The Ministry of Health and Family Welfare has notified the Drugs (Thirteenth Amendment) Rules, 2026, amending Rule 31 of the Drugs Rules, 1945. The amendment revises the residual shelf-life requirement for imported drugs by mandating a minimum of one-year residual shelf-life at the time of import while allowing biological drugs and radiopharmaceuticals to be imported with a minimum of sixty percent of their labelled shelf-life remaining.
The Ministry of Health and Family Welfare, Government of India, has issued Notification G.S.R. 951(E) dated 16 October 2026, introducing the Drugs (Thirteenth Amendment) Rules, 2026. The amendment modifies Rule 31 of the Drugs Rules, 1945 concerning the residual shelf-life requirements for imported drugs.
Under the amended provision, the licensing authority shall not permit the import of any drug that has less than one year of residual shelf-life remaining on the date of import. Recognizing the unique nature and limited shelf-life of biological products and radiopharmaceuticals, the notification provides a relaxation whereby such products may be imported if they retain at least sixty percent of their labelled shelf-life.
The amendment aims to rationalize import requirements, improve supply chain flexibility for specialized products, and ensure continued availability of critical biological and radiopharmaceutical medicines in India