·The Hindu·15 marks·250–350 words

Drug regulation in India suffers from a Centre-State coordination deficit. Examine with reference to recent counterfeit drug rackets.

In this answer
  1. How the architecture divides responsibility
  2. What recent rackets expose
  3. Where coordination does work

The Drugs and Cosmetics Act, 1940 places drug regulation on a shared footing — the Centre sets standards while States license and police manufacture and sale [1]. Recent counterfeit rackets show this division becoming a coordination deficit in enforcement, though not a total institutional failure.

How the architecture divides responsibility

  • CDSCO, under the Health Ministry, approves new drugs, regulates imports and lays down standards; State Drug Controllers grant manufacturing and retail licences and conduct routine inspection [1].
  • Enforcement capacity therefore varies State by State, while the drug market itself is national and seamless.

What recent rackets expose

  • The Bidadi (Karnataka) racket, uncovered in raids on 18 August 2026, ran from an unlicensed farmhouse unit: expired and relabelled cancer drugs and ICU injections of about ₹5 crore label value reached over 90 hospitals and clinics — invisible to routine State surveillance [4].
  • Bulk drugs were sourced from other States and repackaged as imported brands, with one accused fleeing abroad — exposing the absence of standing inter-State investigative channels; Karnataka's response was an ad hoc SIT [4].
  • The earlier Kolkata seizure of suspected spurious anti-cancer and anti-diabetic drugs likewise required a specially mounted CDSCO–West Bengal joint operation, not a routine mechanism [3].
  • Deterrence is weak: the Act's baseline penalty for spurious drugs is imprisonment up to three years, modest against rackets of this scale [2].

Where coordination does work

  • Risk-based inspections run jointly by CDSCO and State controllers since December 2022 covered 905 units, yielding 694 enforcement actions [2].
  • Monthly Drug Alerts pool central and State sample failures into a single national picture [1].

The deficit is thus one of capacity, surveillance and information-sharing, not of legal authority. Institutionalising joint CDSCO–State enforcement cells, uniform inspectorate staffing, and mandatory barcode-based track-and-trace would convert episodic raids into continuous oversight — making cooperative federalism the guarantor of the right to safe medicines under SDG-3.

Sources

  1. 1CDSCO — Spurious Drugs (Central Drugs Standard Control Organisation)CDSCO's role as national drug regulator, Centre–State split of licensing and surveillance, Drug Alerts
  2. 2Steps taken to Prevent Sale of Adulterated Drugs, PIBrisk-based inspections since December 2022, 905 units inspected, 694 actions; penal provisions under the Drugs and Cosmetics Act, 1940
  3. 3Union Health Ministry takes swift action against Spurious Drugs; Major Seizure in Kolkata, PIBCDSCO–West Bengal joint operation against spurious anti-cancer and anti-diabetic drugs
  4. 4"Antidote to drugs", The Hindu, 21 September 2026Bidadi raids of 18 August 2026, ₹5 crore label value, supply to 90+ hospitals, inter-State sourcing, SIT

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