NEW DELHI: Even as the WHO has sought a report from India on the deaths of five women following C-Section, the Centre cracked down on Jackson Laboratories, which supplied fake oxytocin injections to Rajasthan's Kota hospitals, where the maternal deaths were reported.
According to official sources, the Centre has initiated stringent regulatory action against Jackson Laboratories, with the manufacturing licenses of its units in Punjab and Himachal Pradesh being cancelled following joint inspections by the Central Drugs Standard Control Organisation (CDSCO) and the respective state drug regulators.
Oxytocin is administered to induce labour and to prevent excessive bleeding after childbirth.
Five women died between May 5 and May 17 after undergoing a Cesarean-section at the government-run New Medical College Hospital (NMCH), Kota, in Rajasthan. The deceased had symptoms such as kidney failure, urinary failure, and urinary blockage.
Senior officials in the Union Health and Family Welfare said the Centre has also sought a detailed report from the Rajasthan government to establish the facts surrounding the incident.
Meanwhile, the World Health Organisation (WHO) has sought additional information from the Centre following media reports referring to oxytocin injection manufactured by Jackson Laboratories.
Ministry sources clarified that the WHO's communication is a routine part of the global pharmacovigilance and regulatory surveillance mechanism.
Senior officials said 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.
Officials stressed 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 of assessing potential public health risks.
According to officials, CDSCO, along with the State Drug Regulators of Punjab and Himachal Pradesh, carried out detailed inspections of Jackson Laboratories' 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 have cancelled the manufacturing licences of the concerned units.
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," officials added.
“The ministry is awaiting the Rajasthan government's detailed report even as regulatory authorities continue their investigation into the matter,” officials said.
