Drug Import Policy – Government Proposes New Shelf-Life Norms for Imported Medicines
Drug Import Policy – The Central Government has proposed a significant revision to the shelf-life requirement for imported medicines, aiming to improve supply chain efficiency while maintaining patient safety.
The Central Government has introduced a draft proposal to revise the rules governing the import of medicines into India by changing the existing residual shelf-life requirement. According to the proposal issued by the Ministry of Health and Family Welfare (MoHFW), imported medicines would only need to have a minimum remaining shelf life of 12 months at the time they enter the country. The move is intended to simplify pharmaceutical imports, reduce unnecessary losses, and support smoother business operations without compromising medicine availability.
Draft Amendment Open for Stakeholder Feedback
The ministry has released a draft notification suggesting amendments to Rule 31 of the Drugs Rules, 1945, and has invited comments and suggestions from industry participants and other stakeholders before the proposal is finalised. At present, imported medicines are required to retain more than 60 percent of their total shelf life when they arrive in India. If approved, the revised rule would replace this percentage-based condition with a fixed minimum requirement of one year of remaining shelf life.
Special Categories to Continue Under Existing Rules
The proposed relaxation will not apply to all products. The government has decided to retain the current residual shelf-life requirement for biological products and radiopharmaceuticals. These categories are considered highly specialised and play an important role in public health, making stricter regulatory standards necessary for their import and distribution.
Focus on Better Supply Chain Management
Officials believe the revised framework will make pharmaceutical logistics more efficient by giving importers greater flexibility in managing stock. The ministry noted that medicines imported with at least 12 months of remaining shelf life would still provide sufficient time for distribution, retail availability, and patient use before their expiry dates.
The proposal is also expected to reduce avoidable wastage that occurs when medicines fail to meet the current percentage-based shelf-life requirement despite remaining suitable for use. Improved inventory planning could help pharmaceutical companies lower operational costs while ensuring a more consistent supply of medicines across different regions of the country.
Expected Benefits for Medicine Availability
The government believes that easing the import condition could strengthen the availability of essential medicines by allowing a wider range of products to enter the Indian market without unnecessary regulatory hurdles. Better inventory utilisation may also improve the efficiency of the overall pharmaceutical supply chain, helping distributors and healthcare providers maintain adequate stock levels.
Quality and Safety Standards Remain Unchanged
The Ministry of Health and Family Welfare has clarified that the proposed amendment relates only to the shelf-life requirement applicable at the time of import. It does not alter any existing legal provisions concerning the quality, safety, or effectiveness of medicines. All imported drugs will continue to remain subject to the regulatory standards prescribed under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
The draft notification is currently open for stakeholder feedback, following which the government will review the responses before taking a final decision on implementing the revised import regulations.