WHO seeks data on Kota deaths; India cancels pharma licences over GMP violations
The World Health Organization has requested information from the Indian government regarding the alleged supply of substandard oxytocin injections to government hospitals in Kota, Rajasthan, following the deaths of five women after Caesarean deliveries in May.
Indian regulators have cancelled the manufacturing licences of units belonging to Jackson Laboratories in Punjab and Himachal Pradesh after joint inspections by the Central Drugs Standard Control Organisation and state drug regulators found deficiencies in Good Manufacturing Practices.
The action comes amid an investigation into the deaths of postpartum women and reported infections at Kota hospitals. The oxytocin injections manufactured by the company have been linked to the deaths.
Health Ministry sources clarified that the WHO's communication is routine, part of global pharmacovigilance, and should not be seen as a finding against the product or manufacturer. The WHO regularly seeks information to assess whether incidents are localised or could affect other countries.
Senior officials stated that the Centre has also sought a detailed report from the Rajasthan government to establish facts. The CDSCO, along with state regulators, inspected Jackson Laboratories' facilities and found deficiencies in GMP compliance. Based on these findings, state licensing authorities 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 is underway, and additional action will be taken based on investigation findings.
Five women died between May 5 and May 17 at JK Lone Hospital and the Super Speciality Wing of Government Medical College in Kota after Caesarean section deliveries. The WHO has sought additional information regarding the oxytocin injections and the deaths.
Ministry sources emphasised that the 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.
