MEDICAL WASTE MANAGEMENT

The Bangalore District Chemists and Druggists Association has recently expressed concern over the improper disposal of expired medicines and medical waste. The Association has rightly said that most people associate environmental protection with planting trees, reducing plastic waste, and keeping our surroundings clean. While these are important, expired medicines, discarded syringes, medical packaging, and pharmaceutical waste can contaminate soil, water bodies, and ecosystems if not disposed of responsibly. These pollutants can harm wildlife, contribute to environmental degradation, and pose risks to public health. Certainly, every expired medicine disposed of safely is a step towards protecting our environment, our communities, and future generations. 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 over 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. 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.

Definitely, Indian pharma needs a regulatory surveillance in place to monitor the disposal of unused and date expired drugs. Currently, in the absence of any rules under the Drugs & Cosmetics Rules, disposal is guided by the Biomedical Waste Management Rules under State Pollution Control Board (SPCB) norms. Rule 65(17) of D&C Rules only states about not to sell such drugs and to keep aside with proper labelling till its disposal, but does not provide any procedure for disposal of such drugs. It is true that last year the CDSCO had released a guidance document for safe disposal of unused and expired medicines. Certainly, it was 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. But the issue is far from over. There is a dire need for some exclusive 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, Bio-medical Waste Management Act and Hazardous Waste Management Act.