The World Health Organisation (WHO) has sought details from the Indian government following reports linking oxytocin injection manufactured by Jackson Laboratories to maternal deaths case in Rajasthan, even as the Centre clarified that this is part of a routine global pharmacovigilance process and not a finding against either the product or the manufacturer.
“The WHO 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,” the government officials told ET.
Officials stressed that the request should not be construed as a finding against the product or the manufacturer, but as part of the standard international process of assessing potential public health risks.
Meanwhile, the manufacturing licences of Jackson Laboratories’ units in Punjab and Himachal Pradesh have been cancelled following joint inspections by the Central Drugs Standard Control Organisation (CDSCO) and the State Drug Regulators, which found the facilities non-compliant with Good Manufacturing Practices (GMP).
The move comes amid investigations into a Rajasthan incident in which media reports have linked Oxytocin Injection manufactured by the company to maternal deaths.
CDSCO, along with the State Drug Regulators of Punjab and Himachal Pradesh carried out detailed inspections of Jackson Laboratories’ manufacturing facilities to assess GMP compliance.
Based on deficiencies observed during the inspections and on the recommendations of the joint inspection teams, the State Licensing Authorities cancelled the manufacturing licences of the concerned units, sources told ET.
The Centre has also sought a detailed report from the Rajasthan Government to establish the facts surrounding the incident, they further said.
“Further examination is underway and additional action will be taken in accordance with the findings of the ongoing investigation and applicable regulatory provisions”.
Officials said the action reflects the government’s zero-tolerance approach towards violations of quality and manufacturing standards in the pharmaceutical sector.
The Ministry said it is awaiting the Rajasthan Government’s detailed report as the investigation continues.
