Seven Maternal Deaths in Rajasthan Trigger Nationwide Oxytocin Safety Probe; WHO Seeks Report
核心洞察
Seven postpartum women died within two months at government hospitals in Rajasthan, with a substandard oxytocin injection ('TOCIN') suspected as the cause.
Laboratory analysis by the Rajasthan Drug Control Department found the injection failed quality standards due to insufficient active oxytocin ingredient.
The Union Health Ministry cancelled the manufacturing licence of Jackson Laboratories Private Limited (搜索), and the WHO has requested a detailed report from India.
A cluster of seven unexplained maternal deaths across government hospitals in Rajasthan has escalated into a nationwide drug safety investigation, drawing the attention of the World Health Organisation (WHO) and prompting the Union Health Ministry to cancel the manufacturing licence of the pharmaceutical company behind the suspected oxytocin injection.
The seven women, all of whom had recently given birth, died over a span of less than two months. Five perished after Caesarean section deliveries at two government hospitals in Kota between May 5 and May 17, while two passed away at a hospital in Bikaner in June. The deceased have been identified as Payal (New Medical Hospital, Kota, May 5), Jyoti (May 7), Priya Mahawar (J.K. Lon Hospital, Kota, May 9), Pinki Mahawar (May 10), Shireen (New Medical Hospital, Kota, May 17), Preeti (PBM Hospital, Bikaner, June 19), and Sharda Nayak (PBM Hospital, Bikaner, June 21).
Substandard Drug Identified
As investigators focused on medicines administered during delivery, attention zeroed in on 'TOCIN' (Oxytocin Injection 5 ml), manufactured by M/s Jackson Laboratories Private Limited (搜索) in Amritsar. Laboratory analysis conducted by the Rajasthan Drug Control Department revealed that the sample failed to meet quality standards because it did not contain the prescribed quantity of the active oxytocin ingredient.
Oxytocin is among the most critical medicines used in maternity care worldwide. It is routinely administered to induce labour when childbirth does not begin naturally, to control excessive bleeding after delivery — one of the leading causes of maternal mortality — and to help manage incomplete miscarriages by contracting the uterus. Many of the women who lost their lives reportedly had severe blood loss, and any compromise in the drug's quality can have serious consequences for both mothers and newborns.
Regulatory and International Response
Acting on the laboratory findings, the Central Drugs Standard Control Organisation (CDSCO), together with state drug regulators in Punjab and Himachal Pradesh, conducted joint inspections at Jackson Laboratories' manufacturing facilities to assess compliance with good-manufacturing practice norms. Based on the inspection findings, the licensing authorities of both states cancelled the company's manufacturing licences, and the Union Health Ministry accepted the recommendation. It was also decided to recall the company's products from across the country.
The licence of a distributor in Rajasthan, Rajasthan Medical Hall (搜索) in Kota, was also cancelled by state authorities. An inspection of the distributor allegedly revealed that it had purchased more than 9,000 units of the suspected injections from Jackson Laboratories and sold over 10,000 units from the same batch.
The WHO has intervened by seeking a detailed report from the Indian government, asking whether similar incidents have occurred elsewhere in the country and whether defective batches were distributed outside Rajasthan. Sources in the health ministry stated that the WHO's communication is routine under global pharmacovigilance protocols, and that the organisation regularly seeks such information from national regulators to determine whether incidents are localised or carry cross-border implications.
Broader Investigation Underway
The Union Health Ministry has also sought a comprehensive factual report from the Rajasthan government. Authorities are now examining supply chains, batch distribution records, and hospital procurement systems to determine the full extent of the issue. The investigation is expected to establish whether the maternal deaths were directly linked to the substandard drug and whether additional regulatory action is required to strengthen quality surveillance of essential medicines used in public healthcare facilities.
Jackson Laboratories has reportedly been blacklisted in several other states, including Karnataka, Odisha, Tamil Nadu, and the Union Territory of Jammu and Kashmir. The company's Managing Director, Jugal Kishore, stated on May 27 that the firm had been manufacturing the critical medicine for nearly 40 years without any prior serious complaint.
In addition to the seven fatalities, eight women developed severe health complications, including kidney impairment and septicemia, following C-sections at a district hospital in Jodhpur. The Rajasthan health department has halted surgeries across affected operation theatres and tested batches of IV fluids and drugs. Preliminary findings pointed to both institutional and administrative negligence, and departmental actions have been initiated against concerned medical staff members at the hospitals where the cases occurred.