Even as the Centre had cited the “rampant misuse” of Oxytocin in the country as a justification for its February 8 decision to restrict the sale of Oxytocin, the data provided by the central drug regulator to the Delhi High Court shows that it did not seize a single ampoule of Oxytocin in 2016-17 and 2017-18.
Also, in 2016-17, the central regulator — Central Drugs Standard Control Organisation (CDSCO) — did not seize any raw material (or the Active Pharmaceutical Ingredient) used in the manufacturing Oxytocin while in 2017-18, it seized just 614 grams of the API. The CDSCO has also informed the court that it has cancelled licences of just three companies since 2015-16 citing Oxytocin misuse.
However, in 2018-19, the CDSCO swung into action after the central government took the decision on February 8 this year to restrict the sale of Oxytocin in India. Between April and August this year, the CDSCO seized 11.2 lakh ampoules of Oxytocin meant for use on animals. However, in April-August period of 2018, it has not cancelled licenses of any of the Oxytocin manufacturers.
From April 2015 to August 2018, pharmacuetical companies – which include private as well as public companies — manufactured and dispatched around 16.5 crore ampoules of Oxytocin in India. State drug licensing authorities have been comparatively more active in seizing Oxytocin across India. They 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 2015-16, 2016-17 and 2017-18.
The data regarding production, dispatch and seizures was provided by the Union health ministry through an affidavit that was submitted at Delhi high court during this week. The CDSCO works under Union health ministry only. A two-judge Bench of Justices S Ravindra Bhat and A K Chawla have been hearing three petitions against the proposed ban on Oxytocin production by private companies for domestic use. The proposed ban is to come into force from December 1.
S Eswara Reddy, Drug Controller General of India, who heads the CDSCO, did not respond to the queries mailed by The Indian Express. On August 30, the central government counsel 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.”
Justice Bhat asked the Centre on September 20 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 on September 20 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?”