UPSC Darpan

Health & Life SciencesGS2 · GS36 October 2026

Centre weighs central licensing of all sterile drugs after courts limit CDSCO inspectors’ powers

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The news

New Delhi. The Centre is considering a legal opinion before bringing all sterile drug products under the Central Licence Approving Authority (CLAA) scheme, The Economic Times reports. Per ET, the Drugs Consultative Committee, which advises the Centre and States, discussed the proposal at a recent meeting and recommended a sub-committee to examine feasibility. The trigger, ET reports, is the Supreme Court’s dismissal of the Centre’s challenge to a Himachal Pradesh High Court ruling of June 22 that a CDSCO drugs inspector has no independent enforcement power under Chapter IV of the Drugs and Cosmetics Act, which governs manufacture, sale and distribution; executive powers there “ordinarily vest in the State Government”. The CLAA now covers only large-volume parenterals (big intravenous fluid bags), sera and vaccines, recombinant DNA, cell and gene therapy products and xenografts. States license small-volume injectables and eye drops, a framework the proposal calls fragmented.

The chain in one line: The 1940 Act leaves most manufacturing licences to States → the CLAA covers only a few high-risk categories → contaminated and spurious injectables expose uneven State inspection → courts confine CDSCO enforcement under Chapter IV → the Centre weighs central licensing of all sterile drugs

Static syllabus linkage

  1. The Drugs and Cosmetics Act, 1940 divides drug control between Centre and States. Drugs and poisons are Entry 19 of the Concurrent List. The Central Drugs Standard Control Organisation, headed by the Drugs Controller General of India, approves new drugs and clinical trials and regulates imports; State licensing authorities license manufacture and sale. The Drugs Technical Advisory Board (Section 5) advises on technical matters and the Drugs Consultative Committee (Section 7) secures uniform administration.
  2. Revised Schedule M sets modern manufacturing standards. Schedule M of the Drugs Rules, 1945 prescribes Good Manufacturing Practices. A revised Schedule M, notified in December 2023, moved Indian standards closer to WHO-GMP by requiring a pharmaceutical quality system and quality risk management, with a longer compliance window for smaller units.

Why UPSC loves this

  1. Drug quality is a test of health governance. GS2 lists “Issues relating to development and management of Social Sector/Services relating to Health”. Patient safety, a court ruling and Centre-State powers together make a ready governance case.

Prelims nuggets

  • “Drugs and poisons” is Entry 19 of the Concurrent List.
  • The Drugs Technical Advisory Board is constituted under Section 5, and the Drugs Consultative Committee under Section 7, of the Drugs and Cosmetics Act, 1940.
  • Chapter IV of the Drugs and Cosmetics Act, 1940 deals with the manufacture, sale and distribution of drugs and cosmetics.
  • Schedule M of the Drugs Rules, 1945 lays down Good Manufacturing Practices for pharmaceutical products.

Analysis

  1. The Centre has more responsibility than power, and a new rule may not close the gap. The High Court said the Act lets the Centre prosecute only under listed provisions such as Sections 26A, 26B and 33P. Central licensing would change who approves a licence, but inspection and prosecution would largely stay with States. That is why a legal opinion comes first: amending the Drugs Rules may not suffice, and the Act itself may need change. Centralising approval without enforcement adds paperwork, not safety.
  2. Lens — Centre and States: one standard for high-risk drugs, shared enforcement. An injectable made in one State reaches hospitals everywhere, so weak inspection anywhere becomes a national risk; that argues for one standard. But the CDSCO lacks the inspectors to replace State regulators, who know their units. The sensible judgement is central licensing for sterile products, joint inspections and a shared database of failed samples, not a takeover.
  3. Sterile products deserve risk-based regulation. A tablet meets the gut’s defences; an injection or eye drop enters the body directly, so one microbial lapse can harm many patients. Risk-based regulation puts the strictest checks where harm is greatest. The counter-view is cost: small makers already facing revised Schedule M may exit, causing shortages of cheap injectables. A phased timeline with technical help answers that better than exemption.

Possible Mains question

Critically examine whether central licensing of all sterile drugs can fix India’s drug-quality problem, given the States’ role under the Drugs and Cosmetics Act, 1940. (15 marks, 250 words)

Model approach

  1. Directive — Critically examine. Weigh the gains of central licensing against its legal and capacity limits; conclude.
  2. Introduction — courts have confined CDSCO enforcement while sterile-drug failures persist. Cite the Himachal HC ruling and the DCC proposal, as ET reports.
  3. Central licensing gives one standard for the riskiest products. Value addition: revised Schedule M (December 2023).
  4. Licensing without enforcement power is not enough. Chapter IV powers rest with States; the Act may need amendment.
  5. Cooperative regulation is the workable middle. Draw a flowchart: central licence → joint inspection → shared failed-sample database → State prosecution.
  6. Conclusion — centralise standards, share enforcement. Fund State capacity alongside the reform.

Administrator's brainstorm

As a State Drugs Controller, eye drops from a unit in your State are reported contaminated elsewhere. What do you do?

I would recall the batch and suspend production pending inspection, since Chapter IV powers lie with the State. I would inspect jointly with CDSCO so findings carry weight everywhere, alert other controllers, and prosecute if samples fail. Fast, open action protects patients and the regulator’s credibility.