HC extends till Dec 15 stay on ban to make, sell Oxytocin by private companies

The Delhi High Court on Friday extended till December 15 its stay on the government decision to ban private firms from producing and selling oxytocin, a drug used for inducing labour contractions and controlling bleeding.

A bench of Justice S Ravindra Bhat and A K Chawla passed the order while reserving its verdict on several pleas by private firms seeking to set aside the government's decision of April this year.

The Centre had restricted private companies from making or supplying the drug, which helps new mothers lactate, to prevent its alleged misuse in the dairy sector for increasing milk production.

Oxytocin is also 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.

As per the Centre's April 27 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 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.

Thereafter, the court had extended the stay from time to time while it was hearing arguments in the matter.

During the arguments, the Centre had defended its decision saying it was not a knee jerk reaction and was being deliberated since 1997.

The court had earlier 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 in April this year.

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 have 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.