DR RAM MANOHAR LOHIYA NATIONAL LAW

UNIVERSITY, LUCKNOW

Subject: Environmental Law

Final Draft

On

Laws Relating to Processing Of Bio Medical Waste

UNDER THE SUPERVISION OF: SUBMITTED BY:

Dr. Amandeep Singh Jinisha Bhatt

Assistant Professor (Law) Enrolment No- 150101059

DR RMLNLU, Section- ‘A’

Lucknow Semester-VI
 Table of Contents

INTRODUCTION 4

WASTE 5

BIO-MEDICAL WASTE 5

CONTROLLING OF BIO MEDICAL WASTE 8

COMMON BIO MEDICAL WASTE FACILITIES 9

PROBLEM OF BIO-MEDICAL WASTE 10

LAW RELATING TO BIO-MEDICAL WASTE MANAGEMENT 12

BIO MEDICAL (MANAGEMENT AND HANDLING) RULES, 1998 16

CONCLUSION 18

BIBLIOGRAPHY 19

INTRODUCTION
The Bio medical waste is of special kind of waste.  The infectious nature of the bio-
medical waste itself to health and safety hazards to patients, health care providers and to the
community at large as well as to the environment reveals the danger of
mismanagement. In order to provide for better management of bio-medical waste the Bio-
medical (Handling and Management) Rules, 1998 was notified under the Environment Protection
Act, 19861. I will be dealing with the law relating to the processing of biomedical waste products
and the lacuna of the rules if any.

WASTE

 Waste is generally defined as “something, which is not put into proper usage at a given time”. 2
Everything is made for a defined purpose ‘anything which is not intended for further use is
termed as waste’3. The original definition of waste ‘res derilicta’ (or the abandoned object)
corresponds to the concept of “ throw away” culture. Wastegenerally, is of three kinds – 1.
Solid wastes 2. Liquid wastes. 3. Gaseous wastes. Waste can also be categorized according to its
origin as domestic waste, industrial waste, and hospital waste. Bio- medical waste is a hospital
waste.

BIO-MEDICAL WASTE

1
The Ministry of Environment & Forests notified the Bio-medical Waste (management & handling) Rules, 1998
(BMW Management) in July 1998. In accordance with the rules, every hospital generating BMW needs to set up
requisite BMW treatment facilities on site or ensure requisite treatment of waste at common treatment facility. No
untreated BMW will be kept stored beyond a period of 48 hours.
2
Oxford Dictionary

3
Bio-medical waste management scenario in Delhi, at http://health.delhigovt.nic.in/Health/ files/bio.html
‘Bio-medical waste’ means any waste, which is generated during the diagnosis, treatment or
immunisation of human beings or animals or in research activities pertaining thereto or in the
production or testing of biologicals. It means any solid or liquid waste which may present a
threat of infection to humans, including non-liquid tissue, body parts, blood, blood products, and
body fluids from humans and other primates; laboratory and veterinary wastes which contain
human disease-causing agents; and discarded sharps. The following are also included:
(1) used, absorbent materials saturated with blood, blood products, body fluids, or excretions or
secretions contaminated with visible blood; and absorbent materials saturated with blood or
blood products that have dried; and
(2) non-absorbent, disposable devices that have been contaminated with blood, body fluids or,
secretions or excretions visibly contaminated with blood, but have not been treated by an
approved method.
BMW4 results from the provision of human or animal health care, related medical research and
teaching, the operation of laboratories, morgues and funeral establishments, the use of
biotechnology (such as the production and testing of vaccines), and from mobile health care
activities5. According to the Bio-Medical Waste (Management and Handling) Rules 1998 the
words ‘bio-medical wastes’ means any waste, which is generated during the diagnosis, treatment
or immunisation of human beings or animals or in research activities pertaining thereto or in the
production or testing of biologicals 6. BMW is any solid or liquid waste, which may present a
threat of infection to humans. BMW is generated from healthcare establishments such as
hospitals, blood banks, laboratories and research institutes, veterinary hospitals, etc 7. Agriculture
and food-processing industry is also generating BMW up to some extent. Hospital waste includes
non-liquid tissue, body parts, blood, blood products, and body fluids from humans and other
primates, laboratory and veterinary wastes which contain human disease-causing agents, and
discarded sharps8. BMW management is a special case wherein the hazards and risks exist not
just for the generators and operators but also the general community.

