Maneka Gandhi’s 19-year-long quest to ban oxytocin, a life-saving drug, without scientific basis

Maneka Gandhi’s battle against oxytocin began in July 1999 and has led to a government order restricting the manufacture of the drug. Yasbant Negi/India Today Group/Getty Images
28 September, 2018

Since 2013, Maneka Gandhi, the minister of women and child development, doggedly wrote letters to the ministry of health and family welfare asking the central government to stop the “misuse” of the drug oxytocin. She even sought a ban on the sale of the drug, calling it “the single main disease-giving drug in India.” Gandhi’s claims have no scientific basis—in fact, the science shows that oxytocin is a life-saving drug that is widely used to prevent and treat postpartum haemorrhage, or bleeding following the delivery of a baby.

Oxytocin is naturally secreted by the pituitary glands as a chemical messenger in the brain, controlling key functions of the reproductive system, including childbirth and lactation, and other aspects of human behavior. It is chemically synthesised and sold by pharmaceutical companies across the world. The drug is commonly used to increase contractions during labour and it is essential for the prevention of postpartum haemorrhage, a leading cause of maternal mortality. In December 2015, the health ministry issued guidelines recommending the use of oxytocin for every single of the estimated 2.07 crore deliveries that are conducted in the country.

Yet, in April 2018, the government released a far reaching order to restrict manufacture and sale of the drug. At the time, oxytocin was sold by 112 manufacturers to people across India. But according to the health ministry’s April order, only one company would be granted the license to manufacture and sell the drug, which will vastly reduce the availability of the drug and may lead to an increase in maternal mortality. The government order was challenged before the Delhi High Court in August this year. On the last hearing, on 28 September, the court stayed the restriction on oxytocin till November this year.

The government order was the fruition of Maneka Gandhi’s incessant campaign, of almost two decades, against oxytocin. She has repeatedly claimed, without any scientific citations, that the drug can make cows barren and the milk produced harmful. In most of her arguments, Gandhi completely sidesteps the drug’s life-saving utility. Over the years, she has written letters to the health ministry, attended technical drug regulatory meetings, and been involved in communication about oxytocin between government departments that have no relation to her.

Maneka Gandhi is known to be a long-standing animal-rights activist, who has often taken up issues related to the ethical treatment of animals before the Central Drugs Standard Control Organisation. Oxytocin is given to animals illegally, such as buffaloes, for maximum let-down of milk, and Gandhi’s position against the drug rests on allegations of animal abuse as well as purported health complications for humans. She elaborates her stance in a June 2016 article in Firstpost:

Oxytocin sends the animal into labour, so for two hours a day the animal is writhing in labour pains till the milk is squeezed out of her inflamed diseased teats. Oxytocin comes into the milk and results in hormonal imbalances in humans, who get diseases like tuberculosis, cancer, blindness in children etc. In fact, the single main disease-giving drug in India is oxytocin which is being smuggled into India from China by a mafia that is headquartered in Kolkata and Mumbai.

The article is evocative in describing the horrible treatment meted to cattle in dairy farms, but the solution Gandhi seeks will not stop cruelty against animals. Her claims about oxytocin’s effects on human beings are unfounded as well. A 2014 study by scientists of the National Institute of Nutrition concluded that oxytocin injections to cattle do not affect their milk or lead to any adverse health consequences. In August 2015, the then health minister also stated in parliament that “no ill effects have been observed in the animals in experiments carried out on the use of oxytocin.”

That month, at a meeting convened by the CDSCO to discuss oxytocin, Dr BS Prakash, an assistant director-general in the agriculture ministry, stated that there is no data on mutagenicity (a change in genetic material), carcinogenicity (a tendency to induce tumours) or teratogenicity (an ability to disturb the environment of the embryo) due to oxytocin. He also said that oxytocin is “inactivated” inside an animal’s body. Prakash reiterated what many scientists before him have said—the drug has a place in both human and veterinary medicine. In her Firstpost article, Gandhi does not substantiate on the alleged Chinese mafia connection.

Gandhi’s pursuit to ban oxytocin involves direct participation in official proceedings and correspondence that have no relation to the portfolios she has held. Gandhi personally attended a meeting of the Drug Consultative Committee, an advisory body under the CDSCO. Moreover, her letters calling for a ban on oxytocin were frequently discussed at meetings of the Drug Testing Advisory Board, another regulatory body under CDSCO whose proposals often result in changes in law and policy. In most meetings that discussed the policy for oxytocin, the expert members conceded that the drug was being sold illegally, without a prescription, in contravention of the Drugs and Cosmetics Act and the Prevention of Cruelty to Animals Act. They recommended increasing surveillance on the illegal use of the drug and almost every year, state and central government drug controllers promise the same.

