“In a recent revelation from Indonesian court documents, a distressing chain of events leading to the use of toxic ingredients in cough syrup, ultimately linked to the tragic deaths of over 200 children in the country, has surfaced. Uncovered details from a 373-page court ruling expose how a shortage of pharmaceutical-grade propylene glycol (PG) set the stage for this catastrophic occurrence. This article delves into the intricate narrative revealed by the court proceedings, shedding light on the deceptive practices within the pharmaceutical supply chain and the profound regulatory oversights that contributed to this devastating health crisis.”
In newly uncovered Indonesian court documents, a detailed sequence of events has come to light, shedding light on the tragic use of toxic ingredients in cough syrup responsible for the deaths of over 200 children in the country last year.
Highlighted in a 373-page court ruling related to a criminal case involving officials at Indonesia’s pharmaceutical company Afi Farma, the narrative unveils how the scarcity of pharmaceutical-grade propylene glycol (PG) in 2021 triggered the distressing turn of events. PG, a crucial component in syrup-based medications, became scarce globally during that time.
During this shortage, CV Samudera Chemical, a struggling Indonesian soap ingredient supplier affected by the Covid pandemic, purportedly started selling drums labeled as PG but containing industrial-grade ethylene glycol (EG). The court ruling referenced testimony from CV Samudera’s Chief Executive, known solely as Endis, who admitted to downloading Dow Chemical Thailand’s logo from the internet and affixing it to EG drums, deceivingly passing it off as PG. These falsely labeled drums were then sold to distributor CV Anugerah Perdana over several months until May 2022.
Unlike PG, EG, commonly used in antifreeze and car de-icing solutions, poses severe health risks if ingested, including acute kidney injury. Despite its dangers, unethical producers substitute it for PG due to its significantly lower cost, according to multiple drug experts.
Endis claimed ignorance about the intended use of the product in medications, stating that the company repackaged it to reduce expenses, considering the exorbitant cost and difficulty in procuring imported propylene glycol. However, CV Anugerah Perdana issued certificates falsely attesting to the authenticity of the fake PG product for pharmaceutical use, bypassing necessary testing protocols.
These hazardous ingredients eventually reached Afi Farma’s drug ingredient supplier and were incorporated into 70 batches of cough syrup. Subsequent police testing revealed that these ingredients contained up to 99% EG, a stark contrast to the World Health Organization’s safety limit of 0.1%.
Recently, four Afi Farma officials were convicted, while Endis, a colleague from CV Samudera, and two CV Anugerah Perdana officials received a 10-year prison sentence for violating drug manufacturing laws. Afi Farma denies deliberately supplying medicines containing lethal ingredients and has filed an appeal.
Attempts to independently contact CV Samudera and CV Anugerah Perdana were unsuccessful.
The documents also shed light on Indonesia’s drug regulator BPOM, accusing it of inadequate monitoring. Despite issuing updated pharmacopeia guidelines in 2020, including maximum limits for EG, Afi Farma proceeded to register its product in 2021 without EG test results, which BPOM approved without due diligence, according to the court ruling.
Testimony from a BPOM official stated that methods for EG analysis were only developed in October last year amid the country’s urgent investigation into acute kidney failure cases affecting children, which resulted in 204 fatalities. BPOM did not respond to requests for comment.
Previously, BPOM had highlighted exploitations of safety loopholes within the drug supply chain, citing insufficient checks on raw ingredients by pharmaceutical manufacturers as a critical issue.
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