Overview The Ministry of Health and Family Welfare (MoHFW) has issued draft Gazette Notification GSR 164(E) dated 9 March 2026 , inviting public comments on a proposed amendment to Drugs Rules, 1945 . The amendment targets Para G (Testing of Blood Products) and seeks to eliminate redundant viral testing of finished blood products, bringing India’s norms in line with the Indian Pharmacopoeia (IP) , British Pharmacopoeia (BP) , United States Pharmacopeia (USP) and European Pharmacopoeia (EP) requirements. Key Developments Removal of duplicate testing for viral markers at the finished‑product stage. Adoption of a single, stringent testing protocol at the pooled plasma stage, consistent with global pharmacopoeial monographs. Public consultation opened; stakeholders can submit comments within the prescribed timeline. Goal to reduce compliance burden while preserving the highest safety standards for plasma‑derived medicinal products. Important Facts Under current Indian regulations, pooled human plasma is tested for Hepatitis B surface antigen (HBsAg) , hepatitis C virus RNA and HIV antibodies. Only plasma that tests negative proceeds to fractionation. However, the final medicinal products derived from these pools are subjected to the same set of tests again, creating a duplicate verification step not practiced in most advanced regulatory systems. The amendment proposes that once a plasma pool clears the initial viral screening, the downstream products will be exempt from repeat testing for the same markers, provided the manufacturing process adheres to Good Manufacturing Practices (GMP) and traceability is maintained. UPSC Relevance Understanding this amendment is vital for GS 1 (Society) and GS 3 (Science & Technology) sections. It illustrates: How India aligns its health‑regulatory framework with international standards, a key aspect of global health governance. The balance between patient safety and regulatory efficiency, reflecting policy‑making challenges. The role of public consultation in democratic policy formulation, a recurring theme in governance questions. Questions may be framed on the significance of pharmacopoeial harmonisation, the impact of reducing redundant testing on cost of blood‑derived therapies, and the procedural aspects of amending statutory rules. Way Forward Stakeholders—including manufacturers, blood banks, and civil‑society groups—are encouraged to review the draft and submit evidence‑based comments. If adopted, the amendment will streamline the regulatory pathway, potentially lowering the cost of plasma‑derived medicines and enhancing India’s compliance with World Health Organization (WHO) recommendations. Continuous monitoring will be essential to ensure that the single‑stage testing continues to guarantee product safety.