The seven issues framed by the Bench also include whether the health ministry’s last year’s notification had resulted in creating a monopoly in favour of public sector companies to the complete exclusion of private sector firms, thus resulting in discrimination, and if such a ban on private companies would achieve the purpose of preventing the unregulated and illegal use of the drug.
The Supreme Court on Thursday referred to a larger Bench the issue of banning manufacture of life-saving drug Oxytocin by private companies. The drug is used to induce labour in pregnant women and stall postpartum bleeding, a leading cause of maternal deaths.
The issues which arise for consideration are the unregulated and clandestine manufacture of Oxytocin, which is allegedly misused in milch animals, on one hand, and 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, on the other, the Bench comprising Justices AM Sapre and Indu Malhotra said, adding that this is a fit case to refer the matter to a larger Bench of three judges.
The seven issues framed by the Bench also include whether the health ministry’s last year’s notification had resulted in creating a monopoly in favour of public sector companies to the complete exclusion of private sector firms, thus resulting in discrimination, and if such a ban on private companies would achieve the purpose of preventing the unregulated and illegal use of the drug. “…the decision either way on any of these questions will have far reaching effect on the rights and health of public at large, and especially on the rights and health of teenage girls, pregnant females and milching animals. 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… In effect, in my opinion, it will not be a judgment inter party but it will be in rem laying down the law on the questions,” Justice Sapre wrote in its separate, but concurring, judgment.
The SC order came on an appeal by the government challenging the Delhi High Court judgment that had quashed the health ministry’s notification of April 27 last year to ban manufacture and sale of the drug by the private sector. As a result of the health ministry’s move, the license of the three pharma companies stood cancelled and terminated. BGP Products Operations GmBH, Mylan Pharmaceuticals and Ciron Drugs and Pharmaceuticals have been manufacturing Oxytocin injections for over three decades in India.
The three companies and others had last year moved the Delhi High Court challenging the validity of the notification that barred them from manufacturing the Oxytocin formulations for domestic use from September 1, last year. The ministry allowed only Karnataka Antibiotics to manufacture the drug, under Section 26(a) of the Drugs and Cosmetics Act.
The HC said the government did not have any scientific basis for banning the drug. It noted that the ban was both unreasonable and arbitrary; the government did neither adequately weigh in the danger to users of the drug, nor consider the deleterious effect to the public generally and women particularly, of possible restricted supply if manufacturing is confined to one unit.
The manufacturers argued that there was no relevant material or evidence placed before the government for it to arrive at a “satisfaction” to completely prohibit manufacturing and sale of the drug by them. They submitted that neither the Drugs Technical Advisory Board nor the Drugs Consultative Committee had recommended or approved the complete prohibition on manufacturing of Oxytocin by private licensees.
They claimed that their market share is at least 50% in terms of manufacturing the drug, but they do not sell the drug directly to the end consumer and only sell by way of wholesale dealing to licensed distributors and licensed retail chemists, and use the very same chain of distribution that KAPL uses.