4
Bio medical wastes.

5
There are various types of bio-medical waste. Each type has to be disposed according to its characteristics

6
Bio-Medical Waste (Management and Handling) Rules 1998, r. 3(6).

7
http://www.co.whatcom.wa.us/health/environmental/biomedwaste/regulations.jsp

8
http://www.expresshealthcaremgmt.com/20020315/focus1.shtml
Generally Bio medical waste is classified into infectious waste and noninfectious waste
categories though the proportion of infectious waste is low. If infectious waste was not disposed
off scientifically, it might contaminate noninfectious waste. WHO has classified hazardous waste
into following categories9:
(1) Infectious waste: (suspected to contain pathogens): for instance laboratory culture, ‘waste
from isolation wards, tissue-swabs, material in contact with infected patient, excreta.
(2) Pathological waste: (containing human tissue or fluids), for instance body parts blood and
other body fluids, foetuses.
(3) Sharps: (Sharp material), for instance needles; infusion sets; scalpels; knives; blades; broken
glass.
(4) Pharmaceutical waste: (containing pharmaceuticals), for instance expired drugs;
contaminated bottles; boxes
(5) Genotoxic waste, for instance waste containing cytostatic drugs; genotoxic chemicals.
(6) Chemical waste, for instance laboratory reagents; film developer expired disinfectants,
solvents.
(7) Waste with heavy metals, for instance batteries; broken thermometer.
(8) Pressurised containers, for instance gas cylinders; gas cartridges; aerosol cans.
(9) Radioactive material, for instance unused liquid from radiotherapy; contaminated glass ware;
urine excreta from patient treated with unsealed radio nucleotides.

CONTROLLING OF BIO MEDICAL WASTE

For the treatment of medical and hazardous waste different type of technologies and equipments
are used. This includes the processes like incineration, autoclaving, microwaving and
hydroclaving. All waste treatment technologies have their advantages and disadvantages and no
single method is applicable to all wastes 10. Hence, treatment depends upon the nature of the
waste, technology that is technically and economically viable and environmentally safe and must
meet public acceptance. Effective management of municipal solid waste is possible only if the
9
http://72.14.235.104/search?q=cache:VAoWX63lpkJ:www.appcb.org/boi_med/guidlines_wastefacilities.doc+
%22Bio+Medical+Waste%22&hl=en&ct=clnk&cd=14&gl=in
10
http://www.tribuneindia.com/2002/20020623/haryana.htm
disposers follow the proper regulations enacted by the pollution control committee. There would
be positive result in BMW management practices, with enactment of few more legislations and
regulation specific to the handling of BMW. New approaches in BMW are implemented in many
parts of the world and show positive results and are sustained in many parts of the world,
because of increase in awareness about the harmful effects of the BMWs11

COMMON BIO MEDICAL WASTE FACILITIES

A Common Bio-Medical Waste Treatment Facility (CBWTF) is a set up where BMW, generated
from a number of healthcare units, is imparted necessary treatment to reduce adverse effects that
this waste may pose. The treated waste may finally be sent for disposal in a landfill or for
recycling purposes. Installation of individual treatment facilities by small healthcare units
requires comparatively high capital investment. In addition, it requires separate manpower and
infrastructure development for proper operation and maintenance of treatment systems12. The
concept of CBWTF not only addresses such problems but also prevents proliferation of treatment
equipment in a city. In turn it reduces the monitoring pressure on regulatory agencies 13. CBWTF
as an option has also been legally introduced in India. The Bio- Medical Waste (Management &
Handling) Rules, 1998, gives an option to the BMW generator that such waste may also be
treated at the common BMW treatment facility14. In order to set up a CBWTF to its maximum
perfection, care will be taken in choosing the right technology, development of CBWTF area,
11
Poor waste management practice includes: Improper packing of biohazard wastes; Improper segregation of
biohazard wastes; Improper waste handling in the disposal site; Improper storage and transportation of wastes; and
Improper treatment, disposal and poor monitoring of waste management.
12
http://72.14.235.104/search?
q=cache:GuT5zGzkoO8J:www.cleantechindia.com/presentations/biomedicalseminar.ppt+how+is+bio+medical+was
te+treated%3F&hl=en&ct=clnk&cd=7&gl=in
13
By running the treatment equipment at CBWTF to its full capacity, the cost of treatment of per kilogram gets
significantly reduced. Its considerable advantages have made CBWTF popular and proven concept in many
developed countries
proper designing of transportation system to achieve optimum results etc. A CBWTF will be
located at a place reasonably far away from residential and sensitive area so that it has minimal
impact on these areas23. The location will be decided in consultation with the State Pollution
Control Board (SPCB)/Pollution Control Committee (PCC). Sufficient land will be allocated for
CBWTF to provide all requisite systems15.

