Rajasthan bans Bupivacaine injection batch after 16 adverse reactions in Hyderabad
Synopsis
Rajasthan has banned a specific batch of Bupivacaine injections used in C-sections and surgeries after 16 patients in Hyderabad suffered seizures and needed ICU care. With 14,000 doses already distributed across seven districts, the state has frozen, recalled, and sampled the stock — even as a national advisory from anaesthesiologists' bodies raises the alarm beyond state borders.
Key Takeaways
Rajasthan Drug Control Department banned sale and use of Bupivacaine Hydrochloride in Dextrose, Batch No.
BKP02601 by Themis Medicare Limited on 3 July .
16 patients at a Hyderabad hospital reportedly suffered nausea, vomiting, severe headache, and seizures after receiving the injection; some required ICU admission and ventilator support .
Approximately 14,000 injections from the affected batch were distributed across 7 districts in Rajasthan including Jaipur, Kota, and Bharatpur.
The department has frozen 7,000 doses , halted sale of 1,500 , collected 1,500 samples for testing, and recalled 2,000 from facilities.
The Indian Society of Anesthesiologists (ISA) and Anaesthesia Patient Safety Association (APSA) have issued a nationwide advisory to discontinue the product.
Themis Medicare Limited has submitted an adverse reaction report to the Drug Controller General of India (DCGI) ; a central investigation team is active.
The Rajasthan Drug Control Department has imposed a statewide ban on the sale and use of a specific batch of Bupivacaine Hydrochloride in Dextrose injections, manufactured by Themis Medicare Limited, following reports of serious adverse reactions in 16 patients at a hospital in Hyderabad. The precautionary measure, announced on 3 July, covers Batch No. BKP02601 and affects approximately 14,000 injections already distributed across Rajasthan.
What Triggered the Ban
According to the department, Themis Medicare Limited submitted a report to the Drug Controller General of India (DCGI) detailing adverse reactions linked to Batch No. BKP02601. The 16 patients at the Hyderabad hospital reportedly experienced 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).
Bupivacaine is widely used to administer spinal anaesthesia during surgical procedures, including Caesarean deliveries. The adverse reactions in Hyderabad triggered a nationwide advisory from the Indian Society of Anesthesiologists (ISA) and the Anaesthesia Patient Safety Association (APSA), urging anaesthesiologists across the country to immediately discontinue use of Bupivacaine injections manufactured by Themis Medicare Limited for spinal anaesthesia.
Scale of Distribution in Rajasthan
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 taken the following steps:
The 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.
What Officials Said
Rajasthan Drug Controller Ajay Phatak confirmed that the ban is a precautionary measure while investigations remain 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,' he said.
Dr Deepak Maheshwari, Principal of SMS Medical College, Jaipur, said: '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.' SMS Medical College has directed all hospital superintendents and Heads of Departments (HODs) to halt use of the injection immediately.
Investigation and Next Steps
The department has instructed officials to collect samples from the affected batch as well as other batches of the product for laboratory testing. A central team is also investigating the matter. All hospitals, medical institutions, and distributors in Rajasthan have been directed to suspend the use and sale of the affected batch until further orders. The ban will remain in place until investigations are completed and the safety of the product is established.
Point of View
000 doses before adverse signals from another state triggered action. The fact that the recall was initiated not by the manufacturer's proactive withdrawal but by a patient safety advisory from anaesthesiologists' associations raises questions about how swiftly Themis Medicare escalated its own DCGI report. With Bupivacaine central to C-section anaesthesia, any lapse in quality control carries disproportionate risk for maternal health. The episode underscores why real-time batch-level pharmacovigilance — not reactive state-by-state bans — is overdue in India's hospital supply ecosystem.
NationPress
3 Jul 2026
Frequently Asked Questions
Which Bupivacaine injection batch has been banned in Rajasthan?
Rajasthan has banned Batch No. BKP02601 of Bupivacaine Hydrochloride in Dextrose, manufactured by Themis Medicare Limited . The ban covers the sale, distribution, and use of this specific batch across the state until investigations are completed.
Why were Bupivacaine injections banned in Rajasthan?
The ban follows reports that 16 patients at a hospital in Hyderabad suffered serious adverse reactions — including nausea, vomiting, severe headache, and seizures — after receiving the injection. Some patients required ICU admission and ventilator support.
How many Bupivacaine injections were distributed in Rajasthan?
Approximately 14,000 injections from the affected batch were supplied to Rajasthan and distributed across seven districts: Jaipur, Hanumangarh, Bharatpur, Karauli, Kota, Sri Ganganagar, and Tonk.
What action has the Rajasthan Drug Control Department taken?
The department has frozen 7,000 doses at its Jaipur depot, halted sale of 1,500 market-available injections, collected 1,500 samples for laboratory testing, and initiated recall of 2,000 injections from hospitals and distributors. A central investigation team is also active.
Is there a nationwide advisory on this Bupivacaine batch?
Yes. The Indian Society of Anesthesiologists (ISA) and the Anaesthesia Patient Safety Association (APSA) have issued a nationwide advisory urging anaesthesiologists to immediately discontinue use of Bupivacaine injections manufactured by Themis Medicare Limited for spinal anaesthesia. Themis Medicare Limited has also submitted an adverse reaction report to the Drug Controller General of India (DCGI) .
