Jackson Labs loses licences over Rajasthan maternal deaths
NEW DELHI: The Centre has cancelled the manufacturing licences of Jackson Laboratories’ units in Punjab and Himachal Pradesh after joint inspections by the Central Drugs Standard Control Organisation and state drug regulators found deficiencies in compliance with good manufacturing practices, as investigations continue into the Rajasthan incident in which oxytocin injections manufactured by the company have been linked to maternal deaths. The action follows reports from a Rajasthan govt hospital where five women died after child birth and six others reportedly developed kidney failure after receiving oxytocin injections during C-sections on May 4. The injections were manufactured by Jackson Laboratories, though officials have said the investigation is ongoing and the exact cause of the adverse events is yet to be established and laboratory testing of drug samples and other investigations are underway. Senior officials in the Union health ministry said a detailed report has also been sought from the Rajasthan govt to establish the facts surrounding the incident, even as regulatory authorities continue their investigation. According to officials, CDSCO, along with drug regulators from Punjab and Himachal Pradesh, carried out detailed inspections of the company’s manufacturing facilities to assess compliance with GMP norms. Based on deficiencies observed during the inspections and the recommendations of the joint inspection teams, the respective state licencing authorities cancelled the manufacturing licences of the concerned units. Meanwhile, the WHO has sought additional information from the Govt of India following media reports referring to oxytocin Injection manufactured by Jackson Laboratories in connection with the Rajasthan incident. Officials stressed that WHO’s request should not be construed as a finding against either the product or the manufacturer, but as part of the standard international process of assessing potential public health risks.
