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Supreme Court of India 2019-11-15 dismissed

M/S T.C.HEALTHCARE P. LTD vs UNION OF INDIA

Bench: 4 — Rohinton Fali Nariman, S. Ravindra Bhat, Arun Mishra, Vineet Saran

In Brief

TC Healthcare and Modi Mundipharma challenged notifications fixing ceiling prices on drug formulations containing Frusemide and Theophylline. The appellants, exempted as small-scale units from price control, argued that the ceiling prices were invalid because they did not account for sustained and continuous release drug delivery technologies. The Supreme Court held that price fixation is a legislative exercise applicable to all manufacturers. The pricing norms recognized sustained release systems, and the notification expressly permitted manufacturers to approach the NPPA for specific price approval of special features. The appellants' failure to seek such approval did not exempt them from compliance with the standard ceiling prices. The appeals were dismissed.

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Pharmaceutical Regulation Drug Price Control Administrative Law Statutory Interpretation Price Fixation

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