Daijiworld Media Network - New Delhi

New Delhi, Jun 26: The Centre has proposed relaxing the residual shelf-life requirement for imported medicines by replacing the existing rule of having more than 60 per cent of the product's shelf life remaining with a simpler requirement of a minimum of 12 months' shelf life at the time of import.

The proposed change, announced by the Ministry of Health and Family Welfare (MoHFW), is aimed at improving pharmaceutical supply chains, reducing medicine wastage and enhancing the ease of doing business in the sector.

The ministry has issued a draft notification seeking to amend Rule 31 of the Drugs Rules, 1945, and has invited comments and suggestions from stakeholders before finalising the revised regulation.

Under the proposal, all imported drugs would need to have at least 12 months of residual shelf life upon entry into India, replacing the current requirement that more than 60 per cent of the product's total shelf life must remain.

However, the government has proposed no change for biological products and radiopharmaceuticals, which will continue to be governed by the existing norms because of their specialised nature and public health importance.

According to the ministry, the revised provision is intended to simplify import regulations while ensuring that patients continue to receive medicines with sufficient usable shelf life for distribution and consumption before their expiry.

The proposed amendment is also expected to streamline inventory management by allowing greater flexibility in the import of pharmaceutical products. Officials believe the move will help minimise unnecessary wastage of medicines resulting from restrictive shelf-life requirements, lower supply chain costs and improve operational efficiency for importers.

The ministry further said the changes are likely to strengthen the availability of essential medicines across the country by facilitating smoother and more efficient distribution.

Clarifying the scope of the amendment, the government stated that the proposal relates only to the residual shelf-life requirement applicable at the time of import. It does not alter any existing provisions governing the quality, safety or efficacy of medicines under the Drugs and Cosmetics Act, 1940, or the Drugs Rules, 1945.