As it looks into the deaths of more than 150 children from acute renal injury, Indonesia’s food and drug administration announced on Monday that it has revoked licences for syrup-type medicine production by two local enterprises for breaking manufacturing regulations (AKI).
The BPOM agency made its judgement after Indonesia temporarily outlawed the sale of various syrup-based drugs and found the presence of ethylene glycol and diethylene glycol in some goods as potential causes of the AKI deaths, the majority of which were of children under the age of five.
The two ingredients are also used as a less expensive substitute for glycerine, a solvent or thickening agent in many cough syrups, in some pharmaceutical products. They are also used in antifreeze, brake fluid, and other industrial applications. The hazardous chemicals ethylene glycol and diethylene glycol can cause AKI.
The two companies, PT Yarindo Farmatama and PT Universal Pharmaceutical Industries, had their licences to manufacture ‘oral liquids’ cancelled, according to BPOM CEO Penny K. Lukito, who also said BPOM was taking legal action against them.
According to Penny, the two companies manufactured medications using poor quality raw materials, concealed an ingredient change, and used some compounds in excess of recommended amounts.
In a statement, PT Yarindo Farmatama denied utilising inferior raw materials in its goods and claimed that no distributor issues existed and that BPOM had approved adjustments to its components for 2020.
Invoking the ongoing inquiry, a lawyer for PT Universal Pharmaceutical Industries declined to comment.
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