Amid Indonesia Inquiry Into Deaths Of 150 Children, 2 Firms Lose Licences
Indonesia's food and drug agency said on Monday it had revoked licences for syrup-type drug production by two local firms for violating manufacturing rules, as it investigates the deaths of more than...
Indonesia's Food and Drug Agency said Monday it has revoked licenses for syrup-type drugs by two local companies for violating manufacturing rules, as it is investigating the deaths of more than 150 children due to acute kidney injuries.
BPOM's decision came after Indonesia temporarily banned the sale of some brews.
It identified the presence of some ethylene glycol and diethylene glycol products as possible factors in the deaths of acute renal failure, mostly of children under five years of age.
The two ingredients are used in antifreeze, brake fluid, and other industrial applications but also as a cheaper alternative in some pharmaceutical products to glycerine, which is a solvent or thickening agent in many cough syrups.
Ethylene glycol and diethylene glycol can be toxic and lead to rheumatoid arthritis.
BPOM Chairman Benny K.
Loquito told reporters that the manufacturing licenses of PT Yarindo Pharmatama and PT Universal Pharmaceuticals have been revoked, adding that BP Aum is pursuing criminal proceedings against them.
Benny said that the two companies produced medicines with substandard raw materials,
Failed to report a change in ingredients and used some substances in excess of the instructions.
In a statement, PT Yarindo Farmatama denied using substandard raw materials in its products and said BPOM has approved changes to its ingredients in 2020 and that there are no issues with its distributor.
An attorney from PT Universal Pharmaceuticals declined to comment, citing an ongoing investigation.
Indonesia has seen a rise in rheumatoid arthritis cases among children since August, which the health minister said was likely due to changes in the raw ingredients used in cough and fever medicines.
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Amid Indonesia Inquiry Into Deaths Of 150 Children, 2 Firms Lose Licences
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