Govt tightens rules for importing medicines, sets minimum shelf-life requirement

The amendment is aimed at ensuring that medicines entering the Indian market have an adequate shelf life remaining | Photo Credit: REUTERS

The Union Health Ministry has tightened rules for importing medicines into India, mandating that drugs must have at least one year of shelf life remaining at the time of import. However, the requirement will be different for biological drugs and radiopharmaceuticals, for which at least 60 per cent of their labelled shelf life must remain.

In a notification, the Ministry of Health and Family Welfare amended Rule 31 of the Drugs Rules, 1945, stating that the licensing authority “shall not allow the import of any drug having less than one year residual shelf-life period as on the date of import”.

For biological drugs and radiopharmaceuticals, the government has provided a separate threshold, allowing imports where “Sixty percent of the labelled shelf-life may be allowed”.

Avoiding Wastage

The amendment is aimed at ensuring that medicines entering the Indian market have an adequate shelf life remaining, reducing the possibility of drugs nearing expiry being imported and subsequently entering the supply chain.

The amendment is also expected to improve utilisation of pharmaceutical inventories across the supply chain by reducing avoidable wastage of medicines arising from restrictive residual shelf-life requirements. This, in turn, is expected to optimise supply management, reduce costs, and strengthen the availability of essential medicines in the country.

The government had earlier sought objections and suggestions from stakeholders. The government said the objections and suggestions received from the public “have been considered by the Central Government” before finalising the rules.

Published on October 30, 2026