A two judge bench of Supreme Court on August 22 referred the matter to a larger bench, with a set of questions to decide on whether it would be in public interest to restrict manufacture of life-saving drug Oxytocin for domestic use to a single public sector undertaking.
“We are of the considered view that this is a fit case to refer the matter to a larger Bench of three Judges to consider the aforesaid questions of law, and authoritatively pronounce upon the same,” the two-bench Supreme Court said in its order.
Moneycontrol saw a copy of the order.
The bench directed the Apex Court's registry to place the matter before the Chief Justice of India for necessary directions.
The case came up before Supreme Court after the Central government challenged the Delhi High Court's verdict of December last year that quashed the government’s decision to ban private manufacturers from making and selling Oxytocin, calling it unreasonable and arbitrary.
The Centre in April, 2018, had prohibited private firms from the sale and manufacture of Oxytocin on the grounds of widespread misuse of the drug in the dairy sector to increase milk productivity.
Questions for larger bench
The apex court bench, consisting of Justices A M Sapre and Indu Malhotra, have formulated several questions for the larger bench in their judgement order.
Oxytocin is a hormonal drug used to induce labour and prevent bleeding during child birth. The is categorized as essential life-saving drug, which is included in the National List of Essential Medicines (NLEM), 2011.
Some of the questions raised by the bench include:
Whether a drug included in the NLEM 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?
Section 26A gives powers to the government to ban drugs or prohibit their manufacture.
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 lifesaving 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 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?