The article extensively analyses two aspects in relation to bio medical waste, firstly problem

what the problem the bio-medical waste is posing, secondly, the status of mechanism
adopted to meet the problems of the bio-medical waste, thirdly, lacuna in the law relating to bio-
medical waste. Lastly the conclusion highlights certain suggestions for effective management of
bio-medical waste.  It is in this context, the researcher intends to move in detail with
regard to hospital waste.
 

PROBLEM OF BIO-MEDICAL WASTE

The perils of medical waste first garnered attention in the late 1980s, when items such as used
syringes washed up on several East Coast beaches USA, which lead to the law regulating the
medical waste. However in India the seriousness about the management came into limelight only
after 1990’s.

Medical wastes may be generated throughout healthcare facilities wherever medical procedures

are conducted.16 The ill effects of poor management of bio-medical waste have aroused concern
14
The Second Amendment of the Rules in June, 2000, further eased the bottleneck in upbringing the CBWTF by
making Local Authority responsible for providing suitable site within its jurisdiction. The concept of CBWTF is also
being widely accepted in India among the healthcare units, medical associations and entrepreneurs.
15
It is felt that a CBWTF will require minimum of one acre land area. So, preferably, a CBW as per the provisions
of Bio-Medical (Management & Handling) Rules, 1998, waste falling in most of the categories may be treated in
systems based on non-burn technologies. Such waste account for about 90 per cent of the total waste streams in a
healthcare unit. The wastes falling under category five that is discarded medicines, cytotoxic drugs and category 10
that is chemical wastes (solids) may be disposed in a secured landfill.
16
http://www.ul.com/eph/insights/ephiv4n4/med.html
all over the world especially due to its far-reaching effects on human health and environment.
Moreover new hospitals are coming up in a mushrooming speed to meet the health hazards.
Main cause for increase in quantity of medical waste is the shift from reusable
items to disposables goods.17  The problem of medical waste has acquired gargantuan
proportions and complex dimensions. On an average a hospital bed generates 1 kg of waste per
day, out of which 10-15 per cent is infectious18 and rest is general waste. 
 
The quantities become unmanageable and the hospital prefers to throw them in municipal bins.
General waste, which is rich in organic material, is a very strong media for the
microorganisms in infectious waste component of hospital waste. Thus one would give the
microorganisms good environs to multiply if the wastes are mixed. Exposure to health-
care waste can result in disease or injury.
Rag pickers who rummage through this waste in search of disposables are also at great risk. They
get exposed to the waste through any open wounds; inhalation of air borne pathogens and pricks
by sharps and all this makes them prone to infections.   Because of this improper handling,
treatment and disposal of the Bio-medical Waste leads to spreading of diseases such as HIV and
Hepatitis and Infections like Ocular, genital & skin infection. There may be anthrax, meningitis,
hemorrhagic fevers, septicemia, bacterial and fungal infection etc.
 

LAW RELATING TO BIO-MEDICAL WASTE MANAGEMENT

17
The quantity of medical and infectious wastes is increasing mainly because of medical advances and the over-
dependence in the medical community on disposable items.
 

18
Infectious waste may contain any of a great variety of pathogenic micro-organisms.
Pathogens in infectious waste may enter the human body by a number of routes
 In 1994, a writ petition was filed under Article 32 of the Constitution against the concerned
hospital to provide clean and health environment.  The main issue, which was raised, was
improper waste management case in B.L. Wadhera v. Union of India19

 
The court gave series of directions. The most important among them are:
 
1. All hospitals with 50 beds and above should install incinerators or any of effective alternative
method under their own administrative control.
 
