Delhi HC quashes Centre’s decision to ban distribution, manufacturing of Oxytocin by private firms

On December 14, a bench of Justices S Ravindra Bhat and A K Chawla of the Delhi High Court quashed and set aside the Centre’s decision to ban the manufacture and distribution of Oxytocin—a medication that is used to cause contraction of the uterus to start labor, increase the speed of labor, and to stop bleeding following delivery—by private firms in India, stating that the ban was “arbitrary and unreasonable”.

The judgment disposed of a batch of writ petitions challenging the validity of a notification [GSR 411(E) dated 27.04.2018] issued by the Union of India (UOI) and the Ministry of Health & Family Welfare (MHA), in exercise of the powers under Section 26A of the Drugs and Cosmetics Act, 1940.

The notification prohibited the manufacture and distribution of Oxytocin injection for domestic use, human use, by private sector companies, including the Petitioners.

The writ petitioners complained that the impugned notification endangers the lives of pregnant women and young mothers. In addition, the Petitioners also challenged the validity of an Office Memorandum dated 21.05.2018.

According to the notification, state-run Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL) was solely allowed by the Centre to make the drug to meet the country’s needs.

The order came on the pleas of BGP Products Operations GmbH, a subsidiary of Mylan Laboratories, Neon Laboratories, and NGO All India Drug Action Network (AIDAN), which works to ensure access to essential medicines.

In this case, the court noted that “The decision of prohibiting a country wide existing manufacturing base for Oxytocin, a life-saving drug (through the over hundred private licensed units spread across the country), for over three decades or so, on one hand and reserving it to the public sector through a single manufacturing entity, which has no previous record in its production, is thus fraught with potential adverse consequences.”

The court highlighted, “One of the important directive principles of State Policy (Article 47) is the that ―The State shall regard the raising of the level of nutrition and the standard of living of its people and the improvement of public health as among its primary duties. Maternal welfare too is considered a directive principle (Article 42). Correspondingly, the right of women, generally and pregnant women and young mothers in particular, to have a safe post-partum recovery and avoid risk of haemorrhaging that can be potentially fatal, is an integral part of Article 21 of the Constitution of India. The potential impact may or may not be direct; even if it leads to a few incidents, that would be a grave consequence contrary to public interest.”

The court also observed that “the weighing in of options so crucially necessary to balance these interests was not resorted to. The 78th Meeting of the DTAB, held on 12th February, 2018 (contemporaneously with the decision taken that ultimately led to the impugned notification), recommended that Oxytocin should be sold only to hospitals and licensed clinics. Similarly, other such restrictive conditions with respect to sale and possibly movement of the bulk drug could have been considered. What appeared to have weighed most, with the Central Government, instead was the direction by the HP High Court and the view that Oxytocin was harmful to milch cattle (as discussed earlier, the record shows that even till December, 2015, the Central Government’s official position was that scientific experts had ruled out that possibility).

The court said, “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.”

The court further added, “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.”

The court thus concluded, “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.”