New Delhi: Punjab’s Food and Drugs Administration (FDA) has revoked the manufacturing licence and product permissions of Jackson Laboratories Pvt Ltd after investigations linked its substandard oxytocin injection to the deaths of five pregnant women at New Medical College Hospital in Kota, Rajasthan in May, according to two officials and documents reviewed by Mint. The investigations found the company had continued manufacturing despite stop-production orders three years ago.
Oxytocin injection is a lifesaving drug and used for augmenting labour and to control postpartum haemorrhage.
The deaths triggered an emergency alert by the Rajasthan’s Drugs Controller on 25 May 2026, which led to a high-level joint central and state raid on the company’s facility on 27-31 May.
According to a 3 June order reviewed by Mint, the drugmaker must recall all products manufactured since 25 April 2023, and safely destroy all semi-finished, finished, labeled and unlabeled stocks under the supervision of the zonal licensing authority of Amritsar within 14 days. With this first step of regulatory action being taken, further investigations are underway in the case.
A joint team from the Drugs Controller of India (DCGI) and the Punjab FDA found Jackson Laboratories to be in gross violations of the Drugs and Cosmetic Act, 1940 and Drug Rules, 1945 and declared its oxytocin injection to be ‘not of standard quality,’ despite the Amritsar headquartered-firm claiming to comply with the World Health Organization’s-cGMP (Current Good Manufacturing Practices).
According to the 3 June order, the Punjab FDA had issued a ‘stop production order” way back in April 2023 following an initial joint inspection that unearthed gross deficiencies.
In late 2023, there were investigations on a complaint from AIIMS Jodhpur after the firm’s contaminated caffeine citrate injection had caused in newborns. Despite explicit, ongoing prohibitory orders, Jackson Laboratories continued manufacturing on a massive scale, producing thousands of prohibited batches across multiple categories between 2023 and 2026.
“By continuing manufacturing activities despite the prohibitory order, your firm has acted irresponsibly and potentially jeopardizing the quality and safety of the drugs made available to public,” the order said.
Founded in the 1980s, Jackson Laboratories’ portfolio spans five main sections including small volume parenterals (injections and hormones), tablets (steroids and beta-lactams), capsules and liquid orals.
Every rule flouted
The May 2026 joint investigation revealed data manipulation, deleted audit trails, uncalibrated laboratory equipment, and contamination risks. The company had also commercially distributed 24 batches of medicines despite them actively failing sterility tests inside the facility’s incubators. The probe also found mislabeling and large quantities of expired drugs, and the firm had no pharmacovigilance in place, according to the documents reviewed by Mint.
The checks discovered several gaps in basic biological containment and sanitation protocols, finding that products had failed safety benchmarks inside the laboratory before leaving the site.
Rejecting a last-minute email request from Jackson Laboratories on 28 May 2026 to surrender its hormonal and external preparation sections, the Punjab drug control department had proceeded with its order on the complete licence cancellation. The department noted that the company had been given multiple opportunities and personal hearings but had only shown progressive deterioration, operating the facility in an unhygienic conditions that posed a severe public health risk, the documents showed.
Systematic data manipulation was found within the quality control department. The firm had generated fake testing records using uncalibrated machinery and even deleted entry logs to conceal its actions from regulatory tracking systems. As per the documents, the drug inspectors noted that the logbook data of manufacturing, quality control, stores, or microbiology were heavily compromised and couldn’t be trusted.
The firm had also failed to perform basic system suitability tests, lacked standard reference materials for drug validation, and operated without an authorized document control process, indicating a complete absence of oversight by quality assurance.
Queries sent to Jackson Laboratories, the health and family welfare ministry, , Punjab FDA, and the zonal licensing authority (drugs), remained unanswered until press time.
How critical is oxytocin?
Public health experts stressed the need for quality controls and underscored the serious fallouts of flouting standards.
Highlighting the dangers of compromised quality of the injection, Dr Archana Dhawan Bajaj, a gynaecologist and expert, at New Delhi based Nurture IVF Clinic said, “The alleged supply of oxytocin vials containing inadequate or no active ingredient is an extremely serious concern because oxytocin is a critical drug used to induce labour and prevent excessive bleeding after childbirth.”
She said that insufficient quantities can increase risk of postpartum haemorrhage, severe blood loss, anaemia, hypovolaemia, and, in rare cases, life-threatening shock. “Beyond maternal care, the issue highlights a larger threat posed by substandard or spurious medicines that can compromise treatment outcomes across medical specialties,” Dr Bajaj added.
Dr Rajeev Jayadevan, a public health expert and former president at Indian Medical Association of the Cochin Chapter, agreed that oxytocin is a critical medicine used during childbirth. “While the exact cause of death remains to be determined, it is important to ensure reliable quality testing of all medications. There can be no compromise, as people’s lives are at stake,” he said.