14-10-2023 (JAKARTA) Shocking revelations have emerged in a court filing in Kediri, East Java, implicating Indonesian drugmaker Afi Farma in the deaths of over 200 children last year. Prosecutors allege that the company employed ingredients with toxin concentrations as high as 99% in 70 batches of medicine, marking a significant development in a case that has raised concerns about the safety of drug supply chains.
This criminal case takes place against the backdrop of a global effort to tighten oversight of pharmaceutical supply chains following a spate of poisonings linked to contaminated cough syrups, resulting in the tragic deaths of numerous children in countries such as Gambia and Uzbekistan.
Court documents reveal that two batches of propylene glycol, a vital base for syrupy medications received by Afi Farma between October 2021 and February 2022, contained alarming levels of a toxic substance, ethylene glycol (EG), ranging from 96% to 99%. The testing to determine these toxic concentrations was carried out by the police last year, as confirmed by prosecutor Ikhsan Nasrulloh.
Afi Farma, represented by lawyer Reza Wendra Prayogo, refutes any claims of intentional poisoning, asserting that Indonesia’s drug regulator, BPOM, does not mandate rigorous testing of ingredients. Prayogo points to a 2018 BPOM regulation that permits drugmakers to rely on tests conducted by raw material suppliers, with no requirement for toxicity testing.
The World Health Organization (WHO) and Indonesia’s health ministry have established a safe limit for known toxins such as EG and diethylene glycol (DEG) at no more than 0.10%, in accordance with global standards. EG, typically used in antifreeze and de-icing solutions for automobiles, can cause acute kidney injury if ingested.
Unscrupulous producers often substitute EG and DEG for propylene glycol, given their lower cost, as highlighted by drug experts. Afi Farma’s license to manufacture drugs was revoked last year, and its products were removed from the market for violating manufacturing rules.
The charge sheet in the case indicates that four Afi Farma officials, including the CEO and quality control manager, have been arrested and charged with negligence. They allegedly failed to conduct essential testing on the ingredients, despite having both the means and responsibility to do so. Instead, the company relied on certificates provided by its supplier concerning product quality and safety.
Prosecutors are now seeking sentences of up to nine years for the implicated officials, according to the charge sheet.
Afi Farma has consistently denied these accusations through its legal representation. Indonesia’s drug regulator, BPOM, previously acknowledged that multiple parties in the drug supply chain exploited gaps in safety regulations, resulting in drugmakers conducting inadequate checks on raw materials.
