Last week, data submitted in Delhi High Court by the Central Drugs Standard Control Organisation (CDSCO) showed that it had not seized a single ampoule of oxytocin in 2016-17 and 2017-18. This came amid repeated assertions by the central government that there has been “rampant misuse” of oxytocin in India.
Oxytocin is a naturally secreted hormone that is also used as a drug. It is chemically synthesised and sold by pharmaceutical companies across the world, and used as a drug during childbirth because it can contract the uterus and induce delivery, control bleeding, and promote the release of breast milk. On various grounds including health concerns — Himachal Pradesh High Court passed an order listing the grave dangers oxytocin posed to humans — the government earlier this year notified a ban on production by private companies for domestic use.
Why it’s in court
For the last five months, the two-judge bench of Justices S Ravindra Bhat and A K Chawla has been hearing three petitions against the proposed ban. On September 20, when the government counsel said “rampant misuse” of oxytocin “was in the knowledge of all the departments”, Justice Bhat asked: “What knowledge is there with the departments? We want to know the basis on which this conclusion has been reached.” The court asked the government if it has any data to show “rampant” misuse; it added there has to be threshold over which it can be said that 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?”
On August 30, the court had criticised the Centre for not having data on oxytocin’s diversion to the illegal market by private licensed manufacturers.
In last week’s affidavit, the Centre stated that central regulator CDSCO did not seize any raw material (or Active Pharmaceutical Ingredient) for manufacturing oxytocin in 2016-17; and seized just 614 grams of the API in 2017-18. Since 2015-16, CDSCO has cancelled the licences of just three companies for oxytocin misuse, it said.
In 2018-19, in the wake of a decision on February 8 this year to restrict the sale of oxytocin, the CDSCO seized 11.2 lakh ampoules meant for use on animals. This was between April and August this year. For this period, the Centre has not cancelled licences of any of the manufacturers. Since 2015-16, it has suspended 45 licences since 2015-16 for oxytocin misuse, the government told the court. On October 25, when the court asked if all these 45 licences were of oxytocin manufacturers only, the government counsel replied that they were not. The court then asked for detailed data showing how many manufacturers’ licences have been suspended.
From April 2015 to August 2018, pharmaceutical companies — private as well as public — manufactured and dispatched around 16.5 crore ampoules of oxytocin in India, according to the affidavit. State drug licensing authorities, in contrast to central authorities, seized 2.3 lakh, 1.39 lakh and 1.45 lakh ampoules in 2015-16, 2016-17 and 2017-18 respectively. However, the state authorities did not seize any oxytocin API in these three years.