The Central government’s decision to restrict manufacturing of oxytocin formulations for domestic use to public sector undertakings (PSUs) would lead to drastic shortage of the essential drug in the market, industry representatives have warned.
According to a notification issued by the government last week, manufacturing of the widely misused neurotransmitter and peptide hormone will be allowed only by the PSUs. However, private companies can produce the drug if it is intended for export purposes. The regulations will come into force on July 1.
Under the new rules, the active pharmaceutical ingredient (API) of oxytocin for domestic use can be supplied only to the PSUs. Moreover, the label of the product shall bear barcodes and its sale won’t be allowed through a retail chemist in any form or name.
The regulatory changes have dealt a severe blow to the industry which has been lobbying against the proposal to stop private companies from producing the hormone. “The government’s move will definitely create huge shortage and logistic problems as the PSUs don’t have the capacity or wherewithal to make this wonder drug available across the country,” Federation of Pharma Entrepreneurs (Fope) President BR Sikri told Pharmabiz.
The ministry notification further states that 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.
Often called the ‘love hormone’ as it is released when people snuggle up or bond socially, oxytocin causes uterine contractions thereby inducing labour naturally and controls post-delivery bleeding. It is misused in the dairy industry where livestock are injected with it to make them release milk at a convenient time. Many farmers use it to plump up vegetables. Studies have proved that its sustained use can cause hormonal imbalance in humans and ruin the reproductive system of animals, cutting their life span substantially.
“We don’t understand the logic behind the decision to partially ban its manufacturing. In fact they are giving permission to private sector also if it is for exports. If the intention is to curb misuse, the supply chain should be tightened. I'll discuss this issue with the state drugs controller before deciding the future course of action because if it is implemented strictly, there will be acute shortage for genuine users. The government has a tendency to run away from its responsibilities,” Bihar Drugs and Pharmaceutical Manufacturers Association president Sanjiv Rai said.
Oxytocin is 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. The decision to block its production in the private sector will put a huge question mark over the future of many firms. There are more than 60 companies -- spread across Maharashtra, Andhra Pradesh, Gujarat and Punjab -- manufacturing oxytocin injections in India. Many of them will be forced to down shutters after July, say industry sources.
The country’s apex drug regulator, after a meeting in February with manufacturers and industry lobby groups, had mooted stern steps to check oxytocin distribution. A key proposal under consideration was restricting its manufacturing and distribution to public sector Karnataka Antibiotics and Pharmaceuticals Limited and HLL Lifecare respectively. As a first step, the government last month banned the import of oxytocin and customs officials were asked to step up vigilance against those trying to smuggle it into the country.
“These curbs won’t prevent misuse. They have to weed out unscrupulous elements that use it for illicit purposes. We have informed the government many times that this wonder drug will be in short supply if the Drug Technical Advisory Board recommendations are implemented,” Sikri, whose association has been pitching for checks and balances to tighten the drug supply chain, added.
The ready availability of oxytocin is high-priority for a country like India where, as per a WHO report, five women die every hour from complications developed during childbirth with heavy blood loss caused by haemorrhage being a major factor.“The government should think twice before banking on PSUs for the production of an indispensable drug. The lack of oxytocin in the armamentarium of gynaecologists would put lives of many pregnant women at risk,” a healthcare professional added.