With public health being a State subject, how should the Centre ensure uniform blood safety standards, including advanced molecular screening technologies, across all States? Discuss with reference to the Drugs and Cosmetics Act framework.

Q. With public health being a State subject, how should the Centre ensure uniform blood safety standards, including advanced molecular screening technologies, across all States? (15 marks, 250-350 words)

Although public health is Entry 6 of the State List, human blood is a "drug" under Section 3(b) of the Drugs and Cosmetics Act, 1940 [1]. The Centre therefore possesses a standard-setting lever; uniformity must be achieved through regulation plus co-financing, not unfunded mandates.

The existing legal architecture - Blood centres are licensed against conditions in Schedule F, Part XII-B of the Drugs and Cosmetics Rules, 1945, covering accommodation, staff, equipment and mandatory screening for HIV, HBV, HCV, syphilis and malaria [1]. - Licences are granted by State Licensing Authorities while norms are Centrally prescribed — a built-in cooperative federal model needing no fresh legislation [1].

Route 1: Regulatory upgradation - Any Nucleic Acid Test (NAT) mandate requires amending Part XII-B to add molecular screening alongside, not in place of, serology. - A tiered, phased notification — beginning with regional referral and thalassaemia-serving centres — avoids shutting down small district blood centres.

Route 2: Institutional convergence - The National Blood Transfusion Council (NBTC), constituted in 1996 pursuant to a Supreme Court directive and housed in NACO, is the apex policy body and coordinates State Blood Transfusion Councils [2]. - Updating the National Blood Policy, 2002 and NBTC standards to cover molecular screening would harmonise practice across States [2][4].

Route 3: Fiscal design and technology choice - WHO recommends serological plus NAT screening and notes many countries use centralised hub-and-spoke NAT models for efficiency [3]; Madhya Pradesh's centralised model shows domestic feasibility. - Pooled NAT and regional hubs cut per-unit cost; Central co-financing through NACP/NHM addresses the fiscal-capacity objection that led the Court to defer to the executive.

Route 4: Assurance and accountability - Mandatory external quality assessment — globally only 63% of screening laboratories participate [3] — plus haemovigilance reporting and e-Rakt Kosh-based transparency [4].

Uniform blood safety is best secured not by judicial fiat but by the Centre setting graded statutory standards, financing the technology gap, and letting States implement through regional hubs. Such calibrated cooperative federalism converts safe transfusion from a privilege of well-resourced States into a substantive Article 21 guarantee for every patient.

(~330 words)

Sources: 1. CDSCO, Regulatory Requirements of Blood and/or Its Components, Ministry of Health & Family Welfare — blood as a "drug" under Sec. 3(b), Schedule F Part XII-B licensing conditions, mandatory TTI tests, State Licensing Authority role 2. National Blood Transfusion Council (NBTC), NACO, MoHFW — NBTC constituted 1996 on Supreme Court directive, apex policy body, coordination of SBTCs, National Blood Policy 2002 3. WHO, Blood safety and availability fact sheet — serology plus NAT screening recommendation, centralised hub-and-spoke NAT models, 63% laboratory participation in external quality assessment 4. NBTC Policies and Guidelines, MoHFW — national standards and guidelines for blood centres, haemovigilance and e-Rakt Kosh reporting