Rajasthan Drug Controller Ajay Phatak said that the Bupivacaine Hydrochloride in Dextrose, manufactured by Themis Medicare Limited, Batch No. BKP02601 has been restricted for sale and use.
The Rajasthan Drug Control Department has imposed a statewide ban on the sale and use of a specific batch of Bupivacaine injection. The precautionary action comes after 16 patients reportedly developed adverse reactions after receiving the injection in Hyderabad. Bupivacaine injection is a common anaesthetic drug used to numb an area of the body during and after surgeries, childbirth, or dental procedures.
“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,” said Dr Deepak Maheshwari, Principal, SMS Medical College.
Rajasthan Drug Controller Ajay Phatak said that the Bupivacaine Hydrochloride in Dextrose, manufactured by Themis Medicare Limited, Batch No. BKP02601 has been restricted for sale and use. Additionally, the department has instructed officials to collect samples of the affected batch as well as other batches of the product for laboratory testing.
The Indian Society of Anesthesiologists (ISA) and the Anaesthesia Patient Safety Association (APSA) have issued a nationwide advisory urging anesthesiologists to immediately discontinue the use of Bupivacaine injections manufactured by Themis Medicare Limited for spinal anaesthesia.
Themis Medicare Limited has also submitted a report to the Drug Controller General of India (DCGI) regarding adverse reactions associated with Batch No. BKP02601 of the injection. As per the report, 16 patients at a Hyderabad hospital experienced symptoms including 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).
Around 14,000 injections from the contaminated batch were supplied across Rajasthan, including the cities of Jaipur, Hanumangarh, Bharatpur, Karauli, Kota, Sri Ganganagar, and Tonk. The Drug Control Department has seized 7,000 injections at its depot in Jaipur, halted the sale of 1,500 injections currently in the market, gathered 1,500 samples for quality analysis, and started the process of recalling 2,000 injections from healthcare facilities and distributors.
What is a Bupivacaine injection?
Bupivacaine injection is a local anaesthetic. It is used to block pain during and after cesarean deliveries and other surgeries. Instead of putting you to sleep like general anaesthesia, it only targets a specific part of your body while you stay awake and conscious. This medicine is to be given only by or under the direct supervision of your doctor.
Bupivacaine works by causing a loss of feeling and preventing pain by blocking signals at the nerve endings. It stops sodium from entering the nerve cells, which completely blocks the pain signals from travelling to the brain.
Common uses
Bupivacaine is a common anaesthesia injection that is used in surgeries that require numbing a specific region. It is commonly used in cesarean deliveries and is also given as an epidural into the lower back to relieve labour pains. In dental procedures, Bupivacaine is used to numb the gums and mouth. It can also be used for other surgical procedures like an arm or leg.
Bupivacaine also provides long-lasting pain relief to a surgical wound area after the operation is over.
Should patients delay surgeries because of the ban?
No, patients do not need to delay their surgeries as the government of Rajasthan has not banned the drug Bupivacaine itself, but has only suspended the sale and use of one specific, suspicious batch manufactured by Themis Medicare Limited.
This precautionary safety measure has been taken for a particular batch. Side effects like headaches, nausea, or seizures have been reported in 16 patients. No adverse reactions have been reported.
Hospitals and medical authorities have successfully recalled, frozen, or blocked thousands of vials from this specific batch to ensure patient safety.
Why shouldn’t you worry
Hospitals do not rely on just one single batch or brand of medication. Hospitals are typically equipped with safe, unaffected batches of the same and other anaesthetic drugs. If needed, anesthesiologists can easily switch to other highly effective numbing medications such as lidocaine, ropivacaine, or prilocaine. Delaying a necessary surgery can often pose a much bigger risk to your health.
