After several years of deliberations on restricting or prohibiting the oxytocin injection to prevent its rampant misuse by diary and horticulture industry, the Union Health Ministry has recently come out with a notification restricting the manufacture and distribution of oxytocin formulations for domestic use. From July 1 this year, manufacturing and distribution of this drug will be restricted to public sector Karnataka Antibiotics and Pharmaceuticals Limited and HLL Lifecare respectively. As a first step to control its entry into the country, the government has already banned the import of oxytocin and customs officials were asked to step up vigilance against those trying to smuggle it into the country. Obviously, the government's action is aimed at preventing the widespread misuse of this so-called wonder drug by the dairy and horticulture industry in the country. It is widely misused in the dairy industry where livestock are injected with it to make them release milk at a convenient time. Many farmers also misuse this drug to plump up vegetables. What is alarming is the fact that several studies have proved that sustained use of oxytocin drug can cause hormonal imbalance in humans and ruin the reproductive system of animals, cutting their life span substantially. Under the new rules, the active pharmaceutical ingredient of oxytocin for domestic use can be supplied only to these PSUs. Moreover, the label of the product should bear barcodes to ensure traceability and its sale will not be allowed through a retail chemist in any form or name. However, private companies can produce the drug if it is intended for export purposes. The PSU producers of oxytocin formulations, licensed under the Drugs and Cosmetics Rules 1945, should supply the product only to registered hospitals and clinics directly or to the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) and Affordable Medicines and Reliable Implants for Treatment (Amrit) outlets.
Of course, the ministry has taken a considered decision as the drug cannot be prohibited in the country as it has definite use for therapeutic purposes. The Drugs Technical Advisory Board, which is the highest authority on technical matters, had also repeatedly recommended during the last several years that the drug need not be prohibited as it has definite use for therapeutic purposes. Often called the ‘love hormone’ as it is released when people snuggle up or bond socially, the drug oxytocin has medical use as it causes uterine contractions thereby inducing labour naturally and controls post-delivery bleeding. But, while trying to restrict its manufacture and distribution, the government should ensure that there is no shortage of this critical medicine which was included in the National List of Essential Medicines as a critical and life saving drug as it takes effect sooner than most other uterotonic drugs. Healthcare experts and the industry have already warned the government of acute shortage of the drug while totally banking on PSUs for the production of an indispensable drug like oxytocin. In a country like India where, as per WHO report, five women die every hour from complications developed during childbirth with heavy blood loss caused by haemorrhage being a major factor, ready availability of oxytocin should be a high-priority