISBN-13: 978-3659147302 Prashant Mehta
My Publications:
• Legal Provisions and Management Perspectives of Biomedical and Hospital Waste in India. Journal
Club for Management Studies (JCMS),1(II), 11-36 (2014).Dr. Prashant Mehta. ISSN No : 2394 - 3033, V –
1, I – 2, 2014
• Biomedical Waste Disposal: Indian Perspective: Scholasticus, Journal of National Law University,
Jodhpur Vol. 5 No. 1, September 2007, Prashant Mehta, ISBN: 0975-1157, Indexed