NEW DELHI: The Union Ministry of Health and Family Welfare (MoHFW) has invited public comments on a draft amendment to the Drugs Rules, 1945, proposing to rationalise the residual shelf-life requirement for imported medicines. The regulatory shift is aimed at improving supply chain efficiency, optimizing inventory management, and promoting the ease of doing business in the pharmaceutical sector.
The proposed amendment, published through Gazette Notification G.S.R. 505(E) dated June 22, 2026, seeks to amend Rule 31 of the Drugs Rules, 1945.
Shift to a Flat 12-Month Rule
Under the existing framework, medicines must have more than 60 percent of their total shelf life remaining when they enter the country. The proposed revised framework completely replaces this proportional rule for standard drugs:
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New Minimum Requirement: Imported drugs will simply be required to have a minimum residual shelf life of 12 months at the exact time of import.
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Wastage Reduction: The Ministry noted that a flat one-year remaining shelf life provides adequate time for domestic distribution and consumer consumption before expiry, while dramatically reducing unnecessary product wastage caused by the rigid 60 percent norm.
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Cost Efficiency: The revised policy is expected to reduce supply chain overheads, streamline inventory pipelines, and strengthen the steady availability of essential medicines across India.
Exceptions for Biologicals and Radiopharmaceuticals
While standard chemicals and formulations will transition to the new 12-month rule, the Ministry has proposed retaining the current 60 percent residual shelf-life requirement for biological products and radiopharmaceuticals. This exception has been carved out due to their highly specialized nature, temperature sensitivities, and critical public health considerations.
The Ministry explicitly clarified that this amendment is strictly limited to shipping and import-time residual shelf-life requirements. It does not affect, alter, or dilute any existing regulatory provisions governing the core quality, safety, or efficacy of medicines mandated under the Drugs and Cosmetics Act, 1940.
Public Consultation and Feedback
The draft notification has been placed in the public domain for stakeholder consultation. The Health Ministry has invited objections, feedback, and structural suggestions from industry stakeholders, healthcare professionals, and the general public before finalizing the statutory amendment.
How to Submit Comments: Feedbacks may be submitted to the Under Secretary (Drugs), Ministry of Health and Family Welfare, at Kartavya Bhawan-1, New Delhi, or forwarded via email to drugsdiv-mohfw@gov.in within the prescribed consultation period.
