Breaking SUPREME COURT REAFFIRMS PUBLIC DOMAIN PROTECTION FOR DIGITAL LAWS
New Delhi · Sunday, 20 September 2026 9888666310 | [email protected]
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Supreme Court of India 2017-12-15 disposed

Union of India and Anr vs Pfizer Limited and Ors

Bench: 2 — R.F. Nariman

In Brief

The Supreme Court resolved whether the Central Government must consult the Drugs Technical Advisory Board (DTAB) before banning medicines under Section 26A of the Drugs and Cosmetics Act. The Court held that while consultation is not legally mandatory, the Government must base its ban decision on expert advice and relevant material showing the drug poses public health risks or lacks therapeutic value. The Court approved bans of 344 Fixed Dose Combinations by the Central Government but directed the DTAB to re-examine them with deeper analysis, ensuring affected manufacturers and health advocates are heard before final decisions are made.

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Drugs and Cosmetics Law Administrative Law Statutory Interpretation Public Health Pharmaceutical Regulation Fixed Dose Combinations (FDCs) Judicial Review

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