Right prescription: lifting the ban on oxytocin

The Delhi High Court restores the retail sale and private manufacture of a life-saving drug

December 18, 2018 12:02 am | Updated 06:19 pm IST

In a crucial development that exposes the flaws in health policy-making in the country, the Delhi High Court quashed a government ban on the retail sale and private manufacture of oxytocin . Notified by the Union Ministry of Health and Family Welfare in April, the ban referred to a 2016 Himachal Pradesh High Court judgment, which discussed oxytocin’s misuse in dairy cattle, fruits and vegetables. However, soon after the order was issued, health experts pointed to the absurdity of it. Oxytocin is a life-saving drug used to stem post-partum bleeding among new mothers. Because of this it had been listed by both the World Health Organization and the Health Ministry as an essential medicine. Around 45,000 women die from post-partum complications in India each year, and in 38% of the cases the reason is haemorrhaging. Without the easy availability of inexpensive oxytocin, efforts to stem the maternal mortality epidemic could have suffered a costly setback. These worries led to the All India Drug Action Network (AIDAN), a patient-rights group, to challenge the order in the Delhi High Court.

In its judgment on December 14, in response to AIDAN’s and drug manufacturers’ petitions, the court struck down the ban, calling it “unreasonable and arbitrary”. The court found that the government had failed to weigh the danger the ban posed to thousands of young mothers. What is more, it had failed to show that the drug was widely misused for veterinary purposes, the purported reason behind the order. Several bits of evidence cited in the judgment support this analysis. Even though the Centre claims to have made 25 illegal drug seizures across India in a three-year period, 12 of them didn’t actually find oxytocin. Among those that did, none involved licensed drugmakers. Karnataka Antibiotics & Pharmaceuticals Limited, the only authorised oxytocin producer after the ban, did not have the capability to manufacture it until mid-2017. It is mystifying why the Centre clamped down on licensed manufacturers with a proven track record, while roping in a state firm with no real experience. The most damning observation in the judgment is that the Centre focussed on the health of milch animals, without considering the well-being of women. This was despite the fact that all statutory bodies, including the Drugs Technical Advisory Board, had advised against a ban. This episode ought to compel policy-makers to reflect on the process that led to the ill-conceived order. Several questions must be answered. On what basis did the Centre overrule the advice of multiple statutory bodies? What led to its acceptance of sporadic reports of the drug’s misuse, without clinching proof? 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.

 

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