The Union Health Ministry has issued a draft notification proposing amendments to the Drugs Rules, under which imported drugs must have a minimum residual shelf life of 12 months at the time of import instead of the current threshold of more than 60% of total shelf life. The draft seeks to amend Rule 31 of the Drugs Rules, 1945.
The Ministry said the proposed amendment is aimed at improving efficiency in the pharmaceutical supply chain while ensuring the continued availability of quality medicines for patients.However, given their specialised nature and public health considerations, the existing requirement of at least 60 per cent residual shelf life will continue to apply to biological products and radiopharmaceuticals.
The Ministry said the amendment is also expected to improve the utilisation of pharmaceutical inventories across the supply chain by reducing avoidable wastage of medicines arising from restrictive residual shelf-life requirements. It clarified that the proposal applies only to the residual shelf-life requirement at the time of import of drugs.
The proposal, published as a draft notification for public consultation on June 22, aims to promote ease of doing business while ensuring patients continue to receive quality medicines with adequate usable shelf life.However, the existing requirement of a minimum residual shelf life of more than 60% will continue to apply to biological products and radiopharmaceuticals owing to their specialised nature and public health considerations.
The ministry said the amendment is expected to improve efficiency across the pharmaceutical supply chain by reducing wastage arising from restrictive residual shelf-life norms and enabling better inventory management.
By mandating a minimum remaining shelf life of 12 months at the time of import, the proposal would provide sufficient time for distribution and consumption before expiry, while helping optimise supply management, lower costs and strengthen the availability of essential medicines.
The ministry clarified that the proposed amendment relates only to the residual shelf-life requirement at the time of import and does not alter existing regulatory standards governing the quality, safety or efficacy of medicines under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.The draft notification has been released for stakeholder consultation, and the ministry has invited objections and suggestions before finalising the amendment.
Meanwhile, the Health and Family Welfare Ministry has notified amendments to the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011, to rationalise compliance requirements for food businesses. The amendments, notified through the Food Safety and Standards (Licensing and Registration of Food Businesses) Amendment Regulations, 2026, are aimed at improving the ease of doing business.
The Ministry said non-manufacturing food businesses, including retailers and other similar entities, have been exempted from certain compliance requirements. The move is expected to significantly reduce the compliance burden on food business operators, particularly small and medium enterprises, while maintaining robust food safety oversight in areas where such controls are essential.
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