The Rajasthan Drug Control Department has enforced a statewide prohibition on a specific batch of Bupivacaine injection due to severe adverse effects observed among patients in Hyderabad. Bupivacaine is commonly used for spinal anesthesia in surgeries, including Caesarean sections. Dr. Deepak Maheshwari from SMS Medical College stated that the injection’s usage has been halted based on anesthesiologists’ recommendations until investigations are concluded.
The precautionary measure follows reports of 16 patients encountering adverse reactions post 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 cease using Bupivacaine injections from Themis Medicare Limited for spinal anesthesia. SMS Medical College in Jaipur has instructed hospital superintendents and Heads of Departments to discontinue the injection’s utilization promptly.
Rajasthan Drug Controller Ajay Phatak disclosed that the affected injection, Bupivacaine Hydrochloride in Dextrose, produced by Themis Medicare Limited, is commonly used for spinal anesthesia during surgeries. The decision to ban the sale and usage of this injection in Rajasthan is a preventive step during ongoing investigations. The department has directed officials to gather samples from the affected batch and other batches for laboratory analysis.
According to reports submitted by Themis Medicare Limited to the Drug Controller General of India (DCGI), 16 patients in a Hyderabad hospital exhibited adverse symptoms like nausea, vomiting, and severe headaches post the injection administration. Some patients experienced seizures, necessitating ventilator support and ICU admission. The Drug Control Department has taken various actions, including freezing 7,000 injections, halting the sale of 1,500 injections, collecting 1,500 samples for quality testing, and recalling 2,000 injections from healthcare facilities and distributors in Rajasthan.