This did not prevent Gandhi’s battle against oxytocin, which began in July 1999, when she was the minister of state for consumer affairs and social justice. In a DTAB meeting held in July that year, the attendees discussed her suggestion to ban the manufacturing of oxytocin. The minutes of the meeting record that SD Seth, a pharmacologist, shot down her suggestion and stated that claims of oxytocin causing “cancer, growth retardation, cardiovascular disease” were “not based on sound medical facts.” He also mentioned that the drug’s “misuse for non-medical purposes” must be stopped.

A few weeks after the meeting, Gandhi’s personal assistant received a letter from the assistant commissioner of Gujarat’s intelligence bureau. The letter, which was sent under instruction from Gujarat’s commissioner of food and drugs control administration, informed Gandhi about the action taken against the misuse of oxytocin in the state. It described details of nine seizures from drug manufactures that were not storing oxytocin in a safe manner.

In a November 2013 meeting of the DCC, the members discussed a letter by Gandhi to the health ministry regarding the misuse of oxytocin injections by dairy owners on milch animals. In a DTAB meeting later that month, remarks by Gandhi against oxytocin were mentioned, before adding that the drug “has medical use for induction and augmentation of labour, to control post partum bleeding and uterine hypo tonicity.” The members did note, however, that the use of the drug “in a clandestine way” was a matter of “great concern for public health.”

Following the DTAB meeting, in January 2014, the health ministry released a notification restricting manufacturers of oxytocin to selling the pharmaceutical preparation of the drug only to specific manufacturers licensed under the Drugs and Cosmetics Act. The notification also stated that “the formulations meant for veterinary use shall be sold to the veterinary hospitals only.”

In a DTAB meeting in April 2014, the members noted that Gandhi had again written to the health ministry stating that the misuse of oxytocin was “leading to a substantial loss of livestock in the country.” The members again stated that the drug had a “definite role in the medical field both for humans and animals” and that its sale “cannot be stopped.” The members spoke of the drug’s use in case of a “medical emergency” in rural and remote areas where the drug is available only in retail outlets. The members finally recommended introducing measures to prevent the illegal sale of the drug, such as mandating a retail chemist to maintain records of their oxytocin-related transactions.

Even without the recent restrictions on the manufacture of oxytocin, the drug is not given to every single woman delivering a baby as it should be. Dr Fasih Tasneem, a gynaecologist at a government hospital in Nanded, in Maharashtra, said that their hospital often receives complicated cases of women in the middle of postpartum haemorrage. “Sometimes, the prophylactic drug” —referring to oxytocin—“is not given on time, or sometimes there is a lack of stock in the peripheral hospital.” The other alternative to the drug, misoprostol, is not considered as effective as oxytocin—the health ministry’s December 2015 guidelines state that it should be provided only when oxytocin is not available. Another drug, carbetocin, which has recently been cleared by the World Health Organisation as an alternative to oxytocin, is still not available in India.

In October 2015, Gandhi directly addressed a DCC meeting. She repeated her long-standing claim that the misuse of the drug is making cows barren and causes cancer among bovines. She added that the raw material for the drug is imported illegally by a Chinese company via courier.

According to an affidavit filed by the central government before the Delhi High Court, the last letter related to oxytocin that was copied to Maneka Gandhi was sent in May 2017. The letter mentioned a meeting between Karnataka Antibiotics and Pharmaceuticals Limited, or KAPL—a Bengaluru-based public sector company—and the department of pharmaceuticals, during which the terms and conditions of production of oxytocin were discussed. The joint secretary to the government of India had written to the secretary in the health ministry regarding sanctioning Rs 7.95 crore and placing orders with KAPL to manufacture oxytocin at the earliest. However, KAPL only received its license to manufacture the drug on 6 April this year. Three weeks later, the health ministry issued the order restricting the license to manufacture oxytocin to only one company—KAPL. The affidavit does not explain why the letter was copied to Gandhi.

Two months before the health ministry’s order, on 8 February, the Prime Minister’s Office held a meeting on the harmful effects of oxytocin, during which the decision to restrict the manufacture of the drug was made. The meeting was attended by various stakeholders, including members of the departments of health and family welfare, pharmaceuticals, animal husbandry, agriculture cooperation and farmers’ welfare, revenue and the drug controller general of India. On 5 April, the department of revenue issued instructions to its officers to step up the vigilance regarding the smuggling of oxytocin, in which it referred to the February meeting. KAPL received its license the next day.

