BIO-MEDICAL WASTE MANAGEMENT RULES, 2016
G.S.R. 343(E).-Whereas the Bio-Medical Waste (Management and Handling) Rules, 1998 was published vide notification number S.O. 630 (E) dated the 20th July, 1998, by the Government of India in the erstwhile Ministry of Environment and Forests, provided a regulatory frame work for management of bio-medical waste generated in the country;
And whereas, to implement these rules more effectively and to improve the collection, segregation, processing, treatment and disposal of these bio-medical wastes in an environmentally sound management thereby, reducing the biomedical waste generation and its impact on the environment, the Central Government reviewed the existing rules;
And whereas, in exercise of the powers conferred by sections 6, 8 and 25 of the Environment (Protection) Act, 1986 (29 of 1986), the Central Government published the draft rules in the Gazette vide number G.S.R. 450 (E), dated the 3rd June, 2015 inviting obje
(1) these rules may be called the Bio-Medical Waste Management Rules, 2016.
(2) They shall come into force on the date of their publication in theOfficial Gazette.
(1) These rules shall 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.
(2). These rules shall not apply to,-
(a) radioactive wastes as covered under the provisions of the Atomic Energy Act, 1962(33 of 1962) and the rules made there under;
(b) hazardous chemicals covered under the Manufacture, Storage and Import of Hazardous Chemicals Rules, 1989 made under the Act;
(c) solid wastes covered under the Municipal Solid Waste (Management and
In these rules, unless the context otherwise requires, -
(a)"Act"means the Environment (Protection) Act, 1986 (29 of 1986);
(b)"animal house"means a place where animals are reared or kept for the purpose of experiments or testing;
(c)"authorisation"means permission granted by the prescribed authority for the generation, collection, reception, storage, transportation, treatment, processing, disposal or any other form of handling of bio-medical waste in accordance with these rules and guidelines issued by the Central Government or Central Pollution Control Board as the case may be;
(d)"authorised person"means an occupier or operator authorised by the prescribed authority to generate, collect, receive, store, transport, treat, process, dispose or handle bio-medical waste in accordance with these rules and the guidelines issued by the Central Government or the Central Pollution Co
It shall be the duty of every occupier to-
(a) take all necessary steps to ensure that bio-medical waste is handled without any adverse effect to human health and the environment and in accordance with these rules;
(b) make a provision within the premises for a safe, ventilated and secured location for storage of segregated biomedical waste in colored bags or containers in the manner as specified in Schedule I, to ensure that there shall be no secondary handling, pilferage of recyclables or inadvertent scattering or spillage by animals and the bio-medical waste from such place or premises shall be directly transported in the manner as prescribed in these rules to the common bio-medical waste treatment facility or for the appropriate treatment and disposal, as the case may be, in the manner as prescribed in Schedule I;
(c) pre-treat the laboratory waste, microbiological waste, blood samples and blood
It shall be the duty of every operator to -
(a) take all necessary steps to ensure that the bio-medical waste collected from the occupier is transported, handled, stored, treated and disposed of, without any adverse effect to the human health and the environment, in accordance with these rules and guidelines issued by the Central Government or, as the case may be, the central pollution control board from time to time;
(b) ensure timely collection of bio-medical waste from the occupier as prescribed under these rules;
(c) establish bar coding and global positioning system for handling of bio-medical waste within one year;
(d) inform the prescribed authority immediately regarding the occupiers which are not handing over the segregated bio-medical waste in accordance with these rules;
(e) provide training for all its workers involved in handling of bio-medi
The Authority specified in column (2) of Schedule-III shall perform the duties as specified in column (3) thereof in accordance with the provisions of these rules.
(1) Bio-medical waste shall be treated and disposed of in accordance with Schedule I, and in compliance with the standards provided in Schedule-II by the health care facilities and common bio-medical waste treatment facility.
(2) Occupier shall hand over segregated waste as per the Schedule-I to common bio-medical waste treatment facility for treatment, processing and final disposal:
Provided that the lab and highly infectious bio-medical waste generated shall be pre-treated by equipment like autoclave or microwave.
(3) No occupier shall establish on-site treatment and disposal facility, if a service of common bio-medical waste treatment facility is available at a distance of seventy-five kilometer.
(4) In cases where service of the common bio-medical waste treatment facility is not available, the Occupiers shall set up requisite biomedical waste treatment equipment like inci
(1) No untreated bio-medical waste shall be mixed with other wastes.
(2) The bio-medical waste shall be segregated into containers or bags at the point of generation in accordance with Schedule I prior to its storage, transportation, treatment and disposal.
(3) The containers or bags referred to in sub-rule (2) shall be labeled as specified in Schedule IV.
(4) Bar code and global positioning system shall be added by the Occupier and common bio-medical waste treatment facility in one year time.
(5) The operator of common bio-medical waste treatment facility shall transport the bio-medical waste from the premises of an occupier to any off-site bio-medical waste treatment facility only in the vehicles having label as provided in part 'A' of the Schedule IV along with necessary information as specified in part 'B' of the Schedule IV.
(6) The vehicles used fo
(1) The prescribed authority for implementation of the provisions of these rules shall be the State Pollution Control Boards in respect of States and Pollution Control Committees in respect of Union territories.
(2) 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 Forces under the Ministry of Defence shall be the Director General, Armed Forces Medical Services, who shall function under the supervision and control of the Ministry of Defence.
(3) The prescribed authorities shall comply with the responsibilities as stipulated in Schedule III of these rules.
Every occupier or operator handling bio-medical waste, irrespective of the quantity shall make an application in Form II to the prescribed authority i.e. State Pollution Control Board and Pollution Control Committee, as the case may be, for grant of authorisation and the prescribed authority shall grant the provisional authorisation in Form III and the validity of such authorisation for bedded health care facility and operator of a common facility shall be synchronised with the validity of the consents.
