Home >News >India >SC larger bench to decide over restricting manufacture of Oxytocin to single PSU

SC larger bench to decide over restricting manufacture of Oxytocin to single PSU

  • The bench will decide whether imposing a ban on private companies to manufacture the controversial but life-saving drug is in public interest or not
  • The government decided to confine the drug's manufacturing to Karnataka Antibiotics and Pharmaceuticals Ltd, a govt company

New Delhi: The Supreme Court on Thursday referred the matter to a larger bench to decide on whether it would be in public interest to impose a ban on private companies to manufacture the controversial but life-saving drug Oxytocin and restrict its manufacture to a single public sector undertaking.

“We are of the considered view that this is a fit case to refer the matter to a larger Bench of three Judges to consider the aforesaid questions of law, and authoritatively pronounce upon the same. Accordingly, we direct the Registry to place the present group of appeals before the Hon’ble Chief Justice of India for necessary directions," the court order said.

The health ministry had in April 2018 notified a ban on private drug manufacturers from producing Oxytocin. The government had restricted its imports and decided to confine manufacturing to Karnataka Antibiotics and Pharmaceuticals Ltd, a government company.

However, domestic drug firms and non government organisation-All India Drugs Action Network (AIDAN) resisted the move to regulate the life saving drug and approached the court. Manufacturers were of the view that availability will be severely hit if the government allows only one manufacturer to make it. Oxytocin is included as a lifesaving drug in the National List of Essential Medicines (NLEM).

On Thursday the SC said that since the issue has “far reaching implications" it referred the matter to a three judge bench. “The twin issues which arise for consideration are on the one hand, the unregulated and clandestine manufacture of the drug Oxytocin, which is reportedly misused in milch animals; and on the other hand, the continued supply of an essential life­saving drug, which is used as the first line drug for prevention and treatment of post­partum haemorrhage at the time of childbirth."

According to the SC, the bench should look into various aspects like whether the government notification will result in monopoly, if the restriction on its manufacturing be in public interest, whether the government's decision would achieve the objective and purpose of preventing the unregulated and illegal use of the drug, among others.

“We await the constitution of the three judge bench to decide these questions, access to Oxytocin being of grave importance for maternal health," said Malini Aisola of AIDAN.

Oxytocin, is a uterine stimulant hormone, 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 to control bleeding after childbirth. It may be used for breast engorgement. However, it is also used widely in the dairy industry, agriculture and horticulture to boost production.

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