Medicines arriving in India will now need more life left in them. The Central Government has barred the import of any medicine that has less than one year of shelf life remaining on the date it enters the country. The change came into effect on October 28, 2026.
The rule was notified by the Ministry of Health and Family Welfare in the Official Gazette. It applies at the point of import, which means the check happens before a consignment is allowed in, not after it has reached pharmacy shelves.
For patients, the idea is simple. An imported medicine should still have enough usable life after customs clearance, distribution and dispensing. A pack that arrives with only a few months left can run out of time while it is still moving through the supply chain.
What exactly has changed
The change comes through the Drugs (Thirteenth Amendment) Rules, 2026, which amend Rule 31 of the Drugs Rules, 1945. The Gazette notification says the licensing authority shall not allow the import of any drug having less than one year of residual shelf life on the date of import.
In plain terms:
- A medicine covered by the general rule must have at least 12 months of shelf life left when it is imported.
- The test is applied on the date of import, not the date of manufacture or dispatch.
- If the remaining shelf life falls short, import is not to be allowed.
- The rule has been in effect since October 28, 2026, the date of its publication in the Official Gazette.
A separate provision for biological drugs
Not every medicine is treated in exactly the same way. The notification provides a separate provision for biological drugs and radiopharmaceuticals. For these products, 60 per cent of the labelled shelf life may be allowed, according to the notification.
That distinction reflects how these products work. Biological drugs and radiopharmaceuticals often have shorter labelled shelf lives and different storage and handling needs from conventional tablets and capsules. The government has therefore kept a separate track for them, instead of applying the one-year test in the same form to every product.
How the rule reached this stage
This was not a sudden announcement. The government had published the draft amendment on June 22, 2026, and invited objections and suggestions from affected stakeholders within 30 days of the Gazette copies being made available to the public.
The final amendment was made after consultation with the Drugs Technical Advisory Board, the expert body that advises on technical matters under the drugs law. The notification states that objections and suggestions received from the public on the draft rules were considered before the final version was issued.
What it means for patients and pharmacies
For patients who depend on imported medicines, the most direct effect should be reassurance on usable life. A medicine that clears the new test will have at least a year left when it enters India, which gives the rest of the chain time to do its work without racing the expiry date.
For pharmacies and hospitals, the change is mainly about planning. Stock already in the country is a separate matter from new imports, and the rule is framed around import. But purchasing teams that source from abroad will need to build the one-year check into ordering decisions, especially for medicines ordered in bulk or shipped over long distances.
For importers, the cost of getting it wrong is now clearer. A consignment that arrives short of the one-year mark risks being refused at the import stage. Checking dates before dispatch and allowing a buffer for transit delays will become part of routine compliance.
What to watch next
The first test will be how the rule is applied in practice at ports and airports. Importers will be watching for consistency in how remaining shelf life is calculated, how documents are checked and how the separate provision for biological drugs and radiopharmaceuticals is handled for individual products.
For now, the message from New Delhi is straightforward. If a medicine is coming into India, it needs a year to spare. If it is a biological drug or a radiopharmaceutical, the separate 60 per cent provision applies. And the clock starts on the date of import.
FAQs
When did the new import rule come into effect?
It came into effect on October 28, 2026, the date it was published in the Official Gazette.
How much shelf life must an imported medicine have?
Under the general rule, at least one year of residual shelf life on the date of import. The licensing authority shall not allow the import of a drug with less than that.
Do biological drugs follow the same rule?
No. Biological drugs and radiopharmaceuticals have a separate provision under which 60 per cent of the labelled shelf life may be allowed.
Which rules were amended?
The Drugs (Thirteenth Amendment) Rules, 2026 amend Rule 31 of the Drugs Rules, 1945.
Was the public consulted before the rule was finalised?
Yes. A draft was published on June 22, 2026, with 30 days for objections and suggestions, and the Drugs Technical Advisory Board was consulted before the final notification.
A clear shelf-life line at the border gives patients, pharmacists and importers the same reference point.
