The Union Health Ministry has published a draft notification proposing amendments to the Drugs Rules, mandating that imported drugs have a minimum residual shelf life of 12 months at the time of import. This replaces the current requirement of a minimum residual shelf life exceeding 60% of the total shelf life.
Key Details of the Proposal
The draft amendment, published for public consultation via a gazette notification on June 22, 2026, aims to ensure patients receive medicines with adequate usable shelf life while improving inventory utilisation across the pharmaceutical supply chain. The proposal applies to all imported drugs except biological products and radiopharmaceuticals, which will continue to follow the existing 60% residual shelf life rule due to their specialised nature and public health considerations.
Expected Benefits
According to ministry officials, the amendment is designed to provide sufficient time for distribution and consumption before expiry, thereby maintaining the availability of quality medicines. It is also expected to reduce avoidable wastage arising from restrictive residual shelf-life requirements, optimise supply management, lower costs, and strengthen the availability of essential medicines in the country.
The step would ensure that patients receive medicines with adequate usable shelf life and improve utilisation of pharmaceutical inventories across the supply chain.
By ensuring that imported drugs have a minimum remaining shelf life of 12 months upon entry into the country, the proposal provides sufficient time for distribution and consumption before expiry, thereby ensuring that patients continue to receive medicines with adequate usable shelf life, officials said.
