Government Proposes Simpler Import Rules to Reduce Medicine Wastage

The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, aimed at reducing medicine wastage by simplifying import regulations. The draft proposal seeks to replace the existing shelf-life calculation system with a clearer requirement that imported medicines must have at least one year of remaining shelf life when they enter India. The government has invited public comments before finalising the new rule.

Under the current framework, imported medicines are subject to more complex shelf-life calculations, which often result in consignments being rejected or discarded despite remaining suitable for use. The proposed amendment is expected to simplify compliance for importers while ensuring that medicines reaching patients maintain adequate shelf life.

Healthcare experts believe the revised regulation could significantly reduce pharmaceutical wastage and improve the availability of essential medicines. By introducing a uniform minimum shelf-life requirement, authorities aim to create a more efficient and transparent import process without compromising patient safety.

The proposal is expected to benefit pharmaceutical companies, hospitals and healthcare distributors by reducing unnecessary losses associated with regulatory complexities. Industry stakeholders have welcomed the move, stating that streamlined import procedures can improve supply chain efficiency and reduce operational costs.

Public health specialists note that medicine wastage not only affects healthcare expenditure but can also contribute to supply shortages for critical drugs. Better inventory management and simplified regulatory norms can help ensure timely availability of medicines across hospitals, pharmacies and healthcare institutions.

The Ministry has clarified that the proposed changes relate only to procedural compliance and do not dilute India’s quality or safety standards for imported medicines. All imported pharmaceutical products will continue to undergo the required regulatory checks before entering the domestic market.

Experts believe the amendment aligns with broader efforts to modernize India’s pharmaceutical regulatory framework while supporting ease of doing business. Simplified rules can encourage smoother trade operations and strengthen the country’s position as one of the world’s largest pharmaceutical markets.

Once finalized, the revised import norms are expected to improve efficiency across the healthcare supply chain while minimizing avoidable medicine wastage. The initiative reflects the government’s continued focus on improving healthcare accessibility, regulatory transparency and resource optimization.