The Union Ministry of Health and Family Welfare (MoHFW) has invited public comments on a draft amendment to the Drugs Rules, 1945, proposing to rationalise the residual shelf-life requirement for imported medicines in a move aimed at improving supply chain efficiency and promoting ease of doing business in the pharmaceutical sector.
The proposed amendment, published through Gazette Notification G.S.R. 505(E) dated June 22, 2026, seeks to amend Rule 31 of the Drugs Rules, 1945. Under the revised framework, imported drugs would be required to have a minimum residual shelf life of 12 months at the time of import, replacing the existing requirement that medicines must have more than 60 per cent of their shelf life remaining when they enter the country.
However, the Ministry has proposed retaining the current 60 per cent residual shelf-life requirement for biological products and radiopharmaceuticals, citing their specialised nature and public health considerations.
According to the Health Ministry, the proposed amendment is designed to facilitate greater efficiency in the pharmaceutical supply chain while ensuring that patients continue to receive quality medicines with sufficient usable shelf life.
The Ministry said that requiring imported medicines to have at least one year of remaining shelf life at the time of import would provide adequate time for distribution and consumption before expiry, while reducing unnecessary wastage caused by the existing residual shelf-life norms.
The revised rule will help optimise pharmaceutical inventory management, reduce supply chain costs and strengthen the availability of essential medicines across the country.
Clarifying the scope of the proposal, the Ministry said that the amendment is limited to the residual shelf-life requirement at the time of import and does not affect 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 draft notification has been placed in the public domain for stakeholder consultation. The Ministry has invited objections and suggestions from industry stakeholders, healthcare professionals and the public before finalising the amendment.
Comments may be submitted to the Under Secretary (Drugs), Ministry of Health and Family Welfare, at Kartavya Bhawan-1, New Delhi, or through email (drugsdiv-mohfw@gov.in) within the prescribed consultation period.
