India Proposes Shelf Life Revamp for Imported Drugs

The Indian Health Ministry has proposed amendments to the Drugs Rules, 1945, aiming to cut the residual shelf-life requirement for imported drugs from 60% to a minimum of 12 months. Exceptions will apply to biological products and radiopharmaceuticals. The proposal seeks to optimize pharmaceutical supply chains and reduce wastage.

The Union Ministry of Health and Family Welfare has proposed significant changes to Rule 31 of the Drugs Rules, 1945, aiming to rationalize the residual shelf-life requirements for imported pharmaceuticals. According to a press release, the draft amendment published via Gazette Notification G S R 505 (E) on 22nd June 2026, suggests reducing the minimum shelf life from over 60% to 12 months at the import stage.

While the proposed changes could streamline the pharmaceutical supply chain for most drugs, exceptions have been made for biological products and radiopharmaceuticals, due to their specialized nature and public health relevance. These categories will continue to adhere to the existing requirement of a shelf life exceeding 60%. The amendment is intended to enhance distribution efficiency and ensure drugs remain viable for patients.

Besides improving the supply chain, the reform will likely reduce wastage, lower costs, and bolster the availability of essential medicines. The ministry has clarified that this proposal only modifies the shelf-life terms for imports and does not impact existing regulations concerning the quality, safety, or efficacy of medications. Public feedback on this draft has been solicited by the ministry.