The Central Drugs Standard Control Organisation (CDSCO), under the Directorate General of Health Services, has released guidelines for the safe and proper disposal of expired and unused medicines and drugs. This initiative aims to protect public health, animal health, and the environment, while also addressing the growing concern of Anti-Microbial Resistance (AMR).
In a communication dated May 26, 2025, to all State and UT Drug Controllers, the Drugs Controller General (India) emphasized the critical importance of ensuring the quality, safety, and efficacy of drug products. Improper disposal of these products can lead to hazardous consequences, including water contamination and the emergence of drug resistance.
The guidelines, prepared following recommendations from the Drugs Consultative Committee (DCC) and the Drugs Technical Advisory Board (DTAB), provide best practices for various stakeholders, including manufacturers, wholesalers, retailers, hospitals, government agencies, and the general public.
Key Highlights of the Guidelines
The guidelines clearly define expired drugs (those past their label expiry date) and unused drugs (medications not used by the intended individual). This includes recalled products, unsealed products, cold chain damaged pharmaceuticals, loose tablets/capsules, and medications no longer needed due to improved health or changes in treatment.
The document outlines the detrimental effects of improper disposal, including environmental contamination, potential misuse by scavengers and children, reduced efficacy of expired drugs, and the risk of developing adverse drug reactions. Notably, it highlights the role of un-segregated drug disposal in the rise of AMR.
The guidelines detail various methods for disposal, ranging from landfill (with specific recommendations for open dumps vs. engineered landfills) to waste immobilization techniques like encapsulation and inertization. It also discusses the controlled use of sewers for certain liquid pharmaceuticals in small quantities. Importantly, it advises against burning pharmaceuticals in open containers due to the release of toxic pollutants. Novel high-temperature incineration and chemical decomposition are also mentioned as potential methods under specific conditions.
The guidelines reference existing rules under the Drugs and Cosmetics Act and Rules, 1945, regarding the storage and disposal of substandard and expired drugs at import, retail/wholesale, and manufacturing levels. It also aligns with the Biomedical Waste (Management and Handling) Rules, 2016.
The document provides a step-by-step procedure for the collection and disposal of expired/unused drugs at each level of the supply chain, including retailers (returning to supplier or manufacturer), wholesalers/distributors/stockists (accepting returns and returning to the next level or manufacturer), and manufacturers (accepting and disposing within six months of expiry). Specific record-keeping requirements are outlined for each stakeholder. Hospitals and government agencies are permitted to directly dispose of drugs as per Biomedical Waste Management Rules, 2016.
Recognizing the role of public disposal in environmental contamination, the guidelines suggest the establishment of “drug take back” sites by State Governments and local bodies. It also includes a “flush list” of specific medicines that may be especially harmful if misused and can be safely flushed down the sink or toilet.
The guidelines specify the use of yellow-colored non-chlorinated plastic bags or containers for collecting expired/unused drugs, with separate secure storage for cytotoxic, radioactive, and controlled substances. Transportation to bio-medical waste treatment facilities must adhere to labeling and vehicle requirements outlined in the Bio-Medical Waste (Management and Handling) Rules, 2016.
The document includes annexures detailing the records to be maintained by various stakeholders (retailers, wholesalers, hospitals, Govt. agencies, manufacturers) and provides a table outlining specific disposal methods for different categories of drugs, dosage forms, and packaging.
The CDSCO has urged all State and UT Drug Controllers to encourage concerned stakeholders in their respective jurisdictions to adopt these guidelines, emphasizing their importance in the national effort to combat Anti-Microbial Resistance and safeguard public and environmental health.
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