The Delhi High Court on Friday quashed the Centre's decision to ban private firms from making and selling Oxytocin, used to induce labour and prevent bleeding during child birth, saying it was "unreasonable and arbitrary" as it did not consider the "deleterious effect" of such a move on pregnant women and young mothers.
A bench of Justices S Ravindra Bhat and A K Chawla said the government did not consider that restricted supply of the drug, by confining its production to one state-run unit, would pose a danger to the users of the "potentially life-saving" medicine.
The Centre by a notification issued in April this year had prohibited private licensed firms from manufacturing and selling Oxytocin, also used to help young mothers lactate, on the ground of widespread misuse of the drug in the dairy sector.
The April 2018 decision was challenged in four separate petitions filed by BGP Products Operations GmbH -- a subsidiary of Mylan Laboratories -- Neon Laboratories, NGO All India Drug Action Network (AIDAN) and Ciron Drugs and Pharmaceuticals Pvt Ltd.
Allowing the petitions, the bench held that "the notification is both unreasonable and arbitrary. The 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."
The court said scarcity of the drug or even restricted availability can have "drastic consequences", like increase in maternal fatalities during childbirth and impairing lives of thousands of innocent young mothers.
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"The notification and preceding decision making process placed far greater importance on the need to prohibit availability of Oxytocin from what was perceived to be widespread veterinary misuse. Clearly the trigger for the move was the Himachal Pradesh (HP) High Court judgment, which did not notice that Oxytocin was an essential drug.
"Correspondingly there was no scientific basis, and insufficient data to support the conclusion that the drugs existing availability or manner of distribution posed a risk to human life," the bench said.
It also said that the HP High Court also did not consider the facts that Oxytocin was in the national and WHO list of essential medicines and that it was one of the prime reasons for fall in rate of maternal mortality caused by post-partum haemorrhage.
The HP High Court in March 2016 had directed the state of Himachal Pradesh and the Centre to bring about an efficient system to regulate the manufacture, import and distribution of drugs, especially medicines like Oxytocin.
"Maternal welfare too is considered a directive principle under Article 42 of the Constitution. Correspondingly, the right of women, generally and pregnant women and young mothers in particular, to have a safe post-partum recovery and avoid risk of haemorrhaging that can be potentially fatal, is an integral part of Article 21 (right to life) of the Constitution," it said.
The court further said that ban on licensed manufacturers must be premised on data showing that they were misusing their licences and engaging in illegal import, manufacture, distribution or sale of the drug.
"In the entire counter affidavit (of the Centre) there is not a single instance established, of such misuse by any licensed manufacturer," the court said.
It also said that confining production of the drug to state-run Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL) was a decision which was taken without taking into account the "inherent vulnerability", like shutdown of operations on account of unforeseen situations like fire, disasters and strike, of such a move.
"This court notices that the decision of prohibiting a country wide existing manufacturing base for Oxytocin, a life-saving drug (through the over hundred private licensed units spread across the country), for over three decades or so, on the one hand and reserving it to the public sector through a single manufacturing entity, which has no previous record in its production, is thus fraught with potential adverse consequences," the bench said in its 100-page judgement.
Dealing with the government's argument that Oxytocin was being widely misused in the dairy sector, the court said there was no "hard convincing data" to assume there was a critical and urgent need to prohibit domestic licensed manufacturers from producing the life-saving drug,
Furthermore, even according to the record, there is no scientific evidence about long term adverse impact because of Oxytocin use on milch cattlei.e. cows and buffaloes.
It further said that even if there was good case to conclude that the drug was a risk to cattle health, its therapeutic benefit to humans "could not have been overlooked or given less importance".
On the issue of confining production of the medicine to one state-run entity, the court said that while authorities can suspend or cancel licences after following the prescribed procedure, there was no provision in the Drugs Act that authorises the taking over of an entire line of drug business for monopoly production by one licensee.
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