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Supreme Court of India 2019-08-22 remanded

UNION OF INDIA & ANR. ETC vs BGP PRODUCTS OPERATIONS GMBH AND HAGENE IMMERMATT WEG. & ANR. ETC

Bench: 2 — Abhay Manohar Sapre, Indu Malhotra

In Brief

The Supreme Court considered challenges to a 2018 notification restricting manufacture of Oxytocin (an essential drug for preventing postpartum haemorrhage) to public sector companies only, excluding private manufacturers. The Court identified complex constitutional and regulatory issues: whether drugs on the National List of Essential Medicines can be regulated under Section 26A; whether the notification creates an unconstitutional monopoly violating Articles 14 and 19(6); and whether the Central Government possessed sufficient material to justify the restriction. Balancing competing interests—preventing illegal misuse of Oxytocin in animals versus ensuring adequate supply of this life-saving drug—the Court determined the issues warranted determination by a larger Bench due to their far-reaching implications for public health and citizens' rights.

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Pharmaceutical Regulation Administrative Law Constitutional Law Public Health Essential Medicines Monopoly Drug Control Public Interest

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