HC extends Suspension of Oxytocin Ban till November

The ban on the production and sale of the Oxytocin formulation has been suspended by the Delhi High Court till November 1st, 2018.
New Delhi: The Delhi High Court suspended for another 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.
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.
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.
Read also: Import banned, Only public sector to manufacture oxytocin
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.
Read also: Oxytocin manufacture banned from 1st July 2018, only this one firm will manufacture it
Challenging this, companies went to court.
Responding to the petitions in the month of August 2018, the two-judge bench had postponed the date of the ban to October 1. Now, the ban has been further postponed to November 1. The court is still hearing the matter
“There is an issue of proportionality of the measure. You may have some material (evidence), but is it proportionate to the decision you have taken,” Justice Bhat said adding that all aspects of this decision — about what happens when such disruption occurs due to a policy decision or what happens if the status quo is maintained — has to be taken into account.
At the same time, the bench was clearly opposed to one firm being given the entitlement to manufacture the drug
New Delhi: The Delhi High Court suspended for another 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.
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.
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.
Read also: Import banned, Only public sector to manufacture oxytocin
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.
Read also: Oxytocin manufacture banned from 1st July 2018, only this one firm will manufacture it
Challenging this, companies went to court.
Responding to the petitions in the month of August 2018, the two-judge bench had postponed the date of the ban to October 1. Now, the ban has been further postponed to November 1. The court is still hearing the matter
“There is an issue of proportionality of the measure. You may have some material (evidence), but is it proportionate to the decision you have taken,” Justice Bhat said adding that all aspects of this decision — about what happens when such disruption occurs due to a policy decision or what happens if the status quo is maintained — has to be taken into account.
At the same time, the bench was clearly opposed to one firm being given the entitlement to manufacture the drug
The Indian Express quotes Justice Bhat as stating: “You are creating a monopoly. On one end there is a monopoly, on the other hand, we have companies that have a license and the licensed activities are going on for the purposes of exports … These companies’ licenses have not been taken so we have to see what is the level of satisfaction for you on which basis you have taken this decision.”
All India Drug Action NetworkBan on OxytocinDelhi high courtJustice A K ChawlaJustice S Ravindra BhatKAPLKarnataka Antibiotics and Pharmaceuticals LtdMylanMylan LaboratoriesNeon LaboratoriesOxytocinOxytocin banPfizer
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