The high-decibel discussion over the hormone Oxytocin has taken a legal turn with the US generic drugs major Mylan approaching the Delhi High Court.

“We have challenged the notification, issued by the Ministry of Health and Family Welfare, Department of Health and Family Welfare, placing restrictions on the manufacture and supply of Oxytocin, before the Delhi High Court and the matter is sub judice,” a company spokesperson confirmed with BusinessLine .

Earlier this month, a Health Ministry notification banning private companies from producing Oxytocin and allowing only the public sector unit Karnataka Antibiotics & Pharmaceuticals Ltd (KAPL) to make the drug, was to come into effect.

Widespread misuse

Oxytocin is used to treat excessive bleeding during birth, but the move to ban was necessitated by its widespread misuse in the dairy and poultry sector, where it was used to increase milk secretion and production. Concerns were also raised of its misuse on young girls to induce puberty.

But the proposed ban on private production was deferred to September 1, as doctors raised an alarm on the possible shortfall of Oxytocin supply that could arise if only one company was permitted to make this drug.

It is a price-controlled drug and the companies making it in India include Mylan and Pfizer.

May lead to monopoly

Even as Mylan takes the issue to Court, doctors and industry representatives are calling for a government rethink, as they say a ban was unlikely to stop the diversion and misuse of the drug.

In fact, it creates a monopoly of a PSU kind, cautions an industry representative, adding that supplies of this critical drug would be hit if the sole supplier encountered an adverse situation like a strike or a cyclone.

Also, if the Government was concerned about illegal versions of the bulk drug (used to make the final product) makings its way into the Indian market from China, the proposed ban would only exacerbate the situation by driving out legitimate companies, an industry representative familiar with the issue said.

Quality, price

Calling for a withdrawal of this notification for the time being, Kerala-based KV Babu says that the existing versions of Oxytocin are quality products and competitively priced.

Besides, he said, the PSU was making the product for the first-time. “There is no hurry”, he said, adding that the government could take another six months to a year to see how all the versions of the drug worked in terms of quality, efficacy, supply and price, before making its next move.

Countering the concerns on quality and short supply, a Ministry source, however, said that the annual requirement in the country was three crore ampoules or 25 lakh ampoules a month.

Though KAPL had about three lakh stock at present, it would have about 50 lakh by September 1, the source said, when the deadline barring private companies would kick in. Presently, there is an order for only 15,000 ampoules, the source said.

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