New Delhi: The legal status of oxytocin, a drug essential for the well-being of new mothers, is still in limbo, with a two-judge Supreme Court bench Thursday asking a larger bench to check the basis for the central government’s ban on it.
Colloquially called the ‘love hormone’ due to its role in sexual activity and childbirth, oxytocin is given to mothers just after childbirth to prevent excessive bleeding, which is the most common reason for maternal mortality in India.
However, the Centre banned private manufacture of the drug in April 2018, saying it was being misused on milch cattle to increase yield, which not only affects the health of the cattle, but also humans who consumed the milk. It only allowed one state-run firm to continue production.
The bench of Justices A.M. Sapre and Indu Malhotra have raised seven points for a three-judge bench to consider, chief among which is whether an essential drug can be banned in the manner it has been, under the Drugs and Cosmetics Act.
“The twin issues which arise for consideration are, on the one hand, the unregulated and clandestine manufacture of the drug oxytocin, which is reportedly misused in milch animals; and on the other hand, the continued supply of an essential life-saving drug, which is used as the first line drug for prevention and treatment of postpartum haemorrhage at the time of childbirth,” the bench said.
The Delhi High Court, in December last year, had quashed the Centre’s notification barring the manufacture of oxytocin, and called it “arbitrary” and lacking any scientific basis.
ThePrint traces the two-decade long battle over oxytocin, the lack of scientific evidence to support the central government’s ban, and its own admissions about the impact on mothers versus the impact on cattle.
India’s maternal mortality problem
India suffers from a high maternal mortality rate, ranking 129th among 184 countries in terms of this problem. The primary reason for maternal mortality in India is postpartum bleeding, which is the loss of more than 500-1,000 ml of blood within the first 24 hours of childbirth.
Over the years, the number of women dying during childbirth has fallen, and that’s thanks to two factors — a lower number of infections, and immediate attention to postpartum bleeding via oxytocin.
So why did Centre ban oxytocin?
The central government asserted that oxytocin is used on milch cattle to enhance milk production, which has adverse effects on cattle as well as humans who drink the milk. It decided that only one public sector undertaking — the Karnataka Antibiotics and Pharmaceuticals Limited (KAPL) — would be permitted to produce the hormone to meet the needs of the entire country.
It told the courts that KAPL has the capacity to produce 1.8 lakh ampoules of oxytocin every day, and a current output of 1.7 lakh, which was adequate to meet the demand of approximately 1.6 lakh ampoules per day across the country.
The court was also told that the KAPL has pan-India presence with 20 branches and over 700 distributors to cover all states and Union Territories.
KAPL was ill-equipped
However, file notings from the drug regulation section of the Ministry of Health and Family Welfare presented a totally different picture.
The notings stated that KAPL had never manufactured the drug before, and had to be given Rs 7.5 crore by the central government to start production. According to records, the KAPL had no ability to produce the drug until as recently as mid-2017.
The central government also did not consider that the Department of Investment and Public Asset Management under the finance ministry had already made plans to sell KAPL under the government’s strategic sale policy.
“The Cabinet Committee on Economic Affairs (CCEA), in its meeting held on 1 November 2017, accorded ‘in principle’ approval for a strategic disinvestment of the PSU, according to a December 2017 year-end review of the Ministry of Chemicals and Fertilisers. A report submitted to Parliament as recently as December 2018 shows this plan had not changed,” The Indian Express reported.
No scientific basis
According to documents filed by the central government in the courts, the deliberations to ban oxytocin began in 1997. A ban was first suggested in July 1999 to the country’s apex advisory committee on drug-related matters — the Drugs Technical Advisory Board (DTAB) — alleging that oxytocin caused cancer, growth retardation and cardiovascular disease.
Between 2011 and 2018, the drug’s misuse in the dairy sector was brought up several times in DTAB and Drugs Consultative Committee (DCC) meetings, but both bodies were against the idea of banning oxytocin for human use. They recommended “strong vigilance”.
A multi-disciplinary committee set up by the government in July 2014 also highlighted that there was no data to support the allegation of misuse of oxytocin.
In 2014, at a meeting of an inter-ministerial committee to decide on the future of oxytocin, the government sought details from several departments, including health, dairy and fisheries, livestock and animal husbandry.
However, medical advisory boards never recommended a ban on the human consumption of oxytocin due to missing scientific evidence on potential side-effects. Also, the government lacked the data to show the misuse on cattle.
“On the basis of deliberations, it was summarised that there was no data on the scale of misuse of oxytocin,” said the document filed by the central government in court.
HP High Court’s intervention
In 2016, the Himachal Pradesh High Court took suo motu cognisance of the misuse of oxytocin and passed a judgment stating that there weren’t enough checks and curbs in place. It had suggested that the manufacture of the drug be undertaken only by the public sector.
This judgment was the tipping point, leading to the direct involvement of the Prime Minister’s Office and the NITI Aayog in the deliberations that followed. The matter escalated, with several government bodies, including the health ministry, the Central Board of Excise and Customs, and various state police departments working on it.
What followed was the central government’s April 2018 notification banning its manufacture in the private sector.
Most drastic option, said Delhi HC
In its 100-page judgment on the central government’s notification, the Delhi High Court held the ban to be “arbitrary and unreasonable”, and rapped the government for failing to “adequately weigh in the danger to the users of oxytocin, nor consider the deleterious effect to the public generally and women particularly, of possible restricted supply if manufacture is confined to one unit, to the pregnant women and young mothers, of a potentially life-saving drug”.
It noted that what appeared to have weighed the most with the central government was the view that oxytocin was harmful to milch cattle, instead of its potentially life-saving qualities.
It further opined that the trigger for the ban was veterinary misuse, despite the fact that there was insufficient data and no scientific basis to conclude that the drug’s existing availability or the manner of its distribution posed a risk to human life.
These parts of the court’s judgment were admitted to by the central government itself on various platforms. For instance, in response to a query in Parliament in August 2014, Harsh Vardhan, the Union Minister of Health and Family Welfare, had admitted that while there were media reports on the misuse of the drug, “scientific data on the extent of such practice is not available”.
The minister had added that according to the expert body Indian Council for Agricultural Research (ICAR), “no ill effects have been observed in the animals in the experiments carried out on the use of oxytocin”.
The government also claimed that the drug was being used to accelerate puberty in girls, who were being trafficked. However, this was also based on media reports, with the government acknowledging that “scientific data on the extent of such practices is not available”.
The high court, therefore, opined that the central government had chosen the “most drastic option” without considering the alternatives available, and without any scientific proof to support its assertions.