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THE DISPOSAL POLICY

Ramesh Shankar
Wednesday, November 20, 2024, 08:00 Hrs  [IST]

The Department of Pharmaceuticals (DoP) is in the process of framing a ‘Disposal Policy’ for removing the unused and date-expired drugs from the sale premises and also from the households. For this, a separate committee has been formed by the DoP, in which the Kerala drug controller is the only member representing state regulators. The Kerala drug controller’s inclusion in the committee is quite understandable as it was the then Kerala drug controller, Dr. Revi Menon, who started a novel project in 2018 to tackle the unsafe disposal of expired and unused drugs from retail shops and houses, in association with the All Kerala Chemists and Druggists Association. Together they launched the ‘Program on Removal of Unused Drugs’ or PROUD which is still in operation in Thiruvananthapuram district in Kerala. As part of the project, drug collection boxes are kept at selected retail shops to facilitate people to drop the expired or unused medicines from their houses. The shops can also dump their unsold and expired drugs into the drug collection boxes. The department will collect the boxes and send them to an agency for destroying them in incinerators. DoP’s efforts to frame a ‘Disposal Policy’ is a right step as unscientific disposal of expired, leftover, substandard, spurious and adulterated medicines is one of the most significant factors for antimicrobial resistance among animals and human beings. The DoP’s initiative in this regard is a timely move as in the wake of the rising antimicrobial resistance worldwide, the World Health Organisation has also called for developing policies for safe disposal of expired or unused medicines, especially antibiotics. Several studies have shown that antibiotic residues and antibiotic resistance lead to serious environmental and health risks.

Definitely, there is 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, Bio-medical 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. This rather chaotic situation prevailing in the country at present calls for the need for a proper drug waste management system. 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. According to an industry estimate, the quantum of date expired drugs ranges between 1.5 to 2 per cent of the total drug market which in absolute terms amount to a huge amount of waste. Under this background, the DoP’s move to frame a Disposal Policy is laudable.

 

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