INTRODUCTION

Medical Facilites are very vital and important for our life and health, but the waste generated from

medical activities creates a real problem for the surrounding and human world. Improper

management of waste generated in health care facilities causes a direct health impact on the

community, the health care workers and on the environment Every day, relatively large amount of

potentially infectious and hazardous waste are generated in the health care hospitals and facilities

around the world. Indiscriminate disposal of Bio medical waste or hospital waste and exposure to

such waste possess serious threat to environment and to human health that requires specific treatment

and management prior to its final disposal.

The present work deals with the basic issues as definition, categories, problems relating to

biomedical waste and procedure of handling and disposal method of Biomedical Waste Management

and also with the further amendments which was made. It also intends to create awareness amongst

the personnel involved in health care unit.

Biomedical waste management has recently emerged as an issue of major concern not only to

hospitals, nursing home authorities but also to the environment. the bio-medical wastes generated

from health care units depend upon a number of factors such as waste management methods, type of

health care units, occupancy of healthcare units, specialization of healthcare units, ratio of reusable

items in use, availability of infrastructure and resources etc.1The proper management of biomedical

waste has become a worldwide humanitarian topic today. Although hazards of poor management of

biomedical waste have aroused the concern world over, especially in the light of its far-reaching

effects on human, health and the environment.

Now it is a well established fact that there are many adverse and harmful effects to the environment

including human beings which are caused by the “Hospital waste” generated during the patient care.

Hospital waste is a potential health hazard to the health care workers, public and flora and fauna of

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the area. The problems of the waste disposal in the hospitals and other health-care institutions have

become issues of increasing concern.

About the Statute

Bio-medical Waste (Management & Handling) Rules, 1998 were notified by the Ministry of

Environment & Forests (MoEF) under the Environment (Protection) Act, 1986. In exercise of the

powers conferred by Section 6, 8 and 25 of the Environment (Protection) Act, 1986 (29 of 1986), and

in supersession of the Bio-Medical Waste (Management and Handling) Rules, 1998 and further

amendments made thereof, the Central Government vide G.S.R. 343(E) dated 28 th March, 2016

published the Bio-medical Waste Management Rules, 2016.

These rules apply to all persons who generate, collect, receive, store, transport, treat, dispose, or

handle bio medical waste in any form including hospitals, nursing homes, clinics, dispensaries,

veterinary institutions, animal houses, pathological laboratories, blood banks, ayush hospitals,

clinical establishments, research or educational institutions, health camps, medical or surgical camps,

vaccination camps, blood donation camps, first aid rooms of schools, forensic laboratories and

research labs.

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 Salient Features Of The Act
The Bio medical waste rules was published by Govt. of India, under Section 6 & 25 of
environmental Protection Act 1986 on 20/7/98 and appeared in official gazette of India on 27/7/98.It
deals with the generation/handling/treatment/disposal of Bio Medical Waste.
Rule 4 specify duty of occupier (generator) to take all steps to ensure that such waste is handled
without any adverse effect to human health and the environment.
Rule 5 and 6 specifies waste management procedures.
Section 7 is about prescribed authority that shall implement these rules.
These rules apply to all persons who generate, collect, receive, store, transport, treat, dispose or
handle bio-medical Waste in any form. Every occupier of an institution generating, collecting,
receiving, storing, transporting, treating disposal and for handling Bio-medical waste in any other
manner, except such occupier of clinics, dispensaries, pathological laboratories, blood banks
providing treatment/service to less Than 1000 patients per month and also the operators of
Biomedical waste facility are covered under these rules.
Form 1 has been fixed for application of authorization. Govt. has also prescribed necessary fee. of
M.P.
An advisory Committee as required under rule 9 has also been constituted by Govt. of M.P.
Constitution of appellate authority is underway.
Following the rule 7(1) of the said rules, the Government of M.P. Has nominated M.P. Pollution
Control Board, Bhopal as prescribed authority to implement these rules in Madhya Prudish, vide
their order dated 23/10/98.
Govt. of M.P. has also issued a notification in regard of necessary fee for issuance of authorization
under rule 8(3) of these rules on dated 12/2/99.
As per these rules, this shall be the duty of every occupier {as defined in rule 3(8)} of an institution
generating bio-medical waste which includes a hospital, nursing home, clinic dispensary, veterinary
institution, animal house, pathological laboratory blood bank by what ever name called to take all
steps to ensure that such waste is handled without any adverse effect to human health and the
environment.

