Biomedical Waste (Management & Handling) Amendment Rules,2003
Biomedical Waste (Management & Handling) Rules,1998
Based on the powers conferred by section 6, 8, and 25 of the Environment (Protection) Act 1986, the Central Govt. has made the Biomedical Waste Management Rules 2016 to safeguard the public and health care workers from the risk arising due to Biomedical Waste. The penalties are same as specified in Environment (Protection) Act 1986. These rules apply to all persons who generate, collect, receive, store, transport, treat, dispose, or handle bio-medical waste in any form 1. "Act" means the Environment (Protection) Act, 1986 (29 of 1986);
2. "Animal House" means a place where animals are reared/kept for experiments or testing purposes;
3. "Authorization" means permission granted by the prescribed authority for the generation, collection, reception, storage, transportation, treatment, disposal and/or any other form of handling of bio-medical waste in accordance with these rules and any guidelines issued by the Central Government;
4. "Authorized person" means an occupier or operator authorized by the prescribed authority to generate, collect, receive, store, transport, treat, dispose and/or handle bio-medical waste in accordance with these rules and any guidelines issued by the Central Government;
5. "Bio-medical waste" means any waste, which is generated during the diagnosis, treatment or immunization of human beings or animals or in research activities pertaining to in the production or testing of biologicals, and including categories mentioned in Schedule 1;
6. "Biologicals" means any preparation made from organisms or micro organisms or product of metabolism and biochemical reaction intended for use in the diagnosis, immunization or the treatment of disposal of human beings or animals or in research activities pertaining, hereto;
7. "Bio-medical waste treatment facility" means any facility wherein treatment, disposal of bio-medical waster or processes incidental to such treatment or disposal is carried out;
8. "Occupier" in relation to any institution generation bio-medical wastes, which includes a hospital, nursing home, clinic, dispensary, veterinary institutions, animal house, pathological laboratory, blood bank by whatever name called, means a person who has control over that institution and/or its premise.
9. "Operator of a bio-medical waster facility" means a person who owns or controls or operates a facility for the collection, reception, storage, transport, treatment, disposal or any other form of handling of bio-medical waste;
10. "Schedule" means schedule appended to these rules; It shall be the duty of every occupier of an institution generating bio-medical waste, which includes a hospital nursing home, clinic, dispensary, veterinary institutions, and animal house, pathological laboratory, blood bank by whatever name called to take all steps to ensure that such waste is handled without any adverse effect to human health and the environment. 1. Bio-medical waste shall be treated and disposed of in accordance with Schedule 1, and in compliance with the sandards standards in Schedule V.
2. Every occupier, where required, shall set up requisite bio-medical waste treatment facilities like incinerator, autoclave, 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. 1. Bio-medical waste shall not be mixed with other wastes.
2. 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 labelled according to Schedule III.
3. If a container is transported from the premises where bio-medical waste is generated to any waste treatment facility outside the premises, the container shall, apart from the label prescribed in Schedule III, also carry information prescribed in Schedule IV.
4. Notwithstanding anything contained in the Motor Vehicle Act, 1988, or rules there under, untreated biomedical waste shall be transported only in such vehicles as may be authorized for the purpose by the competent authority as specified by the government.
5. 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 environment. 1. The Government of every State and Union Territory shall establish a prescribed authority with such members as may specified for granting authorization and implementing these rules. If the prescribed authority comprises of more than one member, a chairperson for the authority shall be designated.
2. The prescribed authority for the State or Union Territory shall be appointed within one month of the coming into force of these rules.
3. The prescribed authority shall function under the supervision and control of the respective Government of the State or Union Territory.
4. The prescribed authority shall on receipt of Form 1 make such enquiry as it deems fit and if it is 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.
5. 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.
6. The prescribed authority may after giving reasonable opportunity of being heard to the application and for reasons thereof to be recorded in writing, refuse to grant or renew authorization.
7. Every application for authorization shall be disposal of by the prescribed authority within ninety days from the date of receipt of the application.
8. The prescribed authority may cancel or suspend an authorization, if for reason, to be recorded in writing, the occupier/operator has failed to comply with any provision of the Act or these rules.

