Pvt firms barred from producing, selling oxytocin after due deliberation

New Delhi: The Centre on Thursday told the Delhi High Court that the decision to ban private firms from producing and distributing oxytocin, a drug used to induce labour contractions during child birth and control bleeding, was not a knee-jerk reaction and it was being deliberated since 1997.

A bench of Justice S Ravindra Bhat and A K Chawla was informed by the central government counsel that the drug was being misused in the dairy sector to increase milk secretion and production.

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

The court was hearing several pleas by private firms seeking to set aside the government's ban.

Additional Solicitor General Maninder Acharya, appearing for the Centre, said the government was seized of the issue of misuse and abuse of oxytocin since 1997 and there was nothing new.

"Various minds were put in and deliberations took place. It was not a knee-jerk reaction. If it would have been only the abuse of the drug, it was easy for us to ban it.

Our problem increased because the drug has a use and we are aware of the fact that it should reach every woman who requires it," she said.

The ASG said there was no gap in the deliberations and they were continuous and consistent.

On being asked by the bench about the data on prosecutions by the states and Union Territories for abusing the drug, the ASG said that it was not available currently and for gathering data, the Centre would have to get in touch with the states and UTs.

The high court had on August 31, suspended till September 30, the central government's prohibition on sale and manufacture of oxytocin by private companies for domestic use.

The government had in April this year restricted private companies from making or supplying the drug, used for treating excessive bleeding in women during child birth and help new mothers lactate to prevent its alleged misuse in the dairy sector for increasing milk 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 had 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 licensed to manufacture the drug and it was issued the licence only this April.

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 has 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 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.