The Bio-medical waste (Management & Handling Rules), 1998 is applicable to all persons, who
generate, collect, receive, store, transport, treat, dispose or handle bio-medical waste in any form.

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The occupier of an institution generating bio-medical waste is required to take all steps to ensure that
such waste is handled without any adverse effect or human health and the environment.

Occupier in relation to any institution generating bio-medical waste, which includes the hospital,
nursing home, dispensary, clinic, veterinary institution, animal house, pathological laboratory, blood
bank, means a person who has control over that institution or its premises.

Every occupier shall set up bio-medical waste treatment facilities like incinerator, autoclave and
microwave system to treat and dispose such waste.

 For human anatomical waste (human tissues, organs, body parts) the recommended treatment
is incineration or deep burial.
 Wastes such as needles, syringes, scalpels, blades, glass, etc., are required to undergo
chemical treatment, autoclaving or shredding.
 Solid waste items contaminated with blood and body fluids including cotton, dressing, soiled
plaster casts, bedding and other materials are to be treated by incineration, autoclaving or
microwaving.
 Solid wastes generated from disposable items such as tubes, catheters, intravenous sets are to
be disinfected by chemical treatment or microwaving mutilation or shredding.

Bio-medical waste shall not be mixed with other wastes and shall be segregated into containers or
bags of different colours like yellow, red, blue and black depending upon the type of waste. The
untreated bio-medical waste should not be stored in the premises beyond a period of 48 hours and
shall be transported only in such vehicles authorized for the purpose by the Government.

Prescribed Authority

 The prescribed authority for the enforcement of these provisions of these rules shall be the
State Pollution Control Boards (SPCBs) in respect of States and the Pollution Control
Committees (PCC) in respect of the union territories and all pending cases with the
prescribed authority appointed earlier shall stand transferred to the concerned State Pollution
Control Board, or as the case may be, PCCs.
 a) The prescribed authority for enforcement of the provisions of these rules in respect of all
health care establishments including hospitals, nursing homes, clinics, dispensaries,
veterinary institutions, animal houses, pathological laboratories and blood banks of the armed

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 forces under the Ministry of Defence shall be the Director General Armed Forces Medical
Services.
 The prescribed authority for the State or Union Territory shall be appointed within one month
of the coming into force of these rules.
 The prescribed authority shall function under the supervision and control of the respected
Governments of the State or the Union Territory.
 An authorization shall be granted for a period of three years, including an initial trial period
of one year fro the date of issue. Thereafter, an application shall be made by the occupier /
operator for renewal. All such subsequent authorization shall be granted for a period of three
years.
 The prescribed authority shall dispose off every application for authorization within ninety
days from the date of receipt of the application.

Advisory Committee
The Government of every State / Union territory shall constitute an advisory committee. The
committee will include experts in the field of medical and health, animal husbandry and veterinary
sciences and other such related department / organization including NGOs.

Appeal
Any person aggrieved by an order made by the prescribed authority under these rules may, within
thirty days from the date on which the order is communicated to him, prefer an appeal to such
authority as the State Government / Union Territory may think fit to constitute.

Common Disposal Incineration Sites.

The municipal Corporations, Municipal Boards or urban local bodies, as the case may be shall be
responsible for providing suitable common disposal / incineration site for the bio-medical waste
generated in the area under the jurisdictions and in areas outside the jurisdiction of any municipal
body, it shall be the responsibility of the occupier generating waste / operator of a waste treatment
facility to arrange for a suitable site individual or in association so as to comply with the provisions
of these rules.

The environmental considerations must form an integral part of all development and be
supplemented by mechanisms to see that environmental safeguards proposed are actually
implemented together with systematic monitoring to assess the effectiveness of such precautions in
protecting the environment.

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 A Comparative Study

1998 v. 2011

The new Rules of 2011 on Bio medical waste are elaborate, stringent and several new provisions
have been added in it. The Rules are not applicable for the radioactive waste, hazardous waste,
municipal solid waste and battery waste which would be dealt under the respective rules.

