IML Testing and Research Monitors Cases of EG/DEG Contamination in Medicinal Syrup

The case of ethylene glycol and diethylene glycol (EG/DEG) contamination began with information shared by the WHO on October 5, 2022, regarding cases of kidney failure in children in Gambia, allegedly caused by four medicinal syrups containing EG/DEG contaminants exceeding the safety threshold, produced by Meiden Pharmaceuticals Limited, India. Following this, Indonesia’s BPOM conducted an investigation to determine whether these four syrup products were distributed in Indonesia. The investigation revealed that the products were not found in Indonesia. However, on October 10, 2022, BPOM received reports of acute kidney failure cases in Indonesia, prompting further investigation into the presence of EG/DEG contamination in syrup products in the country. Subsequently, on October 22, 2022, BPOM announced that five syrup medications in Indonesia were found to contain EG/DEG levels exceeding safe limits.

Excessive levels of EG/DEG can have toxic effects, such as abdominal pain, vomiting, diarrhea, inability to urinate, headaches, altered mental states, and acute kidney injury, which can be fatal. Therefore, the allowable limit for EG/DEG is set at 0.5 mg per kilogram of body weight per day to minimize these risks.

Based on BPOM's investigation, the EG/DEG contamination in the medicinal syrups is suspected to have originated from the use of solvents such as propylene glycol, polyethylene glycol, sorbitol, and glycerol. Polyethylene glycol, glycerol, and sorbitol not only act as solvents but also function as preservatives and antimicrobial agents in syrup formulations. While EG/DEG in their parent compound forms are generally non-toxic, their metabolites are responsible for causing toxicity in the body.

In addressing the five medicinal syrup products found to contain EG/DEG levels exceeding safe limits, BPOM imposed several administrative sanctions on these products. These measures included halting the production of the affected syrups, revoking the distribution permits for all syrup medicines, recalling and ensuring the withdrawal of the distributed syrups, and destroying the entire stock of the contaminated syrups that had been produced.

This case prompted IML Testing and Research to support BPOM in handling cases of distribution of syrup medicinal products containing EG/DEG with real action. IML Testing and Research provides product laboratory testing services to produce product laboratory test results report documents that can be used to apply for distribution permits to BPOM. If the product laboratory test results show that the EG/DEG content exceeds the safe threshold, then it is certain that the product will not pass the application for a distribution permit to BPOM. IML Testing and Research stated, “From the many cases of distribution of dangerous syrup drugs, BPOM has even carried out several sanctions against many brands, but there are still many drug manufacturers who do not know the importance of carrying out toxicity tests or level tests on drugs they want to distribute.” Even though this makes us want to continue to increase awareness of drug manufacturers to always prioritize consumer health and safety.” 

IML Testing and Research will continue to assist BPOM in monitoring drug distribution by conducting product tests in laboratories with ISO 9100 and ISO/IEC 17025 quality standards. “We will continue to strive to carry out product testing to assist drug manufacturers in obtaining non-toxic (safe) formulation results. that are effective and in accordance with the regulations set by BPOM,” said IML Testing and Research.

Reference

Altamimy, M. A., Alshehri, Y. M., Aldawsari, F. S., Altalyan, N. H., AlShmmari, S. K., Alzaid, S. F., Al-Qahtani, N. A., Alsagoor, T. M., & Al Shahrani, M. S. (2024). A Selective Gas Chromatography–Tandem Mass Spectrometry Method for Quantitation of Ethylene and Diethylene Glycol in Paediatric Syrups. Heliyon, 10(7). https://doi.org/10.1016/j.heliyon.2024.

Badan Pengawas Obat dan Makanan Republik Indonesia (BPOM RI). 2023. BPOM Rilis Sirup Obat Aman dari Cemaran EG dan DEG, Masyarakat Bisa Gunakan Sesuai Aturan. Diakses pada tanggal 7 September 2024

Badan Pengawas Obat dan Makanan Republik Indonesia (BPOM RI). 2023. Seri Buku Saku : Penanganan Kasus Cemaran Etilen Glikol dan Dietilen Glikol (EG/DEG) dalam Sirup Obat.https://www.pom.go.id/berita/bpom-rilis-sirup-obat-aman-dari-cemaran-eg-dan-deg-masyarakat-bisa-gunakan-sesuai-aturan-pakai. Diakses pada tanggal 7 September 2024