Indonesian Cough Syrup Tragedy: In a shocking revelation, Indonesian court documents have laid bare the series of events that culminated in the deadly contamination of cough syrup, leading to the tragic deaths of more than 200 children in the country last year. The 373-page court ruling, previously undisclosed, details a criminal case involving officials at Indonesian drugmaker Afi Farma, unraveling a chain of negligence and malpractice that shook the nation.
The seeds of this tragedy were sown in 2021 amid a global shortage of pharmaceutical-grade propylene glycol (PG), a crucial base for syrupy medicines. The court documents expose how, during this shortage, CV Samudera Chemical, a struggling Indonesian soap ingredient supplier, began selling drums of industrial-grade ethylene glycol (EG) falsely packaged as PG. The testimony of CV Samudera Chief Executive Endis, as cited in the ruling, reveals that the company even downloaded the logo of major PG supplier Dow Chemical Thailand from the internet to deceive buyers.
The fake PG, containing up to 99% ethylene glycol, was sold to distributor CV Anugerah Perdana Gemilang for several months until May 2022. The court documents disclose that this dangerous substitution occurred as EG is significantly cheaper than PG and is sometimes used unscrupulously by producers despite its potential health hazards.
Endis, claiming ignorance of the intended use of the product, stated that the company repackaged the substance to reduce expenses, emphasizing the difficulty of procuring the authentic propylene glycol due to its import status. CV Anugerah Perdana Gemilang, complicit in the scandal, issued certificates of ingredient analysis for the batches of fake PG, falsely attesting to its suitability for pharmaceutical use without conducting proper testing.
Also Read: Novo Nordisk Billion-Euro Bet: Macron Unveils Game-Changing Investment in French Health Sector
The contaminated material eventually found its way to Afi Farma’s drug ingredient supplier, leading to its inclusion in 70 batches of cough syrup. Police testing later revealed that these batches contained up to 99% ethylene glycol, far surpassing the World Health Organization’s safety limit of 0.1%. Earlier this month, four officials at Afi Farma were convicted in connection to the incident. Additionally, Endis and a CV Samudera colleague, along with two officials at CV Anugerah Perdana Gemilang, were sentenced to 10 years in prison last month for violating drugmaking laws. Afi Farma, however, denies intentionally supplying drugs with deadly ingredients and has filed an appeal against the conviction.
The court documents also shed light on the alleged negligence of Indonesia’s drug regulator, BPOM, accusing it of failing to perform the monitoring required. Despite issuing updated drug standards guidelines in 2020, including maximum allowed limits of ethylene glycol, Afi Farma adhered to the previous edition, and BPOM approved its product registration in 2021 without EG test results.
The document cites a BPOM official’s testimony, indicating that the methods of EG analysis were developed only in October of the following year when the country was grappling with the sudden surge in acute kidney failure cases affecting children.
BPOM, which previously pointed out gaps in safety rules exploited by various parties in the drug supply chain, has yet to respond to requests for comment. As Indonesia continues to grapple with the aftermath of this pharmaceutical tragedy, the court ruling provides a damning exposé of systemic failures and underscores the urgent need for stringent regulatory measures to prevent such devastating incidents in the future.
Our Reader’s Queries
What is the issue with cough syrup in Indonesia?
Four officials, including the boss, of an Indonesian company have been sentenced to two years in jail and fined 1bn Indonesian rupiah ($63,056; £51,786) after their cough syrup was linked to the deaths of more than 200 children. The severity of the punishment reflects the gravity of the situation and sends a strong message to other companies that the safety of consumers must be a top priority. It is a tragic reminder of the devastating consequences that can result from negligence and a lack of accountability.
Which cough syrups are contaminated?
It has been discovered that Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup may contain diethylene glycol and/or ethylene glycol. This contamination poses a serious health risk and should be avoided. It is important to take necessary precautions and seek medical attention if you have consumed any of these products.
Did Indonesia families sue government over cough syrup deaths injuries?
The lawsuit aims to secure $195,000 for each child who lost their life and $130,000 for every child who suffered injuries. The attorney representing the parents has confirmed that other affected families can also participate in the lawsuit. It’s important to note that no amount of compensation can truly make up for the tragic events that have occurred.
How many people died from Indian cough syrup in Gambia?
In a span of just seven days, Lamin passed away. Sadly, he was one of the 70 children under the age of five who lost their lives in The Gambia due to acute kidney injuries. The cause of this tragedy was linked to the consumption of cough syrups manufactured by Maiden Pharmaceuticals, an Indian company. This unfortunate incident occurred between July and October last year.