Private companies making Oxytocin received a shot in the arm on Friday with the Delhi High Court quashing the Government’s decision to ban them from making and selling the drug in the country.

The reprieve, though, could be short lived as the Centre is expected to appeal the decision at the Supreme Court, a top official in the Health Ministry told BusinessLine .

Oxytocin is used in preventing excessive bleeding during childbirth, but the Health Ministry had called for a ban on the private production of the drug to prevent its misuse in cattle and poultry, besides its abuse in young girls. In a 100-page judgment, a Bench comprising Justices S Ravindra Bhat and A K Chawla called the Government’s decision “unreasonable” and “arbitrary”.

“There was no scientific basis, and insufficient data to support the conclusion that the drugs existing availability or manner of distribution posed a risk to human life (a requirement of Section 26A). The weighing of options or balancing act, to bring in a suitable measure geared to achieve the same objective in a different, or drastic manner was not undertaken,” the judgment said.

The Health Ministry had called for a ban on private producers of Oxytocin from July 1. And to cater to domestic supplies, the Centre had appointed public sector unit Karnataka Antibiotics & Pharmaceuticals Ltd (KAPL). The move had gynaecologists raising an alarm on the possibility of hospital supplies of this critical drug being hit by the ban on private producers. They also cautioned against depending on a single company, albeit a PSU, who had not made the product earlier.

A major participant in the segment, Mylan approached the Delhi HC on the ban. And later non-government organisation All India Drug Action Network (AIDAN) also approached the Court, in a separate case. The ban on private companies was repeatedly deferred, and the last stay on ban was to lapse on December 15. Pfizer is the other major producer of the drug, besides Neon Laboratories, which is also one of the petitioners.

The Centre’s efforts to curb Oxytocin misuse came against the backdrop of, among other issues, concerns raised by social workers that it was being misused in young girls to advance puberty. The other critical reason was the misuse of the drug in cattle to increase milk production, and to induce ripening in fruits and vegetables.

In fact, to tackle the veterinary problem, the Drug Controller General of India had already brought in restrictions in 2014.

But the Oxytocin discussion seems unlikely to end here if indeed the Centre decides to appeal the decision in a higher court.

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