2. The incinerator or alternative methods should be fitted with necessary pollution control
mechanism, approved and confirming to the standards laid down by the Central Pollution control
Board.
3. The Central Pollution control Board and the State Pollution Control Boards should regularity
send its inspection teams in different areas toascertain that the collection, transportation and
disposal garbage/wastes is carried out satisfactorily.  Under the Indian Penal Code, 1860 a
polluter of the environment can also be punished if he does an act which causes any
common injury, danger of annoyance to the public or tothe people in general then the act may be
treated as public as defined under Section 268 and the offender may be treated punished under
Section 290 or 291 of the Code,  There are also penal provision under a situation which either
causes, or destroys, or diminishes the value or utility of any property, of affects the
property injuriously as provided under the Section 426, 230, 231, and 432 of the Indian Penal
Code. This otherwise means that if any person who generates, collects, receives, stores,
transport, treated, disposes or handles bio-medical wastes in any form shall be treated as a
contravener of the above penal provisions.

It is important to note that these provisions did not come much help in management of  the bio-
medical waste.

The Bio- Medical Waste (Management and Handling) Rules 1998 (Bio- Medical Waste Rules)
framed under EPA authorise the levy of different fees- one to apply for getting authorisation,
another annual fee on the basis of the number of hospital beds, and the other annual flat fee of
Rs. 1,000/- from every institution. Examining the nexus between EPA and Bio-Medical Waste
Rules, Karnataka High Court examined these questions in Mullers Hospital, Mangalore vs.
19
AIR 1996 SC 2969
Member Secretary, Bangalore20 It was contended that the levy may be found valid under the
rulemaking power under s. 25 (2)(f)21. The provision runs as follows: ‘In particular, and without
prejudice to the generality of the foregoing power, such rules among others may provide the
following, namely, ‘for the functions of the environmental laboratories, the procedure for
submission to such laboratories of samples of air, water, soil and other substances for analysis or
test, the form of laboratory report, the fees payable for such report and other matters to enable
such laboratories to carry out their functions under s. 12(2)’. The court observed that this
delegation to levy fees is only in respect of laboratory test report for the analysis carried out on
samples tested at such laboratory, and not for any other purposes.

According to the court, the empowerment of levy is so express and limited that it may not be
extended to any other activity. A process of interpretation may not be extended to any other
activity. A process of interpretation may not expand the scope of the power of the delegated
authority. The court continued that the traditional concept of quid pro quo in respect of fee has
undergone a transformation. A fee almost partakes the character of tax except for the imitation
that the total fee levied has a proper co-relation to the cost of providing services. The levy must
be specific, permitted, and authorised by law, it may not be by implication. The court found that
the imposition of the fees is ultra vires the EPA, and it does not stand the tests evolved in the
context of levy of fee by a delegated authority. These rules issued under EPA does not take into
cognisance the availability of new and better means of management and disposal of waste, but
rather lay too much importance on incineration as a method of disposal. Under these rules, no
serious effort has been made to solicit the informed consent of all the stakeholders for siting
disposal facilities. These rules emphasize more on segregation (s. 6) of bio medical wastes. This
provision looks beyond the reality in most of the hospitals where the actual personnel who
involved with final disposal are least educated and not aware of the potential health hazard. The
regulatory agencies for implementation of these rules are yet to be notified, and in all probability
the pollution control agencies will be given this responsibility. The pollution control boards are
over stressed because of the lack of revenues, infrastructure, manpower, and technical power to
implement the existing legislations. New responsibilities of this kind will certainly put added
pressure on boards and, in turn, may result in poor implementation. These rules and their

20
AIR 2004 Kant 342.

21
Ibid at p. 347
implementation highlight the fact of total lack of preparation on the part of the state, in terms of
both infrastructure and skill, before evolving the rules.

