Substandard Oxytocin Batch Found During Probe Into Kota Maternal Deaths

JAIPUR, Rajasthan — Rajasthan health authorities have taken action against a drug company after a batch of Oxytocin injections manufactured by Jackson Laboratories was found to be substandard during laboratory testing linked to the investigation into maternal deaths in Kota.

Officials said disciplinary proceedings are being initiated against the company, and an immediate statewide ban has been imposed on the sale and use of the affected batch. Hospitals, pharmacies and medical stores have been directed to remove the injections from their inventories.

Rajasthan Principal Secretary for Health Gayatri Rathore confirmed that disciplinary proceedings are underway against the pharmaceutical company. She said investigators are also checking whether the drug was administered to other pregnant women admitted to hospitals.

However, medical experts cautioned against directly linking the injections to the deaths.

Gynecologist Ritika Mathur told IANS that it appeared highly unlikely the injection directly caused the maternal deaths. She noted that one of the deceased women, identified as Shirin, had reportedly not been given the injection but still suffered kidney failure and later died.

The controversy followed the deaths of five women during treatment in Kota. After the incident, a team from All India Institute of Medical Sciences Delhi visited Kota to conduct an inquiry.

The expert team recommended that medicines given to the patients be tested before any conclusion was drawn about the cause of the deaths.

Samples were collected and sent for laboratory analysis, which found that the Oxytocin injection batch was substandard and lacked the required active ingredient.

The findings have raised serious concern within the State Medical Department and drug control authorities. According to a drug alert issued by the Rajasthan Food Safety and Drug Control Commissionerate, the sample failed quality testing by the Central Drugs Laboratory.

Investigators said the tested sample contained no Oxytocin. The injection was reportedly supplied to hospitals in Kota through local procurement channels.

Authorities are now investigating whether the same batch was distributed to other hospitals or reached the open market.

Assistant Drug Controller Devendra Kumar Garg said the injections were supplied by Rajasthan Medical Hall. He said the injections had reportedly been administered to nearly 12,500 women during childbirth procedures over a four-month period.

After authorities received the drug testing report Monday, they seized the remaining stock of the failed batch. Officials confiscated 2,479 injections from the store of Kota Medical College, with an estimated value of about Rs 25,000. Another 72 injections were seized from J.K. Lon Hospital, while nearly 950 injections held by the supplier for further distribution were also confiscated.

Garg said the injections failed chemical analysis because the required active ingredient, Oxytocin, was absent. He said use of the injection was unlikely to directly cause death, kidney failure or similar fatal complications.

Mathur said Oxytocin is primarily used to induce labor pain and stimulate uterine contractions during normal deliveries. If labor does not progress naturally, doctors often proceed with cesarean delivery.

She questioned why the injection batch alone was being blamed when several women undergoing normal deliveries had reportedly received the same injections without complications. She said fluids administered along with anesthesia during cesarean procedures should also be investigated.

“This injection cannot be the cause of these deaths,” Mathur said.

Rajasthan Drug Controller Ajay Phatak also said the injection is used for normal deliveries, while the women who died in Kota underwent cesarean deliveries.

“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,” Phatak said.

Investigations into the broader maternal deaths case are continuing. (Source: IANS)