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 The Bangalore District Chemists & Druggists Association (BDCDA) foresees operational challenges from the retailers `perspective to implement the recent guidance document issued by CDSCO on safe disposal of expired and unused drugs.
B. Thirunavukkarasu, president, BDCDA said that from a retailer's perspective, the operational challenges related to the disposal of expired drugs can be significant. These challenges affect inventory management, compliance, profitability, and public health responsibilities.
First and foremost, we need clarity on strip cutting. Here there is a need for a standardized policy for reimbursement of partially sold strips. Second is the 30-day return timeline. This should align with the industry practice of 150 days for expired returns or provide a flexible period of 90–150 days. Third is the batch number mismatches. We see the need for common mismatches due to fragmented supply chains which must be resolved to avoid denied returns, Thirunavukkarasu told Pharmabiz.
Yet we laud the CDSCO for releasing the guidance document on the safe disposal of expired and unused drugs. We recognize this as a progressive step that addresses a long-standing need for structured and environmentally responsible pharmaceutical waste management, he added.
From the pharmacy trade fraternity, there is appreciation as it focuses particularly from a consumer safety and public health perspective. The inclusion of drug take-back programs and provisions for flushing certain high-risk medications demonstrates the government’s intent to reduce the risk of misuse and environmental pollution.
Viewing it from a patient perspective, the guidance empowers consumers with proper disposal methods for harmful drugs. However, implementation requires local awareness and active pharmacy participation.
Some of our suggested operational models via biomedical waste agencies would be that retailer raises an expired goods return invoice to the wholesaler. The Biomedical Waste Agency collects expired drugs from the retailer and acknowledges receipt, said Thirunavukkarasu.
In the case where the wholesaler issues a credit note and forwards a return invoice to CFA/manufacturer, the agency collects from wholesaler and provides acknowledgment for final reconciliation, he said.
Now there are key questions that need clarification. One is how should expired medicines under PCD (Propaganda Cum Distribution) pharma Franchise on a monopoly basis be handled when companies do not accept returns. The other is where high trade margins are cited, what would the disposal and return process for expired generics entail. Also on the likely disposal mechanisms for expired surgical products like gloves, syringes, stated the BDCDA president.
Thirunavukkarasu further said that digital & system-level recommendations are being put forth. These include the national single window system for universal brand coding, batch number registry accessible by all stakeholders, and use of blockchain technology for secure tracking across the supply chain. There are interlinked software systems for retailers, wholesalers, and CFAs to enable real-time exchange of purchase, expiry, and return data.
Among the key benefits of our suggestions are that whole process should ensures complete traceability and accountability, reduces disputes and operational bottlenecks, supports nationwide uniform practices and digital transformation besides protects environment and prevents expired stock re-circulation, said Thirunavukkarasu.
Now CDSCO is requested to facilitate a practical, unified, and digitally enabled system for managing expired and unused medicines across the country. Here BDCDA remains committed to collaborating with regulatory authorities for improving medicine safety, public health, and sustainable pharmaceutical practices, said Thirunavukkarasu.
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