·PIB·15 marks·250–350 words

Discuss the role of the Drugs Technical Advisory Board in India's drug regulation and the challenges of Centre–State coordination in enforcing drug laws.

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In this answer
  1. Role of DTAB
  2. Challenges of Centre–State coordination

India's drug regulation is split between two levels of government. "Drugs and poisons" is a Concurrent List subject. The Centre makes the rules, while the States license and inspect most manufacturers and chemists. The Drugs Technical Advisory Board (DTAB), set up under Section 5 of the Drugs and Cosmetics Act, 1940, gives technical advice to both levels [1].

Role of DTAB

  • Statutory expert adviser: It advises the Central and State Governments on technical matters arising from the Act [1].
  • Expert composition: The Director General of Health Services chairs it. Its members include the Drugs Controller (India) and heads of central laboratories, along with nominated and elected experts [1].
  • Shapes the rules: The Centre generally frames rules under the Act after consulting the Board [1]. For example, its 93rd meeting (Feb 2026) recommended the draft Rule 65(22). This rule would bar retailers and wholesalers from advertising Schedule H, H1 and X drugs without the Centre's prior approval [2].
  • Supports participatory rule-making: DTAB's advice feeds into draft notifications that are opened for 30 days of public objections [2].

Challenges of Centre–State coordination

  • Approval and punishment are split: Under the draft rule, the Centre approves drug advertisements [2]. But only the State Licensing Authority can suspend or cancel a seller's licence under Rule 66 [3]. The draft does not require the Centre to publish the approvals it grants, so State inspectors cannot easily tell whether an advertisement is legal [2].
  • Uneven State capacity: The number of inspectors and testing laboratories varies widely across States, so the same law is enforced unevenly.
  • Weak paper trail: Only Schedule H1 sales have to be recorded in a register kept for 3 years [3]. Ordinary Schedule H sales leave no record for inspectors to check.
  • Digital gaps: Online platforms that do not hold a sale licence fall outside licence-based controls [2].
  • Advisory, not binding: DTAB advises but cannot enforce. The Drugs Consultative Committee under Section 7 is meant to keep enforcement uniform across States [1].

DTAB is the technical base of drug policy, but the system's weakest link is the gap between Central rules and State enforcement. Publishing all Central approvals online, building up State drug-control staff, and giving DTAB's guidance a clearer role across States would make enforcement more uniform. This would support the right to health under Article 21 and SDG 3.

Sources

  1. 1The Drugs and Cosmetics Act, 1940 (PRS India)Section 5 (DTAB's mandate and members), Section 7 (Drugs Consultative Committee), consulting the Board before rules are framed
  2. 2PIB: Union Health Ministry Proposes Tighter Curbs on Advertising of Prescription Drugs by Retailers and Wholesalers (Release ID 2321172)93rd DTAB meeting, draft Rule 65(22), Central approval of advertisements, 30-day objection window
  3. 3Drugs and Cosmetics Act, 1940 and Rules, 1945 (PRS India)Rule 65 licence conditions, Rule 66 licence suspension or cancellation, Schedule H1 sales register

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