Therapeutic Benefit To Humans Could Not Have Been Given Less Importance: Delhi HC Quashes Ban On Manufacture And Sale Of Oxytocin By Pvt Cos [Read Judgment]

“The risk of such a consequence can be drastic: the scarcity of the drug, or even a restricted availability can cause increase in maternal fatalities, during childbirth, impairing lives of thousands of innocent young mothers. The impugned notification and preceding decision-making process placed far greater importance on the need to prohibit availability of Oxytocin from what was perceived to be widespread veterinary misuse.”

The Delhi High Court on Friday quashed the notification issued by Central Government which prohibited the manufacture and distribution for domestic use, of the essential drug OXYTOCIN injection for human use, by private sector companies.

The bench comprising Justice S. Ravindra Bhat and Justice AK Chawla were considering writ petitions filed by All India Drug Action Network and others. They had challenged this notification contending that it endangers the lives of pregnant women and young mothers.

The bench said that the predominant consideration in the government’s decision-making process is that Oxytocin had been misused in the past, resulting in adverse impact on the health of animals.

“In a case like this assuming the respondents had a good case to conclude Oxytocin was a risk to cattle health nevertheless in the nature of things its therapeutic benefit to humans could not have been overlooked or given less importance. The availability of the drug through established channels and licensees with long experience in its quality and the potentially unsettling effect of a canalized supply with attendant shortages (as KAPL had no previous experience in its manufacture) was an important and vital consideration as it impacted the right to life under Article 21 of the Constitution, of thousands of pregnant women” the court said.

The bench also observed that the Centre did not adequately weigh in the danger to the users of Oxytocin, nor consider the deleterious effect to the public generally and women particularly, of possible restricted supply if the manufacture is confined to one unit, to the pregnant women and young mothers, of a potentially life-saving drug.

 “The risk of such a consequence can be drastic: the scarcity of the drug, or even a restricted availability can cause an increase in maternal fatalities, during childbirth, impairing lives of thousands of innocent young mothers. The impugned notification and preceding decision-making process placed far greater importance on the need to prohibit availability of Oxytocin from what was perceived to be widespread veterinary misuse: clearly the trigger for the move was the HP High Court judgment, which did not notice that Oxytocin was an essential drug”, the bench said.