Drug regulation in India suffers from a Centre-State coordination deficit. Examine with reference to recent counterfeit drug rackets.
In this answer
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
- 1CDSCO — Spurious Drugs (Central Drugs Standard Control Organisation)CDSCO's role as national drug regulator, Centre–State split of licensing and surveillance, Drug Alerts
- 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
- 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"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