An Indonesian drugmaker, Afi Farma, is facing serious allegations after its cough syrup was linked to the tragic deaths of over 200 children in the last year. According to prosecutors in a court filing in Kediri, East Java, where the company is headquartered, it was revealed that Afi Farma used ingredients with toxin concentrations of up to 99% in 70 batches of medicine.
The primary toxic substance found in these ingredients was ethylene glycol (EG), which is normally used in making antifreeze and de-icing solutions for vehicles, among other industrial applications. When ingested, EG can lead to acute kidney injury and other severe health problems. A key component of cough syrups, propylene glycol, is normally safe for human consumption, but in this case, two batches supplied to Afi Farma contained extremely high levels of EG, ranging from 96% to 99%. This revelation has raised concerns about the safety of the medicines produced by the company and has led to criminal charges against them.
The testing that uncovered these dangerous ingredient levels was conducted by the police, although the exact methodology and procedures used in the testing remain unclear. Afi Farma’s defense lawyer, Reza Wendra Prayogo, argued that no intentional poisoning by the company had been proven, and they claimed that the Indonesian drug regulator, BPOM, did not require rigorous testing of ingredients. According to Prayogo, a 2018 BPOM regulation permitted drug manufacturers to rely on tests conducted by their raw material suppliers, which only needed to consist of “identification tests” that did not include toxicity testing.
The World Health Organization (WHO) and Indonesia’s health ministry both specify a safe limit for the known toxins EG and diethylene glycol (DEG) at no more than 0.10% based on global standards. In this case, the levels of EG found in Afi Farma’s products were dangerously higher.
Afi Farma has already had its drug manufacturing license revoked, and its products were removed from shelves for violating manufacturing rules. Four company officials, including the CEO and quality control manager, were arrested and charged with negligence for not adequately testing the ingredients despite having the means and responsibility to do so. The charge sheet indicates that they relied solely on certificates provided by their suppliers regarding product quality and safety. Prosecutors are now seeking jail terms of up to nine years for these officials, while Afi Farma continues to deny the accusations against them.
These allegations and subsequent actions against Afi Farma are part of a larger global effort to tighten oversight of drug supply chains, particularly in response to a series of poisonings linked to contaminated cough syrups, which have resulted in the deaths of numerous children in various countries, including Gambia and Uzbekistan. It highlights the critical need for stringent quality control and safety measures in pharmaceutical manufacturing to protect the health and well-being of consumers.