Misuse Of Oxytocin In Milch Animals Vs. Its Use As Essential Life Saving Drug: SC Refers Centre's Appeal To Larger Bench [Read Judgment]
"The decision either way on any of these questions will have its far reaching effect on the rights and health of public at large and especially on the rights and health of the teenage girls, pregnant females and milching animals."
The Supreme Court has referred to larger bench an appeal filed by Union of India against the Delhi High Court judgment quashing a notification that restricted the manufacture of Oxytocin formulations for domestic use, only by public sector undertakings or companies, to the complete exclusion of the private sector companies.
The bench comprising Justice Abhay Manohar Sapre and Justice Indu Malhotra observed that these appeals raise serious issues having far reaching implications. After considering the submissions made by both sides, the said:
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 thereafter referred the following 'substantial questions of law' to a larger bench:
- Whether a drug included in the National List of Essential Medicines published under Schedule 1 of the Drugs (Prices Control) Order, 2013 notified under Section 3 of the Essential Commodities Act, 1955 would be subject to the provisions of Section 26A of the Drugs and Cosmetics Act, 1940?
- Whether the impugned notification has resulted in creating a monopoly in favour of public sector companies, to the complete exclusion of private sector companies, and if so, whether it would be protected by Article 19(6)(ii) read with Article 14 of the Constitution?
- 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?
- 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?
- Whether there was relevant and objective material before the Central Government to form the basis of satisfaction to exercise the power to prohibit the manufacture of the drug by the private sector companies for domestic use, under Section 26A of the Drugs and Cosmetics Act, 1940?
- Whether the object of curbing the clandestine manufacture and unregulated use of the drug Oxytocin, which is covered by Section 18 of the Drugs and Cosmetics Act, 1940, can be achieved by taking recourse to Section 26A by imposing a ban on the manufacture of licensed drugs by private sector companies?
- Whether the exercise of power by the Central Government under Section 26A of the Drugs and Cosmetics Act, 1940 is legislative or executive in nature?
Justice AM Sapre penned a separate opinion, and observed that the decision either way on any of these questions will have its far reaching effect on the rights and health of public at large and especially on the rights and health of the teenage girls, pregnant females and milching animals. The judge said:
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.
Delhi HC View: Therapeutic Benefit To Humans Could Not Have Been Given Less Importance
In December, 2018, the division bench of the High Court comprising Justice S. Ravindra Bhat and Justice AK Chawla had allowed the writ petitions filed by All India Drug Action Network and others who challenged this notification contending that it endangers the lives of pregnant women and young mothers.
The bench, while quashing, had observed that the Centre 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 the 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 an 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 bench had said.