New Delhi: 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 shelf life of 12 months at the time of import — a decision aimed at improving supply chain efficiency and promoting ease of doing business in the pharmaceutical sector — according to an official statement on Friday.
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 be required to have a minimum residual shelf life of 12 months when they enter the country instead of complying with the existing requirement of more than 60 per cent of their total shelf life remaining.
However, the government has proposed to retain the current norm for biological products and radiopharmaceuticals, considering their specialised nature and public health significance.
The proposed change is intended to rationalise import regulations while ensuring that patients continue to receive medicines with adequate usable shelf life, according to the ministry.
The ministry said the revised requirement would provide sufficient time for the distribution and consumption of imported medicines before their expiry, while improving the efficiency of pharmaceutical supply chains.
Moreover, the proposed amendment is expected to reduce avoidable wastage of medicines caused by restrictive residual shelf-life requirements, optimise inventory management and lower supply chain costs.
The ministry further noted that it is expected to strengthen the availability of essential medicines across the country.
In addition, the government has clarified that the proposed amendment 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.
(IANS)
