Kota maternal deaths: Oxytocin batch by Jackson Labs found substandard; statewide ban imposed
Synopsis
Key Takeaways
A batch of Oxytocin injections manufactured by Jackson Laboratories has been found substandard during laboratory testing linked to the investigation into maternal deaths in Kota, Rajasthan, officials confirmed on 26 May. Authorities have imposed an immediate statewide ban on the sale and use of the affected batch and initiated disciplinary proceedings against the pharmaceutical company.
Key Developments in the Kota Probe
Rajasthan Principal Secretary (Health) Gayatri Rathore confirmed that disciplinary proceedings are underway against the pharma company. Authorities have directed hospitals, pharmacies, and medical stores across the state to remove the affected injections from their inventories. An investigation is also underway to determine whether the drug was administered to other pregnant women admitted to hospitals in the region.
According to an official Drug Alert issued by the Rajasthan Food Safety and Drug Control Commissionerate, the sample failed quality testing conducted by the Central Drugs Laboratory. Investigators confirmed that the Oxytocin content in the tested sample was found to be completely absent — meaning the injections lacked the required active ingredient entirely.
Scale of the Affected Supply
Assistant Drug Controller Devendra Kumar Garg said that the firm Rajasthan Medical Hall had supplied the injections to hospitals in Kota through local procurement channels. According to Garg, over a four-month period, the injections had reportedly been administered to nearly 12,500 women during childbirth procedures.
Following receipt of the drug testing report, authorities seized the remaining stock. Officials confiscated 2,479 injections from the store of Kota Medical College, valued at approximately ₹25,000. Another 72 injections were seized from J.K. Lon Hospital, and nearly 950 injections held by the supplier for further distribution were also confiscated. Authorities are now investigating whether the same batch was distributed to other hospitals or entered the open market.
What Medical Experts Say
Medical experts have cautioned against directly linking the substandard injections to the deaths. Gynaecologist Dr. Ritika Mathur said the possibility of the injection directly causing the maternal deaths appeared highly unlikely. She noted that one of the deceased women, identified as Shirin, had reportedly not been administered the injection at all, yet also suffered kidney failure and later died.
Dr. Mathur pointed out that Oxytocin is primarily used to induce labour and stimulate uterine contractions during normal deliveries, and questioned why the batch alone was being implicated when several women undergoing normal deliveries had reportedly received the same injections without complications. She said the role of fluids administered alongside anaesthesia during caesarean procedures should also be investigated. 'This injection cannot be the cause of these deaths,' she said.
Rajasthan Drug Controller Ajay Phatak stated: 'This injection is administered for normal delivery. Women who died in Kota underwent Cesarean deliveries. An investigation is underway to determine whether or not they were administered this injection. The concerned batch has been suspended. The reports for the remaining 21 medications are normal.'
AIIMS Delhi Team and Background
The controversy intensified following the deaths of five women during treatment in Kota. A team from the All India Institute of Medical Sciences (AIIMS) Delhi subsequently visited Kota to conduct an inquiry. The expert team recommended that all medicines administered to the patients be tested before drawing any conclusions regarding the cause of deaths. Samples were collected and sent for laboratory analysis, leading to the discovery of the substandard Oxytocin batch.
What Happens Next
Investigations into the broader maternal deaths case are continuing. Authorities are widening the probe to trace the full distribution chain of the affected batch, while the drug controller's office has confirmed that test reports for the remaining 21 medications administered to the patients have returned normal. The findings have triggered serious concern within the State Medical Department and Drug Control authorities, and the outcome of the disciplinary proceedings against Jackson Laboratories is awaited.