India has barred the import of medicines that have less than one year of shelf life left when they arrive in the country, under a Health Ministry notification that took effect on its publication in the Official Gazette on October 28, 2026. The change comes through the Drugs (Thirteenth Amendment) Rules, 2026, which amend Rule 31 of the Drugs Rules, 1945.

Source: ANI via Devdiscourse

"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 of Health and Family Welfare said in the Gazette notification. In practice, every imported medicine covered by the general rule must now reach India with at least twelve months of usable life remaining.

A separate provision applies to biological drugs and radiopharmaceuticals. For those products, 60 per cent of the shelf life printed on the label may be allowed, the notification states: "in case of biological drugs and Radiopharmaceuticals, Sixty percent of the labelled shelf-life may be allowed."

Source: ANI via New Kerala

1 yearMinimum residual shelf life now required for most imported medicines
60%Labelled shelf life allowed for biological drugs and radiopharmaceuticals
28 Oct 2026Date the amended rules took effect on Gazette publication

The amendment was finalised after consultation with the Drugs Technical Advisory Board and after considering public feedback on a draft published on June 22, 2026. "Objections and suggestions received from the public on the said draft rules have been considered by the Central Government," the notification stated.

When the draft was issued in June, the Health Ministry said through the Press Information Bureau that replacing the earlier norm of more than 60 per cent residual shelf life with a flat twelve-month floor was meant to rationalise import rules, cut avoidable wastage of medicines and give imported drugs enough time for distribution and use before expiry, while keeping the stricter percentage rule for biological products and radiopharmaceuticals because of their specialised nature.

Source: Press Information Bureau

For importers, distributors and pharmacies, the immediate effect is at the port and the licensing desk: a consignment that lands with less than a year left on its label can no longer be cleared for import under the general rule, whatever its remaining percentage of total shelf life.