Why govt's attempt to ban life-saving hormone Oxytocin was unscientific

The government relied mostly on unsubstantiated media reports, though scientists published several reports disproving alleged adverse effects of the life-saving hormone

In a 100-page judgement delivered this month, the Delhi high court categorically quashed the Centre’s attempts to restrict the sale of the life-saving hormone – oxytocin.

The judgment has embarrassingly laid bare the government’s unscientific approach, even on matters which can result in the loss of human life. Oxytocin is key to saving the lives of women during pregnancies as it prevents excessive bleeding.

With 130 women dying per 100,000 live births, India undoubtedly struggles with an unacceptably high maternal morality rate.

The court order called the government’s moves “unscientific,” and also spoke at length about how it imperiled the lives of women simply because it was more concerned about the alleged misuse of this hormone on cattle.

In an editorial this week, The Hindu said, “It is time for a post-mortem of how health policy is made, because that is the only way to safeguard the right to health of Indian citizens.” It asked how the government overruled multiple statutory bodies on the uses of oxytocin but instead believed theories on its misuse without any scientific proof.

Here’s a post-mortem of the government’s decision to overlook the evidence on the importance of oxytocin.

Maneka Gandhi’s attempts to ban oxytocin since 1999

Maneka Gandhi has been a key figure – operating in the shadows – trying to take oxytocin off the shelves since 1999.

As union minister for women and child development since 2014, she has been more concerned about the impact of oxytocin on cattle and not the welfare of women.

In 2016, she made her views on oxytocin public by writing in Firtpost. She made bold claims like oxytocin is the “single main disease-giving drug in India” and also that it is smuggled into the country by a Chinese mafia, which operates out of Kolkata and Mumbai.

These claims have not held up in court as the government has failed to substantiate them with any police reports or other investigations.

A Caravan article this year chronicled the many meetings on oxytocin which Gandhi attended, or where her letters were discussed, even though it was not within her ministry’s jurisdiction.

In 2013, the Drugs Consultative Committee (DCC) discussed a letter she had written to the health ministry on the “misuse” of oxytocin injections by dairy owners. Her comments were discussed again that year, at another meeting of the Drugs Technical Advisory Body (DTAB).

In 2014, the DTAB again discussed a letter she had written to the health ministry. This time she alleged that the misuse of oxytocin was “leading to a substantial loss of livestock in the country.”

In 2015, Gandhi addressed a meeting of the DCC, despite not being a medical doctor or a scientist. She once again said that oxytocin makes cows barren and gives them cancer and that it was imported illegally by a Chinese company.

As of last year, Gandhi was still briefed on the health ministry and the department of pharmaceuticals’s decisions on oxytocin. Copies of documents from these ministries were sent to her office.

The Caravan reports that her interest in oxytocin goes as far back as 1999, when she was the minister of state for consumer affairs and social justice. DTAB meeting records from the time show that her proposals on banning oxytocin were discussed even then.

The science in favour of oxytocin

The Delhi high court order looks into several government reports prepared on oxytocin over the past few years.

On Maneka Gandhi’s fear that oxytocin was used to over-milk cows, the court reiterated, “There is no scientific evidence about long-term adverse impact because of oxytocin use on milch cattle i.e. cows and buffaloes.”

The order records, “all the statutory expert bodies’ minutes of meetings recommended consistently that the drug had definite therapeutic use and could not be banned.”

For example, a report from the National Dairy Research institute (NDRI) said there “is no scientific evidence that artificial use of oxytocin has adversely affected progeny of cattle and buffaloes resulting in dwindling of livestock.”

The court notes that the Indian Council of Agriculture Research said no ill-effects were observed in animals during experiments carried out on the use of oxytocin.

In 2014, an expert group constituted by the government looked into the matter and found “no data to support such allegations of misuse,” and also asked state level enforcement authorities to send data on this.

In the same year, a question was raised in parliament on the alleged misuse of oxytocin to increase the size of fruits and vegetables. To this, however, the government said it had heard about such things from news media reports, but “scientific data on the extent of such practices is not available.”

The National Institute of Nutrition published a paper in 2014 which addressed the belief that milk from animals pumped with oxytocin can have “adverse health consequences.” From testing samples, the scientists concluded that external injections of oxytocin into milch animals does not influence its content in the milk and the oxytocin present in the milk is actually “rapidly degraded” during digestion, “ruling out” its absorption and associated adverse health consequences, if any.

In 2015, the health minister told the parliament that “no ill effects have been observed in the animals during experiments carried out on the use of oxytocin.”

A meeting of the DTAB that year also saw several scientists weigh-in on the issue, concluding: “After deliberations, the members agreed that the drug, legitimately manufactured in the country, is required for medical purposes and as such cannot be prohibited. The misuse of the drug in a crude form, can only be curbed through constant surveillance by the regulatory authorities.”

In 2015, the health ministry released a guidance note on the prevention of postpartum haemorrhaging and “strongly recommend” oxytocin for the active management of third stage of labour, because it “reduces postpartum haemorrhaging by more than 60%.”

Media reports not backed by science influenced law and policy

The Delhi high court’s order quashing the Centre’s move to ban oxytocin follows a 2016 order from the Himachal Pradesh high court. In 2016, this court took suo moto cognisance of a report in the Hindi newspaper, Amar Ujala, that spoke about the dangers of oxytocin.

With just this article as its premise, the court asked the government to look into restricting the manufacture of oxytocin in both, the public and private sector.

In 2018, loosely following the Himachal Pradesh high court’s order, the Centre said that only one public sector undertaking – Karnataka Antibiotics and Pharmaceuticals Limited – would be permitted to manufacture oxytocin for the domestic market.

This year, the government went so far as to tell the court that oxytocin was also being used to speed up puberty in girls who were being trafficked. The Caravan reported that in this instance as well, the government relied on news reports to substantiate its claim and did not supplement it with any medical reports or scientific studies. Published in arrangement with The Wire.