The Centre has cancelled the manufacturing licences of Jackson Laboratories' units in Punjab and Himachal Pradesh following regulatory inspections, amid investigation into the Rajasthan incident which linked the company's Oxytocin Injection to maternal deaths.
The Ministry of Health and Family Welfare has also sought a detailed report from the Rajasthan government to ascertain the facts surrounding the incident, senior ministry officials told NDTV.
The regulatory action follows the deaths of several new mothers at government hospitals in Rajasthan, an incident that triggered widespread concern over drug safety and quality control. The women reportedly died after being administered Oxytocin injections during childbirth, prompting authorities to launch an investigation into the possible role of the medicine.
Samples of the drug were collected for testing, while health officials initiated an inquiry into procurement and distribution practices at the hospitals concerned. The incident has also raised broader questions about oversight mechanisms in the pharmaceutical supply chain and the need for stricter monitoring of medicines used in critical maternal care.
According to officials, CDSCO, along with the State Drug Regulators of Punjab and Himachal Pradesh, conducted detailed inspections of Jackson Laboratories' manufacturing facilities to assess compliance with GMP norms.
Based on deficiencies identified during the inspections and the recommendations of the joint inspection teams, the respective State Licensing Authorities cancelled the manufacturing licences of the concerned units.
Officials said that the matter remains under examination and that further regulatory action will be taken based on the findings of the ongoing investigation and the applicable legal provisions.
Meanwhile, the World Health Organization (WHO) has sought additional information from the Government of India following media reports linking Jackson Laboratories' Oxytocin Injection to the Rajasthan incident.
Ministry sources said the WHO's communication is part of its routine global pharmacovigilance and regulatory surveillance process. According to officials, the organisation regularly seeks information from national drug regulators to determine whether such incidents are confined to a particular location or whether they could have implications for other countries where the product may have been supplied.
Officials stressed that the WHO's query should not be interpreted as a finding against either the product or the manufacturer, but as part of the standard international process for assessing potential public health risks.
The Ministry is awaiting the Rajasthan government's detailed report even as CDSCO and other regulatory authorities continue their investigation into the matter.
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