Draft Rule Seeks New Shelf-Life Norm for Imported Drugs

The Health Ministry invited public comments on a draft amendment to rationalise residual shelf-life requirements for imported drugs. The proposal seeks to replace the over 60 percent rule with a minimum 12-month shelf-life at the time of import.

The draft amendment to Rule 31 of the Drugs Rules, 1945 is aimed at improving efficiency in the pharmaceutical supply chain while ensuring adequate usable life for medicines. Biological products and radiopharmaceuticals have been kept outside the proposed relaxation and will continue under the older rule due to their specialised nature. The government stated that the proposal would reduce avoidable wastage, improve inventory use and strengthen medicine availability. It clarified that the amendment affects only residual shelf-life requirements and does not dilute quality, safety or efficacy standards.