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.
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.