Government Proposes Simpler Shelf-Life Norms for Imported Medicines to Reduce Wastage
The Union Health Ministry has proposed replacing the current complex shelf-life requirement for imported medicines with a simpler rule: drugs must have at least one year of shelf life remaining at the time of entry into India. The draft notification, amending Rule 31 of the Drugs Rules, 1945, has been released for public comments.
Under the existing rule, imported medicines must have more than 60% of their approved shelf life left at the time of import. This percentage varies depending on the total shelf life of each drug, leading to different requirements for different medicines. The proposed change would apply a uniform standard of 12 months to most imported medicines, simplifying compliance.
The Health Ministry expects the amendment to benefit a range of medicines, including certain specialised cancer therapies, treatments for rare diseases, and other high-value drugs. By reducing avoidable wastage, the new rule could improve inventory management, lower logistics costs, and strengthen the availability of essential medicines in the country.
The proposal clarifies that the change only affects the shelf-life requirement at the time of import and does not alter any quality, safety, or efficacy standards. The ministry has invited public feedback on the draft notification before finalising the amendment.