 In Delhi, the 27 big and 55 medium sized hospitals and about 2,500 nursing homes an
dispensaries generate about 200 tons of waste of which 70 tons is infectious. In 1999, Srishti, a
New Delhi based NGO ignored the supreme court order which directed that medical institutions
and nursing homes to install facilities to take care of its BMWs and dispose it properly. Most
hospitals are burning wastes, some even burning plastics and releasing harmful toxins into the
atmosphere. The situation is equally pathetic in other big cities and town in India64. It must be
noted that 90 per cent of the hospitals in Bihar have no waste disposal facilities, and the liquid
waste and human organs are dumped in the nearest river or any other waste body. The picture
that emerges is that of a very careless and irresponsible attitude of the medical institutions and
the governments of course in dealing, not dealing rather, with this problem22.

The Division Bench of Andhra Pradesh High Court in C.S. Prakash vs. The HUDA23

held as under: ‘It may be that hospitals may be construed in a residential area in terms of
Regulation 6.1.2 of the 1981 Zoning Regulations. There may not further be any doubt that before
construction of a big hospital is permitted not only care has to be taken about the convenience of
the residents of the locality but also as to whether the permission from the competent authority
had been taken for disposal of bio-medical wastage. Prevention of ecology and health of the
populace come within the purview of the Constitution of India, art. 21. The state pollution
control board must therefore strictly apply the laws governing the field’. It is true as a matter of
rule all the hospitals may not be directed to be situate outside the municipal limits or the
residential zone. It is for the competent authority to consider the efficacy of grant of such
permission in that regard. But, while doing so, it must also be borne in mind that by construction
of such big hospitals further health hazards may not to caused. Adequate protection for disposal
of BMW be taken in terms of the Bio-medical Wastage (Management of Handling) Rules, 1998.

In M. Vijaya vs. Singareni Collieries Company Limited24, the Andhra Pradesh High Court issued
several directions while considering the question relating to preventive and remedial measures to
22
http://www.pon.nic.in/stategovt/scitech/envisnew/bio-medical%20%20manage.htm

23
ILR (2001) 2 AP 323 (DB).

24
ILR (2002) 1 AP 108
be taken in relation to AIDS tests of HIV patients. All the concerned authorities must, therefore,
also take into consideration the relevant directions issue in the abovementioned direction before
granting any permission

BIO MEDICAL (MANAGEMENT AND HANDLING) RULES, 1998

The Bio-medical Rules came into existence in 1998 through a notification in exercise of the

powers conferred by Sections 6, 8 and 25 of the Environment (Protection) Act, 1986.
 
Bio-medical Rules is the first of its kind of national law   in whole South- East Asian
Region in relation to bio-medical waste management. The definition of Bio-medical waste is
very comprehensive and extensive one. National legislation is the basis for improving health
care waste practices in any country. There should be a clear designation of responsibilities before
the law is enacted. Unfortunately, Indian law fails to come up to the standard prescribed by the
World Health Organization. The Committee on Solid Management 25 recommends that bio-
medical waste should be refrained from throwing on the streets or open places as well
as into municipal dust bins or the domestic waste collection sites. This means majority of
the institutions still managed to throw the bio-medical waste municipal bins near to their
premises. So it can be said that utter failure of the law in implementing it. The Rules is very wide
and includes the occupier who generates bio-medical waste.26 The Rules which speak about
setting up of incinerator or any other alternative mechanism in a hospital. Let us presume that the
all the hospitals have set up the incinerator. Has the Pollution Control Board equipped with
enough infrastructures to check and each and every incinerator of a hospital in relation its
operation and emission standards?27 Just by imposing deadline regarding setting up
of incinerator even after it has been discarded by western countries or any other methods.
The incinerator should be used at it optimum level otherwise the waste may not be treated
properly.In a hospital environment, technologies like incineration fail because untrained janitor
Solid Waste Management in Class I cities in India, (New Delhi Committee appointed by Supreme Court Report.
25

March 1999). P.29Hon’ble Supreme Court’s order dated 16-1-1998constituted the Committee on Solid Waste
Management
26
Rule 4 of Bio-medical waste (Management and Handling) Rules 1998.

