The Bio-Medical Waste Management Rules, 2016 are covered under the Environment (Protection) Act, 1986. These rules were notified by Ministry of Environment Forest & Climate Change in March, 2016, stipulates that every Healthcare Facility shall take all necessary steps to ensure that biomedical waste is handled without any adverse effect to human health and the environment.

Effective biomedical waste management is crucial for safeguarding public health and protecting the environment from the hazards posed by medical waste.

Objectives:

• Prevent Health Hazards: Minimize the risk of infection and injury to healthcare workers, patients, and the public by safely managing infectious and hazardous waste.
• Protect the Environment: Reduce environmental pollution by ensuring proper treatment, segregation, and disposal of biomedical waste to prevent contamination of air, water, and soil.
• Ensure Compliance: Adhere to legal and regulatory frameworks (like the Biomedical Waste Management Rules, 2016) to maintain high standards of public health and environmental safety.
• Public Awareness and Training: Ensure proper training for healthcare workers on the safe handling of biomedical waste and raise public awareness on the dangers of improper waste management.

Applicability of Rules: 

These rules apply to all individuals and entities involved in the generation, collection, receipt, storage, transportation, treatment, disposal, or handling of biomedical waste in any form. This includes, but is not limited to, hospitals, nursing homes, clinics, dispensaries, veterinary institutions, animal houses, pathological laboratories, blood banks, research or educational institutions, health camps, vaccination camps, blood donation camps, first aid rooms in schools, forensic laboratories, and research labs.

Occupier’s role in bio medical waste disposal (Rule 4):

1. Take all necessary measures to handle biomedical waste in a way that does not harm human health or the environment and complies with the rules.

1. Provide a secure, well-ventilated area within the premises for storing biomedical waste in color-coded bags or containers as specified. This prevents any further handling, theft of recyclables, or spills caused by animals. The waste should be directly transported to a treatment facility or for disposal according to the prescribed rules.
2. The occupier must disinfect or sterilize laboratory waste, microbiological waste, blood samples, and blood bags on-site following guidelines from the World Health Organization (WHO) or National AIDS Control Organization (NACO) before sending them to a biomedical waste treatment facility for final disposal.
3. The occupier must stop using chlorinated plastic bags, gloves, and blood bags within two years from the date these rules are announced.
4. Every person in charge must train all their health care workers and others who handle medical waste when they start their job and then once a year. They must include the details of the training, how many people were trained, and how many did not receive any training in their Annual Report.
5. It shall be the duty of every occupier to dispose of solid waste other than bio-medical waste in accordance with the provisions of respective waste management rules made under the relevant laws and amended from time to time. Everyone in charge must not mix treated medical waste with regular garbage.
6. It shall be the duty of occupier to make sure all healthcare workers and others handling medical waste are vaccinated against diseases Hepatitis B and Tetanus, following the rules set by the National Immunization Policy or Ministry of Health and Family Welfare.
7. Everyone in charge must set up a bar-code system for bags or containers of medical waste being sent out within one year of these rules being announced.

9. They must separate liquid chemical waste from the start and treat or neutralize it before mixing it with other waste from healthcare facilities.
10. It shall be the duty of every occupier to ensure treatment and disposal of liquid waste in accordance with the Water (Prevention and Control of Pollution) Act, 1974 (6 of 1974).
11. It shall be the duty of every occupier to ensure occupational safety of all its health care workers and others involved in handling of biomedical waste by providing appropriate and adequate personal protective equipments.
12. It shall be the duty of every occupier to conduct health check-ups for all healthcare workers and others handling medical waste at the time of induction and at least once a year, and keep records of these check-ups.
13. He must keep and update a daily record of medical waste management and show the monthly details on their website, following the categories and colour codes listed in schedule I.
14. Every occupier must set up a system to review and monitor bio-medical waste management, either by using an existing committee or forming a new one. This committee must meet every six months, and minutes of these meetings should be included in the annual report submitted to the prescribed authority. Healthcare establishments with fewer than thirty beds must appoint a qualified individual to oversee bio-medical waste management and submit the annual report.
15. It shall be the duty of every occupier to maintain all record for operation of incineration, hydro or autoclaving etc., for a period of five years.
16. He needs to inform to prescribed authority immediately in case the operator of a facility does not collect the bio medical waste within the intended time or as per agreed time.

