Indian pharma calls for guidance document on disposal of expiry dated drugs

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The Union government will need to formulate a guidance document on disposal of unused and expiry dated drugs as there is a pressing need for a system of collection, segregation and disposal of pharmaceutical products at the domestic as well as specific stages, said Atul Nasa, Deputy Drugs Controller, Controlling Authority& Licensing Authority, Delhi Drugs Control Department.

The collection and safe disposal system for unused and expired medicines must be developed and implemented at the local government level, he added.

Further there should be monitoring of large scale disposal of unused pharmaceuticals, Nasa said at an IDMA webinar on ‘Disposal of Expired Medicines,’ on the occasion of Swatchhata Pakhwada Fortnight Programme being conducted from September 1 to 15, 2020.

Development of a nationwide awareness on the ill-effects of unsafe and inappropriate disposal mechanism of drugs needs to be addressed. Moreover, consumers should be responsible to reduce unnecessary medicine purchase or consumption. The need of the hour is to dispose safe and prevent abuse, noted Nasa.

Dr. Rubina Bose, Deputy Drugs Controller (India), CDSCO West Zone, Mumbai, said, “India had taken up this initiative and brought about guidelines in 2005. There are international norms on drugs that could be flushed to prevent accidental consumption. It is time for India to have a ‘drug take back’ programme for the industry.”

In a telecon post the webinar, Daara B Patel, secretary general, IDMA told Pharmabiz that there is awareness among consumers on medicine disposal. During the pandemic lockdown, households had stocked up on medicines and are now apprehensive about how to dispose of unused drugs. Therefore, there is need for a guidance for consumers.

NGOs and like-minded individuals have plans to source large, tamper-proof boxes sponsored by pharma companies or other organisations. These will be placed across all healthcare centres and pharmacy outlets enabling users to discard unused and expiry drugs. These can be dispatched to any pharma distributor who could in turn send them to drug manufacturers. IDMA members are already toying with this concept and will support this initiative, said Patel.

Kaushik Deasi, pharma consultant who was not part of the event noted that there is no specific guidance in the D&C Act on handling of expiry dated drugs, except that companies normally keep the expiry dated products in controlled temperature for year as a retention sample and then destroy it. In order to bring in a system for disposal of such drugs, pharma companies have drafted their own internal processes, he added.

Currently, only WHO has issued guidelines to handle expiry drugs during any epidemic where large quantity of medicines are procured by the government. It has highlighted that drugs will have to be incinerated ensuring no impact on environment, humans, animals and contamination of soil. But now, COVID-19 is a pandemic. There is definitely a need for WHO to provide a global guidance on the management of unused and date expiry drugs. Often, poor drug storage practices lead to its spoilage and they require to be discarded, said Desai.

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