Health Ministry Seeks Public Feedback on Imported Drug Shelf-Life Rule

CNB WORLD TIMES

New Delhi, June 26: The Union Ministry of Health and Family Welfare (MoHFW) has invited public comments on a draft amendment to the Drugs Rules, 1945, proposing changes to the residual shelf-life requirement for imported drugs.

The draft notification, published as Gazette Notification G.S.R. 505(E) on June 22, 2026, proposes replacing the current requirement of more than 60% residual shelf life with a minimum residual shelf life of 12 months at the time of import.

However, the existing requirement of more than 60% residual shelf life will continue to apply to biological products and radiopharmaceuticals due to their specialised nature and public health considerations.

Aim of the Amendment

The proposed amendment is intended to improve efficiency in the pharmaceutical supply chain while ensuring that patients continue to receive quality medicines with adequate usable shelf life.

According to the Ministry, requiring imported medicines to have at least 12 months of remaining shelf life at the time of import will provide sufficient time for distribution and consumption before expiry.

Benefits for the Pharmaceutical Sector

The Ministry said the proposed change is expected to:

·         Improve pharmaceutical inventory management.

·         Reduce wastage caused by restrictive shelf-life requirements.

·         Strengthen the availability of essential medicines.

·         Lower supply chain costs.

·         Support the Government's Ease of Doing Business initiatives in the pharmaceutical sector.

No Change in Safety or Quality Standards

The Ministry clarified that the amendment relates only to the residual shelf-life requirement at the time of import. It does not affect any existing regulations governing the quality, safety, or efficacy of medicines under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.

Public Consultation

The Ministry has invited stakeholders, industry representatives, and members of the public to submit their objections or suggestions on the draft notification within the prescribed period.

Comments may be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, U-6, Work Hall–C Wing, First Floor, Kartavya Bhawan-1, New Delhi – 110001, or through email at drugsdiv-mohfw[at]gov[dot]in, within the prescribed period.