The World Health Organization (WHO) has sought information from the Government of India on the alleged supply of spurious oxytocin injections to government hospitals in Kota by a pharma distributor, leading to the deaths of five women following Caesarean deliveries in May.
The manufacturing licences of units of Jackson Laboratories in Punjab and Himachal Pradesh were cancelled following joint inspections by the Central Drugs Standard Control Organisation (CDSCO) and the respective State drug regulators.
The government action comes amid an investigation into the deaths of postpartum women and reported infections at some hospitals in Kota, with the oxytocin injections manufactured by the company linked to the deaths.
Sources in the Health Ministry clarified that it was routine communication by the WHO to determine public health risk and should not be seen as a finding against either the product or the manufacturer.
Senior officials in the Union Health Ministry said the Centre have also sought a detailed report from the Rajasthan government to establish the facts on the matter.
According to the officials, CDSCO, along with the drug regulators of Punjab and Himachal Pradesh, carried out detailed inspections of Jackson Laboratories' manufacturing facilities to assess compliance with "Good Manufacturing Practices" or GMP.
Based on deficiencies observed during the inspections and the recommendations of the joint inspection teams, the respective state licensing authorities cancelled the manufacturing licences of the concerned units, they said.
Officials said the regulatory action reflects the government's zero-tolerance approach towards violations of quality and manufacturing standards in the pharmaceutical sector.
Further examination of the matter is underway and additional action will be taken in accordance with the findings of the ongoing investigation and applicable regulatory provisions, they added.
The WHO has sought additional information from the government regarding oxytocin injections and the deaths in Kota.
Ministry sources said the WHO's communication is a routine part of the global pharmacovigilance and regulatory surveillance mechanism.
The organisation regularly seeks information from national regulatory authorities to determine whether such incidents are confined to a particular location or whether there could be implications for other countries where the product may have been distributed, they said.
Officials stressed that the WHO's request should not be construed as a finding against either the product or the manufacturer, but as part of the standard international process of assessing potential public health risks.
Five women died between May 5 and May 17 at the JK Lone Hospital and the Super Speciality Wing of Government Medical College in Kota, Rajasthan, following Caesarean section deliveries.
