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The Central Government has barred the import of medicines with less than one year of remaining shelf life, while allowing a separate provision for biological drugs and radiopharmaceuticals, according to a notification issued by the Ministry of Health and Family Welfare.
The new rule, notified under the Drugs (Thirteenth Amendment) Rules, 2026, amends Rule 31 of the Drugs Rules, 1945, and has come into effect from the date of its publication in the Official Gazette on October 28, 2026. "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," the ministry said in the Gazette notification. The amendment means that medicines covered by the general requirement must have at least one year of shelf life remaining when they are imported into India. However, the government has provided a separate provision for biological drugs and radiopharmaceuticals, under which 60 per cent of the shelf life mentioned on the product label may be allowed. The notification states, "in case of biological drugs and Radiopharmaceuticals, Sixty percent of the labelled shelf-life may be allowed." According to the ministry, the amendment was finalised after consultation with the Drugs Technical Advisory Board and consideration of public feedback on the draft rules. The government had earlier published the draft amendment on June 22, 2026, inviting objections and suggestions from affected stakeholders within 30 days of the Gazette copies being made available to the public. "Objections and suggestions received from the public on the said draft rules have been considered by the Central Government," the notification stated. (ANI)
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