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The Central Drugs Standard Control Organisation has recently released the guidance document for safe disposal of unused and expired medicines. Definitely, it is an important step by the CDSCO in combating the growing menace of Anti-Microbial Resistance (AMR) in the country. The document is expected to help various stakeholders including the general public to dispose of expired or unused medicine in a safe manner. The guidance document details the procedures to be followed by stakeholders for the disposal of such drugs at each level. The manufacturers, wholesalers or distributors or stockists, and the retailers have their roles to play in disposing the unused or expired drugs, with timelines stipulated at each level for completing the procedure, as per the Biomedical Waste (Management and Handling) Rules, 2016. Besides, the procedures to be followed by the government and private hospitals, government agencies, and the samples drawn by the drugs inspectors from time to time for testing have also been detailed. The guidance document also details the procedures for collection, storage and transportation of unused and expired drugs, and most importantly disposal of expired or unused medicines by the general public. This includes suggestions to the State governments to establish a methodology and facility for collection and disposal of these drugs. Initially state drugs control departments and concerned chemists and druggists’ Associations may jointly launch ‘Drug take back’ site or program at designate locations, where people can drop expired or unused drugs from their homes and that can be disposed finally by such Associations under intimation to concerned state drug licensing authority with the help of registered/licensed external agencies as registered under Biomedical Waste Management Rules, 2016.
Certainly, it is a timely and much-needed step by the CDSCO that aligns with the global best practices for environmental safety, public health, and pharmaceutical responsibility. It will address the issues emerging from careless disposal of unused or expired medicines and the health hazards it creates in the environment and on public health. In the absence of a dedicated set of rules on timely recall of the date expired and damaged drugs, the issue of safe disposal of these drugs still remains an untangled knot in the country. As the Drugs & Cosmetics Act is rather vague on this issue, the pharma industry and the pharma trade are frequently engaged in passing the buck and are in a real dilemma on how to handle the issue of increasing stocks of date expired drugs which continue to get accumulated in their companies or at trade outlets. This issue is all the more relevant now as the domestic pharma industry is growing at a fast pace and is presently valued at Rs. 1.2 lakh crore. Associated with this growth comes a key responsibility of disposing of medicines and pharmaceutical wastes generated at the level of the consumers, hospitals, retail chemists, wholesale distributors and manufacturers. Definitely, there was a need for some regulations to handle and manage the pharmaceutical waste generated in manufacturing sites, drug stores, hospitals, premises of wholesalers, distributors and in households. In fact, the country needed a separate Act for Pharmaceutical Waste Management like Solid Waste Management Act, Plastic Waste Management Act, Biomedical Waste Management Act, Hazardous Waste Management Act, etc. The situation is alarming because if the retailers and common people destroy and dispose of these hazardous chemicals unscientifically, it may cause serious diseases and allergic reactions in humans and animals. Under this backdrop, the CDSCO has taken a laudable initiative.
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