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

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

Matter involves substantial questions of law with far-reaching implications for public health and regulatory powers. Decision on executive or legislative nature of Section 26A will impact legality of the impugned notification restricting manufacture of Oxytocin for domestic use to only public sector entities. The case requires authoritative determination on constitutional and statutory grounds and is referred to a larger Bench.

Parties
Appellant: Union of India; Respondents: BGP Products Operations GMBH and Hagene Immermatt Weg & Anr.
Jurisdiction
India
Judgment Date
22 August 2019
Procedural Posture
Civil Appeal / Reference to Larger Bench
Outcome
Matter referred to larger Bench
Legal Topics
State Monopoly, Essential Medicines, Executive Vs Legislative Powers, Regulatory Notification Challenge, Equality Before Law, Public Health
Constitutional Law Administrative Law Drug Regulation State Monopoly Essential Medicines Executive Vs Legislative Powers Regulatory Notification Challenge Equality Before Law +1 more

Case Brief

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Parties

Union of India

Appellant

BGP Products Operations GMBH and Hagene Immermatt Weg & Anr.

Respondents

Procedural Posture

Civil Appeal / Reference to Larger Bench

Legal Issues

  1. 1 Whether a drug included in the National List of Essential Medicines published under Schedule 1 of the Drugs (Prices Control) Order, 2013 notified under Section 3 of the Essential Commodities Act, 1955 would be subject to Section 26A of the Drugs and Cosmetics Act, 1940.
  2. 2 Whether the impugned notification has resulted in creating a monopoly in favour of public sector companies to the exclusion of private sector companies, and if so, whether it would be protected by Article 19(6)(ii) read with Article 14 of the Constitution.
  3. 3 Whether the classification made by the impugned notification between public sector and private sector companies in the manufacture of Oxytocin for domestic use would achieve the object of preventing unregulated and illegal use.

Ratio Decidendi

Matter involves substantial questions of law with far-reaching implications for public health and regulatory powers. Decision on executive or legislative nature of Section 26A will impact legality of the impugned notification restricting manufacture of Oxytocin for domestic use to only public sector entities. The case requires authoritative determination on constitutional and statutory grounds and is referred to a larger Bench.

Court Disposition

Matter referred to larger Bench

Orders

  • Registry directed to place the group of appeals before the Hon’ble Chief Justice of India for necessary directions.