The Supreme Court on 22nd August referred to its larger bench the question whether it would be in public interest to restrict manufacture of life -saving drug, Oxytocin, for domestic use to a single public sector undertaking.


The apex court framed several questions for authoritative pronouncement by its larger bench while dealing with the Centre's appeal against Delhi High Court's December last year verdict quashing the government's decision to ban private firms from making and selling Oxytocin, used to induce labour and prevent bleeding during child birth.

A bench of Justices A M Sapre and Indu Malhotra said the plea before it raises serious issues "having far-reaching implications" and it is a fit case to refer the matter to a larger bench of three judges to consider the questions of law and authoritatively pronounce upon the same.

"The twin issues which arise for consideration are on the one hand, the unregulated and clandestine manufacture of the drug Oxytocin, which is reportedly misused in milch animals; and on the other hand, the continued supply of an essential life- saving drug, which is used as the first line drug for prevention and treatment of post partum haemorrhage at the time of childbirth," the bench said. The top court noted that Oxytocin is an essential life -saving drug, which is included in the National List of Essential Medicines, 2011 (NLEM).

It framed several questions for adjudication by a larger bench, including, "Whether it would be in public interest to restrict the manufacture of a life -saving drug for domestic use, to a single public sector undertaking, to the complete exclusion of the private sector companies, particularly in view of the high maternal mortality rates in the country?" 

It said the larger bench will also decide on whether the Centre's notification restricting the manufacture of Oxytocin formulations for domestic use, only by public sector undertakings, "has resulted in creating a monopoly in favour of public sector companies, to the complete exclusion of private sector companies".

"Whether the classification made by the impugned notification between licensed public sector and private sector companies, in the manufacture of the drug Oxytocin for domestic use, would achieve the object and purpose of preventing the unregulated and illegal use of the drug," it said. The bench directed the apex court registry to place the matter before the Chief Justice of India for necessary directions.

Justice Sapre, who concurred with the views of Justice Malhotra, also gave his opinion on the issue and said it needs to be decided whether the nature of powers exercised by the Central government under the provision of the Drugs and Cosmetics Act are legislative or executive. He said the decision either way will have its "far-reaching effects on the right and health of public at large qua the state." 

"It will also decide the scope of the powers of the Central government under Section 26-A of the Drugs and Cosmetics Act qua the rights of the persons, who are engaged in business of manufacture and sale of drugs specified under the Drugs and Cosmetics Act read with Essential Commodities Act," he said.

The high court, in its verdict delivered on December 14 last year, had quashed the Centre's decision to ban private firms from making and selling Oxytocin, saying it was "unreasonable and arbitrary" as it did not consider the "deleterious effect" of such a move on pregnant women and young mothers.

The Centre via a notification issued in April last 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.