Blood Screening & National Blood Transfusion Bill, 2025
Context:
The National Blood Transfusion Bill, 2025 has been introduced in Parliament to create a central regulatory framework for blood services.
Concurrently, patient advocacy groups (Thalassemia Patients Advocacy Group) are demanding the mandatory implementation of Nucleic Acid Amplification Testing (NAAT) to achieve zero risk of Transfusion-Transmitted Infections (TTIs).
Key Provisions of the Bill:
It establishes a National Blood Transfusion Authority (NBTA) to enforce uniform standards for collection, testing, and storage nationwide.
All blood centres (formerly blood banks) must register with the NBTA; unlicensed operation will attract strict penalties.
It prioritizes voluntary, non-remunerated donation, aiming to phase out replacement donation.
Haemovigilance:
Mandates a system for tracking adverse reactions and ensures donor traceability.
ELISA vs. NAAT
Current regulations under the Drugs and Cosmetics Act mandate screening for HIV, HBV, HCV, Syphilis, and Malaria, primarily done using ELISA.
The demand is to shift to NAAT.
Feature
ELISA (Enzyme-Linked Immunosorbent Assay)
NAAT (Nucleic Acid Amplification Test)
What it Detects?
It looks for the immune system's response (antibodies) or viral proteins (antigens).
It directly detects the DNA or RNA of the virus itself.
Window Period
It takes time for the body to produce antibodies.
For example, HIV window period is approx. 3-4 weeks
It can detect the virus before antibodies form.
For example, HIV window period reduces to 7-11 days
Sensitivity
Might miss infections in the very early stages (window period) or occult infections.
Extremely sensitive
Can detect very low levels of viral load.
Cost & Complexity
Less expensive, requires standard lab equipment.
Expensive, requires advanced molecular lab infrastructure