The Rajasthan Drug Control Department has banned the sale and use of a batch of oxytocin injections supplied to government hospitals after laboratory testing found the samples failed quality standards. The action comes amid an ongoing investigation into the deaths of pregnant women who developed severe complications after cesarean deliveries at government hospitals in Kota.
According to officials, the affected batch involved TOCIN Oxytocin Injection 5 ml manufactured by Jackson Laboratories Pvt Ltd. Rajasthan Drug Controller Ajay Phatak said authorities seized the stock from hospitals and medical suppliers linked to the distribution chain after the samples failed potency tests.
According to ETV Bharat, 3,501 injections from the affected batch were seized from government hospitals and associated distributors in Kota, while 12,499 injections from the same supply had already been used before the alert was issued. ETV Bharat estimated the total value of the supplied stock at around ₹1.60 lakh. Authorities have halted the medicine’s sale and use across Rajasthan while the investigation continues. The Commissionerate of Food Safety and Drug Control also issued statewide alerts directing hospitals, medical stores, and drug distributors to immediately stop the sale and use of the affected batch.
According to officials quoted by ETV Bharat, the injections were supplied under the medical college’s rate contract and distributed to wards at the New Medical College Hospital and JK Lon Hospital in Kota. Reports also stated that Rajasthan Medical Services Corporation Limited was instructed to immediately halt the use and distribution of the affected stock. Separately, Bhaskar English reported that Kota Medical College had also procured a separate 1 ml batch from the same manufacturer at the local level, though officials had not publicly released test findings for that batch at the time of reporting.
The investigation began after several women reportedly died following cesarean sections at New Medical College Hospital and JK Lon Hospital, two associated government healthcare facilities in Kota, earlier this month. Health officials said the women developed serious complications within hours after surgery.
According to India Today, some patients experienced sudden drops in blood pressure and platelet counts along with signs of kidney failure within 8 to 12 hours after the procedures. The affected women had reportedly undergone cesarean deliveries before developing postoperative complications. The Rajasthan government has launched a high level inquiry to determine the exact cause of the deaths.
Officials are examining whether medicines, intravenous fluids, infection control issues, or other factors contributed to the complications. Authorities have not yet confirmed a direct link between the oxytocin injections and the deaths.
The state government also suspended several members of the medical staff connected to the case pending investigation.
Oxytocin is a hormone that doctors commonly use during and after childbirth. In hospital obstetric settings, it is usually administered through intravenous infusion or intramuscular injection depending on the clinical situation. It is routinely used to induce labor, strengthen or augment labor contractions, and reduce excessive bleeding after vaginal or cesarean delivery. Excessive bleeding after childbirth, medically known as postpartum hemorrhage, remains one of the leading causes of maternal deaths worldwide.
The World Health Organization includes oxytocin in its Model List of Essential Medicines for maternal care because it can help prevent life threatening blood loss after childbirth when used correctly. Oxytocin is also included in India’s National List of Essential Medicines and is widely used in public maternal healthcare programs, government maternity centers, and hospitals across the country.
Oxytocin is temperature sensitive and generally requires cold-chain storage conditions to maintain potency. Improper storage can reduce the effectiveness of the medicine even when manufacturing standards are met. However, authorities investigating the Kota case have not stated that storage conditions caused the reported quality failure.
Because oxytocin directly affects uterine contractions and bleeding control during childbirth, maintaining proper manufacturing quality, storage conditions, and distribution standards is important for patient safety.
India Today reported that laboratory testing found the affected oxytocin samples failed potency and quality standards. Statements by Rajasthan Drug Controller Ajay Phatak, quoted by ETV Bharat, said the injections either contained insufficient quantities of oxytocin or lacked the active ingredient altogether. ETV Bharat also reported that authorities were testing additional medicine samples and other batches from the same manufacturer as the broader investigation continued. Authorities subsequently classified the batch as substandard after laboratory analysis showed it failed to meet prescribed pharmacopeial standards for oxytocin content.
In pharmaceutical regulation, a substandard drug refers to a medicine that fails to meet officially approved quality specifications. This differs from a counterfeit or fake medicine, which involves deliberate misrepresentation of identity or source. While India Today described the injections as fake, officials investigating the case have primarily referred to the tested batch as substandard pending further investigation.
Officials also stated that the department was still verifying whether the specific batch had been administered to all of the women who later died following childbirth complications. Most reports did not publicly disclose the affected batch numbers, and authorities continued broader precautionary testing of related medicine stocks during the investigation.
However, officials have not yet released a final forensic or toxicological conclusion linking the medicine to the patient deaths.
The case has also triggered broader scrutiny of medicine quality monitoring in Rajasthan. Drug Control Officers from Kota and Bundi collected samples of more than 30 medicines from postoperative gynecology wards and hospital drug stores during the investigation. According to ETV Bharat, 21 of those medicines cleared testing, while results for the remaining samples are still pending.
Bhaskar English reported that authorities directed testing of additional batches of oxytocin injections manufactured by the same company along with other medicines produced by the firm. Earlier this year, Rajasthan drug regulators had also reported several medicines from different companies as substandard during separate testing drives.
An expert team from the All India Institute of Medical Sciences Delhi visited the hospitals in Kota as part of the investigation into the maternal deaths and postoperative complications. Officials said the team inspected hospital facilities and reviewed treatment procedures as part of the ongoing inquiry.
The incident has raised concerns about the monitoring of medicine supply chains in public hospitals, especially for drugs used in emergency obstetric care. Oxytocin remains one of the most widely used medicines during childbirth in India.
Drug quality failures can reduce treatment effectiveness and may increase risks for patients if medicines do not contain the required active ingredients or fail sterility standards. Reliable oxytocin supply is considered critical in obstetric emergency care because delays or ineffective treatment during postpartum hemorrhage can rapidly become life threatening. In the case of oxytocin, inadequate active ingredient levels may impair the medicine’s ability to support uterine contractions or control postpartum bleeding during childbirth care. Public health experts have repeatedly emphasized the importance of strict quality control, storage monitoring, and batch testing for medicines used in maternal and emergency care.
In India, medicine quality regulation is overseen under the Drugs and Cosmetics Act through central and state drug regulatory authorities, including state drug control administrations responsible for testing, surveillance, and enforcement actions involving medicines distributed within their jurisdictions.
The Rajasthan government has said investigations are ongoing and that further action will depend on the final findings.
No public statement or clarification from Jackson Laboratories Pvt. Ltd. regarding the investigation or the reported test findings was available in the reviewed reports at the time of writing.
World Health Organization. WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage. Geneva: World Health Organization, 2012. https://www.who.int/publications/i/item/9789241548502
World Health Organization. WHO Model List of Essential Medicines, 23rd List. Geneva: World Health Organization, 2023. https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2023.02
Ministry of Health and Family Welfare, Government of India. National List of Essential Medicines 2022. New Delhi: Ministry of Health and Family Welfare, 2022. https://nppaindia.nic.in/wp-content/uploads/2022/09/NLEM-2022-final.pdf