January 31, 2023

Filipino Guardian

Sentinels of Filipino Free Press

Indonesia revokes firms’ fever syrup licenses amid investigation into 150 deaths

JAKARTA – Indonesia’s Food and Drug Administration announced on Monday that it had revoked licenses to manufacture syrup medicines from two local firms for violating manufacturing regulations, as they claimed the deaths of more than 150 children from acute kidney injury (AKI). examined.

The BPOM agency’s decision came after Indonesia temporarily banned the sale of some syrup-based drugs and identified the presence of ethylene glycol and diethylene glycol in some products as possible factors in the AKI deaths, most of which were children under the age of five.

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 glycerin, a solvent or thickening agent 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 two companies, PT Yarindo Farmatama and PT Universal Pharmaceutical Industries, had had their “oral liquids” manufacturing licenses revoked, adding that BPOM is taking criminal action against them.

Penny said the two companies made drugs with inferior raw materials, failed to report an ingredient change and used some materials in excess of guidelines.

PT Yarindo Farmatama denied using substandard raw materials in their products in a statement, saying that BPOM approved changes to their ingredients in 2020 and that there were no problems with its distributor.

A lawyer for PT Universal Pharmaceutical Industries declined to comment, citing the ongoing investigation.

Indonesia has seen a spike in AKI cases in children since August, most likely due to changes in raw materials used in cough and fever syrups, the health minister said.

According to the Ministry of Health, Indonesia imports its raw materials for medicines mainly from China and India.

Indonesian health officials said the solvents used in the two companies’ syrups contained impurities.

BPOM said Monday one of those solvents, propylene glycol, was made by Dow Chemical Thailand.

Dow Chemical Thailand said in a statement that “none of the suppliers named by BPOM are our customers” and that its product does not contain ethylene glycol or diethylene glycol. It said it submitted analytical data to the BPOM.

BPOM said it will investigate the two drugmakers’ distributors to see if they were supplying materials to other pharmaceutical companies.

Indonesia has been investigating AKI cases in consultation with the World Health Organization (WHO) after a similar incident in The Gambia earlier this year that saw at least 70 deaths linked to syrup drugs from Indian company Maiden Pharmaceuticals. – Reuters