Rajasthan bans spinal anaesthesia drug batch after Hyderabad reactions

The Rajasthan Drug Control Department has imposed a statewide ban on the sale and use of a specific batch of Bupivacaine Hydrochloride in Dextrose after reports of serious adverse reactions among patients at a hospital in Hyderabad, triggering a nationwide safety alert.

The affected drug, manufactured by Themis Medicare Limited, is widely used to administer spinal anaesthesia during surgeries, including Caesarean deliveries. The action follows reports that 16 patients developed severe complications after receiving the injection.

According to authorities, patients experienced nausea, vomiting and severe headaches, while some reportedly suffered seizures, requiring ventilator support and admission to intensive care units (ICUs).

Rajasthan drug controller Ajay Phatak said the ban was a precautionary measure while investigations are underway.

"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 department identified the affected batch as Batch No. BKP02601 and has ordered an immediate halt to its sale and use across the state. Officials have also been directed to collect samples from the affected and other batches for laboratory testing.

The decision comes after Themis Medicare Limited submitted a report to the Drug Controller General of India (DCGI) detailing adverse reactions linked to the batch.

The Indian Society of Anesthesiologists (ISA) and the Anaesthesia Patient Safety Association (APSA) have meanwhile issued a nationwide advisory urging anaesthesiologists to immediately stop using Bupivacaine injections manufactured by the company for spinal anaesthesia until further notice.

Acting on the advisory, SMS Medical College, Jaipur, directed all hospital superintendents and heads of departments to immediately discontinue the injection.

"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 of SMS Medical College.

Of the 14,000 injections supplied to Rajasthan, authorities said 7,000 have been frozen at the Jaipur depot, the sale of 1,500 available in the market has been stopped, 1,500 samples have been collected for quality testing, and the recall of 2,000 injections from hospitals and distributors has been initiated.

The affected stock had been distributed across Jaipur, Hanumangarh, Bharatpur, Karauli, Kota, Sri Ganganagar and Tonk.

The Drug Control Department has directed all hospitals, medical institutions and distributors to suspend the use and sale of the affected batch until further orders, while a central team continues to investigate the cause of the adverse reactions.

With IANS inputs