The Union Health Ministry on Friday proposed easing residual shelf-life norms for imported drugs, requiring them to have a minimum remaining shelf life of 12 months at the time of import instead of the current threshold of more than 60 per cent of total shelf life.
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 per cent 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.
