Centre Cancels Jackson Laboratories’ Manufacturing Licences Due to Compliance Issues
NEW DELHI: In a significant move, the Centre has annulled the manufacturing licences of Jackson Laboratories’ facilities located in Punjab and Himachal Pradesh. This action follows joint inspections conducted by the Central Drugs Standard Control Organisation (CDSCO) and state drug regulators, which revealed several deficiencies in adherence to good manufacturing practices (GMP). The investigations are ongoing, particularly concerning a serious incident in Rajasthan where oxytocin injections produced by the company have been linked to maternal fatalities.
The decision to cancel the licences comes in the wake of distressing reports from a government hospital in Rajasthan, where five women tragically lost their lives shortly after childbirth on May 4. Additionally, six women reportedly developed kidney failure after receiving oxytocin injections during C-sections. While these injections were manufactured by Jackson Laboratories, authorities have stressed that the investigation is still underway, with laboratory testing of samples and further inquiries in progress to ascertain the precise cause of these adverse effects.
Senior officials from the Union health ministry have indicated that a comprehensive report has been requested from the Rajasthan government to gather all pertinent facts surrounding this incident. The CDSCO, alongside drug regulators from both Punjab and Himachal Pradesh, implemented detailed inspections of the company’s manufacturing units to evaluate compliance with GMP norms.
As a result of the deficiencies identified during these inspections and based on the recommendations provided by the joint inspection teams, the respective state licensing authorities proceeded to revoke the manufacturing licences of the affected facilities. Concurrently, the World Health Organization (WHO) has solicited additional information from the Indian government in light of media reports linking Jackson Laboratories’ oxytocin injections to the troubling outcomes in Rajasthan.
Officials have emphasized that the WHO’s inquiry should not be interpreted as an adverse judgment against either the product or its manufacturer. Instead, it is part of the standard international protocol for evaluating potential public health risks. The regulatory scrutiny and ongoing investigations reflect a commitment to ensuring the safety and efficacy of pharmaceutical products within the market.
