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HC Suspends Till Oct Centre's Ban on Oxytocin drug production & Sale by Pvt Firms, Next Hearing on Sep 12

HC's interim ban comes on pleas by private firms seeking to set aside the Government's ban on Oxytocin drug production and sale which was to come into effect from tomorrow.

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The Delhi High Court today suspended for a month the Centre's ban on private companies producing and distributing oxytocin, a drug used to induce labour contractions during child birth and control bleeding after it. A bench of Justices S Ravindra Bhat and A K Chawla passed an interim order on the pleas seeking to set aside the government's ban, which was slated to come into effect from tomorrow.

The court said on the first view, it was of the opinion that the prohibition on sale and manufacture for domestic use of Oxytocin should be suspended for one month. The bench listed the matter for September 12 for further arguments in the matter.

The government had in April this year restricted private companies from making or supplying the drug, used to treat excessive bleeding in women during child birth and help new mothers lactate, prevent its alleged misuse in the dairy sector to increase milk secretion and production.

As per the Centre's notification, the state-run Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL) was solely allowed by the Centre to make the drug to meet the country's needs. The court noted that the material placed before it showed that when the decision was taken in February this year to restrict the sale of Oxytocin, KAPL was not even licenced to manufacture the drug and it was issued the licence only this April.

Additional Solicitor General Maninder Acharya, appearing for the Centre, said the public sector unit had the capacity to cater to the entire nationwide demand for the drug and the government was taking the full responsibility for it.

One purported harmful effect of Oxytocin, mentioned by the Centre, was in the dairy sector where it was injected into the animals to increase their milk production. The court was hearing pleas of BGP Products Operations GmbH, a subsidiary of Mylan Laboratories, Neon Laboratories and NGO All India Drug Action Network (AIDAN) which works to ensure access to essential medicines.

Some private companies which made and sold the drug in India are Pfizer, Mylan and Neon. The NGO contended in its plea that it would not be advisable to depend on one company alone, especially when it allegedly has not made the product earlier.

The petitioners claimed the sudden and abrupt issuance of April 27 notification was arbitrary and also without application of mind. During the earlier hearings, the court had asked the Centre to explain why it was singling out Oxytocin when there were many other medicines such as painkillers, that were being abused by people.

Oxytocin is administered to pregnant women to "prevent and treat" postpartum haemorrhage (PPH). PPH accounts for about 35 per cent of all maternal deaths, says the World Health Organization. 


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