Syllabus:
GS2: Issues Relating to Development and Management of Social Sector/Services relating to Health, Education, Human Resources.
Context:
The Central Drugs Standard Control Organization (CDSCO) has issued disposal guidelines for expired and unused drugs, urging state and UT drug controllers to promote their adoption.
More on the News
- The guidelines were based on a 2018 AIIMS study that warned of ecological risks from dumping expired drugs in landfills.
- In 2019, Delhi-based Centre for Science and Environment (CSE) flagged improper drug disposal in the Delhi-NCR and pushed for drug take-back initiatives to ensure that expired and unused medicines are returned from their point of generation to a facility for safe disposal.
- CSE suggested adding an Extended Producer Responsibility (EPR) clause to hold both branded and generic drug manufacturers accountable for disposing of unused medicines.
Risk Associated with Improper Disposal
- Anti-Microbial Resistance (AMR): A major reason for the guidelines is the growing threat of AMR. Improper antibiotic disposal can pollute soil and water, fostering resistance. Given India’s high AMR burden, these measures are crucial.
- Environmental Contamination: Pharmaceuticals, including APIs, can contaminate soil and water, disrupt ecosystems, and enter the food chain, leading to long-term health risks for humans and animals.
- Occupational Hazards: Without proper segregation and disposal, waste handlers like municipal workers risk exposure to hazardous pharmaceutical waste.
Key guidelines of the CDSCO
- Reverse Supply Chain: Expired drugs should be returned up the supply chain—from retailers to suppliers and then to manufacturers. Wholesalers must accept and segregate returns for proper disposal.
- Role of Manufacturers and Hospitals: Manufacturers are required to accept returns, while hospitals and agencies can either return unused drugs or dispose of them under the Biomedical Waste Rules, 2016.
- Limitation: consumers are not included in the reverse supply chain process, unlike drug take-back programmes in Europe and the United States, where consumer participation is central under EPR mandates.
- Disposal Methods and Procedures: The guidelines specify disposal methods like encapsulation, inertisation, and incineration, and outline protocols for collection, storage, and transport.
- Flush List Drugs: A list of 17 drugs has been identified as safe to flush down sinks or toilets to prevent environmental or health hazards.