MedicineImports – Government Proposes New Shelf-Life Norms for Imported Medicines
MedicineImports – The Central Government has proposed a significant revision to the rules governing the import of medicines into India, aiming to improve supply chain efficiency while ensuring that patients continue to receive safe and effective pharmaceutical products. The draft proposal focuses only on the remaining shelf-life of imported medicines at the time they enter the country and is expected to simplify business operations across the pharmaceutical sector.
Draft Amendment Targets Shelf-Life Requirement
The Union Ministry of Health and Family Welfare has released a draft notification suggesting changes to Rule 31 of the Drugs Rules, 1945. Published through Gazette Notification G.S.R. 505(E) dated June 22, 2026, the proposal has been opened for public consultation, allowing stakeholders to submit their views before the amendment is finalised.
Under the existing rules, imported medicines must have more than 60 percent of their original shelf life remaining when they arrive in India. The Ministry has now proposed replacing this condition with a simpler requirement that imported medicines should have at least 12 months of remaining shelf life at the time of import.
Special Categories Remain Under Existing Rules
The Ministry has clarified that certain specialised products will continue to be governed by the current requirement. Biological products and radiopharmaceuticals will still need to meet the existing standard of having more than 60 percent of their shelf life remaining due to their unique characteristics and the public health considerations associated with their use.
Officials believe this distinction is necessary because these products require stricter handling and storage conditions compared to conventional medicines.
Improving Supply Chain Efficiency
According to the Ministry, the proposed amendment is designed to improve the movement and management of medicines throughout the pharmaceutical supply chain. By requiring a minimum of one year of usable shelf life at the time of import, medicines can be distributed and supplied to healthcare facilities with sufficient time before their expiry dates.
The proposal is also expected to reduce unnecessary wastage of medicines caused by the current residual shelf-life restrictions. Better inventory utilisation may help companies manage stocks more efficiently while lowering operational costs and strengthening the availability of essential medicines across the country.
Quality and Safety Standards Remain Unchanged
The Ministry has emphasised that the proposed amendment is limited to the shelf-life requirement applicable during the import process. It does not change any existing legal provisions related to the quality, safety, effectiveness, or regulatory approval of medicines under the Drugs and Cosmetics Act, 1940, or the Drugs Rules, 1945.
All existing standards governing the manufacture, testing, and approval of pharmaceutical products will continue to remain fully applicable even if the amendment comes into effect.
Stakeholders Invited to Submit Feedback
Before implementing the proposed changes, the Ministry has invited comments, suggestions, and objections from industry representatives, healthcare professionals, importers, and other interested stakeholders. The public consultation process is intended to gather feedback on the draft notification before a final decision is taken.
The proposed revision reflects the government’s broader effort to streamline regulatory processes while maintaining patient safety and ensuring uninterrupted access to quality medicines through a more efficient pharmaceutical supply system.