Indonesia’s Food and Drug Agency announced on Monday that it has revoked the licenses of two local firms to produce a syrup-type medicine for violating manufacturing rules as it investigates the deaths of more than 150 children due to acute kidney injury (AKI). BPOM’s decision came after Indonesia temporarily banned the sale of some syrup-based medicines and identified the presence of ethylene glycol and diethylene glycol in some products as possible factors in the AKI deaths, most of which were in children under the age of five.
These two ingredients are used in antifreeze and brake fluids and other industrial applications, but also as a cheaper alternative in some pharmaceutical products to glycerin, a solvent or thickener in many cough syrups. Ethylene glycol and diethylene glycol can be toxic and lead to AKI. BPOM chief Penny K. Lukito told reporters that the “oral liquid” manufacturing licenses of two companies, PT Yarindo Farmatama and PT Universal Pharmaceutical Industries, had been revoked, adding that BPOM was prosecuting them.
Penny said the two firms manufactured drugs with poor quality ingredients, failed to report changes in ingredients and used some materials beyond the guidelines. In a statement, PT Yarindo Farmatama denied using substandard ingredients in its products and said BPOM had approved changes to their ingredients in 2020 and there were no issues with its distributor.
A lawyer for PT Universal Pharmaceutical Industries declined to comment, citing an ongoing investigation. Indonesia has seen an increase in AKI cases among children since August, which its health minister said was most likely due to changes in the ingredients used in cough and fever syrups. Indonesia imports its raw materials for medicine mostly from China and India, according to the Ministry of Health.
Indonesian health authorities said the solvents used in the syrups from the two companies contained impurities. BPOM said on Monday that one of these solvents, propylene glycol, was produced by Dow Chemical Thailand. Dow Chemical Thailand said in a statement that “none of the suppliers mentioned by BPOM are our customers” and that its product does not contain ethylene glycol or diethylene glycol. It stated that it submitted analytical data to BPOM.
The BPOM said it would look into the distributors of the two drugmakers to see if they supplied materials to other pharmaceutical firms. Indonesia is investigating cases of AKI in consultation with the World Health Organization (WHO) following a similar incident in Gambia earlier this year that saw at least 70 deaths linked to syrupy medicine made by India’s Maiden Pharmaceuticals.
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