"YLKI urges to thoroughly investigate the cases from upstream to downstream, starting from the supply of medicinal raw materials, production processes, to marketing," he said here on Monday.
The massive occurrence of AKI cases has shown that the supervision mechanism implemented by the National Agency of Drug and Food Control (BPOM) as part of pre-market and post-market control has not been effective, he added.
For that reason, President Joko Widodo must evaluate the performance of BPOM in terms of supervision and the agency's policies, he said.
"As well as supervision by manufacturers in the production process because the drug manufacturing process should refer to the Good Manufacturing Practices (GMP) aspect," he added.
Regarding the findings of ethylene glycol and diethylene glycol in syrup medicines, YLKI said it suspects that quality control was not carried out as part of the internal management of drug manufacturers.
Earlier, in a press statement issued by the Health Ministry here on October 20, 2022, Health Minister Budi Gunadi Sadikin had confirmed that three dangerous chemical substances had been found in syrup medicines that were suspected of causing AKI in children.
The three substances were ethylene glycol (EG), diethylene glycol (DEG), and ethylene glycol butyl ether (EGBE), which ideally should not exist in syrup medicines.
The chemical substances can be found in syrups if polyethylene glycol, within strict tolerance limits, is used to increase the solubility of syrup medicines.
According to Indonesia Pharmacopoeia, EG and DEG were not used in the medicine formulation. However, as contaminants in syrup medicines, the tolerable limit for glycerine and propylene glycol is 0.1 percent and polyethylene glycol 0.25 percent.
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Translator: Anita Permata, Raka Adji
Editor: Rahmad Nasution
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