Prior Authorization

The first features of the new rules is that now every occupier, operator regardless of the number of
patients being serviced has to seek prior authorization from the prescribed authority which is the
State Pollution Control Board for States and Pollution Control Committee for Union Territories.
Earlier hospitals serving thousand or more patients only required to obtain authorization from the
concerned authorities. The present Rules also specifies that irrespective of the quantum of wastes
generated, every occupier such as from the hospitals, nursing homes, clinics, dispensaries, veterinary
institutions, animal houses, pathological laboratories and blood banks generating, collecting,
receiving, storing, transporting, disposing or handling bio medical wastes needs to obtain
authorization from the prescribed authority. “Such a change has been proposed because earlier
hospitals did not give a clear picture of the number of patients being served and thus evaded
authorization and were exempted from treating their wastes. It was also difficult to ascertain the
number of patients being treated in any hospital” . However given the fact that there are a large
number of HCEs and other medical facilities operating in every nook and corner of cities, towns and
villages it is very difficult for the regulatory bodies to keep a tab on their activities. Also considering
the capacity of regulators, it is more likely to remain a paper work.

The new Rules have incorporated State Ministry of Health for grant of license to HCEs after they get
authorization from the SPCBs. The new Rules have bridged the gap since earlier the HCEs only
required to obtain license from State Ministry of Health and carried out their functions but now they
have to obtain prior authorization before commencing their activities. SPCBs would make sure that
the HCEs have the necessary capacity and adequate equipments and then grant them the
authorization or renew their authorization.

Occupier and Operators duties flagged

Duties of the occupier have been elaborated in the present Rules. Proper training has to be imparted
by the occupier to the health care workers engaged in handling BMW. The training for staff involved
in the hospital waste management involves a number of parameters. The Rules merely mention
proper training but there are no details as such on what kind of training should be imparted to the
health care workers. A set of guidelines or regulations needs to be drafted by the HCEs in
consultation with health and safety experts as a part of training module. There should also be a
benchmark for training imparted to health care workers of both the HCEs and Common Treatment
Facility (CTF) which would facilitate entry of people of right competence in BMW management.
Such guidelines are missing from the rules.

Apart from the duties of the occupier the present rules have also listed duties for the operators of
common BMW treatment facility. The operators now have to ensure that the BMW is collected from

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all the HCEs and is transported, handled, stored, treated and disposed in an environmentally sound
manner. The operators also have to inform the prescribed authority if any HCEs are not handing the
segregated BMW as per the guidelines prescribed in the rules.

Accident reporting a must

Accidents that take place during the management of wastes have been defined in the new Rules.
Accidents like injuries from sharps, mercury spills and fire hazards now have to be reported in Form
III along with the remedial action taken. The Rules have also made mandatory for all the HCEs with
30 or more beds to set up a cell or unit to deal with the BMW management. The cell has to meet
every six months and minutes of the meeting have to be submitted along with the Annual Report to
the prescribed authority. “The move to set up a cell for BMW handling and making them meet every
six months and reporting was initiated since most of the hospitals in various states did not had a
separate unit to deal with such wastes”.

Mandatory treatment and disposal

The new Rules have made the treatment and disposal of Bio Medical wastes mandatory for all the
institutions generating them. The Rules clearly mention that every occupier should set up adequate
treatment facilities like autoclave/microwave/incinerator/hydroclave, shredder prior to
commencement of its operation or ensure that the wastes are treated at a common bio medical waste
treatment facility or an authorized waste treatment facility. Another conspicuous feature of the rule is
the clause on promotion of new technologies. The rules state that if an occupier or operator intends to
install new technologies for treatment and disposal of wastes, they can approach the Central
Government or Central Pollution Control Board (CPCB) for prior approval. The concerned
authorities after considering the suitability and feasibility may grant approval to the proposed
technology. The previous Rules had made mandatory for all the occupiers to set up requisite BMW
treatment facilities like incinerator, autoclave, microwave and shredder within its premises.
However, the new Rules have omitted incinerator as one of the pre requisites for on-site treatment of
BMW. The omission is owing to the various environmental impacts of incineration. The new Rules
say that the occupier having 500 or more beds may install incinerator subject to compliance of all the
guidelines. However studies in the past have shown that even the state of the art incinerators leads to
some emission of toxic gases. It is also observed that incinerators in India are not operated at right
temperatures and without the requisite air pollution control measures. Thus there should be certain
mechanisms to allow the use of incinerators for disposing BMW. Incinerators can be allowed for a
cluster of hospitals or positioned in major part of cities so that HCEs can transport their waste to
them instead of having one.

Deep burial for disposal of BMW has also been removed from the Rules. The Rules says it can be an
option only in rural areas with no access to CTF with prior approval from the prescribed authority.
However it is not mentioned in the rules as to what kind of wastes can be deep buried. Hospitals
generate a lot of wastes which are hazardous and in the absence of CTF deep burial certainly could
not be an option. Rules needs to be clearer and list what kind of wastes can be buried.

