New Delhi: The Union Health Ministry has amended the Drugs Rules, 1945, setting a one-year residual shelf-life requirement in the substituted provision governing drug imports. Biological drugs and radiopharmaceuticals have a separate provision allowing 60% of their labelled shelf life.
Under the amended second proviso to Rule 31, the licensing authority cannot permit the import of a drug with less than one year of shelf life remaining on the date of import. The same provision says biological drugs and radiopharmaceuticals may be allowed with 60% of the shelf life stated on their labels.
Requirement assessed on date of import
The notification is titled the Drugs (Thirteenth Amendment) Rules, 2026. It is dated October 16 and appears in the Official Gazette issue dated October 28. The rules state that they take effect on their publication in the Official Gazette.
The ministry said it considered public objections and suggestions on the draft amendment and consulted the Drugs Technical Advisory Board before finalising the change. The amendment concerns the remaining shelf life at import; the biological-drug and radiopharmaceutical provision is not an unrestricted exemption.
हिंदी में पढ़ें: दवाओं के आयात में शेल्फ लाइफ का प्रावधान