27
Rule 5 of Bio-medical waste (Management and Handling ) Rules ,1998
staff runs them. Most of the surveys incinerators run at temperatures lower than those
specified in the rules. Due to poor operation and maintenance, these incinerators do not destroy
the waste, need a lot of fuel to run, and are often out of order. If every hospital has
an incinerator; definitely it can not be used its optimum level as the amount infectious waste is
less.  This leads improper treatment of bio-medical waste.  The result is obvious causing
danger to human health and the environment Generally waste is disposed through incineration by
heating minimum 1000 o C. Due to failure of  continue supply of electricity the heat will not raise
upto prescribed level. The result is not completion of disposal of waste according to the rules.
The Rules mentions about maximum period of 48 hours.28 The question is how to comply with
this rule. Do we have any technology to test the period of such waste? The only way left to the
authorities to rely on the statement of the hospital staff. The Rules says segregated non bio-
medical solid waste is picked up and transported by the municipal body 29. How can one say
that waste100% non bio-medical solid waste. A small carelessness of throwing a syringe or a
needle or infectious waste will cause serious danger. How feasible is this rule? The utmost care
is required while segregation Do we have that standard of care? The Rules 30  mentions pollution
Control Boards as the prescribed authority. However these Boards are over stressed because of
lack of revenues, infrastructure, manpower and technical power to implement the existing
legislative requirement. New responsibilities of this kind will certainly put added pressure on
Boards and in turn may result in poor implementation. These Rules and their implementation
highlight the fact of total unpreparedness on the part of the states, in terms of both infrastructure
and skill, before evolving the Rules. At present the Rules concentrating much upon the hospitals.
A medical practitioner generates a small quantity of bio-medical waste when it compared to the
hospitals. However, the number of medical practitioners is countless which results in huge
quantity of bio-medical waste. Though the Rules very well mentions responsibility of medical
practitioner; it hardly makes any difference unless it is brought under proper implementation. At
present it is not viable to for India to bring each and every medical practitioners under its
purview. The law is at present concentrating medium and large polluters and leaving the
marginal polluters. If the Rules implemented effectively regarding disposal of needles and

28
Rule 6(5) of the Bio-medical Waste (Management and Handling) Rules,1998

29
Rule 6 (6) of Bio-medical waste (Management and Handling ) Rules ,1998

30
Rule 7 of Bio-medical waste (Management and Handling ) Rules ,1998
syringes, the illegal recycling of needles and syringes does not arise at all. It is a tough job but
there is no alternative to implement effectively. The Rules specifies that the disposal needles
should be shredded or mutilated. If the hospital has not done it is violating the provisions of
Rules especially Rule 4. They made held liable for the contravention. The rules totally neglected
the implementation part. The present situation manifests the same thing. The fear of punishment
for contravention of the Rules seems illusory and meaningless as much enforcement penal
provisions have not been done on the violators of the Environment Protection Act, 1983. The
regulation of bio- medical waste presents significant challenges. The bio-medical Rules
have to face to such challenges in order to strict regulation.
 
 

CONCLUSION

 
 
The scenario of bio-medical waste demands the better management. The present rules
are ineffective to manage the bio-medical waste. The law relating to bio-
medical waste management should play an important play in curbing the menace. Law has
stumbled in performing its duty; much of attribute from the lack of proper implementation
mechanism Though the law relating to bio-medical 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 a need for re look at the rules.
 
The Rules must drop the plan of imposition of setting up of a treatment plant in every hospital.
The Rules should devote its attention towards establishment of common treatment sites
which includes incinerator or autoclave, shredder and an engineered pit despite the fact that the
occupier/operator has means potential to handle the same. The Rules must be strictly enforced
with  Proper segregation is the secret of proper regulation bio-medical waste. Training of these
personnel will lay road in that direction. Since the hospitals have become the source of huge
profits. They owe a duty to protect the interest and the safety of its workers and the public.
Hospitals may face an excessive burden because of regulation of medical waste. But they should
realize that law will no longer tolerate
 

BIBLIOGRAPHY

Rule

Bio Medical Waste (management and handling) rules 1998.

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q=cache:GuT5zGzkoO8J:www.cleantechindia.com/presentations/biomedicalseminar.ppt
+how+is+bio+medical+waste+treated%3F&hl=en&ct=clnk&cd=7&gl=in