BIO-MEDICAL WASTE MANAGEMENT RULES 1998
SHORT TITLE AND COMMENCEMENT
(1) These rules may be called the bio-medical waste (management and handling) rules,
(2) They shall come in to force on the date of their publication in the official
These rules apply to all persons who generate, collect, receive, store, transport,
treat, dispose, or handle bio-medical waste in any form.
In these rules unless the context otherwise requires
- Act - means the environment (protection) act, 1986(29 of 1986);
- Animal house - means a place where animals are reared/kept for experiments
or testing purposes
- Authorization - means permission granted by the prescribed authority for
the generation, collection, reception, storage, transportation, treatment, disposal
and/or handle biomedical waste in accordance with these rules and any guidelines
issued by the central government;
- Authorized person" means an occupier or operator authorized by the prescribed
authority to generate, collect, receive, store, transport, treat, dispose and /or
handle biomedical waste in accordance with these rules and any guidelines issued
by the central government;
- Biomedical waste" means any waste, which is generated during the diagnosis,
treatment or immunization of human beings or animals or in research activities pertaining
thereto or in the production or testing biological and including categories mentioned
in schedule 1;
- Biologicals" means any preparation made from organisms or micro-organisms
or product of metabolism and biochemical reactions intended for use in the diagnosis,
immunization or the treatment of human beings or animals or in research activities
- Bio-medical waste treatment facility" means any facility wherein treatment
disposal of bio-medical waste or processes incidental to such treatment or disposal
is carried out;
- Occupier" in relation to any institution generating biomedical waste, which
includes a hospital, nursing home, clinic dispensary, veterinary institution, animal
house, pathological laboratory, blood bank by whatever name called, means a person
who has control over that institution and/or its premises;
- Operator of a bio-medical waste facility "means a person who owns or controls
or operates a facility for the collection, reception, storage, transport, treatment,
dispose or any other form of handling of bio-medical waste;
(10)"Schedule" means schedule appended to these rules;
DUTY OF OCCUPIER
It shall be the duty of every occupier of an institution generating bio-medical
waste which includes a hospital, nursing home, clinic, dispensary, veterinary institution,
animal house, pathological laboratory, blood bank by whatever name called to take
steps to ensure that such waste is handled without any adverse affect to human health
and the environment.
- Bio-medical waste shall be treated and disposed of in accordance with schedule I,
and in compliance with the standards prescribed in schedule V
- Every occupier, wherever required shall set up in accordance with the time-schedule
in schedule VI, requisite bio-medical waste treatment facilities like incinerator,
microwave system for the treatment of waste, or, ensure requisite treatment of waste
at a common waste treatment facility or any other waste treatment facility.
SEGREGATION, PACKING, TRANSPORTATION AND STORAGE
- Biomedical waste shall not be mixed with other wastes.
- Bio-medical waste shall be segregated into containers/bags at the point of generation
in accordance with schedule II prior to its storage, transportation, treatment and
disposal. The containers shall be labeled according to schedule III
- If a container is transported from the premises where bio-medical waste is generate
to any waste treatment facility outside the premises, the container shall, apart
from the label prescribed in schedule III, also carry information prescribed in
- Notwithstanding anything contained in the motor vehicles act, 1988, or rules hereunder,
untreated bio-medical waste shall be transported only in such vehicle as may be
authorized for the purpose by the competent authority as specified by the government.
- No untreated bio-medical waste shall be kept stored beyond a period of 48 hours:
Provided that if for any reason it becomes necessary to store the waste beyond such
period, the authorized person must take permission of the prescribed authority and
take measures to ensure that the waste does not adversely affect human health and
- The government of every state and union territory shall establish a prescribed authority
with such members as may be specified for granting authorization and implementing
these rules. If the prescribed authority which such members as may be specified
for granting authorization and implementing these rules. If the prescribed authority
comprises of more than one member, a chairperson of r the authority shall be designated.
- The prescribed authority for the state or union shall be appointed within one month
of the coming into force to these rules
- The prescribed authority shall function under the supervision and control of the
respective government of the state or union territory
- The prescribed authority shall in receipt of form I make such Enquirer as it deems
fit and if satisfied that the applicant possesses the necessary capacity to handle
bio-medical waste in accordance with these rules, grant or renew an authorization
as the case may be
- An authorization shall be granted for a period of three years, including an initial
trial period of one year from the date of issue. Thereafter, an application shall
be made by the occupier/operator for renewal. All such subsequent authorization
shall be for a period of three years. A provisional authorization will be granted
for the trial period, to enable the occupier/operator to demonstrate the capacity
of the facility.
- The prescribed authority may after giving reasonable opportunity of being heard
to the applicant and for the reasons thereof to the recorded in writing, refuse
the grant or renew authorization
- Every application for authorization shall be disposed of by the prescribed authority
within ninety days from the date of receipt of the application
- The prescribed authority may cancel or suspend an authorization, if for reason,
to be recorded in writing provided that no authorization shall be cancelled or suspended
without giving a reasonable opportunity to the occupier/operator of being heard.
- Every occupier of an institution generating, collecting, receiving, storing, transporting,
treating, disposing and /or 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 (one thousand) patients per moth shall make
an application in form I to the prescribed authority for grant of authorization
for grant of authorization.
- Every application in Form I for grant of authorization shall be accompanied by a
fee as may be prescribed by the government of state or union territory.
The Government of very 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, environmental management, municipal administration, and
any other related department or organization including non-governmental organizations.
The state pollution control board/pollution control committee shall be represented.
As and when required, the committee shall advise the government of the state/union.
Territory and the prescribed authority on matters related to the implementation
of these rules.
Every occupier/operator shall submit an annual report to the prescribed authority
in formII by 31 January every year, to include information about the categories
and quantities of bio-medical wastes handled during the preceding year, The prescribed
authority shall send this information in a complied form to the central pollution
control board by 31 march every year.
MAINTENANCE OF RECORDS
- Every authorized person shall maintain records related to the generation, collection,
reception, storage, transportation, treatment, disposal, and or any form of handling
of bio-medical waste in accordance with these rule s and any guidelines issued.
- All records shall be subjected to inspection and verification by the prescribed
authority at any time.
When any accident occurs at any institution or facility or any other site where
bio-medical waste is handled or during transportation of such waste, the authorized
person shall report the accident in form iii to the prescribed authority forthwith.
Any person aggrieved by an order made by the prescribed authority under these rules
may, within thirty days form the date on which the order is communicated to him,
prefer an appeal to such authority as the government of state/union territory may
think fit to constitute.
Provided that the authority may entertain the appeal after the expiry of the said
period of thirty days if the satisfied that the appellant was prevented by sufficient
cause from filling the appeal in time.