The Union Health Ministry has released a draft notification proposing amendments to existing drug import rules, suggesting that imported medicines must have a minimum residual shelf life of 12 months at the time of entry into India.
The proposed change seeks to ensure that patients receive medicines with sufficient usable shelf life and to improve efficiency across the pharmaceutical supply chain.
At present, imported drugs are required to have more than 60 per cent of their shelf life remaining. The new draft proposes replacing this condition with a fixed minimum of 12 months. However, biological products and radiopharmaceuticals will continue to follow the existing rule due to their specialised nature and public health considerations.
Officials said the proposed amendment aims to reduce wastage of medicines, enhance inventory management, and ensure better availability of essential drugs across the country. It is also expected to lower costs and improve overall supply chain efficiency.
The ministry clarified that the proposal only concerns residual shelf-life requirements at the time of import and does not change existing regulations related to the quality, safety, or efficacy of medicines under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.
Stakeholders have been invited to submit objections and suggestions on the draft notification as part of the public consultation process.
