The Ministry of Health and Family Welfare has issued a draft Gazette notification proposing amendments to provisions governing the testing of blood products under the Drugs Rules, 1945.
The draft notification, G.S.R. 164(E) dated March 9, 2026, invites public comments on a proposal to amend Para G (Testing of Blood Products), Part XII C of Schedule F of the Drugs Rules.
According to the ministry, the proposed amendment aims to align India’s regulatory requirements for testing blood products with internationally accepted pharmacopoeial standards.
Under existing global pharmacopoeial guidelines, stringent testing protocols are applied at the stage when human plasma is pooled for fractionation. Official monographs in the Indian Pharmacopoeia, British Pharmacopoeia, United States Pharmacopeia and the European Pharmacopoeia prescribe mandatory testing for viral markers at this stage.
The first homogeneous plasma pool must be tested for Hepatitis B surface antigen (HBsAg), Hepatitis C virus RNA and antibodies to the Human Immunodeficiency Virus (HIV). Plasma pools are required to test negative for these markers before they are cleared for fractionation.
Only plasma pools that meet these safety standards are permitted for use in the manufacture of plasma-derived medicinal products.
However, under the current regulatory framework in India, finished products manufactured from already tested plasma pools are again required to undergo testing for the same viral markers.
Officials said this results in duplication of testing at both the pooled plasma stage and the final product stage, a requirement that does not align with prevailing international regulatory practices.
The draft amendment proposes removing the provision that mandates testing of final products for HIV I and HIV II antibodies, Hepatitis B surface antigen and Hepatitis C virus antibodies.
The Central Government has stated that the proposed change is intended to bring regulatory harmonisation, rationalise testing requirements based on scientific evidence, and reduce avoidable compliance burdens while maintaining patient safety standards.
The draft rules have been published after consultation with the Drugs Technical Advisory Board under powers granted by the Drugs and Cosmetics Act, 1940.
The government has invited objections and suggestions from stakeholders within 30 days from the date the Gazette notification is made available to the public. Submissions may be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, New Delhi, or by email to [email protected].
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