The Indian government has introduced a new rule to prevent medicines nearing their expiry dates from entering the country. Under the Drugs (Thirteenth Amendment) Rules, 2026, most imported medicines must have at least 12 months of shelf life remaining at the time of import. The rule came into effect on October 28, 2026. The Tribune+1
7 Major Benefits of This Decision:
1. Better Patient Safety: Patients will have a lower risk of receiving imported medicines that are close to their expiry dates.
2. More Time to Use Medicines: A minimum of one year of remaining shelf life provides sufficient time for distribution, storage and consumption.
3. Reduced Medicine Wastage: Fewer medicines are likely to be discarded because of insufficient remaining shelf life.
4. Improved Medicine Quality: The rule supports better management of medicines throughout the supply chain.
5. Better Availability: Improved inventory management may help maintain the availability of essential medicines.
6. Reduced Financial Losses: Importers and pharmaceutical companies may save money by avoiding unnecessary medicine wastage.
7. Stronger Import Regulations: The government can prevent the import of medicines that do not meet the prescribed remaining shelf-life requirement.
Important Exception: Biological medicines and radiopharmaceuticals can be imported with at least 60% of their labelled shelf life remaining, under the separate provision. The Tribune+1
Conclusion: This decision aims to improve medicine availability, reduce wastage and ensure that imported medicines have adequate usable shelf life. It does not replace other existing quality, safety and efficacy standards.