The health ministry passed the order on 27 April, citing “public interest” to restrict and regulate the manufacture of oxytocin. The order claimed that the “unregulated and illegal use” of the drug could be a “risk to human beings and animals.” The order also relies on a March 2016 judgment of the Himachal Pradesh High Court as one of the reasons that gave impetus to the significant policy shift. In the case, the high court had taken suo moto cognizance of a November 2014 report in the Hindi daily Amar Ujala about the dangers of oxytocin. The article quoted one Dr Udit Kumar from a hospital in the state’s Solan district: “Oxytocin is not required in the body. If it is used, it can be life-threatening because of its side effects.” As with Maneka Gandhi, the Amar Ujala report does not provide any scientific basis for these claims either. But the Himachal Pradesh High Court directed the state government to consider the feasibility of restricting the manufacture of the drug to public sector companies and limiting the manufacture of licensed private companies.

As per the health ministry’s order, KAPL would have become the sole manufacturer of oxytocin from July, but this was subsequently pushed to 1 September. On 14 August, the All India Drug Action Network, a network of non-profit organisations that works towards increasing access to medicines, filed a public-interest litigation in the Delhi High Court challenging the order. The petition said that restricting the manufacture of oxytocin to a medium-scale company “with no proven ability” to manufacture a large quantity of the drug in a timely manner would impact the availability of the life-saving drug.

The central government submitted its response in a counter affidavit, introducing a new concern in the alleged misuse of oxytocin. It claimed that the drug was given to pre-pubescent trafficked girls to speed up the onset of puberty. To support this claim, the government did not attach any police investigation in this regard or reports of medical examinations of victims of trafficking, but instead submitted news reports of raids in which traffickers were found with possession of the drug. The affidavit stated that such possession could attract a provision of the Trafficking of Persons (Prevention, Protection, and Rehabilitation) Bill, 2018—a controversial bill introduced by Gandhi and passed in the Lok Sabha in June 2018.

Dr Gopal Dabade, a health activist and medical doctor, in the Karnataka-based Drug Action Forum, questioned this claim in the affidavit, noting that oxytocin is not a growth hormone. “Why would traffickers use oxytocin?” Dabade asked. “It has no action on sexual reproductive organs. One has to perhaps use estrogen or progesterone.” He has also written an open letter to Gandhi contesting her claims about the drug.

On 31 August, the Delhi High Court stayed the government order restricting the manufacturing of the drug. The court noted that both the DTAB and DCC had emphasised in their meetings that “the extreme measure of prohibition and restricted sale would not be in order.” It also took note of the fact that the sole manufacturer designated by the government did not get its license to manufacture oxytocin till April 2018. “We applied for the license last year and completed the stability test required for the license,” Nirja Saraf, the managing director of KAPL, told me. She said that the company is all set to produce and distribute enough to meet the country’s needs.

The Delhi High Court also asked a larger question while delivering the stay order—what actions did the government take to increase surveillance on the misuse of the drug, as had been repeatedly recommended by the DTAB and DCC. The order points out that of 116 inspections over the past three to four years, the government only conducted 12 prosecutions against illegal use. Moreover, only two manufacturers have lost their license. The court also took note of the looming presence of Maneka Gandhi via letters, and a one-time appearance in these meetings. During the next hearing, on 20 September, the government stated to the court that the ministries of health and animal husbandry were on board with the decision to restrict oxytocin. The government also filed another affidavit, which further highlighted Gandhi’s role in the events leading up to the health ministry’s order.

In the courtroom, sitting alongside the joint secretary of the health ministry and the drug controller general of India, was Gauri Maulekhi. Maulekhi is the trustee of Maneka Gandhi’s non-profit, People for Animals, and is often referred to as Gandhi’s advisor in news reports. I went up to Maulekhi and asked why she was present for the hearing. “I was in court so I just dropped by,” she said. Maulekhi also told me Gandhi would not be giving any statements about the matter anymore. In court, Maulekhi answered a question posed by the judge about a raid carried out at a dairy farm in Ghazipur, which is mentioned in the affidavit, and later appeared to be having an animated discussion with the prosecutor.

As Maulekhi had hinted might happen, Gandhi has not responded to our queries regarding the science behind her quest to ban oxytocin.