Published Nov 02, 2026 | 10:17 AM ⚊ Updated Nov 02, 2026 | 10:17 AM
Union Ministry of Health and Family Welfare has tightened shelf-life requirements for imported medicines
Synopsis: The Centre has barred the import of medicines with less than one year of shelf life remaining, tightening requirements under the Drugs Rules, 1945. Biological drugs and radiopharmaceuticals may receive an exemption, with licensing authorities allowed to consider imports retaining 60% of their labelled shelf life.
The Union Ministry of Health and Family Welfare has tightened shelf-life requirements for imported medicines, prohibiting licensing authorities from allowing the import of drugs with less than one year of residual shelf life on the date of import.
However, biological drugs and radiopharmaceuticals may be allowed to enter the country with 60 percent of their labelled shelf life remaining, subject to the licensing authority’s approval.
The changes were notified through the Drugs (Thirteenth Amendment) Rules, 2026, published in the Gazette of India on 28 October.
The amended provision states: “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 and in case of biological drugs and Radiopharmaceuticals, Sixty percent of the labelled shelf-life may be allowed.”
This establishes a minimum 12-month residual shelf-life requirement for imported drugs. In other words, medicines arriving in India must have at least one year before their expiry date.
The amendment, however, treats biological drugs and radiopharmaceuticals differently. For these categories, the notification states that 60 percent of the labelled shelf life “may be allowed”.
The wording does not make the relaxation automatic. Instead, it leaves the decision with the licensing authority, which can decide whether to permit imports meeting the 60 percent threshold. The notification does not specify the criteria authorities must follow while exercising this discretion.
The amendment also does not provide a separate transition period for consignments already in transit or imports initiated before its publication.
The government first proposed the changes through notification G.S.R. 505(E), dated 22 June 2026, inviting objections and suggestions from people likely to be affected by the proposed amendment.
The notification stated that objections and suggestions could be submitted “within a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public”.
The Gazette copies became publicly available on 25 June 2026. The final notification records that objections and suggestions received from the public “have been considered by the Central Government” before the amendment was notified.
The Centre framed the amendment under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, after consulting the Drugs Technical Advisory Board.
The final notification, numbered G.S.R. 951(E), was dated 16 October 2026 and published in the Gazette of India, Extraordinary, on 28 October. It was signed by Pushpendra Rajput, Joint Secretary to the Government of India. The amendment came into force on the date of its publication in the Official Gazette.
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(Edited by Sumavarsha)
