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

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.