Examine the institutional mechanism (DTAB) involved in regulating drug imports under the Drugs and Cosmetics Act, 1940.

Q. Examine the institutional mechanism (DTAB) involved in regulating drug imports under the Drugs and Cosmetics Act, 1940. (15 marks, 250-350 words)

The Drugs Technical Advisory Board (DTAB), constituted under the Drugs and Cosmetics Act, 1940, is India's apex technical advisory body on drug regulation, advising the Centre and States on technical matters arising from the Act's administration [3]. Its recent role in notifying Navi Mumbai Airport as a port for drug import shows how this expert mechanism operationalises import control.

Statutory design and composition - Functions under the Drugs and Cosmetics Act, 1940, with meetings coordinated under the chairmanship of the Director General of Health Services (DGHS); it must meet at least once every calendar year [3]. - Combines ex-officio officials with domain experts, insulating technical decisions from purely administrative discretion; each member has one vote, the Chairman holding a casting vote [3]. - Serviced by the CDSCO, the executive drug regulator, giving advice-to-enforcement continuity [3].

Role in regulating drug imports - Rule 43A of the Drugs Rules, 1945 operates as a positive list: drugs may enter India only through notified ports, making DTAB-vetted notification a legal precondition for any import gateway. - Amendments to this list are issued by the Ministry of Health and Family Welfare after consultation with DTAB, as mandated by the parent Act [1]. - Example: on 8 July 2026, Navi Mumbai Airport was added, taking notified ports of entry across air, sea, road and rail to 42 [1] — leveraging the greenfield airport inaugurated in October 2025 [2].

Assessment - Strengths: technical rigour is preserved even where the objective is trade facilitation; the subordinate-legislation route allows quick response to new infrastructure without amending the Act. - Limitations: an advisory board meeting infrequently, dependent on CDSCO's stretched inspectorate, can lag behind rising import volumes; enforcement capacity at each new port must scale correspondingly.

DTAB thus supplies the scientific spine to India's import-control architecture, balancing patient safety with the logistics needs of the "pharmacy of the world". Strengthening port-level testing laboratories, digitising clearance, and holding more frequent DTAB sittings would let this consultative mechanism keep pace with expanding trade — advancing both Article 21's guarantee of health and SDG-3.

(~330 words)

Sources: 1. Government notifies Navi Mumbai Airport as a Port for Import of Drugs under the Drugs Rules, 1945 — PIB, MoHFW (8 July 2026) — Rule 43A amendment, DTAB consultation, 42 notified ports 2. PM inaugurates Navi Mumbai International Airport — PIB (8 October 2025) — greenfield airport operationalisation 3. DTAB–DCC, Central Drugs Standard Control Organisation (CDSCO) — statutory basis, DGHS chairmanship, by-laws, advisory function