The amendment, notified as the Drugs (Thirteenth Amendment) Rules, 2026, came into force on the date of its publication in the Official Gazette.
New Delhi: The Centre has tightened regulations governing the import of medicines into India by introducing a minimum residual shelf-life requirement for imported drugs. The move aims to ensure that medicines entering the country have sufficient usable life remaining before their expiry.
The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, stipulating that licensing authorities cannot permit the import of any drug with less than one year of residual shelf life on the date of import.
However, the amendment provides a separate provision for biological drugs and radiopharmaceuticals, permitting their import if at least 60% of their labelled shelf life remains. The notification does not prescribe a separate fixed minimum period for these categories.
The amendment, notified as the Drugs (Thirteenth Amendment) Rules, 2026, came into force on the date of its publication in the Official Gazette.
The revised provision replaces the second proviso to Rule 31 of the Drugs Rules, 1945. Under the new regulations, the remaining shelf life of a medicine will be a key consideration for licensing authorities when deciding whether to permit its import into India.
The mandatory minimum period is expected to help reduce the risk of imported medicines reaching distributors, healthcare facilities and patients with insufficient time remaining before their expiry dates.
The amendment follows a consultation process initiated by the Centre in June 2026. The government published a draft of the proposed changes through notification G.S.R. 505(E), dated June 22, 2026, inviting objections and suggestions from stakeholders likely to be affected by the proposal.
The Gazette containing the draft notification was made available to the public on June 25, 2026. After considering the objections and suggestions received, the government finalised the amendment in consultation with the Drugs Technical Advisory Board.
The notification was issued under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, which empower the government to frame rules governing drugs.
