Overview
- On Friday the Rajasthan Drug Control Department ordered a statewide halt on sale and use of Batch No. BKP02601 of Bupivacaine as a precaution while investigations proceed.
- The action followed a company report that 16 patients at a Hyderabad hospital developed nausea, vomiting, severe headache and some seizures after receiving injections from the implicated batch, with several needing ICU care or ventilator support.
- Officials say roughly 14,000 doses of the batch were supplied to Rajasthan and that about 7,000 were frozen at the Jaipur depot, 1,500 market sales were stopped, 1,500 samples were collected for testing and about 2,000 doses have been recalled from hospitals and distributors.
- The Indian Society of Anesthesiologists and the Anaesthesia Patient Safety Association have issued a nationwide advisory to stop using Themis-manufactured Bupivacaine for spinal anaesthesia until laboratory results are available.
- A central investigation team is examining whether the cause is product quality, contamination, handling or another issue, and hospitals have been told to remove the batch and use alternative anaesthetics where needed without delaying urgent surgery.