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NEW DELHI: The union health ministry’s ban on retail sale of oxytocin has sent gynaecologists and obstetricians into panic mode. While they’ve stocked up as much as possible before the ban set in, it is unclear to doctors how a single public sector company, Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL), will replace production and country-wide distribution of the lifesaving injection by about 60 big and small companies.

Oxytocin injections are used to prevent and treat post partum haemorrhage (PPH), one of the commonest causes of maternal deaths in India, where an estimated 32,000 women die during childbirth every year.

Interestingly, the Himachal Pradesh high court order cited by the ministry in its notification on oxytocin hadn’t actually asked for a ban. The court had taken up the case suo motu because of concerns regarding “rampant and extensive misuse of oxytocin” in the dairy, agriculture and horticulture sector. But the court’s suggestion to “consider the feasibility of restricting the manufacture of oxytocin only in public sector companies and restricting and limiting the manufacture of oxytocin by companies to whom licences have already been granted” was just one among 12 suggestions it gave.

According to the health ministry notification of April 27, even the Drug Technical Advisory Board (DTAB) had only recommended that oxytocin for human use be restricted by supplying it only to registered hospitals and clinics. While DTAB said that “it is necessary and expedient to regulate and restrict the manufacture, sale and distribution of the drug Oxytocin”, it had not asked for a country-wide ban on retail sale.

Doctors told TOI that when they got in touch with KAPL to register for supply, they were told that manufacturing started on July 2 and that the drug would not be ready before middle of July, even though the ban came into effect on July 1. Protests by doctors and some state governments pushed the ministry to extend the deadline for the ban on manufacturing by private companies to August 31.

“The government has been unable to control oxytocin misuse. It is making people pay the price for its regulatory failure. Who will be responsible for maternal deaths in case of non-availability of the medicine?” asked Dr Arun Gadre, a gynaecologist and member of the Alliance of Doctors for Ethical Healthcare (ADEH).

The Federation of Obstetric and Gynaecological Societies of India (FOGSI), with over 33,000 members, wrote to the health ministry in April stating that regulating or stopping the misuse of oxytocin “should not be at the cost of women losing their lives due to disruptions in availability, supply chain and failure to make the drug available in adequate quantity at the point of need”.

“Oxytocin distribution requires a cold chain without which the drug can be rendered useless. Does KAPL have this in place? No one knows. We are unable to get through to KAPL officials’ numbers given by the ministry. When we do, they tell us to keep checking the website. Oxytocin is part of the Government of India and WHO recommended protocol for post-delivery care. This ban is irresponsible,” said Dr Chandrakant Sanklecha who heads the Nashik Obstetric and Gynaecological Society.

“What was the tearing hurry? How can you ban a lifesaving drug without making alternate arrangements? KAPL is producing this drug for the first time. Couldn’t the ministry have waited till KAPL produced several batches, which were tested for quality? Can the ministry give an assurance that this ban will put a definite stop to misuse? Or, will it be like demonetization that promised to put an end to counterfeiting and terror funding but did neither, while plunging the country into chaos. In this case it could be worse as women will pay with their lives for the government’s misadventure,” said Dr KV Babu from Payyanur in Kerala.

