WHO seeks India report as Centre cancels Jackson Labs' licences in Kota oxytocin case
The WHO has sought details from India on the Rajasthan maternal deaths case linked to Jackson Laboratories' oxytocin injection. The query is part of routine pharmacovigilance as Indian regulators examine product quality and manufacturing standards.
According to senior officials in the Union health ministry, the WHO has reached out to India's national regulatory authorities to ascertain whether the reported incident is limited to a particular location or if it could have implications for other countries where the product may have been supplied.
Ministry sources stressed that such requests are a standard part of the international regulatory surveillance mechanism whenever safety concerns are reported and should not be interpreted as evidence of wrongdoing.
The Centre has also sought a detailed report from the Rajasthan Government to establish the facts surrounding the incident, while regulatory authorities continue to investigate the matter.
In early May, at least five women in a government medical college in Rajasthan’s Kota died following C-sections while several others developed serious kidney complications following the procedure.
A regional level probe indicated that oxytocin, supplied by Jackson Laboratories, that is administered to control post-partum haemorrhage (PPH), a common complication post C-sections, contained only water – no active pharma ingredient.
In two separate incidents, six women in Bikaner reportedly developed acute kidney complications following Caesarean section procedures, prompting another investigation, while another episode came to light in Jodhpur more recently.
REGULATORY ACTION
In the meantime, the Centre said it has initiated stringent action against Punjab-based Jackson Laboratories, with the manufacturing licences of its units in Punjab and Himachal Pradesh being cancelled following joint inspections by the Central Drugs Standard Control Organisation (CDSCO) and the respective State Drug Regulators.
Officials said the inspections were carried out to assess compliance with Good Manufacturing Practices (GMP).
Based on deficiencies observed during the inspections and the recommendations of the joint inspection teams, the state licencing authorities cancelled the manufacturing licences of the concerned manufacturing units.
The government described the move as reflective of its zero-tolerance approach towards violations of quality and manufacturing standards in the pharmaceutical sector.
Officials added that further examination of the case is underway and additional action will be taken in accordance with the findings of the ongoing investigation and applicable regulatory provisions.
At least seven other women also fell critically ill, with many developing severe kidney complications. A majority of them remain hospitalised more than six weeks after the incident, according to officials familiar with the matter.
The fallout was swift. Punjab's Food and Drug Administration had cancelled Jackson Laboratories' licence and ordered a nationwide recall of the company's products several days ago.
Officials said the Ministry, meanwhile, said that it is awaiting the Rajasthan Government's detailed report, which will help determine the sequence of events and guide any further regulatory or legal action.
They reiterated that the investigation remains ongoing and that all aspects of the case, including the quality of the medicines supplied and adherence to manufacturing standards, are being examined.
According to senior officials in the Union health ministry, the WHO has reached out to India's national regulatory authorities to ascertain whether the reported incident is limited to a particular location or if it could have implications for other countries where the product may have been supplied.
Ministry sources stressed that such requests are a standard part of the international regulatory surveillance mechanism whenever safety concerns are reported and should not be interpreted as evidence of wrongdoing.
The Centre has also sought a detailed report from the Rajasthan Government to establish the facts surrounding the incident, while regulatory authorities continue to investigate the matter.
In early May, at least five women in a government medical college in Rajasthan’s Kota died following C-sections while several others developed serious kidney complications following the procedure.
A regional level probe indicated that oxytocin, supplied by Jackson Laboratories, that is administered to control post-partum haemorrhage (PPH), a common complication post C-sections, contained only water – no active pharma ingredient.
In two separate incidents, six women in Bikaner reportedly developed acute kidney complications following Caesarean section procedures, prompting another investigation, while another episode came to light in Jodhpur more recently.
REGULATORY ACTION
In the meantime, the Centre said it has initiated stringent action against Punjab-based Jackson Laboratories, with the manufacturing licences of its units in Punjab and Himachal Pradesh being cancelled following joint inspections by the Central Drugs Standard Control Organisation (CDSCO) and the respective State Drug Regulators.
Officials said the inspections were carried out to assess compliance with Good Manufacturing Practices (GMP).
Based on deficiencies observed during the inspections and the recommendations of the joint inspection teams, the state licencing authorities cancelled the manufacturing licences of the concerned manufacturing units.
The government described the move as reflective of its zero-tolerance approach towards violations of quality and manufacturing standards in the pharmaceutical sector.
Officials added that further examination of the case is underway and additional action will be taken in accordance with the findings of the ongoing investigation and applicable regulatory provisions.
At least seven other women also fell critically ill, with many developing severe kidney complications. A majority of them remain hospitalised more than six weeks after the incident, according to officials familiar with the matter.
The fallout was swift. Punjab's Food and Drug Administration had cancelled Jackson Laboratories' licence and ordered a nationwide recall of the company's products several days ago.
Officials said the Ministry, meanwhile, said that it is awaiting the Rajasthan Government's detailed report, which will help determine the sequence of events and guide any further regulatory or legal action.
They reiterated that the investigation remains ongoing and that all aspects of the case, including the quality of the medicines supplied and adherence to manufacturing standards, are being examined.
