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. The proposal was issued through draft Gazette Notification GSR 164(E) dated March 9, 2026.
The proposed amendment seeks to revise Para G (Testing of Blood Products), Part XII C, Schedule F of the Drugs Rules to remove duplicate viral testing requirements that are not followed under global best practices. According to international pharmacopoeias such as the Indian Pharmacopoeia, British Pharmacopoeia, United States Pharmacopeia, and European Pharmacopoeia, strict testing protocols are already prescribed for pooled human plasma used in medical products.
Under these standards, the first homogeneous plasma pool must undergo mandatory testing for viral markers such as Hepatitis B surface antigen, Hepatitis C virus RNA, and antibodies to HIV. Only plasma pools that test negative for these markers are permitted for fractionation and used in the production of plasma-derived medicinal products.
However, under the current regulatory framework, finished products made from already tested plasma pools are tested again for the same viral markers, resulting in duplication. The ministry stated that such double testing is not consistent with international regulatory practices.
The proposed amendment aims to bring regulatory harmonization, rationalize scientific testing requirements, and reduce unnecessary compliance burden while maintaining high standards of patient safety. The ministry has invited stakeholders and the public to review the draft notification and submit their suggestions within the specified timeline.
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