Health Ministry bans import of drugs with less than one-year residual shelf life

PTC News Desk: The Ministry of Health and Family Welfare has amended Rule 31 of the Drugs Rules, 1945, to reduce medicine wastage. Under the new rule, medicines with less than one year of shelf life remaining cannot be imported.

Biological medicines and radiopharmaceuticals are an exception. They can be imported if at least 60% of their shelf life remains.

The amendment was notified under the Drugs (Thirteenth Amendment) Rules, 2026, through Gazette Notification G.S.R. 951(E), dated October 16, 2026. It came into effect on October 28, when it was published in the Official Gazette.

"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," the ministry said in the Gazette notification.

"In case of biological drugs and Radiopharmaceuticals, sixty percent of the labelled shelf-life may be allowed," the notification added.

The government had published a draft of the amendment on June 22, 2026, and invited public objections and suggestions within 30 days. The notification said the government had considered the responses received.

Why the change matters ?

The new rules are intended to prevent near-expiry medicines from entering or building up in India’s supply chain.

• Less medicine waste: The shelf-life requirement gives medicines more time to move through the supply chain before they expire.

• Fewer import delays: Importers will need to ensure shipments meet the shelf-life limits when they arrive.

• Continued access to certain medicines: The 60% requirement provides a separate rule for biological medicines and radiopharmaceuticals, which may have shorter shelf lives.

The amendment aims to make import requirements clearer, protect medicine quality and reduce the accumulation of products close to expiry.