Indonesia may take legal action against pharma companies as child deaths rise

Found as contaminants in syrup-based medicines, ethylene glycol and diethylene glyccol are thought to be the cause in acute kidney injury cases and deaths.

Linda Yulisman

Linda Yulisman

The Straits Times


Police officers visiting a pharmacy in Banda Aceh city to inspect syrup formulas for children, following numerous deaths from kidney injury in Indonesia. PHOTO: AFP

October 26, 2022

JAKARTA – The Indonesian authorities should approve the use of only safe solubility enhancers by drug manufacturers in medicinal syrups, said public health experts on Tuesday, as the health authorities investigate a suspected link between liquid drugs and acute kidney injury (AKI) in children.

The presence of ethylene glycol and diethylene glycol as impurities in polyethylene glycol, which is used as a solvent in syrups for fever, cough and flu, came into the spotlight after the deaths of more than 100 children because of AKI.

Under Indonesia’s regulations pertaining to drug manufacturing, the tolerable daily intake of both substances is 0.5mg per kg of body weight.

The death toll surged to 143 on Monday, representing 56 per cent of the 255 AKI cases among children in 26 provinces so far in 2022, according to the Health Ministry.

Dr Windhu Purnomo, a public health expert from Airlangga University, said that to ensure the safety of medicinal syrups for children, the government should prohibit drug manufacturers from using ingredients such as polyethylene glycol, propylene glycol, sorbitol and glycerine, which may contain toxic impurities.

“The safest measure is to ensure there are no impurities at all in the drug ingredients. So they should not be used at all,” he told The Straits Times.

Dr Windhu noted that the consumption of multiple drugs at a time or recurrent use of certain drugs by children may raise the possibility of exceeding the “safe limit” of the impurities in the drug solubility enhancers.

Without tight supervision by the Drug and Food Monitoring Agency (BPOM), allowing the use of certain ingredients may pave the way for drug manufacturers to break the rules, he said.

“There has been a lack of quality control over the pharmaceutical industry by the agency. As a result, we didn’t know the impurities exceeded the safe limit,” he said.

Mr Hermawan Saputra from the Indonesian Public Health Expert Association also said that the use of solubility enhancers such as polyethylene glycol should be avoided.

“Such substances should not become the main choice of ingredients used in drug manufacturing,” he told ST. “There should be substitutes that are proved safe in studies and their applications must also be controlled.”

On Tuesday, the Health Ministry said it had lifted a temporary ban on 156 types of medicinal syrups, which BPOM had found to be free of ethylene glycol and similar substances that could cause AKI in children.

“Medicines beyond the 156 items are still temporarily banned for use in health facilities and sale in pharmacies until further announcement from the government,” the ministry’s spokesman, Dr Mohammad Syahril, told a press briefing.

On Monday, BPOM chief Penny Lukito said that the agency had identified two drug manufacturers whose products breach the tolerable levels of ethylene glycol and diethylene glycol, and it is working with the police to bring a criminal case against them.

To reduce the fatality rate, the government seeks to widen the use of fomepizole injections for severely ill children. Ten vials of the antidote from Singapore have proved effective in improving the condition of 10 patients treated at Jakarta’s Cipto Mangunkusumo Hospital.

The government secured another 16 vials of the antidote from Singapore and 16 vials from Australia earlier this week. It will also import 200 vials from the United States and Japan.

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