The Union Health Ministry has issued a draft notification proposing amendments to the Drugs Rules, under which imported drugs must have a minimum residual shelf life of 12 months at the time of import. The draft seeks to amend Rule 31 of the Drugs Rules, 1945.

The Ministry said the proposed amendment is aimed at improving efficiency in the pharmaceutical supply chain while ensuring the continued availability of quality medicines for patients.

However, given their specialised nature and public health considerations, the existing requirement of at least 60 per cent residual shelf life will continue to apply to biological products and radiopharmaceuticals.

The Ministry said the amendment is also expected to improve the utilisation of pharmaceutical inventories across the supply chain by reducing avoidable wastage of medicines arising from restrictive residual shelf-life requirements. It clarified that the proposal applies only to the residual shelf-life requirement at the time of import of drugs.