17. BIOMEDICAL WASTE MANAGEMENT RULES 2016

BIOMEDICAL WASTE MANAGEMENT RULES, 2016

Biomedical Waste Management Rules, 2016 (BMWM) was issued by the notification of the Ministry of Environment, Forestry, and Climate Change in March 2016 stating that every healthcare facility must take all necessary efforts to guarantee that biological waste is managed safely and without causing harm to human health or the environment.

DEFINITIONS UNDER THE RULES

• Biological: Any preparation made from organisms or micro-organisms for diagnosis, immunisation, treatment, or research.
• Biomedical Waste: Any waste generated during diagnosis, treatment, immunisation, research, or production/testing of biologicals, including categories in Schedule I.
• Biomedical Waste Treatment and Disposal Facility: Any facility wherein treatment and disposal of biomedical waste is carried out, including common biomedical waste treatment facilities (CBMWTF).
• Handling: Includes generation, sorting, segregation, collection, use, storage, packaging, loading, transportation, unloading, processing, treatment, destruction, conversion, offering for sale, transfer, or disposal of waste.
• Occupier: Person having administrative control over institution and premises generating biomedical waste (hospital, nursing home, clinic, dispensary, pathological laboratory, blood bank, etc.).
• Operator of a CBMWTF: Person who owns or controls a Common Biomedical Waste Treatment Facility.

CATEGORIES OF BIOMEDICAL WASTES (10 CATEGORIES)

1. Category 1: Human anatomical wastes (human tissues, organs, and body parts)
2. Category 2: Animal wastes
3. Category 3: Microbiology and biotechnology wastes
4. Category 4: Waste sharps
5. Category 5: Discarded medicines and cytotoxic drugs
6. Category 6: Solid wastes (cotton, dressings, plaster casts, linen, bedding contaminated with blood)
7. Category 7: Solid wastes from disposable items (tubing, catheter, IV sets)
8. Category 8: Liquid wastes
9. Category 9: Incineration ash
10. Category 10: Chemical wastes

SCHEDULES OF BMWM RULES, 2016

• Schedule I (Part 1 & 2): Categorisation and Management of BMW
• Schedule II: Standards for treatment and disposal of BMW
• Schedule III: Prescribed authorities and corresponding duties
• Schedule IV: Label of containers or bags (Part A) and label for transportation (Part B)

PROCEDURE OF BMW MANAGEMENT

Segregation of Wastes

1. Waste segregated at point of generation (not in later stages).
2. Posters/placards in each ward and waste storage area.
3. Colour-coded bins/containers/bags at point of generation.
4. Colour-coded plastic bags comply with Plastic Waste Management Rules, 2016.
5. PPE given to staff handling biomedical waste.

Waste Collection and Storage

1. Biomedical waste collected daily at definite times.
2. Human anatomical, animal anatomical, soiled, and biotechnology wastes disposed within 2 days.
3. General waste collected separately, not in same trolley as biomedical waste.
4. Collection times scheduled as per waste generation pattern.
5. General waste collected immediately after visiting hours.
6. Staff responsible provided with PPEs.

Packaging and Labelling

1. Bags/sharps containers carry not more than three-quarters capacity; then sealed.
2. Plastic bags tied or sealed with plastic tag/tie (not stapled).
3. Replacement bags/containers at every waste-collection site.
4. Colour-coded bags bear bio-hazard symbol, labelled with date, waste type, quantity, sender’s name, receiver’s details, and bar-coded label.
5. Bar-coded stickers as per CPCB guidelines.
6. Biohazard or cytotoxic hazard symbol as per BMWM Rules, 2016.

Transportation

• Closed trolleys/containers with wheels for intramural transport.
• Trolleys used only for biomedical waste (not patient trolleys).
• Route with low traffic flow of patients and visitors.
• Not through high-risk areas.
• Supplies and wastes transported by separate routes.
• Central waste collection area easily accessible.
• Safe transport with no spillage.

Treatment and Disposal Methods

• Incinerators: High-temperature method (1800-2000°F / 982-1093°C). Disadvantage: air pollution.
• Autoclaving: Most popular alternative; steam sterilisation; cost-effective; destroys microbes. Not appropriate for cytotoxic, pathological, radiotoxic, toxic chemical wastes.
• Gas Sterilisation: Formaldehyde or ethylene oxide gas. EPA does not advise ethylene oxide for infectious waste (toxic).
• Chemical Disinfection: Mostly for liquid waste; chlorine used.
• Microwave: Wastes shredded, mixed with water, heated internally; less energy-intensive than incinerators.
• Irradiation: Cobalt source emits gamma rays; kills all microbes. High cost; not advised for pathological wastes.
• Thermal Inactivation: High temperature heating for liquid waste.
• Land Disposal: After decontamination; areas with low groundwater level, far from flooding sources.

ASPECTS RELATED TO PHARMA MANUFACTURE TO DISPOSAL OF PHARMA/MEDICAL WASTE

BMW Management at Homes

• Examples: Used adult/baby diapers, bloodstained cotton buds, inserted needles, spilt mercury, band-aids, X-ray pictures, pregnancy/blood sugar test strips, abandoned insulin pens, expired medications.
• HBMW must be separated and given to municipal waste collectors in distinct bags/containers.
• Urban Local Bodies must have partnership with CBMWTF.

BMW Management at Pharmacies

1. Segregation: Separate from other BMW; specially designed containers.
2. Disposal: Incineration or authorised recyclers. Not in open landfills or waterways.
3. Reverse Logistics: Mechanism for gathering expired/unused medications; secure transport to approved disposal location.

BMW Management at Hospitals

1. Segregation: Colour-coded containers at point of generation.
2. Storage: Secure locations, inaccessible to unauthorised individuals.
3. Transportation: Enclosed vehicles with appropriate labels.
4. Treatment and Disposal: Environmentally responsible manner.
5. Home Care: Clear instructions to patients; waste disposed by licensed collectors/recyclers.

Dr. Saint Paul

Dr. Saint Paul is a pharmacy educator, Pharm.D graduate, and academic content creator from Jawaharlal Nehru Technological University Kakinada (JNTUK), where he completed his Doctor of Pharmacy (Pharm.D) degree between 2015 and 2021.

He has more than 7 years of experience creating pharmacy educational content, writing study materials, and reviewing academic articles for pharmacy students. He has also contributed guest articles to pharmacy education platforms, including PharmD Guru.

At D.PharmGuru, his work focuses on simplifying complex Diploma in Pharmacy (D.Pharmacy) subjects into easy-to-understand notes, practical explanations, and exam-oriented educational resources for students across India.

His areas of focus include Human Anatomy and Physiology, Pharmaceutics, Pharmacology, Pharmaceutical Chemistry, Hospital and Clinical Pharmacy, and other core D.Pharmacy subjects.