In News:

The Government has introduced the National Blood Transfusion Bill, 2025 in Parliament to create a dedicated legal and institutional framework for blood transfusion services in India. At present, blood and blood components are regulated under the Drugs and Cosmetics Act, a law primarily designed for pharmaceuticalsseen as inadequate for managing blood as a life-saving public health resource. The new Bill seeks to move the sector into a clear, safety-first national system with uniform standards and stronger oversight.

Why a New Law?

• Public health sensitivity: Blood transfusion carries risks of transfusion-transmitted infections and adverse reactions, requiring rigorous quality control.
• Regulatory gaps: The existing drug-law framework does not fully address donor management, component therapy, traceability, and haemovigilance.
• Standardisation need: Wide variation in practices across States and facilities necessitates uniform national standards.

Institutional Architecture

The Bill provides for a statutory National Blood Transfusion Authority (NBTA). As the apex technical and regulatory body, NBTA will frame national norms and coordinate with State authorities to ensure consistent implementation.

Core Regulatory Provisions

• Uniform standards across the chain: NBTA will prescribe norms for collection, testing, processing, storage, distribution, issue, and transfusion of whole blood and components (e.g., packed red cells, platelets, plasma).
• Mandatory registration: All blood centres will require registration/authorization, improving traceability and accountability.
• Quality and safety protocols: Emphasis on validated testing, component separation, cold-chain maintenance, and documentation.
• Haemovigilance system: A national haemovigilanceprogramme will monitor and analyse transfusion-related adverse events to improve safety practices.
• Ethics and compliance: The Bill proposes stringent penalties for unsafe collection, improper storage, unlicensed operations, or other unethical practices.
• Promotion of voluntary donation: Strengthened, coordinated efforts to increase voluntary, non-remunerated blood donation, reducing reliance on replacement donations.

Expected Impact

• Patient safety:Standardised screening and monitoring reduce risks of infections and transfusion reactions.
• System efficiency: Better inventory management and component use can improve availability, especially during emergencies.
• Transparency and trust: Clear legal backing and oversight enhance public confidence in blood services.
• Data-driven regulation:Haemovigilance enables continuous quality improvement based on evidence.