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To reduce medicine wastage, the Ministry of Health and Family Welfare has amended Rule 31 of the Drugs Rules, 1945, under which drugs with less than one year of shelf life remaining cannot be imported. However, biological drugs and radiopharmaceuticals can be imported if they have at least 60% of their shelf life remaining. These regulations can help streamline the entry of foreign medications into the domestic supply chain.
The new rule, notified under the Drugs (Thirteenth Amendment) Rules, 2026, amends Rule 31 of the Drugs Rules, 1945, and took effect on the date of its publication in the Official Gazette on October 28, 2026.
The amendment has been introduced through the Drugs (Thirteenth Amendment) Rules, 2026, vide Gazette Notification G.S.R. 951(E), dated October 16, 2026. Published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), dated October 28, 2026, the rules take effect from the date of their publication in the Official Gazette.
"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.
"In case of biological drugs and Radiopharmaceuticals, sixty percent of the labelled shelf-life may be allowed," the notification added.
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.
Why this matters
The policy aims to make shelf-life requirements clearer and safer while avoiding the buildup of products that are close to expiring.
- Reducing Waste: A one-year buffer ensures that medicines stay effective after traveling through the supply chain.
- Improving Supply Chain: Importers need to avoid delays that could make their shipments have less than 12 months of shelf life or risk rejection.
- Protecting Biologics: The 60% rule ensures that short-shelf-life cancer therapies and vaccines remain available.
The policy change aims to rationalise shelf-life requirements, streamline drug safety, and prevent the influx or accumulation of near-expiry pharmaceutical products into the domestic market.
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