Medicines imported into India must now have at least 12 months of shelf life left on the day they arrive. The Union Ministry of Health and Family Welfare notified the change through the Drugs (Thirteenth Amendment) Rules, 2026, published in the Gazette of India on 28 October 2026. Biological drugs and radiopharmaceuticals keep a separate test based on 60% of labelled shelf life.

What the new imported drugs shelf life rule says

The amendment replaces the second proviso to Rule 31 of the Drugs Rules, 1945. Under the new wording, 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”. For biological drugs and radiopharmaceuticals, it says 60% of the labelled shelf life “may be allowed”.

The notification, G.S.R. 951(E), is dated 16 October 2026 and took effect on the date of publication. It was issued under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, after consulting the Drugs Technical Advisory Board (DTAB), according to the gazette notification listed by CDSCO. It follows a draft, G.S.R. 505(E), released on 22 June 2026 for public comment.

From a 60% rule to a fixed 12-month floor

Until now, imported drugs needed more than 60% of their labelled shelf life remaining at entry. When it released the draft, the Health Ministry said moving to a fixed 12-month minimum would promote ease of doing business, reduce avoidable wastage of stock and still give enough time for distribution and use before expiry. The ministry also said the change does not alter any quality, safety or efficacy requirement.

The effect depends on the product’s total shelf life:

• A drug with a 36-month shelf life earlier needed about 21.6 months left at import; it now needs 12.
• A 24-month product moves from about 14.4 months to 12 months.
• Products with shelf lives under 20 months face a stricter test than before, since 60% of their life is less than a year.

For importers of long-dated generics, APIs in finished form and branded speciality medicines, this widens the window to ship older batches. Short-dated products will need tighter planning between the overseas plant and the Indian port.

Why it matters for pharma supply chains

The rule comes as regulators tighten oversight across the chain. CDSCO recently asked states to enforce batch testing of raw materials, excipients and finished drugs, while NPPA has revised MRPs for 543 cancer drug brands, many of them imported innovator and speciality products.

Two points remain open. The relaxation for biologics is discretionary, and the notification does not set criteria for how licensing authorities should apply it, The South First reported. The rule also has no separate transition period for consignments already in transit. Demand is strong: India’s medicine sales grew 12% to ₹70,180 crore in the September quarter, so importers and distributors will want quick clarity at ports.

Key takeaways

• Imported drugs need at least 12 months of residual shelf life on the date of import, effective 28 October 2026.
• Biologics and radiopharmaceuticals may be allowed in with 60% of labelled shelf life, at the licensing authority’s discretion.
• Long-dated products gain flexibility; products with short shelf lives face a tougher test.

FAQ

When does the 12-month shelf-life rule apply?

It came into force on 28 October 2026, the date the Drugs (Thirteenth Amendment) Rules, 2026 were published in the Gazette of India.

Are vaccines and other biologics covered by the 12-month floor?

No. Biological drugs and radiopharmaceuticals follow a separate test, under which 60% of labelled shelf life may be allowed by the licensing authority.

Does the rule change drug quality standards?

No. The Health Ministry said the amendment covers only residual shelf life at import and leaves quality, safety and efficacy rules unchanged.

Also read: Supreme Court Raps Centre, DCGI Over Antifungal Drug Sold on Expired Approvals

Featured image: Medicine stock on hospital pharmacy shelves (representative). Photo: Mattes / Wikimedia Commons (public domain).

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