Examine the Centre-State coordination challenges in enforcing pharmaceutical regulations in India.

Q. Examine the Centre-State coordination challenges in enforcing pharmaceutical regulations in India. (15 marks, 250-350 words)

Drugs and poisons fall under Entry 19 of the Concurrent List: the Centre, through CDSCO, frames rules and approves new drugs, while State Drug Control Authorities licence manufacture and sale [2]. Enforcement therefore rests on a federal handshake that remains structurally uneven.

Structural roots of the friction - Split mandate: rule-making and scheduling under the Drugs and Cosmetics Act, 1940 vest with the Union Health Ministry, but State Drug Authorities are the licensing authorities for marketing drugs [2]. - Central notification, State execution: the 2026 amendment removing the Schedule K licensing exemption for oral formulations above 12% v/v ethyl alcohol in packings over 30 ml and placing them under Schedule H1 was notified centrally, yet prescription-only sale and record-keeping must be policed by state inspectors [1].

Coordination challenges in practice - Divergent standards: varying interpretation across state licensing authorities enables regulatory "forum shopping" by manufacturers. - Capacity asymmetry: the Parliamentary Standing Committee's 59th Report (2012) on CDSCO functioning flagged thin regulatory staffing and weak approval scrutiny [2]; state inspectorates are similarly stretched. - Delayed transmission: every central Schedule change requires fresh state circulars, inspector training and market surveys before it bites. - Overlapping jurisdictions: alcohol being a State excise subject, high-alcohol medicinal preparations straddle drug-control and excise machinery. - Information asymmetry: misuse of alcohol-based tinctures surfaced only through references from certain State Governments to the Centre — reactive, not systemic, feedback [1].

Consequences - Uneven consumer protection and persistence of spurious and substandard drugs, the very concern the Mashelkar Committee (2003) examined while recommending a stronger regulatory system [3].

The way forward lies in cooperative rather than parallel regulation: activating the Drugs Consultative Committee as a genuine harmonisation forum [4], a unified online licensing and traceability platform, joint Centre-State inspections, and central assistance to upgrade state drug laboratories. Aligning regulatory capacity with SDG-3's medicine-safety goal would convert a divided mandate into shared stewardship of public health.

(~320 words)

Sources: 1. Government amends Drugs Rules, 1945 to Strengthen Regulation of High Alcohol-Containing Drug Formulations — PIB, Ministry of Health and Family Welfare — Schedule K exemption withdrawn, 12% v/v / 30 ml threshold, shift to Schedule H1, State Government references on misuse 2. Lapses in the process of drug approval in India — PRS Legislative Research — State Drug Authorities as licensing authorities; 59th Standing Committee Report (2012) on CDSCO functioning 3. Spurious Drugs — Central Drugs Standard Control Organisation — Mashelkar Committee (2003) on strengthening the drug regulatory system 4. Drugs Consultative Committee (DCC) minutes — CDSCO — statutory Centre-State consultative forum on uniform drug administration