Indonesian court documents have revealed for the first time the chain of events that led to toxic ingredients being used in cough syrup that was among the products blamed for the deaths of more than 200 children in the country last year.
According to the previously unreported 373-page court ruling in a criminal case of officials at Indonesia drugmaker Afi Farma, the seeds of the tragedy were sown in 2021 during a global shortage of pharmaceutical grade propylene gylcol (PG), a key base for syrupy medicines.
The same year, CV Samudera Chemical – a small Indonesian soap ingredient supplier struggling during the COVID pandemic – began selling drums of industrial grade ethylene glycol (EG) repackaged as PG, the ruling said, citing testimony from CV Samudera Chief Executive Endis, who goes by one name.
The company downloaded the logo of major PG supplier Dow Chemical Thailand from the internet and applied it to drums containing EG. It sold them to distributor CV Anugerah Perdana Gemilang for several months until May 2022.
EG is employed in making antifreeze and de-icing solutions for cars, among other uses. If swallowed, it may cause acute kidney injury. It is sometimes substituted for PG by unscrupulous producers because it costs less than half the price, several drug experts said.
Cough syrup contamination in several mostly developing countries has sparked criminal investigations, lawsuits and a surge in regulatory scrutiny worldwide.
Endis said he did not know the product was going to be used in drugs and the company simply repackaged it “to lower expenses because buying propylene glycol would be very expensive and the product was hard to procure because it was imported,” according to the documents.
CV Anugerah Perdana Gemilang issued certificates of ingredient analysis for several batches of fake PG product allowing its pharmaceutical use without testing it.
The material was then supplied to Afi Farma’s drug ingredient supplier, before finding its way into 70 batches of cough syrup. Police testing later showed the ingredients had contained up to 99% of EG, the document showed, when the World Health Organization’s safety limit was 0.1%
OFFICIALS CONVICTED
Four officials at Afi Farma were convicted earlier this month. A separate court sentenced Endis and a CV Samudera colleague, along with two officials at CV Anugerah Perdana Gemilang to 10 years in prison last month for violating drugmaking laws.
Reza Wendra Prayogo, Afi Farma’s lawyer, told Reuters the company denies intentionally supplying drugs with deadly ingredients and had filed an appeal.
Reuters could not independently contact CV Samudera and CV Anugerah Perdana Gemilang.
Authorities also claimed Indonesia’s drug regulator BPOM “allegedly did not perform monitoring as it was supposed to be done,” the document showed.
Indonesia issued the latest version of pharmacopeia, or drug standards guidelines, in 2020 that included for the first time maximum allowed limits of EG.
But Afi Farma followed the previous edition of the guideline and registered its product in 2021 without EG test results, which was approved by BPOM “thoughtlessly,” the ruling said.
The document cites testimony from a BPOM official as saying it developed the methods of EG analysis only in October last year when the country was scrambling to establish the cause of acute kidney failure cases affecting children that led to 204 deaths.
BPOM did not immediately respond to a request for comment.
It previously said several parties in the drug supply chain had exploited gaps in the safety rules, and drugmakers did not run sufficient checks on raw ingredients used.
