India’s proposed Drugs Rules, 1945 amendments introducing an acknowledgement-based system for importing drugs for testing and a 12-month residual shelf-life requirement.

Government Proposes Major Reforms to Drugs Rules, 1945: Simpler Import Procedures and Revised Shelf-Life Requirements

The Ministry of Health and Family Welfare has proposed significant amendments to the Drugs Rules, 1945 aimed at simplifying the import of drugs for analytical and non-clinical testing while revising residual shelf-life requirements for imported medicines. The proposed reforms are expected to enhance ease of doing business, reduce compliance burden, promote pharmaceutical R&D, and improve supply chain efficiency without compromising patient safety.
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