UNION OF INDIA AND ANR. versus PFIZER LIMITED AND ORS.

UNION OF INDIA AND ANR. versus PFIZER LIMITED AND ORS.

Consultation with the DTAB is not a mandatory precondition for the exercise of power by the Central Government under Section 26A of the Drugs and Cosmetics Act, 1940. Section 26A confers an independent, additional power, and as long as the satisfaction of the Government is founded on relevant material, absence of DTAB consultation does not invalidate the notifications; however, a re-examination by the DTAB is mandated in these cases on factual grounds regarding the rationale for prohibiting the specified FDCs.

Parties
Appellant: Union of India; Respondent: Pfizer Limited
Jurisdiction
India
Judgment Date
15 December 2017
Procedural Posture
Civil Appeal / Disposal After Hearing on Appeals and Transferred Cases
Outcome
Appeals disposed of with directions
Legal Topics
Exercise of Delegated Legislative Powers Under Drugs and Cosmetics Act, 1940, Requirement of Consultation With Drugs Technical Advisory Board (dtab) Under S. 26 a, Banning/regulation of Fixed Dose Combinations (fdcs), Judicial Review of Central Government Notifications, Interpretation of Statutes
Administrative Law Pharmaceutical Law Constitutional Law Exercise of Delegated Legislative Powers Under Drugs and Cosmetics Act, 1940 Requirement of Consultation With Drugs Technical Advisory Board (dtab) Under S. 26 a Banning/regulation of Fixed Dose Combinations (fdcs) Judicial Review of Central Government Notifications Interpretation of Statutes

Case Brief

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Parties

Union of India

Appellant

Pfizer Limited

Respondent

Procedural Posture

Civil Appeal / Disposal After Hearing on Appeals and Transferred Cases

Legal Issues

  1. 1 Whether consultation with the Drugs Technical Advisory Board (DTAB) is mandatory before exercising powers under Section 26A of the Drugs and Cosmetics Act, 1940 by the Central Government
  2. 2 Whether the Central Government's action in banning certain Fixed Dose Combinations (FDCs) without DTAB consultation is valid under s. 26A
  3. 3 Scope and nature of Central Government's satisfaction under Section 26A for banning, regulating, or restricting drugs

Ratio Decidendi

Consultation with the DTAB is not a mandatory precondition for the exercise of power by the Central Government under Section 26A of the Drugs and Cosmetics Act, 1940. Section 26A confers an independent, additional power, and as long as the satisfaction of the Government is founded on relevant material, absence of DTAB consultation does not invalidate the notifications; however, a re-examination by the DTAB is mandated in these cases on factual grounds regarding the rationale for prohibiting the specified FDCs.

Court Disposition

Appeals disposed of with directions

Orders

  • Cases concerning 344 FDCs and additional 5 FDCs banned by notifications are sent to the DTAB/Sub-Committee for independent review and report to the Central Government.
  • DTAB/Sub-Committee to hear manufacturers/appellants and All India Drugs Action Network, consider Section 26A parameters, and submit a consolidated report within six months.