Union Health Ministry Lifts BAN on Oxytocin Retail, Regulations Imposed

New Delhi: The ‘Oxytocin Ban’, that followed complaints of rampant misuse of the drug, has finally been lifted by the Union Health Ministry, but strict regulations have been imposed on its sales.

Setting aside its ban on the sale of oxytocin, the Health Ministry has allowed private retail shops to sell the life-saving hormone from September 1, an official said today.

"All retail sale shops are permitted to sell oxytocin," the official said.

While issuing yet another amendment to the original notification banning the private manufacture and retailing of oxytocin, the ministry focused on retaining the monopoly of the public sector on manufacturing the drug for the domestic market. The government has restricted the manufacture of oxytocin formulations for domestic use to just one public sector company. State-owned Karnataka Antibiotics Pvt Ltd (KAPL) will be the only company to manufacture and distribute oxytocin in India from September 1.

Read also: Oxytocin manufacture banned from 1st July 2018, only this one firm will manufacture it

In a meeting on August 6, the ministry had asked the state governments and Union territories to place purchase orders with KAPL to ensure that there is no shortage of oxytocin injections in government hospitals and clinics.

Oxytocin is a naturally-occurring hormone that causes uterine contractions during labour and helps new mothers lactate. It is used to prevent and treat post-partum haemorrhage or excessive bleeding after childbirth, one of the top causes of maternal death

But its misuse is widespread in the dairy industry where livestock are injected with oxytocin to make them release milk at a time convenient to farmers. The hormone is also used to increase the size of vegetables such as pumpkins, watermelons, brinjals, gourds and cucumbers.

The government has already banned the import of oxytocin and its formulations.

Read also: Import banned, Only public sector to manufacture oxytocin

According to the new rules, from September 1, oxytocin will be moved from schedule H to schedule H1. Drugs under schedule H can only be sold against a prescription by a registered medical practitioner. In the case of those under H1, a schedule introduced in 2013 to prevent misuse of third and fourth generation antibiotics, the retailer has to maintain a separate register giving the name and address of the prescriber, the patient, the drug and the quantity supplied. These records have to be maintained for three years and be available for inspection.

The notification also stated that “circumstances have arisen making it necessary to publish this notification without prior consultation of the Drugs Technical Advisory Board” but added that the consultation would be held, reports TOI.

Earlier Medical Dialogues reported that the Delhi High Court sought the Centre’s stand on a PIL against the ban on private companies from producing and distributing the drug. A bench had issued a notice to the Health Ministry and sought its response to the plea by August 26.

Meanwhile, the Drug Technical Advisory Board (DTAB) had approved a proposal to amend the health ministry notification banning the retail sale of oxytocin in order to ensure availability for human use.

Read also: Remove Oxytocin Ban: Health Ministry Panel