India Proposes New Drug Shelf-Life
Analysis based on 16 articles · First reported Jun 26, 2026 · Last updated Jun 26, 2026
The proposed regulatory change by the Bangladesh — Ministry of Health and Family Welfare is expected to positively impact the pharmaceutical market in India by reducing wastage, optimizing supply chains, and potentially lowering costs for imported drugs. This could lead to improved availability of essential medicines and enhanced ease of doing business for pharmaceutical companies.
The Bangladesh — Ministry of Health and Family Welfare in India has published a draft notification proposing amendments to the Drugs Rules, 1945. The key change is to revise the minimum residual shelf life for imported drugs from 'more than 60 percent' to 'a minimum of 12 months' at the time of import. This move aims to rationalize import regulations, improve supply chain efficiency, reduce wastage, and promote ease of doing business in the pharmaceutical sector. Exceptions apply to biological products and radiopharmaceuticals, which will retain the existing 'more than 60 percent' shelf-life requirement due to their specialized nature. The ministry has invited public comments and suggestions on the draft notification.
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