Jaipur: The Rajasthan Drug Control Department has imposed a statewide ban on the sale and use of a specific batch of Bupivacaine injection after reports of serious adverse reactions among patients in Hyderabad, including eight women who had undergone Caesarean deliveries.
The injection, widely used to administer spinal anaesthesia during surgical procedures including Caesarean sections and other operations, has been withdrawn as a precautionary measure.
16 Patients Affected in Hyderabad, Including Caesarean Cases
According to officials, around 16 patients at a hospital in Hyderabad developed adverse reactions after being administered the injection. The affected patients, including eight women who underwent Caesarean deliveries, experienced symptoms such as nausea, vomiting, severe headache, and in some cases seizures, requiring intensive care and ventilator support.
Following these reports, the Indian Society of Anesthesiologists (ISA) and the Anaesthesia Patient Safety Association (APSA) issued a nationwide advisory recommending immediate discontinuation of the use of Bupivacaine injections manufactured by Themis Medicare Limited for spinal anaesthesia.
Rajasthan Orders Massive Recall of Affected Batch
Rajasthan Drug Controller Ajay Phatak said the ban specifically targets Bupivacaine Hydrochloride in Dextrose from a particular batch, which is commonly used in surgeries and obstetric procedures.
He added that approximately 14,000 injections from the affected batch were supplied across Rajasthan and distributed to several districts including Jaipur, Kota, Bharatpur, Hanumangarh, Karauli, Sri Ganganagar, and Tonk.
Out of these, about 7,000 injections have been frozen at the Jaipur depot, 1,500 have been stopped in the market, 1,500 samples have been collected for laboratory testing, and 2,000 injections are being recalled from hospitals and distributors.
βThe use of the injection has been stopped everywhere as a precautionary step. Samples are being tested and further action will depend on the investigation report,β the Drug Controller said.
The department has directed all hospitals, medical institutions, and distributors to immediately suspend the use of the affected batch until further orders. A central investigation is also underway.
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