Stating that there is “no need to throw the baby out with the bathwater”, the Delhi High Court Thursday noted that there may be some “stray cases” where private pharmaceutical companies may be involved in illegal Oxytocin supply but it is “not rampant”.
A two-judge Bench of Justices S Ravindra Bhat and A K Chawla were hearing three petitions on Thursday against the proposed ban on Oxytocin production by private companies for domestic use. As per Centre’s notification, this ban would come in effect from September 1.
“There is no need to throw the baby out with the bathwater. They are licensed manufacturers. If six crore ampoules of Oxytocin are produced, and if one or two manufacturers are involved in misuse, then you (Centre) need to show it empirically. Like how much supply is being diverted in misuse — whether it is one per cent, five per cent etc,” Justice Bhat said.
During the hearing, Additional Solicitor General Maninder Acharya — who was appearing on behalf of the Central government —said: “Most of the (private) licensed manufacturers — we may not have the data to back it — but they are selling two types of drugs: one for the abuse and one for the normal market.”
Listening to this, Justice Bhat said: “There is the possibility that there are some stray cases but it is not rampant.” When the government counsel replied that it is rampant, Justice Bhat stated: “That is the whole point of the matter. In India, there is nothing in statistics. Nothing empirical.” From September 1, only Karnataka Antibiotics & Pharmaceuticals Ltd (KAPL), a public sector entity, would be permitted to manufacture and distribute Oxytocin in India.
Acharya further explained the logic behind the proposed ban: “We have taken this decision so that when a public body (KAPL) is producing this drug, and then it is barcoding it, then we have a record that how much of it is produced and where all it went.”
The court stated that it is not looking for one manufacturer or another but for a “larger solution” to this issue. It suggested to the Central government that it should visualise all kinds of control it wants to put in at each of the manufacturer. “If you (Centre) can place one person for clearance of drugs at factories, I think that the private companies would not have any objection to that… You have to devise the mechanism,” Justice Bhat stated.
While discussing the leakage of Oxytocin to illegal market from licensed companies, the court also stated that now that the GST system has been put in place, there is a record of each transaction with the central government. “So, how does the question of leakage arises when everything has been put on the record?” Justice Bhat asked the Centre. The court will continue hearing the matter on Friday.
One purported harmful effect of Oxytocin, as mentioned by the Centre, is that it is injected in animals to increase their milk production. The court therefore asked on Thursday if the Centre has the data of all the organised diaries that are in India.
“This is one of the missing pieces. We need this data if we have to take a decision of this magnitude,” Justice Chawla said.
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.