News
Health Ministry halts use of controversial anaesthetic from India
The Health Ministry this week withheld until further testing a batch of propofol anaesthetic that was recently bought from an Indian company and for which the National Medicines Regulatory Authority (NMRA) had waived registration, thereby allowing the drug to bypass domestic quality, safety and efficacy checks.
The Sunday Times reported earlier this month that the propofol brand “Anesthefol” from Nandini Medical Laboratories (Pvt) Ltd was flagged in a report by the consultant anaesthetist at the National Eye Hospital in Colombo following the death of a 32-year-old woman who underwent surgery on July 5.
The anaesthetist filed a “report of adverse reactions to medicines, vaccines, devices, traditional remedies & cosmetics” in which she placed a question mark against the propofol (Anesthefol) that had been used. The patient had not had any significant medical history but went into cardiac arrest after about 20-25 minutes of being anaesthetised.
The anaesthetist wrote that, while they were not sure whether the cardiac arrest was owing to the drugs administered–which also included the neuromuscular blocking agent atracurium, and morphine–or any other reason, she was reporting the case at the request of the hospital administration as there had been several recent issues related to anaesthetic drugs.
This was one of three adverse reports on Anesthefol seen by the Sunday Times. It is not known whether there are others, amidst strict gag orders on officials by the Health Ministry.
On June 21, the Sirimavo Bandaranaike Specialised Children’s Hospital’s consultant anaesthetist wrote to the NMRA CEO strongly warning of “alarming issues” related to the quality and safety of the 20ml vials of Anesthefol. His letter was recently tabled in Parliament. Consequently, the Sunday Times gained access to it. The consultant anaesthetist—whose hospital treats children—calls for urgent action to address what he called a “critical matter”.
“During recent clinical usage, it has become evident that these vials of Anesthefol exhibit suspicious physical properties,” he states. “The presence of floating sediment resembling oil and a faded white colour raises serious doubts about the integrity and quality of the product. These anomalies suggest a potential compromise in the manufacturing or storage process, which poses significant risks to patients undergoing anaesthesia.
“Disturbingly, following the administration of this substandard propofol, we have witnessed cases of respiratory arrest during the recovery phase, accompanied by an immediate onset of ever in the post-operative period,” he says.
“These adverse events are not only alarming but also pose a direct threat to patient safety. “Regrettably, some patients have progressed to develop Acute Respiratory Distress Syndrome (ARDS) during their stay in the Intensive Care Unit (ICU), further complicating the recovery and prolonging hospitalisation.
“Considering the gravity of the situation, I earnestly request the National Drug Regulating [sic] Authority to take immediate and decisive action to withhold the distribution, sale and usage
of Anesthefol across
Sri Lanka,” the consultant urges, calling for a thorough investigation “to determine the root cause of these issues and to ensure the prompt removal of this substandard product from the market”.
As early as May 15, the Homagama Base Hospital’s Medical Superintendent filed a report with the Director of the National Drug Quality Assurance Laboratory that they had observed a vial of Anesthefol propofol injection to be “defective”. The report stated that adding 1.2ml of the anaesthetic agent lignocaine (also called lidocaine) to the Anesthefol vial had caused the colour of the solution to change. However, no action was taken by the Health Ministry’s Medical Supplies Division to withhold Anesthefol till this Thursday and it took more than two months for the Laboratory to follow up.
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