MoHFW Draft Amendment to Drugs Rules, 1945

Ministry Invites Public Comments on Draft Amendment to the Drugs Rules, 1945

Proposed Amendment Seeks to Remove Duplicate Viral Testing and Align with Global Standards

Posted On: 11 MAR 2026 | PIB Delhi

The Ministry of Health and Family Welfare (MoHFW) has issued draft Gazette Notification GSR 164(E) dated 9th March 2026. This notification invites public comments on a proposal to amend Para G (Testing of Blood Products), Part XII C, Schedule F of the Drugs Rules 1945.

The primary goal of the amendment is to align regulatory requirements for blood product testing with internationally accepted pharmacopoeial standards and to remove additional testing that is not warranted under global best practices.

Stringent testing protocols for pooled human plasma are already prescribed in several official monographs, including:

• Indian Pharmacopoeia (IP)
• British Pharmacopoeia (BP)
• United States Pharmacopeia (USP)
• European Pharmacopoeia (EP)

Under these harmonized standards, the first homogeneous pool of plasma must be mandatorily tested for Hepatitis B surface antigen (HBsAg), Hepatitis C virus RNA, and antibodies to HIV. This pooled plasma must test negative for these viral markers before it is permitted for fractionation. Only pools meeting these safety requirements are used to manufacture plasma-derived medicinal products.

Despite these existing protocols, the current regulatory framework requires that final products manufactured from already tested and qualified plasma pools undergo another round of testing. This results in a duplication of testing for the same viral markers at both the pooled plasma stage and the finished product stage, a practice that does not align with international regulatory standards.

The MoHFW views this proposed amendment as a progressive step toward scientific rationalization and regulatory harmonization. It aims to reduce the avoidable compliance burden while continuing to uphold the highest standards of patient safety. Stakeholders are encouraged to review the draft and submit their suggestions within the prescribed timeline.

Download Official Press Release

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