CDSCO Issues Comprehensive Guidelines for Disposal of Expired and Unused Drugs

CDSCO Issues Comprehensive Guidelines for Disposal of Expired and Unused Drugs

CDSCO mandates that manufacturers take responsibility for the disposal of expired or unused drugs, including returns from wholesalers, distributors, and retailers, within six months of the expiry date. These must be disposed of either at the manufacturing site or through vendors approved by the Pollution Control Board, in line with the Bio-Medical Waste Management Rules.

“No expired drugs should remain in the supply chain beyond six months,” the CDSCO stated, emphasizing the importance of maintaining disposal records in the prescribed format.

Retailers are required to return expired stock to their supplier or manufacturer within 30 days of expiry. In instances where the supplier is inaccessible, the retailer may directly dispose of the drugs according to biomedical waste norms, ensuring all activities are properly documented.

Obligations for Wholesalers and Distributors

Wholesalers, distributors, and stockists must accept expired or unused products from those they supply and are accountable for their segregation, handling, and return. A tiered return timeline is prescribed: 30 days for each level in the supply chain, ensuring timely movement of expired drugs back to the manufacturer or authorized disposal agency.

If a wholesaler is an authorized agent of the manufacturer and has permission to manage disposal, they may do so under the relevant waste management rules, keeping both the manufacturer informed and regulatory records updated.

Hospital and Government Agency Protocols

Government and private hospitals, along with public agencies, are also permitted to dispose of expired or unused medicines following the Biomedical Waste Management Rules, provided proper records and disposal certificates are maintained. If they opt to return these drugs to the supplier, they must do so within 30 days of expiry.

Environmental and Public Health Objectives

The guidance document, developed by a sub-committee under the Drugs Consultative Committee and endorsed by the Drugs Technical Advisory Board, is intended to standardize and streamline drug disposal practices across the country.

By promoting environmentally sound disposal methods and emphasizing strict compliance with legal requirements, the CDSCO aims to reduce the environmental degradation due to improper disposal of pharmaceutical waste and curb public health risks, including the threat of antimicrobial resistance.

“This document serves as a critical step in ensuring expired and unused drugs are managed responsibly, with the dual goal of environmental protection and public health safety,” the regulator stated.

Click Here to Access the full guidance document here

Tags:  CDSCO,  Expired and Unused Drugs, Guidelines