Reiterating its stand to ban the manufacture and sale of Oxytocin, a drug which induces labour and controls bleeding during child birth, by private companies, the government has approached the Supreme Court contesting the Delhi high court’s decision which set aside the government’s 27 April notification imposing the ban.
The Delhi high court had in December 2018 quashed the Centre’s decision to ban the manufacture and sale of Oxytocin by private firms saying it was “arbitrary and unreasonable". The decision was taken, following a PIL filed by All India Drugs Action Network (AIDAN) opposing the ban.
However, “the government has challenged the High court’s order in the Supreme Court. The government stands-by its notification and wants High court’s decision be quashed, said two people aware of the matter.
Oxytocin is prescribed for the initiation of uterine contractions and induction of labour in women as well as stimulation of contractions during labour.
It is also used to help abort the foetus in cases of incomplete abortion or miscarriage, and control bleeding after childbirth. But it is controversial because it is used widely in the dairy industry, agriculture and horticulture. Authorities are also concerned that the misuse of this growth booster is reported among trafficked children, injected to accelerate puberty among girls. The minister for women and child development, Maneka Gandhi, has been pushing for a ban and had taken up the issue with health minister J.P. Nadda.
Consequently, the government’s top drug advisory board—the Drug Technical Advisory Board (DTAB)—in a meeting on 12 February, 2018 recommended various measures to check the drug’s misuse. Other than proposing curbs on imports, it also proposed the drug be manufactured by only one firm, Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL), a public sector unit, and be marketed by another, HLL Lifecare Ltd. The Central Drugs Standard Control Organization (CDSCO) had proposed to regulate the supply of Oxytocin injection to only one manufacturer, and finally in April came up with a notification restricting its production by private manufacturers.
According to CDSCO, currently there are 80 licenced manufacturers including pharma major Pfizer and Novartis and there is only one manufacturer of Oxytocin active pharmaceutical ingredient (API). Oxytocin is included as a life-saving drug in the National List of Essential Medicines (NLEM).
The Delhi high court bench was not impressed with the Centre’s “far greater" reliance on the need to prohibit availability of Oxytocin from what was perceived to be widespread veterinary misuse. “Correspondingly there was no scientific basis, and insufficient data to support the conclusion that the drug’s existing availability or manner of distribution posed a risk to human life," it said. Adding that the Centre’s decision to allow only a single, state-run entity— with no prior experience in manufacturing Oxytocin—to make and sell the drug, was “fraught with potential adverse consequences". “The risk of such a consequence can be drastic: the scarcity of the drug, or even a restricted availability can cause increase in maternal fatalities, during childbirth, impairing lives of thousands of innocent young mothers," it further said.
Acoording to pharma lobby group Indian Drug Manufacturers’ Association (IDMA), its regulation will lead to “shortages" and “widespread panic". In their representation to the CDSCO, the IDMA raised concerns over the illegal trade of Oxytocin. “Oxytocin API is reportedly widely smuggled into the country, mainly from China and formulated by illegitimate and unlicensed formulators. Government must focus on curbing smuggling of Oxytocin API," it said.
However, the Centre seems hell bent on its decision to restrict its production. “The drug is misused and hence need to be regulated. That’s why the government has approached the SC. The next date of hearing is February 14" added one of the officials quoted above.