Did Afi Farma knowingly use toxic ingredients in cough syrup?

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Afi Farma Accused of Using Highly Toxic Ingredients in Cough Syrup

Prosecutors allege that Indonesian drugmaker Afi Farma knowingly used ingredients with toxin concentrations of up to 99% in 70 batches of its medicine, including two batches of propylene glycol that contained 96-99% toxic ethylene glycol (EG). These levels far exceed the World Health Organization's safe limit of 0.10% for EG and diethylene glycol (DEG). The company's license to manufacture drugs was revoked late last year, and its products were removed from shelves due to violations of manufacturing rules.
Allegations of High Toxin Concentrations

Court filings reveal that prosecutors contend Afi Farma incorporated ingredients with exceptionally high levels of toxins into its pharmaceutical products. Specifically, two batches of propylene glycol, a key component in cough syrups, were found to contain between 96% and 99% ethylene glycol (EG). This substance, commonly used in antifreeze, is a known toxin that can cause acute kidney injury if ingested. The prosecution's case suggests a deliberate disregard for safety standards, with these contaminated batches being used in Afi Farma's cough medicine.
Negligence and Supplier Certificates

In connection with these allegations, four Afi Farma officials have been arrested and charged with negligence. The charges stem from the assertion that these officials "consciously" failed to test incoming ingredients, despite possessing the capability and responsibility to do so. Instead of conducting independent verification, the company reportedly relied solely on certificates provided by its suppliers regarding the quality and safety of the raw materials. This reliance on supplier documentation is central to the negligence claims being pursued by prosecutors.
Company's Defense and Regulatory Interpretation

Afi Farma, through its legal representative, denies intentional poisoning and asserts that no such intent has been proven. The company's lawyer argues that Indonesian regulations, specifically a 2018 BPOM (National Agency of Drug and Food Control) regulation, did not mandate rigorous testing of all incoming ingredients. It is stated that this regulation permitted drugmakers to rely on tests conducted by raw material suppliers, requiring only "identification tests" which allegedly did not stipulate toxicity testing. This interpretation of regulatory requirements forms a key part of the company's defense against the accusations.

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Did Afi Farma knowingly use toxic ingredients in cough syrup?

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