Govt Proposes 12-Month Residual Shelf Life for Imported Drugs

New Delhi, Jun 26: The Union Health Ministry has issued a draft notification proposing that imported drugs should have a minimum residual shelf life of 12 months at the time of import, a move aimed at ensuring patients receive medicines with adequate usable shelf life while improving pharmaceutical inventory management across the supply chain.

The draft amendment, published for public consultation through a gazette notification dated June 22, proposes replacing the existing requirement that imported drugs must have more than 60 per cent residual shelf life with a fixed minimum residual shelf life of 12 months at the time of import.

However, the ministry clarified that the current requirement of more than 60 per cent residual shelf life will continue for biological products and radiopharmaceuticals in view of their specialised nature and public health considerations.

According to the ministry, the proposed amendment is intended to improve efficiency in the pharmaceutical supply chain without compromising the availability of quality medicines. By ensuring imported drugs have at least 12 months of remaining shelf life upon entry into the country, the proposal provides sufficient time for their distribution and consumption before expiry.

Officials said the amendment would also reduce avoidable wastage of medicines caused by restrictive residual shelf-life norms, helping optimise supply management, lower costs and strengthen the availability of essential medicines across the country.

The ministry emphasised that the proposed amendment relates only to the residual shelf-life requirement applicable at the time of import and does not alter any existing regulatory provisions governing the quality, safety or efficacy of medicines under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.

The ministry has invited objections and suggestions from stakeholders on the draft notification. (Agencies)