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Ban on Oxytocin postponed – again

Copyright: ruigsantos / 123RF Stock PhotoThe Centre’s ban on hormone drug Oxytocin was supposed to come into force today, but has been stayed till October by the Delhi High Court (DHC).

The news will surely come as a relief to activists, doctors and drugmakers opposing the Centre’s decision to tighten restrictions on the drug’s production and sale in India. Many worried that the ban would result in shortages of the life-saving drug.

Oxytocin is effective in preventing postpartum haemorrhage (PPH), the leading cause of maternal mortality in India. However, its alleged misuse in other sectors prompted the Union Ministry of Health and Family Welfare (MoHFW) to announce that companies in the private sector would no longer be allowed to produce and sell the drug. Only Karnataka Antibiotics and Pharmaceuticals Limited (KAPL) would be licensed to manufacture and distribute Oxytocin in India.

The Centre later reversed course on the sale of Oxytocin, allowing private chemists to stock the drug. The restriction on production of the drug was to remain in place, however. As such, fears still abounded that Oxytocin shortages would ensue as KAPL has never produced Oxytocin before and lacks distribution centres in 19 of India’s 35 states and union territories.

“Many worried that the ban would result in shortages of the life-saving drug”

Legal challenges filed in the DHC led to the Court staying the ban. It is the second time the ban has been postponed, after the original date of July 1st was pushed back to September 1st so that KAPL would have time to produce sufficient volumes of the drug to meet demand.

The DHC has stayed to ban so as to hear additional arguments on September 12th. It is seeking explanations as to why Oxytocin is being singled out.

Justice S Ravindra Bhat stated “It is an essential drug… There are abuses of many other medicines such as painkillers. Why are you singling out this one? That is what you have to explain.”

“Legal challenges filed in the DHC led to the Court staying the ban”

The DHC also questioned if misuse of Oxytocin is as prevalent as the Centre claims. This was in response to a claim by Additional Solicitor General Maninder Acharya that private drugmakers “are selling two types of drugs: one for the abuse and one for the normal market.”

Bhat responded, “There is the possibility that there are some stray cases but it is not rampant…there is nothing in statistics. Nothing empirical.” (This much was admitted by the Centre, with Acharya stating “We may not have the data to back it.”)

With the ban stayed for another month, one questions if it will come into force at all. Regardless, with fears of shortages assuaged for the moment, mothers can breathe a sigh of relief – for now.

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