India’s Union Ministry of Health and Family Welfare has invited public comments on a draft amendment to the Drugs Rules, 1945, proposing to rationalise the residual shelf-life requirement for imported drugs as part of efforts to improve ease of doing business while ensuring the continued availability of quality medicines.
The draft notification, published through Gazette Notification of June 22, 2026, proposes reducing the existing requirement of a minimum residual shelf life of more than 60% at the time of import to a minimum residual shelf life of 12 months.
Biological products exempted
The ministry has proposed retaining the existing requirement of a minimum residual shelf life of more than 60% for biological products and radiopharmaceuticals, considering their specialised nature and public health significance.
According to the ministry, the proposed amendment seeks to improve efficiency across the pharmaceutical supply chain while ensuring that patients continue to receive medicines with adequate usable shelf life.
Aims to reduce wastage
The ministry said requiring imported drugs to have at least 12 months of remaining shelf life at the time of import would provide sufficient time for distribution and consumption before expiry.
The proposed change is also expected to improve inventory utilisation by reducing avoidable wastage arising from restrictive residual shelf-life requirements. This, in turn, could optimise supply chain management, lower costs and strengthen the availability of essential medicines across the country.
No change in quality standards
The ministry clarified that the proposed amendment relates only to the residual shelf-life requirement applicable at the time of import.
It does not alter any 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 before the amendment is finalised.