The decision of the Ministry of Health to restrict, from September 1, the manufacture of oxytocin only to the public sector unit, Karnataka Antibiotics and Pharmaceuticals Ltd. (KAPL), has sparked fears of shortages and a disruption of supplies of this drug. Oxytocin — which is considered to be a critical drug in maternal health care — is made primarily by the private sector. The restriction is because of alleged misuse of the drug by dairy farmers on milch cattle to stimulate milk production. The Ministry now hopes to control distribution channels and prevent misuse.
The allegations regarding misuse have been made by the Union Minister for Women and Child Development, Maneka Gandhi, for over a decade. Minutes of the meetings of the Drugs Technical Advisory Board (DTAB) and the Drugs Consultative Committee (DCC) — (statutory bodies under the Drugs & Cosmetics Act, 1940 — record several representations by Ms. Gandhi to the government to do something about the misuse. The minutes also cite experts from the medical and veterinary sciences who advised the DTAB that oxytocin is required in the treatment of both humans and animals. Further, two studies by the Central government, by the Indian Council of Medical Research and the National Dairy Research Institute, conclude that the use of oxytocin does not have an adverse effect on either people or animals. With cattle, the danger of misuse is that it may cause addiction, in which case cattle do not react to normal milk ejection stimuli. Both studies have been cited by the Ministers of Health and Agriculture in Parliament while responding to queries about the adverse effects of the drug.
Basis of official response
So why has the Health Ministry restricted the manufacture of the drug to only the KAPL? The official answer cited by the Ministry in its order (under Section 26A of the Drugs & Cosmetics Act, 1940) is a judgment by the High Court of Himachal Pradesh in a public interest litigation (PIL) initiated by the court after it came across newspaper reports of oxytocin misuse. As is often the case with such PILs, the court appointed an amicus to assist it. After hearing the matter for two years, the court passed a judgment in 2016 blaming oxytocin for a number of diseases, including breast and uterine cancers, male impotence, excessive hair growth in women and balding for men. However, the court did not cite a single scientific study to support these claims. Worse, it appeared to be unaware of the scientific studies commissioned by the Central government. Towards the end of its judgment, the court directed the State government to consider the feasibility of restricting manufacture to the public sector.
While the State government appears to have ignored these directions, the Central government, for some reason, decided to adopt the judgment as the basis of its order restricting manufacture to the public sector. The fact is that the High Court sought a study of the feasibility of restricting manufacture to the public sector; it never ordered the restriction to be imposed. From a reading of the government’s order under Section 26A of the said Act, it appears that the government has gone ahead to restrict manufacture without conducting any kind of feasibility study.
Going forward
While courts generally defer to the government when it comes to orders issued under Section 26A of the said Act, they can still set aside such orders if convinced that there is nothing on record to support the final decision. This standard of review was reiterated most recently in Union of India v. Pfizer (2017), where the Supreme Court concluded: “If the power under Section 26A is exercised on the basis of irrelevant material or on the basis of no material, the satisfaction itself that is contemplated by Section 26A would not be there and the exercise of the power would be struck down on this ground.”
An order restricting manufacture of a crucial drug such as oxytocin on the grounds of alleged misuse will have to based on a study of the degree of misuse, the demand for the drug, the manner in which the proposed restriction will affect the supply of the drug, and also its impact on public health. The government has not conducted such a study. The Delhi High Court, which is hearing a challenge against the government’s order, should signal to the government that regulation of drugs has to be rigorous and reasoned. It cannot resemble policy quackery.
Prashant Reddy T. is an Assistant Professor at the National Academy of Legal Studies and Research (NALSAR), Hyderabad
