HC quashes Centre's 'unreasonable' ban on pvt firms making, selling oxytocin

The Delhi High Court on Friday quashed the Centre's decision to ban private firms from making and selling Oxytocin, used to induce labour and prevent bleeding during child birth, saying it was "unreasonable and arbitrary" as it did not consider the "deleterious effect" of such a move on pregnant women and young mothers.

A bench of Justices S Ravindra Bhat and A K Chawla said the government did not consider that restricted supply of the drug, by confining its production to one state-run unit, would pose a danger to the users of the "potentially life-saving" medicine.

The Centre by a notification issued in April this year had prohibited private licensed firms from manufacturing and selling Oxytocin, also used to help young mothers lactate, on the ground of widespread misuse of the drug in the dairy sector.

The April 2018 decision was challenged in four separate petitions filed by BGP Products Operations GmbH -- a subsidiary of Mylan Laboratories -- Neon Laboratories, NGO All India Drug Action Network (AIDAN) and Ciron Drugs and Pharmaceuticals Pvt Ltd.

Allowing the petitions, the bench held that "the notification is both unreasonable and arbitrary. The Union of India 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."
Dealing with the government's argument that Oxytocin was being widely misused in the dairy sector, the court said there was no "hard convincing data" to assume there was a critical and urgent need to prohibit domestic licensed manufacturers from producing the life-saving drug,