Indonesia’s national food and drug control agency (BPOM) has revoked licences for syrup-type drug production by two firms for allegedly violating manufacturing rules and using possibly toxic ingredients while it investigates the deaths of more than 150 children from acute kidney injury (AKI).
The country has been investigating AKI cases in consultation with the World Health Organisation (WHO) after similar incidents in The Gambia this year involving at least 70 deaths related to syrup medications made by India’s Maiden Pharmaceuticals.
The decision by the BPOM agency came after Indonesia temporarily banned sales of some syrup-based medications and identified the presence in some products of ethylene glycol and diethylene glycol as possible factors in the AKI deaths, most of which were of children under five.
Reuters reports that the two ingredients are used in antifreeze and brake fluids and other industrial applications, but also as a cheaper alternative, in some pharmaceutical products, to glycerine, a solvent or thickening agent in many cough syrups. Ethylene glycol and diethylene glycol can be toxic and lead to AKI.
BPOM chief Penny Lukito said the “oral liquid” manufacturing licences of the two companies, PT Yarindo Farmatama and PT Universal Pharmaceutical Industries, had been revoked, and that BPOM was pursuing criminal action against them.
Lukito alleged the two firms produced drugs with substandard raw materials, failed to report a change in ingredients, and used some materials in excess of guidelines.
PT Yarindo Farmatama issued a statement denying using substandard raw materials in its products and said BPOM approved changes in its ingredients in 2020 and that there were no problems with its distributor.
A lawyer with PT Universal Pharmaceutical Industries declined to comment, citing the ongoing investigation.
Indonesia has seen a surge in AKI cases among children since August, which its Health Minister said was most likely due to changes in the raw ingredients used in cough and fever syrups.
Indonesia imports its raw ingredients for medicine mostly from China and India, according to the Health Ministry, which said solvents used in the syrups from the two companies contained impurities.
BPOM said on Monday one of these solvents, propylene glycol, was made by Dow Chemical Thailand.
Dow Chemical 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 said it had submitted analytical data to the BPOM.
BPOM said it would look into distributors of the two drug makers to see if they supplied materials to other pharmaceutical firms.
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