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In the High Court of Delhi at New Delhi, BGP Products Operations GMBH and ANR vs. UOI & ORS; W.P.(C) 6084/2018, C.M. APPL.23517/2018

Litigation, Arbitration & Dispute Resolution | Dec 12 2018

Dear Reader,

The Division Bench of the Hon’ble High Court of Delhi, comprising of Hon’ble Mr. Justice S. Ravindra Bhat and Hon’ble Mr. Justice A.K. Chawla, has by judgment delivered on 14.12.2018, in BGP Products & Anr. Vs. UOI & Ors, W.P. (C) 6084 of 2018, struck down the notification (notification No. GSR 411(E) dated 27.04.2018) issued by the Central Government under Section 26 A of the Drugs and Cosmetics Act, 1947, prohibiting the manufacture and sale of Oxytocin by private sector companies for domestic sale, as unreasonable and arbitrary.The operative part of the judgment is reproduced below for convenience:

“147. In view of the preceding discussion, it is held that the impugned notification is both unreasonable and arbitrary; the UOI did not adequately weigh in the danger to the users of Oxytocin, nor consider the deleterious effect to the public generally and women particularly, of possible restricted supply if manufacture is confined to one unit, to the pregnant women and young mothers, of a potentially life-saving drug. The risk of such a consequence can be drastic: the scarcity of the drug, or even a restricted availability can cause increase in maternal fatalities, during childbirth, impairing lives of thousands of innocent young mothers. The impugned notification and preceding decision making process placed far greater importance on the need to prohibit availability of Oxytocin from what was perceived to be widespread veterinary misuse: clearly the trigger for the move was the HP High Court judgment, which did not notice that Oxytocin was an essential drug. Correspondingly there was no scientific basis, and insufficient data to support the conclusion that the drugs existing availability or manner of distribution posed a risk to human life (a requirement of Section 26A). The weighing of options or balancing act, to bring in a suitable measure geared to achieve the same objective in a different, or drastic manner was not undertaken. It would not be out of context here to say that the welfare of the citizen and the interests of the public are paramount, in any decision that the State takes; in this case, the absence of such weighing or balancing process, and the choosing of the most drastic option renders the decision to issue the impugned notification both arbitrary and unreasonable. For these reasons, this court is of the opinion that the conclusions recorded by this court – to quote the Supreme Court – do not transgress the arena of permissible judicial review, but rather are “enough for us to say that the present case is on the right side of any line that could reasonably be drawn.”

147. During pendency of these proceedings, operation of the impugned notification was suspended by a reasoned interim order dated 31.08.2018 which was extended later till 15.12.2018. In view of the above conclusions, the writ petitions have to succeed; the impugned notification and all the consequential orders are hereby declared as arbitrary and unreasonable; it is, therefore, quashed and set aside. All writ petitions are accordingly allowed.”

In view of the judgment aforementioned, private manufacturers may continue to manufacture, distribute and sell Oxytocin in the domestic market.

A copy of the judgment is attached for your records.

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