Examine the challenges in enforcing the Drugs and Cosmetics Act, 1940 against inter-State counterfeit drug rackets, and the case for a stronger central coordinating mechanism.
The Drugs and Cosmetics Act, 1940, with the Rules of 1945, is India's principal law against spurious drugs, defining them under Section 17B and prescribing imprisonment of not less than seven years, extending to life, where a spurious drug is sold [1][2]. Yet the recent Bengaluru racket — counterfeit cancer drugs and ICU injections allegedly repackaged at a farmhouse and supplied to over 90 hospitals across five States — shows that stringent law is not matched by enforcement capacity.
Challenges in enforcement
- Fragmented federal architecture: licensing and inspection rest largely with State Drugs Controllers, while CDSCO handles central licensing [1]. Rackets deliberately split manufacturing, labelling and distribution across States to fall between jurisdictions.
- Territorial limits of policing: State SITs cannot seamlessly search or prosecute across State lines, forcing ad hoc CBI referrals after crucial delay.
- Weak supply-chain traceability: QR-code authentication was extended only recently, and in stages, from the top-300 brands to vaccines, antimicrobials and anti-cancer drugs [3]; unlicensed repackaging units and informal courier chains remain invisible.
- Procurement failures: hospitals and pharmacies buying at steep discounts without verifying source convert a manufacturing crime into a patient-safety catastrophe, engaging the right to health under Article 21.
- Inspectorate and testing deficits: thin drug-inspector strength and limited testing laboratories mean detection is often incidental rather than systematic.
The case for stronger central coordination
- Inter-State organised crime needs a single investigating and intelligence-sharing authority, with a national spurious-drug database linking State seizures.
- Central-State joint operations have demonstrably worked, as in the Health Ministry's coordinated seizure of spurious drugs in Kolkata [4]; institutionalising such action would replace episodic raids.
- Uniform licensing standards and risk-based inspections would end forum-shopping by offenders.
Counterfeit drugs are less a licensing lapse than a federal coordination failure. Strengthening CDSCO as a coordinating National Regulatory Authority, mandating end-to-end traceability, and enforcing procurement due diligence would protect patients and safeguard India's standing as the "pharmacy of the world."
Sources
- 1Drugs and Cosmetics Act, 1940 and Rules, 1945 — CDSCO, Ministry of Health & Family Welfarestatutory framework; CDSCO as National Regulatory Authority; Centre–State division of licensing
- 2The Drugs and Cosmetics Act, 1940 (full text), India CodeSection 17B definition of spurious drug and penalty provisions
- 3Union Health Ministry Expands QR Code-Based Drug Traceability Framework, PIBphased QR-code traceability from top-300 brands to vaccines, antimicrobials and anti-cancer drugs
- 4Union Health Ministry takes swift action against Spurious Drugs; Major Seizure in Kolkata, PIBCentre–State joint enforcement action against spurious drugs