 Treatment and Disposal of Bio medical Waste (Rule 7):

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. The occupier must send the segregated bio medical waste to common treatment facility for processing and disposal. Lab and highly infectious waste must be pre-treated using equipment like autoclaves and microwaves.
3. No occupier shall establish on-site treatment and disposal facility, if a service of `common biomedical waste treatment facility is available at a distance of seventy-five kilometer.
4. Any person including an occupier or operator of a common bio medical waste treatment facility, intending to use new technologies for treatment of bio medical waste other than those listed in Schedule I shall request the Central Government for laying down the standards or operating parameters.
5. Do not use chlorinated plastic bags for storing or transporting biomedical waste. These bags should not be burned. Instead, use bags that meet the Bureau of Indian Standard.
6. The Occupier or Operator of a common bio-medical waste treatment facility shall maintain a record of recyclable wastes referred to in Rule 7(9) which are auctioned or sold and the same shall be submitted to the prescribed authority as part of its annual report. The record shall be open for inspection by the prescribed authorities.
7. The handling and disposal of all the mercury waste and lead waste shall be in accordance with the respective rules and regulations.

Segregation, packaging, transportation and storage (Rule 8):

1. Human and animal anatomical waste, soiled waste, and biotechnology waste should not be stored for more than 48 hours. Provided that in case for any reason it becomes necessary to stored longer, take measures to protect health and the environment, and notify the authorities with reasons.
2. Microbiology and clinical lab waste must be sterilized or disinfected according to WHO guidelines before being sent to the treatment facility.
3. The vehicles used for transportation of bio-medical waste shall comply with the conditions if any stipulated by SPCB (State Pollution Control Board) /PCC in addition to the requirement contained in the Motor Vehicles Act, 1988 if any or the rules made there under for transportation of such infectious waste.
4. No untreated bio-medical waste shall be mixed with other wastes.

  Maintenance of records (Rule 14):

1. Every authorized 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.

Annual Report (Rule 13):

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 Annual Reports shall also be available online on the websites of Occupiers, State Pollution Control Boards and Central Pollution Control Board.

Accidental reporting (Rule 15):

1. If a major accident happens at any place while handling bio-medical waste, the responsible person must inform the authorities right away and send a report within 24 hours in writing about the actions taken to fix the issue, using 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.

Liability of the occupier, operator of a facility (Rule 18):

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.
   1. As per section 5 —Notwithstanding anything contained in any other law but subject to the provisions of this Act, the Central Government may, in the exercise of its powers and performance of its functions under this Act, issue directions in writing to any person, officer or any authority and such person, officer or authority shall be bound to comply with such directions
   2. As per section 15 —Penalty for contravention of provisions of Act, rules, orders and directions.
      • Where any person contravenes or does not comply with any of the provisions of this Act or the rules made or orders or directions issued there under for which no penalty is provided, he shall be liable to penalty in respect of each such contravention which shall not be less than ten thousand rupees but which may extend to fifteen lakh rupees.
      • Where any person continues contravention under sub-section (1), he shall be liable to additional penalty of ten thousand rupees for every day during which such contravention continues.     
   3. As per section 15A— Penalty for contravention by companies.—
      • Where any company contravenes any of the provisions of this Act, the company shall be liable to penalty for each such contravention which shall not be less than one lakh rupees but which may extend to fifteen lakh rupees.
      • Where any company continues contravention under sub-section (1), the company shall be liable to additional penalty of one lakh rupees for every day during which such contravention continues.

Conclusion:

Bio-Medical Waste Management Rules emphasizes the importance of proper segregation, handling, treatment, and disposal of bio-medical waste to minimize health risks and environmental pollution. It mandates healthcare facilities to implement a systematic approach for waste management, ensuring compliance with standards, reducing potential hazards, and maintaining accountability through regular reporting and monitoring. Effective bio-medical waste management contributes to public health safety and environmental protection.