NEW DELHI, India — The Indian Ministry of Health and Family Welfare has proposed a major revision to the country’s import regulations for pharmaceutical products, aiming to ensure that patients receive medicines with a longer usable shelf life before they expire.
Under the proposed amendment, the minimum residual shelf-life requirement for imported drugs would change from more than 60% of the product’s total shelf life to a minimum of 12 months remaining at the time of import.
The government said the proposed change is intended to provide sufficient time for customs clearance, distribution, storage, and retail sale, ensuring that medicines remain safe and effective by the time they reach patients.
According to the Health Ministry, the revised rule is designed to improve medicine availability, reduce the risk of patients receiving products that are close to their expiration date, and strengthen the overall pharmaceutical supply chain.
Officials explained that the current 60% residual shelf-life requirement can create challenges for manufacturers whose medicines have different overall shelf-life durations. A fixed 12-month minimum is expected to provide greater flexibility while still protecting consumers.
However, the proposal does not apply to biological products, including certain vaccines, blood products, and other biologic medicines. These products will continue to follow the existing 60% residual shelf-life requirement because of their unique storage conditions and higher sensitivity to time and temperature.
The proposed amendment is currently under consideration, and stakeholders from the pharmaceutical industry, healthcare sector, and regulatory bodies are expected to provide feedback before the rule is finalized.
If approved, the revised policy could simplify drug imports, improve the efficiency of medicine distribution across India, and help ensure that patients receive high-quality medicines with adequate remaining shelf life, reducing waste and enhancing public health protection.
