New Delhi, Jun 26 : The Union Health Ministry has proposed amending the Drugs Rules to mandate a minimum residual shelf life of 12 months for imported drugs at the time of their entry into India, aiming to improve medicine availability and reduce wastage across the pharmaceutical supply chain.
The draft notification, published for public consultation on June 22, seeks to replace the existing requirement of a residual shelf life of more than 60 per cent with a fixed minimum of one year for imported medicines.
However, the ministry clarified that the current requirement of a residual shelf life of more than 60 per cent will continue to apply to biological products and radiopharmaceuticals due to their specialised nature and public health considerations.
According to the ministry, the proposed amendment is intended to ensure that patients receive medicines with sufficient usable shelf life while allowing more efficient inventory management and distribution of pharmaceutical products.
Officials said the revised norm would provide adequate time for imported medicines to be distributed and consumed before their expiry, helping reduce avoidable wastage, optimise supply management, lower costs, and strengthen the availability of essential medicines across the country.
The ministry also clarified that the proposed amendment relates only to the residual shelf-life requirement at the time of import and does not affect existing regulatory standards concerning 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 public consultation, and the ministry has invited objections and suggestions from stakeholders before finalising the amendment.
