Govt Seeks Public Feedback on Draft Amendment to Blood Product Testing Rules

New Delhi, March 11: The Ministry of Health and Family Welfare has invited public comments on a draft amendment to the Drugs Rules, 1945 aimed at updating testing norms for blood products and aligning them with international pharmacopoeial standards.

According to a draft Gazette notification (GSR 164(E)) issued on March 9, the proposal seeks to amend provisions related to testing of blood products under Schedule F of the Drugs Rules. The move aims to remove duplicate viral testing requirements and bring India’s regulatory framework in line with global best practices.

Under internationally accepted standards, including the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopeia (USP), and European Pharmacopoeia (EP), pooled human plasma must undergo strict testing. The first homogeneous plasma pool is mandatorily tested for Hepatitis B surface antigen (HBsAg), Hepatitis C virus RNA, and HIV antibodies.

Only plasma pools that test negative for these viral markers are allowed for fractionation and used in manufacturing plasma-derived medicinal products.

However, under the current Indian regulations, finished products derived from already tested plasma pools are again tested for the same viral markers, leading to duplication. Officials say such double testing is not in line with international regulatory practices.

The proposed amendment aims to rationalize testing requirements, reduce unnecessary compliance burden, and harmonize regulations while maintaining high standards of patient safety.

The ministry has urged stakeholders to review the draft notification and submit comments and suggestions within the stipulated time.