Indonesia’s Deadly Cough Syrup Was Almost Pure Toxin, Court Documents Say – ET HealthWorld | Pharmaceutical

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By Stanley Widianto

JAKARTA, – An Indonesian pharmaceutical manufacturer whose cough syrup is among products linked to the deaths of more than 200 children last year used ingredients with toxin concentrations of up to 99% in 70 batches of medicine , prosecutors said in a court filing.

The charges against drugmaker Afi Farma were brought before a court in Kediri, East Java province, where the company is based, and Reuters is the first to report the accusation that it used highly toxic ingredients .

The criminal case comes amid growing efforts around the world to step up oversight of drug supply chains after a wave of poisonings linked to contaminated cough syrups killed dozens more children in countries like Gambia and Uzbekistan.

Two batches of propylene glycol, the key basis of the syrupy medicines that Afi Farma received from October 2021 to February 2022 and used in its cough medicines, on the other hand contained between 96 and 99% of a toxic substance, ethylene glycol (EG), an indictment in the case was shown, in an undated court filing.

Asked who carried out the tests and how, prosecutor Ikhsan Nasrulloh told Reuters it was done by police last year.

A lawyer for Afi Farma, Reza Wendra Prayogo, told Reuters that no accusations of intentional poisoning had been proven against the company, adding that Indonesia’s medicines regulator, BPOM, did not require manufacturers of Medicines conduct rigorous testing of ingredients.

He said a 2018 BPOM regulation allowed drugmakers to use tests performed by raw material suppliers, requiring them only to conduct “identification tests” that do not stipulate toxicity testing.

BPOM did not immediately respond to a request for comment.

Afi Farma is one of four companies charged by Indonesian police in an investigation into the supply of contaminated cough syrups, with the trial due to be heard on October 18.

The World Health Organization (WHO) says the safe limit for the known toxins EG and diethylene glycol (DEG) is no more than 0.10%, based on global standards.

The Indonesian Ministry of Health also adopted this limit in its 2020 guidelines on pharmaceutical standards.

EG is used, among other things, in the manufacture of antifreeze and defrost solutions for cars. If swallowed, it may cause acute kidney injury.

Both EG and DEG can replace propylene glycol for unscrupulous producers because they cost less than half the price, several pharmaceutical experts told Reuters.

Afi Farma’s license to manufacture medicines was revoked late last year and its products were removed from shelves for violating manufacturing rules.

Four company officials, including the general manager and the head of quality control, were arrested and accused of negligence for not having “knowingly” tested the ingredients, even though they had the means and responsibility to do so, says the ‘indictment.

Instead, they relied on certificates provided by its supplier regarding product quality and safety. Prosecutors are now seeking prison sentences of up to nine years for those responsible, according to the indictment.

Afi Farma denied the accusation through his lawyer.

The national medicines regulator, BPOM, has previously said that several parties in the medicines supply chain had exploited a loophole in safety regulations and that drugmakers had not carried out sufficient checks on the raw materials used .

The contaminations have triggered criminal investigations, lawsuits and increased regulatory scrutiny around the world.

Last month, Reuters reported that some Indian drugmakers involved were unable to prove they had purchased pharmaceutical-grade ingredients or tested their drugs for toxins. (Reporting by Stanley Widianto; Editing by Miyoung Kim and Clarence Fernandez)