New Delhi: The Indian government has introduced a minimum residual shelf-life requirement for imported medicines, barring the import of drugs with less than one year of shelf life remaining on the date of import.
The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, directing licensing authorities not to permit the import of medicines that do not meet the prescribed threshold.
Under the revised rules, biological drugs and radiopharmaceuticals are subject to a separate requirement, allowing their import if at least 60% of their labelled shelf life remains. No fixed minimum period has been specified for these categories.
Notified as the Drugs (Thirteenth Amendment) Rules, 2026, the amendment came into effect 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, making residual shelf life a mandatory consideration for licensing authorities when assessing applications for drug imports.
The requirement is intended to ensure that imported medicines have sufficient usable shelf life when they enter the Indian supply chain, reducing the risk of products reaching distributors, healthcare facilities and patients close to their expiry dates.
The amendment follows a consultation process initiated in June 2026, when the government issued draft notification G.S.R. 505(E) on June 22, inviting objections and suggestions from stakeholders affected by the proposed changes. The Gazette containing the draft was made available to the public on June 25.
After considering the feedback 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 Central Government to frame rules regulating drugs.
