Business
India sets 1 year minimum shelf life on imported drugs
The Hindu BusinessLine·
The Union Health Ministry amended Rule 31 of the Drugs Rules, 1945, to block imports of medicines with less than one year of shelf life remaining. Biological drugs and radiopharmaceuticals may enter if at least 60 percent of labelled shelf life remains. Officials said the change aims to keep near-expiry stock out of the supply chain.
Prism
What It Means For You
- Importers must verify residual shelf life before customs clearance under the amended rule.
- Hospitals and pharmacies should see fewer batches with short dating on arrival.
- Stakeholder objections were considered before the Central Government finalised the notification.
What's Happening
- The licensing authority must reject drugs below the one year threshold at import.
- Biological and radiopharmaceutical products follow the 60 percent residual shelf life standard instead.
- Officials said the rule also targets wastage from overly strict prior requirements.
Drugs Rules 1945
- Rule 31 governs conditions attached to import licences for pharmaceuticals.
- Shelf life is the period a drug remains within approved quality specifications.
- The amendment was notified on October 30, 2026.
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