NEW DELHI: The Government has cancelled the manufacturing licences of Jackson Laboratories’ units in Punjab and Himachal Pradesh following joint inspections by the Central Drugs Standard Control Organisation (CDSCO) and the respective State drug regulators, even as the World Health Organization (WHO) has sought information from India on the Rajasthan incident in which media reports linked the company’s Oxytocin Injection to maternal deaths.
The regulatory action follows inspections that reportedly found deficiencies in the company’s manufacturing and quality systems. Based on the recommendations of the joint inspection teams, the respective State Licensing Authorities revoked the manufacturing licences of the affected units.
Senior officials in the Ministry of Health and Family Welfare said the Centre has also sought a detailed report from the Rajasthan Government to ascertain the facts surrounding the incident before drawing any conclusions.
According to officials, the CDSCO, in coordination with the drug regulatory authorities of Punjab and Himachal Pradesh, conducted comprehensive inspections of Jackson Laboratories’ manufacturing facilities to assess compliance with Good Manufacturing Practices (GMP).
Officials said the action reflects the government’s zero-tolerance approach towards violations of pharmaceutical quality and manufacturing standards. Investigations are continuing and further regulatory action, if warranted, will be taken in accordance with the findings and provisions of the Drugs and Cosmetics Act and Rules.
Meanwhile, WHO has sought additional information from the Government following media reports linking Jackson Laboratories’ Oxytocin Injection to the Rajasthan incident.
Health Ministry sources clarified that WHO’s communication is part of its routine global pharmacovigilance and regulatory surveillance mechanism. The organisation routinely seeks information from national regulatory authorities to determine whether a reported incident is confined to a particular location or whether it has implications for other countries where the product may have been distributed.
Officials emphasised that WHO’s request should not be interpreted as a finding against either the product or the manufacturer. Rather, it forms part of the standard international process of assessing potential public health risks based on available evidence.
The Ministry is awaiting the Rajasthan Government’s report even as regulatory authorities continue their investigation into the matter.
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