Jaipur, July 3 (IANS). The Rajasthan Drug Control Department has banned the sale and use of a particular batch of bupivacaine injection across the state following reports of serious adverse reactions in patients at a hospital in Hyderabad.
Bupivacaine is widely used to provide spinal anesthesia during a variety of surgeries, including cesarean delivery.
Principal of SMS Medical College, Dr. Deepak Maheshwari, said, “Instructions have been issued to stop the use of this injection with immediate effect until the investigation is completed. This decision has been taken on the advice of anesthesiologists.”
The precautionary measure comes after reports of serious adverse reactions in 16 patients after being administered the injection at a hospital in Hyderabad.
The Indian Society of Anesthesiologists (ISA) and Anesthesia Patient Safety Association (APSA) have issued an advisory to anesthesiologists across the country to immediately stop the use of bupivacaine injection manufactured by Themis Medicare Limited for spinal anesthesia.
Following this advisory, SMS Medical College, Jaipur has instructed all hospital superintendents and heads of departments (HODs) to immediately stop the use of the concerned injection.
Rajasthan’s Drug Controller Ajay Phatak said that the affected injection is ‘Bupivacaine Hydrochloride in Dextrose’, manufactured by Themis Medicare Limited. It is routinely used to provide spinal anesthesia during surgery.
He said that as a precautionary measure, it has been decided to ban the sale and use of this injection in Rajasthan until the investigation is completed.
The department has directed officials to collect samples of the affected batch as well as other batches of this product for laboratory testing.
According to information received by the department, Themis Medicare Limited has submitted a report to the Drug Controller General of India (DCGI) regarding adverse reactions associated with the injection batch number BKP 02601.
According to the report, symptoms like nausea, vomiting and severe headache were observed in 16 patients after being given injections in a hospital in Hyderabad. Some of these patients also suffered seizures, due to which they had to be put on ventilators and admitted to the Intensive Care Unit (ICU).
Around 14,000 injections from the affected batch were sent to Rajasthan, which were distributed in Jaipur, Hanumangarh, Bharatpur, Karauli, Kota, Sriganganagar and Tonk. The Drug Control Department has reserved 7,000 injections in its depot in Jaipur. It has stopped the sale of 1,500 injections available in the market, collected 1,500 samples for quality testing and initiated the process of recalling 2,000 injections from health institutions and distributors.
Drugs controller Ajay Phatak said, “Around 14,000 injections were supplied to Rajasthan. Their use has been banned across the state and samples of the concerned batch have also been collected for testing.”
The department has directed all hospitals, medical institutions and distributors to immediately stop the sale and use of injections of the affected batch until further orders. A team from the Center is also investigating the matter.
–IANS
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