In 2022, Indonesia reported a significant increase of acute kidney injury (AKI) cases in children. By 5 February 2023, over 300 cases were reported, and over half of them resulted in death. Currently, seven cases are still being managed in Jakarta. These incidents are associated with diethylene glycol (DEG) and ethylene glycol (EG). These toxic chemicals are commonly used in antifreeze but should never be found in medicines. The WHO is working closely with Indonesian authorities to prevent further incidents and ensure the safety and quality of medicines in the country.
Responding to the spike in cases, the Ministry of Health (MOH) formed a team of health and paediatrics experts and launched an investigation into the cause of the AKI cases. Samples were collected from 28 hospitals and primary care facilities, and laboratory analysis showed that 42.2% of drug samples and 60.3% of patient plasma samples tested positive for EG/DEG.
Meanwhile, the Ministry also coordinated with WHO as other countries reported AKI incidents of over-the-counter cough syrups for children with confirmed or suspected contamination with high levels of DEG/EG. In response, the Indonesian drugs regulator (BPOM) started investigating paracetamol syrups in October 2022. The investigation was later expanded to all medicinal syrup products. Impurities of EG/DEG were found in five oral solution products, leading to recalls and revocation of marketing authorizations, Good Manufacturing Practices certifications, and distribution licenses. As a result, BPOM ordered six companies to halt production and distribution of all medicinal syrups, recall and withdraw the products from circulation, and destroy all supplies of medicinal syrup in the presence of BPOM officers. The WHO, working with BPOM, also issued an alert in October 2022 identifying six substandard medical products.
Further monitoring by BPOM identified additional products with above-threshold levels of EG/DEG. By December 2022, 47 oral solution products from six pharmaceutical companies were found not to meet requirements and were recalled from the market. BPOM's monitoring and lab testing of samples is still ongoing. The MOH and BPOM have published a list of products that have been declared safe for use.
BPOM has identified gaps in the raw material supply chain and is taking necessary actions to prevent future contamination of pharmaceutical products, while WHO continues to provide technical assistance to ensure the safety, efficacy, and quality of medicines in Indonesia.
The Indonesian government has taken a proactive approach to investigate and mitigate the risk of further AKI cases. However, WHO continues to urge countries to strengthen regulatory oversight, quality control, and vigilance in the manufacturing and distribution of pharmaceutical products to prevent such incidents from occurring in the future and to protect children from contaminated medicines.
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