On March 9, 2026, the Ministry of Health and Family Welfare issued a draft Gazette Notification (G.S.R. 164(E)) proposing targeted amendments to the Drugs Rules, 1945, to eliminate redundant viral testing of blood products. Under the current framework, plasma-derived medicinal products undergo double testing—first at the pooled plasma stage and again at the final product stage—for markers such as Hepatitis B, Hepatitis C, and HIV. The proposed amendment seeks to remove this duplication by aligning domestic rules with the Indian Pharmacopoeia (IP) and global standards like the British Pharmacopoeia (BP), United States Pharmacopeia (USP), and European Pharmacopoeia (EP) which mandate stringent testing only at the homogeneous plasma pool stage.
This shift acts as a driver for scientific rationalisation and the reduction of avoidable compliance burdens within the biopharmaceutical sector. By focusing on high-fidelity testing at the foundational pooling stage, the government ensures that only qualified, safety-cleared plasma enters the fractionation process, maintaining peak patient safety while streamlining the manufacture of life-saving therapeutics.
Key Pillars of the Draft Amendment (G.S.R. 164(E))
Removal of Duplicate Testing: Eliminating the requirement to re-test final products for viral markers that have already been cleared at the pooled plasma stage.
Global Pharmacopoeial Alignment: Harmonising Para G (Schedule F) with international standards to ensure Indian blood products meet the best practices of the USP, EP, and BP.
Mandatory Pooled Plasma Screening: Maintaining stringent protocols where the first homogeneous pool must test negative for HBsAg, HCV RNA, and HIV antibodies.
Scientific Rationalisation: Transitioning towards a regulatory model where testing is performed at the most effective stage of production rather than through repetitive cycles.
Stakeholder Consultation Window: Inviting objections and suggestions over a 30-day period to be addressed by the Under Secretary (Drugs) at the MoHFW.
Reduced Compliance Burden: Acting as a functional prerequisite for increasing the efficiency and cost-competitiveness of the domestic plasma-fractionation industry.
What is "Plasma Fractionation" Safety? Plasma fractionation safety refers to the technical protocols used to ensure that medicines derived from human blood are free from viruses. It operates on the mechanical theory of early detection; because viral markers are most accurately identified in the "first homogeneous pool" of plasma, ensuring this stage is negative is a prerequisite for safety. Under the new draft rules, this stage acts as the primary mechanic for quality control. By removing the requirement for subsequent "double testing" of final products, the government acknowledges that high-fidelity screening at the initial processing stage is sufficient, thereby bypassing redundant laboratory steps that do not add further safety value under global standards.
Policy Relevance: Enhancing Biopharma Competitiveness
Operationalising Ease of Doing Business: The amendment serves as a primary mechanic for the Department of Pharmaceuticals to reduce technical barriers for blood-product manufacturers.
Internalising Global Best Practices: Aligning with international monographs provides a functional framework for the Ministry of Health to facilitate the global export of Indian-made plasma-derived medicines.
Bypassing Redundant Compliance: Streamlining the Drugs Rules is a prerequisite for lowering the operational costs of life-saving therapies without compromising biological safety.
Link to National Health Standards: The proposal, developed after consultation with the Drugs Technical Advisory Board, is a foundational step in modernising India's decades-old drug regulatory code.
Follow the Full Release Here: Draft Amendment to Update Testing Norms for Blood Products
The Ministry of Health and Family Welfare (MoHFW), Draft Gazette Notification GSR 164(E)
