New Delhi, June 27 -- The Union ministry of health and family welfare has proposed revising the residual shelf-life requirement for imported drugs to ensure medicines entering India have a longer usable shelf life while easing regulatory requirements for the pharmaceutical sector. A draft notification published by the ministry proposes amendments to Rule 31 of the Drugs Rules, 1945, to rationalise the residual shelf-life requirement for imported drugs and promote ease of doing business in the pharmaceutical sector. Under the existing Drugs and Cosmetics Rules, 1945, a drug cannot be imported or distributed in India unless it has more than 60% of its usable shelf life remaining. According to the health ministry, the draft amendment, published for public consultation through Gazette Notification G S R 505 (E) dated June 22, 2026, proposes replacing the existing requirement of a minimum residual shelf life of more than 60% with a minimum residual shelf life of 12 months at the time of import. However, owing to their specialised nature and public health considerations, the existing requirement of a minimum residual shelf life of more than 60% will continue to apply to biological products. It will also include drugs such as radiopharmaceuticals, the notification said. The proposed changes were made following detailed consultations with the Drugs Technical Advisory Board. According to the health ministry, the amendment seeks to improve efficiency in the pharmaceutical supply chain while ensuring the availability of quality medicines for patients. By requiring imported drugs to 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, ensuring patients continue to receive medicines with adequate usable shelf life. The amendment is also expected to improve utilisation of pharmaceutical inventories across the supply chain by reducing avoidable wastage arising from restrictive residual shelf-life requirements. This, in turn, is expected to optimise supply management, reduce costs and strengthen the availability of essential medicines in the country, the ministry said. The ministry clarified that the proposed amendment pertains only to the residual shelf-life requirement applicable at the time of import of the drugs. It does not alter any other regulatory requirements relating to the quality, safety or efficacy of medicines under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945. The draft notification has been placed in the public domain to invite objections and suggestions from stakeholders. After which the final rules related to the matter will be notified in the Gazette. "...is hereby published for information of all persons likely to be affected thereby, and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public...," the notification said. Interested stakeholders can submit comments to the under secretary (drugs) through email at drugsdiv-mohfw@gov.in....