New Delhi, June 26 (IANS): The government has proposed easing the residual shelf-life requirement for imported drugs by replacing the existing norm of more than 60 per cent remaining shelf life with a minimum residual shelf life of 12 months at the time of import, a move aimed at improving supply chain efficiency and promoting ease of doing business in the pharmaceutical sector. The Ministry of Health and Family Welfare (MoHFW) has issued a draft notification proposing amendments to Rule 31 of the Drugs Rules, 1945, and invited comments and suggestions from stakeholders. Under the proposed amendment, imported drugs would need to have at least 12 months of residual shelf life when entering the country instead of complying with the current requirement of more than 60 per cent of their total shelf life remaining. However, the government has proposed retaining the existing norm for biological products and radiopharmaceuticals due to their specialised nature and public health significance.
According to the ministry, the proposed change seeks to rationalise import regulations while ensuring that patients continue to receive medicines with adequate usable shelf life. The revised requirement is expected to provide sufficient time for the distribution and consumption of imported medicines before expiry, improve pharmaceutical supply chain efficiency, reduce avoidable wastage caused by restrictive shelf-life norms, optimise inventory management and lower supply chain costs. The ministry also said the amendment is likely to strengthen the availability of essential medicines across the country. It further clarified that the proposal relates only to the residual shelf-life requirement applicable at the time of import and does not alter any other regulatory provisions governing the quality, safety or efficacy of medicines under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.