Deadly Indonesian cough syrup was almost pure toxin, court papers show
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[October 13, 2023]
By Stanley Widianto
JAKARTA (Reuters) - An Indonesian drugmaker 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 accusations against drugmaker Afi Farma were made in a court in
Kediri, in the province of East Java, where the company is based, and
Reuters is the first to report the charge that it used highly toxic
ingredients.
The criminal case comes as efforts grow worldwide to tighten oversight
of drug supply chains after a wave of poisonings linked to contaminated
cough syrups that killed dozens more children in countries such as
Gambia and Uzbekistan.
![](http://archives.lincolndailynews.com/2023/Oct/13/images/ads/current/businessdirectory_dailycover_2023.png)
Two batches of propylene glycol, a key base for syrupy medicines that
Afi Farma received from October 2021 to February 2022 and used in its
cough medicine, contained instead as much as 96% to 99% of a toxic
substance, ethylene glycol (EG), a charge sheet in the case showed, in
an undated court filing.
When asked who had carried out the testing and how, prosecutor Ikhsan
Nasrulloh told Reuters it was done by police last year.
A lawyer for Afi Farma, Reza Wendra Prayogo, told Reuters no accusation
of intentional poisoning had been proved against the company, adding
that Indonesia's drug regulator, BPOM, did not require drugmakers to do
a rigorous testing of ingredients.
He said a 2018 BPOM regulation allowed drugmakers to use tests done by
raw material suppliers, requiring them only to run "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 Indonesian police have charged in an
investigation into the supply of tainted cough syrups, with a court case
set to be heard on Oct 18.
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![](http://archives.lincolndailynews.com/2023/Oct/13/images/ads/current/atlantabank_lda_PPP_2023.png) 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.
Indonesia's health ministry also adopted that limit in its 2020
guidelines on drug standards.
EG is employed in making antifreeze and de-icing
solutions for cars, among other uses. If swallowed, it may cause
acute kidney injury.
Both EG and DEG can be substituted for propylene glycol by
unscrupulous producers as they cost less than half the price,
several drug experts told Reuters.
Afi Farma's licence to make drugs was revoked late last year and its
products taken off the shelves for violating rules on manufacturing.
Four company officials, including the chief executive and the
quality control manager, have been arrested and charged with
negligence for "consciously" not testing the ingredients, despite
having the means and responsibility to do so, the charge sheet
shows.
Instead they relied on certificates provided by its supplier
regarding product quality and safety. Now prosecutors are seeking
jail terms of up to nine years for the officials, according to the
charge sheet.
Afi Farma denied the accusation through its lawyer.
Domestic drug regulator BPOM has previously said several parties in
the drug supply chain had exploited a gap in the safety rules and
drugmakers did not run sufficient checks on raw ingredients used.
The contaminations have sparked criminal investigations, lawsuits
and a surge in regulatory scrutiny worldwide.
![](http://archives.lincolndailynews.com/2023/Oct/13/images/ads/current/siu_sda_093023.png)
Last month Reuters reported that some Indian drugmakers involved
could not prove they had bought pharmaceutical grade ingredients or
tested their medicines for the toxins.
(Reporting by Stanley Widianto; Editing by Miyoung Kim and Clarence
Fernandez)
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