Jaipur: 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 College.
The precautionary action comes after 16 patients reportedly developed adverse reactions after receiving the injection in Hyderabad.
The 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 anaesthesia.
Following the advisory, SMS Medical College, Jaipur, has directed all hospital superintendents and Heads of Departments (HODs) to immediately stop using the injection.
Rajasthan 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 surgeries.
He said the decision to prohibit the sale and use of the injection in Rajasthan has been taken as a precautionary measure while investigations are underway.
The department has also instructed officials to collect samples of the affected batch as well as other batches of the product for laboratory testing.
According 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 injection.
As 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 (ICU).
Approximately 14,000 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 7,000 injections at its Jaipur depot, stopped the sale of 1,500 injections available in the market, collected 1,500 samples for quality testing, and initiated the recall of 2,000 injections from healthcare facilities 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,” said Ajay Phatak, Drug Controller.
The 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 matter.
