Discuss the federal architecture of drug regulation in India and the role of CDSCO vis-à-vis State Drug Controllers.

Q. Discuss the federal architecture of drug regulation in India and the role of CDSCO vis-à-vis State Drug Controllers. (15 marks, 250-350 words)

Drugs and poisons fall under Entry 19, List III (Concurrent List) of the Seventh Schedule, making drug regulation a shared responsibility exercised through the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945. The 2025-26 diethylene glycol (DEG) cough syrup tragedy has renewed scrutiny of this dual architecture.

The federal design - Centre: frames the parent Act and Rules, and amends schedules through delegated legislation — as with G.S.R. 927(E), which omitted "Syrup" from Schedule K, ending the licence exemption for villages under 1,000 population [1]. - States: implement the same law through State Drug Controllers, who license manufacture, sale and distribution and deploy drug inspectors on the ground [3]. - Uniformity of standards is thus central; enforcement is overwhelmingly provincial.

Role of CDSCO - Apex national regulator under DGHS, MoHFW, headed by the DCGI; approves new drugs and clinical trials, regulates imports, and sets Schedule M (GMP) norms. - Acts as the international interface — it reported DEG contamination in three oral liquid medicines to the WHO on 8 October 2025, preceding Medical Product Alert N°5/2025 [4]. - Issues uniform drug sampling guidelines and runs the SUGAM Labs portal integrating testing laboratories [3].

Role and friction with State Drug Controllers - States grant nearly all manufacturing and retail licences, creating regulatory heterogeneity — variable inspection capacity and forum-shopping by firms. - Coordination works best jointly: CDSCO and state regulators have conducted risk-based inspections of hundreds of units, yielding stop-production orders and licence suspensions [3]. - Last-mile gaps persist; unlicensed rural outlets sold syrups until the Schedule K withdrawal [1].

Drug regulation therefore succeeds only when central standard-setting is matched by state enforcement capacity. Strengthening state drug testing laboratories, a common digital licensing platform, and harmonised inspection norms — as recommended by the Mashelkar Committee — would convert dual control into cooperative federalism, advancing Article 47's mandate to raise public health.

(~330 words)

Sources: 1. Union Ministry of Health and Family Welfare Amends Drugs Rules, 1945; Exemption for Sale of Cough Syrups in Small Villages Withdrawn (PIB) — G.S.R. 927(E), omission of "Syrup" from Schedule K, village population threshold 2. Contaminated medicines affecting children — Q&A (WHO) — DEG/EG contamination of paediatric syrups and its dangers 3. Steps taken to Prevent Sale of Adulterated Drugs (PIB) — state licensing role, joint risk-based inspections, sampling guidelines, SUGAM Labs 4. Medical Product Alert N°5/2025: Substandard (contaminated) oral liquid medicines (WHO, 13 Oct 2025) — CDSCO's 8 October 2025 report to WHO