Indonesian parents sue as tainted drugs scandal highlights lack of safety standards
When Tia Rizki's son, Mohammad Naufal Rizki Mustofa, came down with a slight fever and cough last August, she assumed it was nothing serious.
Rizki, 27, who works as a nurse in Bekasi, a satellite town of Indonesia's capital of Jakarta, took him to the local clinic where the doctor on duty prescribed him liquid paracetamol.
Over the next few weeks Mustofa appeared to be on the mend, although her son's fever still came and went so Rizki gave him more liquid paracetamol. About a month later, on September 2, Mustofa suddenly started screaming in pain. He hadn't urinated since the night before and was clutching his stomach.
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By the next day, Mustofa had still not urinated, so Rizki took him to the local hospital where an abdominal scan found that his kidneys were failing. On September 8, the hospital said he would need to undergo dialysis.
"On September 9, he lost consciousness and was put on a ventilator. I never spoke to him or saw him conscious again," Rizki told This Week in Asia.
Mustofa died on September 26 following six dialysis treatments.
In October, Rizki learned through media reports of other children who died of kidney failure after consuming suspected tainted cough syrup and liquid paracetamol. She also found out that some parents were planning to launch a class-action lawsuit under the guidance of lawyer Awan Puryadi.
"The cases started in September and continued into October and November," Awan said. "All the families involved had been prescribed medicine made by the same companies, and the children had problems urinating and needed dialysis. It was so fast and they suffered massive organ failure."
According to Mohammad Syahril, a spokesman for Indonesia's Health Ministry, there were more than 260 recorded cases of acute kidney failure by the end of October 2022, and some 157 patients had died.
A health ministry investigation later found a range of cough and fever syrups produced by two companies in Indonesia had been contaminated with chemicals including ethylene glycol, diethylene glycol and ethylene glycol butyl ether - substances most commonly used in antifreeze and brake solution, and not meant for human consumption.
According to the Indonesia Food and Drug Supervisory Agency (BPOM), products that had been tainted included fever medicines Termorex Syrup, Unibebi Fever Syrup and Unibebi Fever Drops, as well as cough medicines Unibebi Cough Syrup and Flurin DMP Syrup.
Awan is now helping 25 families sue a range of defendants in a civil case. Among the families, 19 of their children died as a result of acute kidney failure and six were left with life-altering disabilities.
The defendants include two drug manufacturers - PT Afi Farma, based in East Java, and Medan-based PT Universal Pharmaceutical Industries - as well as the Ministry of Health, BPOM and the Ministry of Finance. The lawsuit also lists five suppliers of the tainted medicines as defendants.
"The plaintiffs are asking for compensation for the victims," Awan said. "US$197,000 for each victim that died and US$131,000 for each victim who was injured. That said, no amount of money can adequately compensate them."
According to Awan, while the manufacturers were negligent in using dangerous chemicals in their products, BPOM was also negligent in not ensuring the products were safe for human consumption.
"They said that they do not have protocols in place and that there are no universal standards for ensuring that products are safe, which is just ridiculous," he said. "Both the United States and the European Union have standards in place, and BPOM should have adopted these years ago."
Tulus Abadi, chairperson of the Indonesian Consumer Foundation (YLKI), said the relevant parties needed to take responsibility for what happened, in particular BPOM and the government.
"All consumers in Indonesia are covered by the Consumer Protection Law of 1999 which guarantees consumers the right to consume products safely and to be provided with clear and accurate information about the products they consume."
BPOM and the Indonesian government have yet to publicly comment. Both PT Afi Farma and PT Universal Pharmaceutical Industries declined to comment when contacted by This Week in Asia.
The court case in Indonesia began on January 17, with the next court date scheduled for February 28 in Jakarta.
Rizki, who was eight months' pregnant with her daughter when Mustofa died, said whatever the outcome of the lawsuit, her son was gone forever.
"What is the point of compensation?" she said. "Just give me back my son, not the money."
This article originally appeared on the South China Morning Post (SCMP).
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