Oxytocin: There must be threshold to define drug’s misuse as rampant, says Delhi High Court

Justice Bhat asked the Centre on Thursday if it isn’t a conclusion to use “rampant” in the term “rampant misuse of Oxytocin”. The Central government counsel replied that “rampant misuse was in the knowledge of all departments”. Justice Bhat then asked: “What knowledge is there with the departments? We want to know the basis on which this conclusion (regarding rampant misuse) has been reached.”

Justice Bhat added that there has to be threshold over which it can be said that this drug’s misuse has been “rampant”.  He said: “If out of 30 lakh bottles, around 1 lakh bottles are being leaked or around 2 lakh bottles are leaked (into illegal market), can it be termed as ‘rampant’ misuse? We can’t decide the limit. However, in order for you to say so, there needs to be data …You took the decision (to ban production by private companies), so what was the data with you?”

According to Centre, Oxytocin is misused by the farmers in growing abnormally large sized vegetables and by dairy owners to extract larger amounts of milk from cows and buffaloes. Therefore, Justice Bhat asked the Centre if any diary owner — who was misusing Oxytocin — was prosecuted as yet. Moreover, he asked how many private companies’ licences were cancelled due to their involvement in illegal Oxytocin trade.

He added that if there is any misuse of Oxytocin, it has to be substantiated with data. “A minister says there is misuse, then an official says there is a misuse, but we would like to know how many prosecutions have happened till date for such misuse? How many convictions have happened? How many prosecutions are ongoing? How many seizures have been done at the border?” stated Justice Bhat.

Additional Solicitor General Maninder Acharya — who was appearing on behalf of the Central government — stated that such data can be collected from the states and union territories, but the Centre does not have the data “right now”. Previously, on August 30, Acharya had told the two judge bench: “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.”

From October 1, only Karnataka Antibiotics & Pharmaceuticals Ltd (KAPL), a public sector entity, would be permitted to manufacture and distribute Oxytocin in India. Justice Bhat asked the Centre on Thursday: “Currently, if there are around 100 companies manufacturing this drug, do you know what is their total capability? Do you know where these companies located are? Do each of these companies have export capability? Do you know what would be the impact on them of your decision to ban? Did you take that direction of enquiry?”

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.