Need clarity on disposal and return process for cut medicine strips and surgical products: Bangalore Chemists' Association
Welcoming the guidance document on safe disposal of unused and expired drugs released by the Central Drugs Standard Control Organisation (CDSCO) this week, the Bangalore District Chemists and Druggists' Association (BDCDA) has sought clarification on the disposal methods for expired cut strips of medicines and surgical products. Currently, there is no provision for the return and the disposal of these products.
The CDSCO's guidance document is aimed at addressing issues emerging from the careless disposal of unused or expired medicines and the hazards it creates in the environment and public health. The document is expected to help various stakeholders, including the general public, to dispose of expired or unused medicine in a safe manner, and is also an important move towards curbing the growth of antimicrobial resistance (AMR).
Rajeev Singh Raghuvanshi, Drugs Controller General (India), in a communication dated May 25 to the Drugs Controllers of all States and Union Territories, called on them to encourage the stakeholders concerned in their respective States to adopt the guidelines for safe disposal of expired/unused drugs which will be an important step in combating AMR in the country.
The guidance document analyses various methods, including landfill after encapsulation or inertisation of drugs, use of sewer, burning in open containers, medium temperature incineration, novel high temperature incineration, and chemical decomposition. Examining the existing rule position, it details the procedures to be followed by stakeholders for the disposal of such drugs at each level.
Need clarity
'Upon reviewing the guidance document, we have identified several areas that require clarification and necessary ratification to ensure the successful and practical implementation of the disposal framework,' said BDCDA president B. Thirunavukkarasu.
'We need clarity on the disposal and return process for cut strips of medicines, for Propaganda-cum-Distribution (PCD) medicines, expired generics where high-trade margins are cited, and expired surgical products such as gloves and syringes. Currently, these are disposed of just like any other trash in the dustbin,' Mr. Thirunavukkarasu said.
Elaborating on the operational challenges from a retailer's perspective, he said there is a need to align with the industry practice of 150 days for return of expired medicines presently followed owing to the MoU signed between National Trade body and the pharma companies or provide a flexible period of 60 to 90 days. 'Common batch number mismatches owing to fragmented supply chains must be resolved to avoid denial of returns,' he added.
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