DTAB proposes withdrawal of ban on oxytocin

In a U-turn, a technical advisory panel under the Union health ministry has recommended revoking the newly imposed ban on the retail sale of love hormone oxytocin, fearing a public health crisis.

The Drugs Technical Advisory Board (DTAB) in its July 31 meeting agreed to amend a previous notification (issued on April 27, 2018) in order to continue with the production of oxytocin by licensed entitles to ensure availability for human use, sources told DH. Its retail sale has been allowed, while the curb on the import remains.

The 180-degree turn took place after doctors criticised the ministry's decision to stop the production of the hormone by existing manufacturers and allow only one Karnataka-based public sector unit to make it and supply to the entire country.

The Federation of Obstetrics and Gynaecological Societies (FOGSI) took up the issue with the ministry because of its clinical significance.

“We would like to submit here that oxytocin is a life-saving drug for our mothers, and any impediment in its free and easy availability for human use is likely to result in a significant rise in the loss of women’s lives due to PPH (post-partum hemorrhage) and failure to augment labour when needed,” said FOGSI president Jaideep Malhotra.

Oxytocin is the recommended first-choice drug for prevention of PPH – a leading cause of mortality in C-section.

“It is a life-saving drug in deliveries. With the ban, the government is creating a space for impediment in its easy availability in human use,” said Arun Gadre, a Pune-based doctor and a member of Alliance of Doctors for Ethical Healthcare.

The ministry had announced restrictions on the production and retail sale of the hormone following a judgment from the High Court of Himachal Pradesh and a favourable recommendation from the same DTAB, which now overturned its earlier recommendation.

Karnataka Antibiotics and Pharmaceuticals Limited (KAPL) was to be the only company to manufacture and market oxytocin from July 1. Later two more months were given to the existing manufacturers as KAPL was not ready and the medicine was essential in labour rooms across the country.

There are nearly 20 companies in India manufacturing the hormone. The cost of a high quality, popular brand is Rs 13.77 per vial while at KAPL it would be Rs 17.78 per vial.

“If the oxytocin is not available, the C-section rates would go up in those facilities that have the hormone in its stock. The labour would be prolonged, increasing the still births. The non-availability of oxytocin would be harmful to thousands of mothers and infants,” Gadre said.

The ban was introduced to stop misuse of the hormone by the dairy industry in milch animals to increase milk production ignoring adverse health consequences.

Earlier, Union Minister Maneka Gandhi wrote to the Health Minister J P Nadda arguing in favour of controlling the misuse of oxytocin.