The Delhi high court on Friday set aside the Centre’s decision to ban private companies from manufacturing and selling oxytocin, a drug used to induce labour and control excessive bleeding during childbirth.
A bench of Justices S Ravindra Bhat and A K Chawla quashed the government’s April 27 notification imposing the ban, saying it was “arbitrary and unreasonable” and did not consider the “deleterious effect to the public generally, and women particularly”.
Hearing a bunch of petitions challenging the notification, the court said the Centre’s decision to allow only a single state-run entity — Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL) — with no prior experience in manufacturing oxytocin to make and sell the drug, which has wide public use, was “fraught with potential adverse consequences”.
In its 100-page order, the court said, “… it is held that the impugned notification is both unreasonable and arbitrary; the UOI (Union of India) did not 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.”
Oxytocin is administered to pregnant women to “prevent and treat” postpartum haemorrhage, which accounts for about 35% of all maternal deaths, as per the World Health Organisation. It is also given to lactating mothers to increase milk secretion. While imposing the ban, the Centre had argued that the drug was widely smuggled out of the country and crudely manufactured for use in the dairy sector. But the court said it had failed to produce relevant data to corroborate its claims.
Harping on the danger to women, the court said “scarcity of the drug, or even restricted availability, can cause an increase in maternal fatalities, during childbirth, impairing lives of thousands of innocent young mothers”. It added that there wasn’t sufficient data to establish that the availability of the drug or its manner of distribution posed a risk to human life. Reacting to the verdict, Malini Aisola, co-convener of All India Drug and Action Network, said, “This is the judgment we were hoping for. The court clearly says that paramount is the right to life of mothers. The concern about misuse (of the drug)is secondary, but the court said that there wasn’t any data to support this claim as well. This is a drastic measure that was taken by the government and even a few fatalities resulting from such an action is not acceptable.”
A senior official of the Central Drugs Standard Control Organisation said on condition of anonymity, “We received the order just today (Friday) and cannot comment on how the matter will proceed. It is up to the ministry to decide what to do. It will obviously be studied on what grounds the notification was quashed and addressed.”
The April notification had sparked widespread protests and legal challenges, following which the high court had on August 31 stayed it till September 30. The stay was later extended till December 15.