The ban on the production and sale of the Oxytocin formulation has been suspended by the Delhi High Court till October 1st, 2018.
New Delhi: The Delhi High Court suspended for a month the Centre’s ban on private companies producing and distributing oxytocin, a drug used to induce labour contractions during childbirth 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 childbirth and help new mothers lactate, prevent its alleged misuse in the dairy sector to increase milk secretion and production. This had met with severe oppositions from both the manufacturers and the medical community which had shown concerns about the availability of the essential drug.
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 licensed to manufacture the drug and it was issued the license 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.
The ban was opposed by the doctors as Oxytocin injection is administered to pregnant women to prevent and treat postpartum hemorrhage (PPH) which accounts for about 35 percent of all maternal deaths, says the World Health Organization. Doctors being unclear that how a single public sector company, Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL), will replace production and countrywide distribution of the lifesaving injection.
Medical dialogues have recently reported that the ‘Oxytocin Ban’, that followed complaints of rampant misuse of the drug, had finally been lifted by the Union Health Ministry, but strict regulations have been imposed on its sales.
Below is the attached judment for the same.