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Mumbai: In a major step towards boosting supply chain efficiencies and streamlining processes, the Union Ministry of Health and Family Welfare has proposed to amend Rule 31 of the Drug Rules, 1945. According to a press release, this draft amendment aims to ease stringent shelf-life requirements for imported medicines, thereby improving supply chain efficiency and boosting the ease of doing business.
For years, global pharmaceutical companies have been facing the 60% residual shelf life rule, where no drug could cross Indian customs until it retained more than 60% of its original, factory-certified shelf life. This was a major barrier to the ease of doing business, even if the medicines could be easily used for more than a year until its expiry.
The proposed amendment aims to completely remove this calculation, replacing it with a simple, uniform mandate: the drugs should have a minimum residual shelf life of 12 months at the time of import entry.
This would also facilitate greater efficiency in the pharmaceutical supply chain, making lifesaving drugs available for patients who need them. This is also aimed at improving the utilization of pharmaceutical inventories across the supply chain by reducing avoidable wastage of medicines due to restrictive shelf-life requirements.
The amendment excludes specialty drugs that have a lower shelf life- including therapeutic monoclonal antibodies, gene therapies, insulin derivatives, certain advanced vaccines and specialised nuclear medicine compounds used natively in chemotherapy and radiotherapy.
Union Ministry of Health and Family Welfare Invites Public Comments on Draft Amendment to Rationalise Residual Shelf-Life Requirement for Imported Drugs
Proposed amendment aims to facilitate Ease of Doing Business while ensuring continued availability of quality…
— Ministry of Health (@MoHFW_INDIA) June 26, 2026
The government is inviting feedback for the amendment, and has clarified that the proposal ios only for the shelf life requirements at the time of import, and does not affect the regultatory standards in place for quality, safety or efficacy of the drugs in the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
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