JAKARTA, Nov 23 (Reuters) – Indonesian court documents show toxic ingredients were used in cough syrup, one of the products blamed for the deaths of more than 200 children in the country last year. The series of events was revealed for the first time. .
A previously unreported 373-page court ruling in a criminal case involving executives from Indonesian pharmaceutical company Affi Pharma says the tragedy is that in 2021, pharmaceutical grade The seeds were planted at a time when there was a global shortage of propylene glycol (PG). .
In the same year, CV Samudera Chemical Co., a small-scale Indonesian soap supplier struggling due to the coronavirus pandemic, began selling drums of industrial-grade ethylene glycol (EG) repackaged as PG. said the judgment, citing testimony from CV Samudera CEO Endis. With one name.
The company downloaded the logo of Dow Chemical Thailand, a major PG supplier, from the Internet and applied it to drums containing EG. It was sold to distributor CV Anguera Perdana for several months until May 2022.
EG is used in the production of antifreeze and deicing agents for automobiles. If swallowed, may cause acute kidney injury. Drug experts say it is sometimes used as a substitute for PG by unscrupulous manufacturers because it costs less than half the price.
Cough syrup contamination in several mostly developing countries has sparked criminal investigations, lawsuits and increased regulatory scrutiny around the world.
According to the document, Mr. Endis did not know that the product would be used in medicine, but “to cut costs as propylene glycol was very expensive to purchase and the product was imported and difficult to obtain.” He said it was simply repackaged. .
CV Anugela Perdana issued certificates of ingredient analysis for several batches of fake PG products, allowing them to be used as medicines without testing.
This material was then supplied to Affi Pharma’s pharmaceutical raw material supplier and subsequently used in 70 batches of cough syrup.According to the document, subsequent police testing found the ingredients contained up to 99% EG, when the World Health Organization’s safe limit was 0.1%.
civil servant convicted of a crime
Four Affi Pharma employees were found guilty earlier this month. Last month, another court sentenced Mr. Endis, a colleague of CV Samudera, and two employees of CV Anugela Perdana to 10 years in prison for violating drug manufacturing laws.
Affi Pharma lawyer Reza Wendla Prayogo told Reuters the company denies knowingly supplying medicines containing deadly ingredients and has appealed.
Reuters was unable to independently contact Samudera CV and Anugela Perdana CV.
The authorities also alleged that Indonesia’s drug regulator BPOM “allegedly did not carry out the oversight that it should have done,” the documents show.
In 2020, Indonesia published an updated version of the Pharmacopoeia, or Drug Standards Guidelines, which for the first time included maximum permissible doses of EG.
However, Affi Pharma followed the previous version of the guidelines and registered the product in 2021 without providing EG test results, which BPOM “imprudently” approved, the judgment said.
The document quotes BPOM officials as saying they finally developed the EG analysis method in October last year, when the country was busy trying to determine the cause of cases of acute kidney failure in children that killed 204 people. .
BPOM did not respond to requests for comment.
The agency previously said multiple players in the drug supply chain were exploiting flaws in safety rules and that drug companies were not doing enough testing on the raw materials used.
Report by Stanley Widianto. Edited by Miyoung Kim and Lincoln Feast.
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