Provided that no authorization shall be cancelled or suspended without giving a reasonable opportunity to the occupier/operator of being heard. 1. 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 clinic, dispensaries, pathological laboratories, blood banks providing treatment/service to less than 1000 (one thousand) patients per month, shall make an application in Form 1 to the prescribed authority for grant of authorization.
2. Every operator of a bio-medical waste facility shall make an application in Form 1 to the prescribed authority for grant of authorization.
3. Every application in Form 1 for grant of authorization shall be accompanied by a fee as may be prescribed by the Government of the State of Union territory. The Government of every State/Union Territory shall constitute and 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 Board/ Pollution Control Committee shall be represented. As and when required, the committee shall advise the Union Territory /State Government about matters related to the implementation of these rules. Every occupier/operator submit an annual report to the prescribed authority in Form II 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 compiled form to the Central Pollution Control Board by 31 March every year. 1. 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 rules and any guidelines issued.
2. All records shall be subjected to inspection and verification by the prescribed authority at any time. When any accidents occur 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 forth with. Any person aggrieved by an order by the prescribed authority under these rules may, within thirty days from date on which the order is communicated to them, refer 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 it is satisfied that the appellant of prevent by sufficient cause from filing the appeal in time.

Any person aggrieved by an order by the prescribed authority under these rules may, within thirty days from date on which the order is communicated to them, refer 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 it is satisfied that the appellant of prevent by sufficient cause from filing the appeal in time.

Biomedical waste	Treatment & Disposal
Human Anatomical Waste (Human tissues, organs, body parts)	Incineration/deep burial *
Animal Waste (Animal tissues, organs, body parts carcasses, bleeding parts, fluid, blood and experimental animals used in research, waste generated by veterinary hospitals colleges, discharge from hospitals, animals houses).	Incineration/deep burial *
Microbiology & Biotechnology Waste (Wastes from lab. Cultures, stocks of specimens of micro-organisms live or attenuated vaccines, human and animal incineration* cell culture used in research and infectious agents from research and industrial laboratories, wastes from production of biologicals, toxins, dishes and devices sued for transfer of cultures)	Autoclaving/ micro-waving.
Waste Sharps Needles, syringes, scalpels, blades, glass etc. that may cause puncture andcuts. This includes both used and unused sharps)	Chemical/ disinfection autoclave/ micro-waving and         mutilation/shredding
Discarded Medicines & Cytotoxic drugs (Wastes comprising of outdated contaminated and discarded medicines)	incineration/destruct & drugs disposal in secured landfills
Soiled Waste (Items contaminated with blood, and body fluids including cotton, dressing, soiled plaster casts, lines, beddings, other material contaminated with blood)	incineration/ autoclave micro-waving
Solid Waste (Waste generated from disposable items other than sharps such as tubings catheters, intravenous sets, etc.)	Chemical disinfection autoclave/micro-waving and         mutilation/shredding
Liquid Waste (Waste generated from laboratory and washing, cleaning house-keeping and disinfecting activities)	Disinfect-chemically & discharge into drains
Incineration Ash (Ash from incineration of any bio-medical waste)	disposal in municipal landfill
Chemical Waste (Chemical used in production of biologicals, chemicals used in insecticides etc.)	Chemically treatment disinfection and discharge of drains         for liquid and secured landfill for solids.

1. Chemicals treatment using at least 1-2% hypochlorite solution or any other equivalent chemical reagent should ensure disinfection.
2. Mutilation/shredding must be such so as to prevent unauthorized reuse.
3. There will be no chemical pretreatment before incineration. PVC shall not be incinerated. 1. Incinerators or individual hospitals/nursing homes/medical establishments.
2. Common incinerator to handle waste from a number of hospitals/nursing homes/ pathological laboratories etc. Incinerators should be installed at appropriate location to avoid nuisance to patients and neighbourhood.

Colour Coding	Type of Container	Waste Category	Treatment options
Yellow	Plastic Bag	Categories 1, 2, 3 & 6.	Incineration / deep burial
Red	Plastic Bag	Categories 3, 6, 7	Autoclaving/Micro-waving Chemical Treatment
Blue/White Translucent	Plastic Bag /punctproof containers	Cat. 4, Cat. 7	Autoclaving/Micro-waving/ Chemical Treatment & Destruction / shredding
Black	Plastic Bag	Categories 5, 9, 10	Disposal in secured landfill.

1. Colour coding of waste categories with multiple treatment options as defined in schedule 1, shall be selected depending on treatment option chosen, which shall be as specified in Schedule I.
2. Waste collection bags for waste types needing incineration shall not be made of chlorinated plastics.
3. Categories 8 and 10 (liquid) do not require containers/bags.
4. Category 3, if disinfected locally need not be put in containers/bags. The Gazette of India. Biomedical Waste (Management & Handling) Rules, 1998. No. 460 July 27th , 1998 and Amended No. 375, June 2nd, 2000.