The government is considering altering the shelf-life requirements for imported drugs to enhance supply chain efficiency and facilitate business operations in the pharmaceutical sector. Currently, drugs must have over 60% of their shelf life remaining upon import, but a new proposal suggests a minimum shelf life of 12 months at the time of entry into the country.
The Ministry of Health and Family Welfare has introduced a draft notification seeking feedback on amendments to Rule 31 of the Drugs Rules, 1945. The proposed change aims to streamline import regulations, ensuring that patients receive medicines with a reasonable shelf life for consumption.
While the new norm would apply to most imported drugs, biological products, and radiopharmaceuticals are exempt due to their specialized nature and importance in public health. This adjustment is designed to minimize medicine wastage, enhance inventory management, and reduce supply chain expenses, ultimately bolstering the availability of essential medicines nationwide.
The government emphasizes that the proposed modification solely pertains to the residual shelf-life requirement during import and does not impact other regulatory standards governing medicine quality, safety, or efficacy under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
