Critically examine the limitations of ELISA-based blood screening in India and evaluate how adoption of Nucleic Acid Testing (NAT) can address the residual risk of transfusion-transmitted infections. What governance model would best suit India's federal structure?

Safe blood is integral to the right to life under Article 21, yet most Indian blood banks still screen only by ELISA. The Supreme Court, examining a plea for mandatory NAT, flagged whether resource-constrained States could fund it [1] — framing this as a science-versus-fiscal-capacity question.

Limitations of ELISA-based screening

• ELISA detects antibodies/antigens, not viral genetic material, so recently infected donors test false-negative during the serological window period [4].
• Residual risk is measurable: a 15-year study of 2.1 lakh donations found 205 infections missed by serology (about 1 per 1,005 donations), of which 79.76% were HBV [2].
• The burden falls hardest on repeat-transfusion patients — thalassaemia, haemophilia and cancer cases — converting a rare per-unit risk into a cumulative one.

Evaluating NAT's contribution

• NAT directly amplifies viral RNA/DNA, shrinking the window from weeks to days and cutting residual risk sharply [4].
• Madhya Pradesh's centralised programme found 943 NAT-reactive units among 1.58 lakh seronegative samples (1 in 168) that serology cleared [3].
• Limits persist: individual-donation NAT is capital-intensive, needs trained manpower and assured volumes; pooled NAT dilutes sensitivity; and NAT supplements, not replaces, serology.
• Verdict: the safety gain is proven, but cost-effectiveness collapses at low-throughput district banks — so universal uniform mandating is premature.

A workable governance model Public health is a State subject (Entry 6), but blood products are centrally regulated through the Drugs and Cosmetics Act, 1940 and CDSCO — permitting standard-setting without coercion. The optimal design is a hub-and-spoke centralised NAT network on the Madhya Pradesh public-private partnership template [3], with Centre-funded capital costs and State-run operations, phased from high-volume centres outward.

Blood safety is therefore best advanced not by an unfunded judicial mandate but by cooperative federalism — CDSCO setting the norm, regional hubs delivering economies of scale, and a revised National Blood Policy anchoring the transition, moving India toward SDG-3 and a genuinely enforceable Article 21 guarantee.