Guidelines for Disposal of Expired Drugs in India
The Central Drugs Standard Control Organization (CDSCO) released comprehensive guidelines for the disposal of expired and unused drugs. This initiative aims to mitigate the ecological risks associated with improper drug disposal. The guidelines encourage state and Union Territory drug controllers to promote adherence among stakeholders.
Background
The guidelines stem from a 2018 study by the All India Institute of Medical Sciences. The study identified environmental hazards from expired drugs disposed of in landfills. In 2019, the Centre for Science and Environment brought into light poor disposal practices in the Delhi-National Capital Region. These issues prompted calls for drug take-back initiatives and better accountability for drug manufacturers.
Key Disposal Methods
The guidelines outline several disposal methods. These include encapsulation, inertisation, and incineration. Additionally, a ‘Flush List’ identifies 17 specific drugs that can be safely flushed to prevent environmental contamination.
Extended Producer Responsibility (EPR)
EPR is a central theme in the guidelines. It holds manufacturers accountable for the entire lifecycle of their products. This includes the safe disposal of unused medicines. Effective EPR requires consumer participation and reverse logistics for returning products.
Supply Chain Responsibilities
The guidelines specify responsibilities within the supply chain. Retailers must return expired stock to suppliers. Wholesalers and distributors are required to accept unused drugs for proper disposal. Manufacturers must accept returns from retailers and wholesalers.
Consumer Participation
Unlike EPR models in Europe and the United States, the guidelines do not fully integrate consumer participation. Drug take-back programmes in these regions emphasise consumer involvement in returning expired medications.
Public Disposal Initiatives
State drug control departments are encouraged to establish drug take-back sites. Citizens can drop off unused medicines at designated locations for safe disposal. Kerala has initiated the nPROUD programme to facilitate drug collection from households.
Implementation Challenges
The successful execution of these guidelines hinges on collaboration among drug regulators, pollution control boards, and municipal corporations. The All Kerala Chemists and Druggists Association has expressed optimism but acknowledges the need for effective implementation strategies.
Record-Keeping and Verification
The guidelines stress the importance of meticulous record-keeping. Regulatory authorities must verify compliance to ensure accountability throughout the disposal process.
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