"It turns out that many of these products are sold online. We have conducted cyber patrols for products that do not meet the regulations," BPOM head Penny K. Lukito informed Commission IX of the House of Representatives during a meeting that was accessed from here on Wednesday.
She said that the agency has coordinated with the Communication and Information Ministry and the Indonesian E-Commerce Association (idEA) to take down the 6,001 online links since October 24, 2022.
She informed that the drugs sold via the links have been deemed unsafe for consumption because they are suspected of containing dangerous chemical compounds ethylene glycol (EG) and diethylene glycol (DEG), which have been linked to acute kidney injury cases in Indonesia.
The sampling and testing of 5 of 38 samples of syrups have indicated EG/DEG contamination exceeding the safe limit of 0.1 mg/ml, she informed. The drugs are Termorex Syrup (batch AUG22A06), Flurin DMP Syrup, Unibebi Cough Syrup, Unibebi Fever Syrup, and Unibebi Fever Drops, she added.
"EG and DEG should not be used as additional ingredients in medicinal products taken," she said.
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EG/DEG contamination in drugs may exist within a certain limit, coming from solvents propylene glycol (PG), polyethylene glycol (PEG), sorbitol, and glycerin/glycerol, she added.
In addition, contamination is possible in products that do not meet the international standards for EG/DEG contamination in medicinal products.
"The National Food and Drug Supervisory Agency’s reference is the Indonesian Pharmacopoeia and other standards according to Law 36 of 2009 on Health," she informed.
The safe threshold or maximum tolerable daily intake (MTDI) of EG and DEG is 0.5 mg/kg BW/per day, Lukito informed.
"The results of the EG contamination test found in the products which do not meet the requirements, it can yet support the conclusion that the use of the drug syrup has a link with acute kidney injury," she informed.
Other risk factors may include viral infection, Leptospira bacteria, and multi-system inflammatory syndrome in children (MIS-C) or post-COVID-19 multi-system inflammatory syndrome.
"Therefore, there must be a causality study (to find out) whether the incident is related and caused by drugs," she said.
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Translator: Andi Firdaus, Mecca Yumna
Editor: Suharto
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