Health officers inspect medicinal syrups at a pharmacy in Bandung, Indonesia, on Oct 26, 2022. - Reuters
JAKARTA (The Straits Times/Asia News - Indonesia’s pharmaceutical industry has come under fire over the presence of toxic chemicals in syrups that allegedly caused acute kidney injuries among children and subsequent deaths.
As the death toll climbed to 159 and total cases rose to 304 nationwide on Monday, more evidence has emerged that toxic chemicals were the main culprits.
The chemicals – ethylene glycol (EG) and diethylene glycol (DEG) – appear as impurities in solubility enhancers used in the medications.
Now, all eyes are on the food and drug monitoring agency (BPOM), which has the power to issue permits for drug production and monitor drugs in circulation.
Instead of taking a more proactive approach in periodically examining drugs on shelves, the agency relies heavily on self-assessment by drug manufacturers, leaving a loophole in the supervision over pharmaceutical companies, a consumer group and experts said.
Last Saturday, the Indonesian Consumers Community sent a subpoena to BPOM, pointing out the agency’s negligence in supervising circulating drugs.
“The BPOM has yet to do its job optimally. There are still loopholes in procedures with which it operates,” the group’s chairman David Tobing was quoted as saying by Indonesian news portal Kompas.
Dr Windhu Purnomo, a public health expert from Airlangga University in Surabaya, told The Straits Times that the distribution of a number of unsafe drugs tainted by impurities reveals a lack of supervision by BPOM.
When ordering three drug manufacturers to withdraw five brands of fever, cough and flu syrups, and destroy the stocks on Oct 20, the agency said EG had “exceeded the safe limit”.
“Quality control should not be handed over to the industry. The BPOM should sometimes take samples from circulating drugs in the market and examine if the impurities exceed the safe level,” Dr Windhu said. “If it is left to the industry, it is possible that they will not report it.”
That was also a point underlined by the Indonesian Ombudsman, which is tasked with overseeing the implementation of public services, when making the case for BPOM’s failure to halt the distribution of hazardous drugs.
It noted that the agency had taken a passive approach by letting drug manufacturers conduct independent testing and later report the result.
Ombudsman chief Robert Na Endi Jaweng said: “We demand that the BPOM performs active control, even by taking samples or doing random testing over products made by companies. It should never give up the state authority to the market, to the pharmaceutical companies.”
Defending the absence of routine checks, BPOM chief Penny Lukito pointed out that pharmaceutical companies have the responsibility of assessing the level of impurities in their products, and up to now, there is no international standard that serves as a reference to check the content of EG and DEG in the drugs.
“This is the standard that we should develop now as part of the BPOM’s routine sampling,” she said on Oct 24.
On Monday, BPOM, which is working with the police to bring a criminal case against errant drugmakers, revealed that one company had allegedly committed multiple violations, including changing its drug ingredients such that it contains EG that is above the safe limit, as well as failing to report such a change and assess the qualifications of its raw material supplier.
For instance, the company used propylene glycol tainted by EG at 48mg/ml, well above its tolerable level of 0.1mg/ml.
Professor Junaidi Khotib, dean of the Faculty of Pharmacy at Airlangga University, said that ingredients used in the manufacturing of a drug should not be changed as they have undergone long and strict quality checks before being registered at BPOM.
“When it is registered at BPOM, the (issued) permit is based on their quality at that time. There should be multiple tests in line with existing rules when they need to be changed,” he said.
Prof Junaidi also stressed that there should be a thorough investigation into the tragedy.
Prof Junaidi said that to prevent such cases in the future, it is necessary to gradually reduce the presence of EG and DEG – although both are impurities - in drug manufacturing, or even ban it.
