Rajasthan bans sale, use of Bupivacaine injection used in caesarean deliveries, other surgeries

The Rajasthan Drug Control Department has imposed a statewide ban on the sale and use of a specific batch of Bupivacaine injection following reports of serious adverse reactions among patients at a hospital in Hyderabad Bupivacaine is widely used to administer spinal anaesthesia during various surgical procedures including Caesarean deliveries Instructions have been issued to immediately stop the use of this injection until the investigation is completed This decision has been taken on the advice of anesthesiologists said Dr Deepak Maheshwari Principal SMS Medical CollegeThe precautionary action comes after 16 patients reportedly developed adverse reactions after receiving the injection in HyderabadThe Indian Society of Anesthesiologists ISA and the Anaesthesia Patient Safety Association APSA have issued a nationwide advisory urging anesthesiologists to immediately discontinue the use of Bupivacaine injections manufactured by Themis Medicare Limited for spinal anaesthesiaFollowing the advisory SMS Medical College Jaipur has directed all hospital superintendents and Heads of Departments HODs to immediately stop using the injectionRajasthan Drug Controller Ajay Phatak said the affected injection is Bupivacaine Hydrochloride in Dextrose manufactured by Themis Medicare Limited It is routinely used for spinal anaesthesia during surgeriesHe said the decision to prohibit the sale and use of the injection in Rajasthan has been taken as a precautionary measure while investigations are underwayThe department has also instructed officials to collect samples of the affected batch as well as other batches of the product for laboratory testingAccording to information received by the department Themis Medicare Limited has submitted a report to the Drug Controller General of India DCGI regarding adverse reactions associated with Batch No BKP02601 of the injectionAs per the report 16 patients at a Hyderabad hospital experienced symptoms including nausea vomiting and severe headache after being administered the injection Some patients reportedly suffered seizures requiring ventilator support and admission to the Intensive Care Unit ICUApproximately 14000 injections from the affected batch were supplied to Rajasthan and distributed across Jaipur Hanumangarh Bharatpur Karauli Kota Sri Ganganagar and Tonk The Drug Control Department has frozen 7000 injections at its Jaipur depot stopped the sale of 1500 injections available in the market collected 1500 samples for quality testing and initiated the recall of 2000 injections from healthcare facilities and distributorsAround 14000 injections were supplied across Rajasthan Their use has been stopped everywhere and samples from the concerned batch have also been collected for testing said Ajay Phatak Drug ControllerThe department has directed all hospitals medical institutions and distributors to immediately suspend the use and sale of the affected batch until further orders A central team is also investigating the matterThis story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoever