The Delhi High Court on Wednesday asked the Centre to explain why it is singling out Oxytocin when there are many other medicines, such as painkillers, that are being abused by people.
“If you are not prohibiting the drug (Oxytocin), you are creating a monopoly. This is not per se an illicit drug. It is an essential drug… There are abuses of many other medicines such as painkillers. Why are you singling out this one? That is what you have to explain,” said Justice S Ravindra Bhat on Wednesday. A two-judge Bench of Justices Bhat and A K Chawla were hearing three petitions on Wednesday against the proposed ban on Oxytocin production by private companies for domestic use.
From September 1, only Karnataka Antibiotics & Pharmaceuticals Ltd (KAPL), a public sector entity, would be permitted to manufacture and distribute Oxytocin in India. “We are not concerned with one private manufacturer or the other. We are concerned about the public. We want to know if there is enough capacity with one party (company) to cater to complete Oxytocin demand of India,” Justice Bhat said.
EXPLAINED | Clampdown on oxytocin: why, what now
The court asked the Centre to give complete details of production and distribution of Oxytocin by KAPL in the past four months. “You also need to tell us how much the demand of Oxytocin is across India… Also, you need to tell how much is the combined capacity of all 30 private companies that has been producing Oxytocin in India,” Justice Bhat added. The Centre would have to produce the information with the court on Thursday, when the Bench will continue hearing the matter.
The court added: “These private companies have the capacity and license today. So their sale is not illegal. There is no specific allegation against any private company regarding Oxytocin. So, if you (the Centre) is going to say that there is going to be monopoly, you need to tell what steps you are taking to enhance your capacity.” According to a source privy to the development, KAPL started production of Oxytocin for the first time on July 2. Oxytocin’s import has already been banned by the Centre in April itself.
The three petitioners in this case are BGP Products Operations Gmbh, which is a subsidiary of Mylan Laboratories; Neon Laboratories; All India Drug Action Network (AIDAN). Currently, Pfizer and Mylan are two leading producers of Oxytocin in India. Private firms such as Pfizer, Mylan and Neon would not be permitted to make and distribute Oxytocin for domestic use from September 1.
Oxytocin is administered to pregnant women to “prevent and treat” postpartum haemorrhage (PPH). PPH accounts for about 35 per cent of all maternal deaths, says the World Health Organization.