Evaluate the centre-state dynamics in drug regulation in India, with reference to the roles of CDSCO and State Licensing Authorities.

Drug regulation in India rests on a dual architecture created by the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945 — the Centre sets standards while States licence and enforce [2]. This division delivers federal flexibility but suffers from uneven enforcement capacity.

Division of roles

• CDSCO, under MoHFW, is the National Regulatory Authority — it lays down standards, approves new drugs and clinical trials, regulates imports, and coordinates nationally [3].
• State Licensing Authorities, appointed by State Governments, issue and enforce most manufacturing and sale licences, making States the operational front line of enforcement [2].
• Health and public health being a State subject, while drug standards are centrally fixed, makes the arrangement inherently cooperative-federal.

Merits of the arrangement

• Enables local responsiveness — thousands of retail and manufacturing units cannot be licensed from Delhi alone.
• Central rule-making keeps standards uniform; the 2025 amendment to the Drugs Rules, 1945 (G.S.R. 756(E), 16 October 2025) empowering Licensing Authorities to debar entities submitting fake or fabricated data applies across all States at once [1].
• Due process built into the new debarment power — show-cause notice and appeal — protects legitimate manufacturers from arbitrary State action [1].

Weaknesses

• Uneven capacity across State Drug Control Organisations means a centrally notified tool such as debarment may be applied vigorously in some States and rarely in others [1].
• Firms may exploit differential rigour by forum-shopping for licences in laxer States, diluting national standards.
• Earlier, fabricated data invited only rejection or licence cancellation, with no bar on fresh applications — a gap that persisted precisely because enforcement was fragmented [1].

On balance, the dual structure is sound in design but weak in execution: its worth depends less on legal architecture than on State-level administrative capacity. The way forward lies in uniform training, shared data systems and central handholding of weaker State regulators — so that cooperative federalism in drug regulation genuinely secures the right to health under Article 21.