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 Sections 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 thereto, the Central Government, vide G.S.R. 343(E) dated March 28, 2016, published the Bio-Medical Waste Management Rules, 2016. These rules apply to all persons who generate, collect, receive, store, transport, treat, dispose of, or handle biomedical 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.
The prescribed authority for enforcement of the provisions of these rules in respect of all the health care facilities located in any state Territory is the respective State Pollution Control Board (SPCB) or Pollution Control Committee (PCC), and in the case of health care establishments of the Armed Forces under the Ministry of Defense, it shall be the Director General, Armed Forces Medical Services (DGAFMS). These rules stipulate the duties of the Occupier or Operator of a Common Bio-medical Waste Treatment Facility as well as the identified authorities. According to these rules, every occupier or operator handling bio-medical waste, irrespective of the quantity, is required to obtain authorization from the respective prescribed authority i.e. State Pollution Control Board and Pollution Control Committee, as the case may be. These rules consist of four schedules and five forms.
Bio-Medical Waste Management Rules, 2016