Daijiworld Media Network - Jaipur
Jaipur, Jul 3: The Rajasthan Drug Control Department has suspended the sale and use of a specific batch of Bupivacaine injection across the state after reports of serious adverse reactions in patients who received the drug at a hospital in Hyderabad.
The precautionary measure follows an advisory issued by anaesthesia experts and comes while investigations are underway into the safety of the affected batch.
Bupivacaine Hydrochloride in Dextrose, manufactured by Themis Medicare Limited, is commonly used to administer spinal anaesthesia during surgical procedures, including Caesarean sections and other major operations.
Dr Deepak Maheshwari, Principal of SMS Medical College, Jaipur, said all hospitals have been instructed to immediately discontinue the use of the injection until the investigation is completed.
"The decision has been taken on the advice of anaesthesiologists, and the use of the injection has been stopped as a precautionary measure," he said.
The action follows reports that 16 patients at a Hyderabad hospital developed serious complications after being administered the injection. According to officials, the patients experienced symptoms such as nausea, vomiting and severe headaches, while some reportedly suffered seizures that required ventilator support and treatment in intensive care units.
In response to the incident, the Indian Society of Anesthesiologists (ISA) and the Anaesthesia Patient Safety Association (APSA) issued a nationwide advisory asking anaesthesiologists to stop using Bupivacaine injections manufactured by Themis Medicare Limited for spinal anaesthesia until further notice.
Acting on the advisory, SMS Medical College directed all hospital superintendents and heads of departments to suspend the use of the drug.
Rajasthan Drug Controller Ajay Phatak said the statewide restriction was imposed as a precaution while authorities investigate the reported adverse events.
He said officials have also been instructed to collect samples from the affected batch as well as other batches of the product for laboratory analysis.
According to information received by the department, Themis Medicare Limited has already submitted a report to the Drug Controller General of India (DCGI) regarding adverse reactions linked to Batch No. BKP02601 of the injection.
Officials said nearly 14,000 vials from the affected batch had been supplied across Rajasthan and distributed to Jaipur, Hanumangarh, Bharatpur, Karauli, Kota, Sri Ganganagar and Tonk districts.
Of these, around 7,000 injections have been frozen at the Jaipur depot, while the sale of another 1,500 injections available in the market has been stopped. Authorities have collected 1,500 samples for quality testing and initiated the recall of approximately 2,000 injections from hospitals, healthcare institutions and distributors.
"Around 14,000 injections were supplied across Rajasthan. Their use has been stopped everywhere, and samples from the concerned batch have also been collected for testing," Phatak said.
The Drug Control Department has directed all hospitals, medical institutions and pharmaceutical distributors in the state to immediately suspend the sale and use of the affected batch until further orders. A central team is simultaneously conducting a detailed investigation into the incident to determine the cause of the reported adverse reactions.