Government bars import of medicines with less than one year of remaining shelf life

The Central government has prohibited the import of medicines with less than one year of remaining shelf life, introducing a stricter requirement intended to ensure that imported drugs have adequate time for distribution and use before expiry.

The Ministry of Health and Family Welfare notified the Drugs (Thirteenth Amendment) Rules, 2026, amending Rule 31 of the Drugs Rules, 1945. The amendment came into effect on October 28, following its publication in the Official Gazette.

Under the revised provision, the licensing authority cannot permit the import of a drug if its residual shelf life is less than one year on the date of import. The requirement applies to medicines covered by the general rule, while biological drugs and radiopharmaceuticals have been given a separate provision.

Biological drugs, radiopharmaceuticals get separate provision

The amended rules allow biological drugs and radiopharmaceuticals to be imported when 60 per cent of their labelled shelf life is available. The provision recognises the specialised nature of these products while retaining a minimum residual shelf-life requirement.

The government had earlier proposed the amendment in a draft notification published on June 22, inviting objections and suggestions from stakeholders within 30 days of the Gazette copies becoming available to the public.

According to the ministry, the final amendment was issued after consultation with the Drugs Technical Advisory Board and consideration of the feedback received on the draft rules.

Amendment aims to improve medicine supply management

The revised rule changes the residual shelf-life requirement applicable to imported medicines. The government had said the proposed change was intended to improve pharmaceutical supply-chain efficiency, reduce avoidable wastage and support the availability of quality medicines.

The ministry had also clarified during the consultation process that the amendment concerned only the remaining shelf life required at the time of import. Other regulatory requirements governing the quality, safety and efficacy of medicines under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, remain separate.

The new provision is now in force following publication of the amendment in the Official Gazette.