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

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.