Examine the institutional architecture of drug regulation in India, referencing the Drugs and Cosmetics Act, 1940, and the role of CDSCO.

Q. Examine the institutional architecture of drug regulation in India, referencing the Drugs and Cosmetics Act, 1940, and the role of CDSCO. (15 marks, 250-350 words)

India regulates medicines through a two-tier federal architecture built on the Drugs and Cosmetics Act, 1940 — the Centre approves new drugs and imports, while States license manufacture and sale. CDSCO's marketing authorisation for Qdenga®, India's first dengue vaccine [1], offers a live test of how this architecture performs.

Statutory foundation: the Act and its rules - The Act, with the Drugs Rules, 1945, governs import, manufacture, distribution and sale of drugs, cosmetics and medical devices [2]. - It is layered with subordinate rules — Medical Devices Rules, 2017, New Drugs and Clinical Trials Rules, 2019, and Cosmetics Rules, 2020 [2]. - Qdenga® was cleared under precisely this legal basis, as an imported biological [1].

The central tier: CDSCO - CDSCO, under the Directorate General of Health Services, MoHFW, and headed by the DCGI, is India's National Regulatory Authority [2]. - Its mandate: approving new drugs and vaccines, regulating clinical trials, laying down standards, controlling quality of imports, and coordinating State drug controllers [2]. - It operates through zonal, sub-zonal, port offices and testing laboratories [2]. For Qdenga®, it cleared the vaccine for ages 4–60 after an Indian-population Phase III study [1].

The State tier and technical bodies - State drug control organisations issue manufacturing and sale licences and conduct inspections, producing uneven enforcement capacity across States. - The Drugs Technical Advisory Board and Drugs Consultative Committee, statutory bodies under the Act, supply technical advice and Centre–State harmonisation [2].

Persisting weaknesses - The 59th Parliamentary Standing Committee on Health (2012) documented severe understaffing and weak scrutiny in CDSCO's approval process [3]. - Continued import dependence: Qdenga® is a Takeda (Germany) product [1], while the indigenous candidate DengiAll (ICMR–Panacea Biotec) is still in Phase 3 [4].

The architecture is legally sound but institutionally thin. Strengthening CDSCO's technical manpower, deepening online licensing transparency, and backing indigenous vaccine development would convert regulatory approval into genuine, affordable public health access — advancing the right to health under Article 21 and SDG-3.

(~325 words)

Sources: 1. CDSCO Approves India's First Dengue Vaccine, Strengthening National Dengue Prevention Efforts, PIB (21 July 2026) — Qdenga® approval, Takeda manufacture, age group 4–60, Indian Phase III, legal basis 2. CDSCO — Acts and Rules / Drugs and Cosmetics Act, 1940 — statutory framework, subordinate rules, CDSCO's status as NRA, functions, field offices, DTAB/DCC 3. 59th Report, Department-Related Parliamentary Standing Committee on Health and Family Welfare: Functioning of CDSCO (2012) — understaffing and approval-scrutiny gaps 4. ICMR and Panacea Biotec initiate the First Dengue Vaccine Phase 3 Clinical Trial in India with DengiAll, PIB — indigenous vaccine candidate status