Jaipur: Jackson Laboratories Pvt. Ltd., the Amritsar-based maker of TOCIN, has challenged a Rajasthan health department laboratory report that found no active ingredient in an oxytocin injection batch tested after five post-C-section maternal deaths at Kota’s govt-run New Medical College between May 5 and May 17.The company has moved a Kota court seeking retesting of the batch. Rajasthan has now sent samples to a drug-testing laboratory in Kolkata, and health department officials said proposed prosecution will remain on hold until the fresh report is received. Legal proceedings will be initiated if the batch fails again, officials said.“We have sent the samples to Kolkata for retesting of the oxytocin injection belonging to Jackson Laboratories,” a senior health department official said.The first laboratory report of the disputed product –TOCIN (Oxytocin Injection IP 5 IU/ml), Batch No. I-7881—declared the batch “not of standard quality” and “spurious” after finding oxytocin content to be nil. Oxytocin is widely used to induce labour and control bleeding after childbirth.Samples were collected after Kota’s New Medical College reported five post-caesarean maternal deaths from May 5 to May 17. Two similar deaths were also reported from Bikaner’s PBM Hospital on June 19 and June 21.Following the initial report, the Punjab Licensing Authority cancelled the manufacturing licence of M/s Jackson Laboratories Pvt. Ltd., Amritsar, after inspection found Good Manufacturing Practice violations. The Centre also cancelled manufacturing licences of units run by the firm in Himachal Pradesh after regulatory inspections. The company initiated a recall but disputed the findings, leading to the court-backed retesting process.Rajasthan’s Drug Control Department said it seized the available stock of 3,500 injections, banned the sale and use of the batch, issued statewide alerts, ordered a recall across the supply chain, and coordinated with the Central Drugs Standard Control Organisation and other states.The licence of distributor Rajasthan Medical Hall, Kota, was cancelled over alleged discrepancies in buy and sale records.The World Health Organization sought factual information through the Government of India as part of global pharmacovigilance surveillance. The query was sent to Rajasthan and answered through the Drugs Controller General of India. Rajasthan submitted a detailed factual report outlining the laboratory findings, regulatory action, clinical assessment and examination of hospital records, while stressing that the WHO communication was information-seeking and did not establish causality.