New rules have included a clause saying that the occupier or operators now have to monitor the stack
emissions from incinerator quarterly as per the norms specified and the results have to be recorded
and submitted to the prescribed authority. Reporting the results of emissions would help operators
and occupiers to achieve compliance and strive for further improvement in the operation of
incinerator.

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Mandatory treatment and disposal of BMW would require more treatment and disposal facilities in
the country. There are states like Jharkhand where there is no CTF till date and some states like
Manipur where there is only one CTF in the entire state. “Rules should push towards setting up of
more treatment facilities for BMW. Currently only 168 CTF caters to the need of more than 95,000
hospitals in the country” says Ragini Kumari of Toxics Link.

Ambiguities cleared
The Bio Medical Waste (Management and Handling) Rules 1998 contained ten categories of wastes
which have been reduced in the present rules to eight. The 2011 Rules have discarded Category No.
8 (containing liquid waste generated from laboratory, cleaning, washing and disinfection activities)
and Category No. 9 (containing incineration ash). However, laboratory wastes listed in Category 8
has been included in the present Category 3. The current rules have also cleared the confusion over
the colour coding of the containers used for disposal of BMW. The Schedule II of the 1998 Rules
creates a confusion regarding the disposal of Category 3 and Category 6 wastes which could either
be disposed in yellow or red coloured bags. Similarly, Category 7 wastes could also be disposed in
red or blue bags. The present Rules have thus clarified the ambiguity and allotted one colour code to
each category of waste.

1998 v. 2016

The Ministry of Environment and Forests new Biomedical Waste Management Rules 2016 change
the way the country used to manage biomedical waste and made a big difference to the Clean India
Mission,Union Minister of State for Environment.

Under the new regime, coverage has increased and also provides for pre-treatment of lab waste,
blood samples, etc. It mandates bar code system for proper control. It has simplified categorisation
and authorization.

To understand how the new rules are an improvement over the draft 2011 rules.Health care facilities
(HCFs) must segregate biomedical waste (the wastes involved in diagnosis, treatment and
immunisation such as human and animal anatomical waste, treatment apparatus such as needles and
syringes and cytotoxic drugs) at the individual level in colored bags—yellow, red, blue/white and
black according to the category of the biomedical waste. They can store this waste for up to 48 hours
after which they either treat it in-situ or a worker from a common biomedical waste treatment facility
(CBMWF) comes to collect it. The CMBWF then treats the waste according to the colour of the bag.
Different colours call for different types of treatments—incineration, deep burial, autoclaving,
shredding, chemical treatment, disposal in a landfill, etc.

The first distinction between the new rules and those prescribed in 2011 is their range of application.
While in 2011, the 1998 rules were amended to include all persons who generate, collect, receive,

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store and transport biomedical waste, the 2016 rules bring more clarity by specifying that vaccination
camps, blood donation camps, surgical camps and all other HCFs have been included.

The second distinction comes in the segregation, packaging, transport and storage of biomedical
waste in an HCF. The 2011 draft demarcated eight categories of biomedical waste (down from ten
categories in the 1998 notification). The 2016 notification further brings down the number of
categories to four. “Reduction in categories does not mean that a particular kind of biomedical waste
is not being adhered to. What it means is that all types of wastes have been compiled in four
categories for ease of segregation at a healthcare facility,” Tripti Arora, programme manager at the
non-profit Toxics Link, said.

The new rules also explicitly lay down the duties of an HCF in adhering to the segregation,
packaging and transport rules for the four different categories. The HCF is now responsible for pre-
treatment of laboratory and microbiological waste, blood samples and blood bags through
disinfection/sterilisation on-site in the manner prescribed by the World Health Organization (WHO)
or National Aids Control Organisation (NACO), regardless of whether final treatment and disposal
happens on-site or at a common biomedical waste treatment facility. Use of chlorinated plastic bags,
gloves and blood bags is to be phased out by the HCF within two years to eliminate emission of
dioxins and furans from burning of such wastes. The new rules also call for a bar code system for
bags/containers containing biomedical waste and immunisation of health workers upon their
induction and after every one year interval.

The bar code system can be used to track and identify bags better. But, it will be effective only when
the onus for using barcodes is on CBMWFs. That again is possible only if CMBWFs provide bags to
hospitals. This is not happening right now.

The new rules also specify the duties of the operator of the CBMWFs: In addition to the duties of the
occupier of an HCF, the operator of a CMBWF must ensure timely collection of biomedical waste
from HCFs and assist them in training.

