Home / Health / Ministry Eyes End to Redundant Blood Product Tests
Ministry Eyes End to Redundant Blood Product Tests
11 Mar
Summary
- Proposed dropping Hepatitis B and HIV tests for blood products.
- Ministry cites regulatory harmonization and reduced compliance burden.
- Stakeholders invited to comment on the draft notification.
The union health ministry has put forth a proposal to discontinue mandatory pre-manufacturing testing of blood products for Hepatitis B surface antigen, HIV antibodies, and Hepatitis C antibodies. This potential change, detailed in a draft notification, suggests removing the requirement for these specific tests before blood products are manufactured.
The ministry's rationale centers on achieving regulatory harmonization, scientifically rationalizing testing needs, and easing compliance burdens for manufacturers, all while maintaining high patient safety standards. Currently, the process involves testing pooled plasma for these viral markers, and only compliant pools are used for fractionation.
However, the existing framework mandates a second round of testing on the final products derived from these already-qualified plasma pools. The ministry views this as redundant duplication of testing efforts. This proposal emerges amidst calls from patient groups for even more stringent blood safety norms, including the adoption of nucleic acid amplification testing (NAAT) to shorten the infection detection window period.
