India sets one-year shelf-life floor for drug imports, keeps 60% test for biologicals

The Union Health Ministry has set a one-year minimum residual shelf life for most imported medicines, replacing a percentage test that governed drug imports. The amended Rule 31 of the Drugs Rules, 1945 says 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"¹.

Biological drugs and radiopharmaceuticals keep a separate test. For these, the notification allows imports where "Sixty percent of the labelled shelf-life may be allowed"¹.

CDSCO's list of gazette notifications records the change as G.S.R. 951(E), dated 28 October 2026, with the heading "rationalization of shelf life under Rule 31 of Drugs Rules, 1945"². A draft, G.S.R. 505(E), was issued on 22 June 2026². The ministry said public objections and suggestions "have been considered by the Central Government" before the rules were finalised, BusinessLine reported on 30 October¹.

What changed against the old rule

Residual shelf life is the time left before the expiry date printed on the pack. The earlier test was a percentage. Court orders in import disputes describe the proviso to Rule 31 as barring any drug with less than 60% of its shelf life remaining on the date of import^4, 3.

The new text splits importers into two groups. For ordinary drugs the floor is a flat year, and the wording leaves the licensing authority no discretion: it "shall not allow" the import¹. For biologicals and radiopharmaceuticals the percentage test survives, and the wording is permissive: 60% "may be allowed"¹.

The effect depends on how long the product lasts. Where the labelled shelf life is long, 60% of it comes to more than a year. The old test was then harder to clear, and the flat floor eases the way in. Where the labelled life is short, 60% falls below a year, and the new floor is the stricter test¹.

The quoted wording covers "any drug" and shows no carve-out for bulk drugs or active pharmaceutical ingredients¹. Medical devices sit outside these rules. CDSCO lists amendments to the Medical Devices Rules, 2017 separately from the Drugs Rules².

Why biologicals and radiopharma differ

Radiopharmaceutical products carry a usable life set by radioactive decay, not only by a stability date. Fluorine-18, an isotope used in PET imaging, has a half-life of 109 minutes⁵. A flat one-year floor would shut such products out of the market, while a share of labelled life keeps them importable^1, 5.

The percentage rule has also generated litigation. In a Customs case involving Hetero Labs decided on 16 January 2026, the goods in question were said to have less than 60% shelf life. The ruling recorded that import below that level was restricted³. A 2016 case turned on the same proviso⁴.

What importers should watch

The published account describes no transition period for licences already applied for or for consignments already on the water¹. Because the test is fixed "as on the date of import", a shipment that lands after the change is judged on the life left when it arrives¹.

The ministry's stated aims run in two directions. It wants to stop medicines close to expiry from entering the supply chain. It also wants less waste caused by "restrictive residual shelf-life requirements", which it expects to improve inventory use and cut costs¹.

Buyers of imported medicines, including hospitals, clinics and distributors, will need shelf-life clauses in supply contracts that match one of the two tests. Shipping schedules will also need to leave enough life on the product at the port of arrival¹.