The Centre has scrapped the manufacturing licences of drugmaker Jackson Laboratories’ units in Punjab and Himachal Pradesh amid an investigation into maternal deaths in Rajasthan allegedly caused by its oxytocin injection.
This comes after at least seven women were reported to have died in Kota and Bikaner districts following caesarean section operations. Health authorities examining the cases have suspected fake oxytocin injections to have contributed to the deaths.
Oxytocin injections are generally used to induce or strengthen labour and to prevent or control excessive bleeding after childbirth.
“The regulatory action against Jackson Labs was initiated following joint inspections by the Central Drugs Standard Control Organisation (CDSCO) and the respective state drug regulators,” senior officials in the Union Health Ministry told Business Standard.
They added that the Health Ministry has also sought a detailed report from the Rajasthan government to establish the facts surrounding the incident.
Ministry sources added that central and state regulatory agencies also carried out detailed inspections of Jackson Labs’ manufacturing facilities to assess compliance with Good Manufacturing Practices (GMP).
“Based on the 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,” sources said.
Officials added that the World Health Organization (WHO) has now sought additional information from the Government of India following reports referring to oxytocin injection manufactured by Jackson Labs in connection with the Rajasthan incident.
However, they clarified that 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 any implications for other countries where the product may have been distributed,” sources said.
They added that the WHO’s request should not be construed as a finding against the product or the manufacturer, but as part of the standard international process for assessing potential public health risks.
While further examination of the matter is under way, ministry sources said that additional action will be taken in accordance with the findings of the ongoing investigation and applicable regulatory provisions.
The ministry is awaiting the Rajasthan government’s detailed report, even as regulatory authorities continue their investigation into the matter.