(1) The authorisation shall be one time for non-bedded occupiers and the authorisation in such cases shall be deemed to have been granted, if not objected by the prescribed authority within a period of ninety days from the date of receipt of duly completed application along with such necessary documents.
(2) In case of refusal of renewal, cancellation or suspension of the authorisation by the prescribed authority, the reas
(1) Every State Government or Union territory Administration shall constitute an Advisory Committee for the respective State or Union territory under the chairmanship of the respective health secretary to oversee the implementation of the rules in the respective state and to advice any improvements and the Advisory Committee shall include representatives from the Departments of Health, Environment, Urban Development, Animal Husbandry and Veterinary Sciences of that State Government or Union territory Administration, State Pollution Control Board or Pollution Control Committee, urban local bodies or local bodies or Municipal Corporation, representatives from Indian Medical Association, common bio-medical waste treatment facility and non-governmental organisation.
(2) Notwithstanding anything contained in sub-rule (1), the Ministry of Defence shall constitute the Advisory Committee (Defence) under the chairmanship of Director General of Health Se
(1) The Ministry of Environment, Forest and Climate Change shall review the implementation of the rules in the country once in a year through the State Health Secretaries and Chairmen or Member Secretary of State Pollution Control Boards and Central Pollution Control Board and the Ministry may also invite experts in the field of bio-medical waste management, if required.
(2) The Central Pollution Control Board shall monitor the implementation of these rules in respect of all the Armed Forces health care establishments under the Ministry of Defence.
(3) The Central Pollution Control Board along with one or more representatives of the Advisory Committee constituted under sub-rule (2) of rule 11, may inspect any Armed Forces health care establishments after prior intimation to the Director General Armed Forces Medical Services.
(4) Every State Government or Union territory Administration shall constitu
(1) Every occupier or operator of common bio-medical waste treatment facility shall submit an annual report to the prescribed authority in Form-IV, on or before the 30th June of every year.
(2) The prescribed authority shall compile, review and analyse the information received and send this information to the Central Pollution Control Board on or before the 31st July of every year.
(3) The Central Pollution Control Board shall compile, review and analyse the information received and send this information, along with its comments or suggestions or observations to the Ministry of Environment, Forest and Climate Change on or before 31st August every year.
(4) The Annual Reports shall also be available online on the websites of Occupiers, State Pollution Control Boards and Central Pollution Control Board.
(1) Every authorised person shall maintain records related to the generation, collection, reception, storage, transportation, treatment, disposal or any other form of handling of bio-medical waste, for a period of five years, in accordance with these rules and guidelines issued by the Central Government or the Central Pollution Control Board or the prescribed authority as the case may be.
(2) All records shall be subject to inspection and verification by the prescribed authority or the Ministry of Environment, Forest and Climate Change at any time.
(1) In case of any major accident at any institution or facility or any other site while handling bio-medical waste, the authorised person shall intimate immediately to the prescribed authority about such accident and forward a report within twenty-four hours in writing regarding the remedial steps taken in Form I.
(2) Information regarding all other accidents and remedial steps taken shall be provided in the annual report in accordance with rule 13 by the occupier.
(1) Any person aggrieved by an order made by the prescribed authority under these rules may, within a period of thirty days from the date on which the order is communicated to him, prefer an appeal in Form V to the Secretary (Environment) of the State Government or Union territory administration .
(2) Any person aggrieved by an order of the Director General Armed Forces Medical Services under these rules may, within thirty days from the date on which the order is communicated to him, prefer an appeal in Form V to the Secretary, Ministry of Environment, Forest and Climate Change.
(3) The authority referred to in sub-para (1) and (2) as the case may be, may entertain the appeal after the expiry of the said period of thirty days, if it is satisfied that the appellant was prevented by sufficient cause from filing the appeal in time.
(4) The appeal shall be disposed of within a period of ninety days from
(1) Without prejudice to rule 5 of these rules, the department in the business allocation of land assignment shall be responsible for providing suitable site for setting up of common biomedical waste treatment and disposal facility in the State Government or Union territory Administration.
(2) The selection of site for setting up of such facility shall be made in consultation with the prescribed authority, other stakeholders and in accordance with guidelines published by the Ministry of Environment, Forest and Climate Change or Central Pollution Control Board.
(1) The occupier or an operator of a common bio-medical waste treatment facility shall be liable for all the damages caused to the environment or the public due to improper handling of bio-medical wastes.
(2) The occupier or operator of common bio-medical waste treatment facility shall be liable for action under section 5 and section 15 of the Act, in case of any violation.
Schedule I
[Seerules 3 (e), 4(b), 7(1), 7(2), 7(5), 7 (6) and 8(2)]
Part-1
Biomedical wastes categories and their segregation, collection, treatment, processing and disposal options
| Category | Type of Waste | Type of Bag or Container to be used | Schedule II [Seerule 4(t), 7(1) and 7(6)] Standards for Treatment and Disposal of Bio-Medicalwastess 1. Standards For Incineration.- All incinerators shall meet the following operating and emission standards- A. Operating Standards (1). Combustion efficiency (CE) shall be at least 99.00%. (2). The Combustion efficiency is computed as follows: %CO2
Sch.3 .Schedule III [Seerule 6 and 9(3)] List of Prescribed Authorities and the Corresponding Duties
Sch.4 .Schedule IV [Seerule 8(3) and (5)] Part A Label for Bio-Medical Waste Containers or Bags
Part B Label for Transporting Bio-Medical Waste Bags or Containers
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