Another distinction comes in the treatment and disposal of biomedical waste. According to the 2011
draft, every HCF shall set requisite bio-medical waste treatment facilities like incinerator, autoclave,
microwave system for the treatment of waste, or, ensure requisite treatment at a common biomedical
waste treatment facility. These rules do not state where an on-site treatment facility is necessary and
where dependence on a CMBWF is justified. It also does not mention who will provide land for the

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setup of a CBMWF. The 2016 rules make the guideline more specific: The Department dealing with
allocation of land in the state government shall provide land for setting up a common biomedical
waste treatment and disposal facility but no occupier of an HCF shall establish an on-site treatment
and disposal facility if a CBMWF is available within 75 km. The new rules also have stricter
standards of emission from incinerators: In 2011, the acceptable SPM emission was 150 mg/Nm^3 at
12 per cent CO2 correction. This has been reduced to 50 mg/Nm^3 in the new rules. Similarly, the
standard retention time in the secondary chamber has been increased from 1 second to 2 seconds.
The secondary chamber in incineration is where the temperature is lowered to 100 or 200 degree
Celsius. “This is done to reduce dioxins and furans as, at low temperature, incineration of biomedical
waste leads to the production of carbon dioxide and water. Dioxins and furans are produced at
temperatures greater than 600 degree Celsius.

Further, the new rules lay new criteria for authorisation of a HCF. In 1998, the rules said that
hospitals with more than 1,000 beds must obtain authorisation from State Pollution Control Boards
(SPCBs) while the 2011 darft expanded the ambit of institutions that require authorisation to include
all HCFs. The new rules make the procedure of getting an authorisation very simple: Bedded
hospitals will get automatic authorisation and non-bedded hospitals will get a one-time
authorisation.Non-bedded hospitals are generally small scale clinics that do not keep a record of the
waste generated and the number of beds. So, they cannot be charged on a per bed basis like bedded
hospitals. That is why, they are authorised once and yearly/half-yearly/quarterly prices for treatment
are fixed accordingly.

Another improvement in the new rules is in the monitoring sector. While the 2011 rules have no
provision for a monitoring authority, the 2016 rules state that the MoEF will review HCFs once a
year through state health secretaries, the SPCB and the CPCB. The SPCB, in its turn, will oversee
implementation through district level monitoring committees that will report to the State advisory
Committee or the SPCB. Moreover, according to the new rules, the advisory committee on
biomedical waste management is now mandated to meet every six months.

The total biomedical waste generated in the country is 484 Tonnes Per Day (TPD) from 1,68,869
HCFs. Of this, only 447 TPD is treated before disposal. The problems with unscientific disposal are
multi-fold: 85 per cent of the hospital waste is non-hazardous, 15 per cent is infectious/hazardous.
Mixing of hazardous results in to contamination and makes the entire waste hazardous. Hence, there
is necessity to segregate and treat. Improper disposal increases risk of infection; encourages
recycling of prohibited disposables and disposed drugs; and develops resistant microorganisms.
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 CONCLUSION
At present with advancement of medical science most of the hospitals/nursing homes are now
equipped with latest instruments for diagnosis and treatment of various diseases. One of the most
important aspect associated with hospitals is the safe management of the wastes; generated from
these establishments, which contains human anatomical wastes blood, body fluid, disposable syringe,
used bandages, surgical gloves, Blood bags intravenous tubes etc. The Bio-medical waste generated
from various sources has become a problem and much attention is being given worldwide to find out
solution of this problem. The main concern lies with the hospital waste generated from large
hospitals/nursing homes as it may pose deleterious effects due to its hazardous nature. Bio-medical
wastes, if not handled in a proper way, is a potent source of diseases, like AIDS, Tuberculosis,
Hepatitis and other bacterial diseases causing serious threats to human health. Owing to the
discussed potential threats this waste needs prime attention for its safe and proper disposal.
Medical wastes should be classified according to their source, typology and risk factors associated
with their handling, storage and ultimate disposal. The segregation of waste at source is the key step
and reduction, reuse and recycling should be considered in proper perspectives. We need to consider
innovative and radical measures to clean up the distressing picture of lack of civic concern on the
part of hospitals and slackness in government implementation of bare minimum of rules, as waste
generation particularly biomedical waste imposes increasing direct and indirect costs on society. The
challenge before us, therefore, is to scientifically manage growing quantities of biomedical waste
that go beyond past practices. If we want to protect our environment and health of community we
must sensitize our selves to this important issue not only in the interest of health managers but also in
the interest of community.

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