11 January 2023
BPOM Releases SOHO’s Traditional Medicinal Syrup Products and Health Supplements Safe from EG and DEG Contaminants
Jakarta, January 10, 2023 – As a follow up action to cases of contamination of syrup drugs which are suspected of causing acute kidney injury (AKI) in children in Indonesia, the Food and Drug Supervisory Agency (BPOM) took several steps regarding syrup medicines and supplements for children who are at risk of containing Ethylene Glycol (EG) and Diethylene Glycol (DEG) contaminants. BPOM has also released and regularly updated the list of children's syrup medicines and supplements that are safe against the risk of EG and DEG contamination.
PT. SOHO Industri Pharmasi, which produces traditional medicinal syrups and Health supplements with brands that are trusted by Indonesian families such as Imboost Force, Imboost, Curcuma Plus, Curvit, and others, has also carried out a process of verifying test data on raw materials and finished products which are guided by BPOM RI. As a result, traditional medicinal products and Health Supplements from SOHO Industri Pharmasi have met the requirements and are safe to use as long as they comply with the specified usage rules.
Based on BPOM letter No. B-PW.02.04.4.43.12.22.995 which was issued on December 26, 2022, and BPOM letter with No. B-PW.02.04.4.43.01.23.06 which was issued on January 1, 2023, verification has been carried out on all traditional medicine syrup products and health supplements from PT. SOHO Industri Pharmasi, and all these products are declared SAFE TO USE.
These SOHO Products include, among others: Imboost Force Kids and Imboost Kids Syrup to maintain children's immune system, Curcuma Plus Vitamin Syrup to help children‘s optimal growth & increase appetite, Diapet Anak to treat diarrhea in children, Curvit Syrup to increase appetite, Fucoidan 100 for gastrointestinal health, and Gastin Force to treat gastrointestinal disorders. (see attachment)
The letter was obtained after BPOM verified the results of testing of raw materials, finished products of syrup or liquid in the drug, as well as other related information needed to ensure consistent compliance with standards, quality, safety and efficacy of traditional medicines/health supplements by manufacturers.
Regarding the verification letter from BPOM, DR. Ir. Raphael Aswin Susilo Widodo, ST, M.Si, CIP, IPU, Director of PT SOHO Industri Pharmasi and Vice President of Research & Development, Regulatory, and Medical Affairs at SOHO Global Health Tbk., revealed that all Quality Control (QC) processes SOHO has complied with CPOB (Good Manufacturing Practices) and CPOTB (Good Traditional Medicine Manufacturing) standards set by BPOM for industries that produce medicinal products, health supplements, and traditional medicines. "SOHO has also conducted self testing on EG/DEG contamination test on raw materials and all finished products, and the results meet the safe limits required by BPOM RI," he said.
"We also regularly and consistently conduct audits of vendor and supplier facilities for raw materials and packaging materials used for the production of SOHO products," he continued. During the production process, added Aswin, SOHO also carries out in-process control inspections and QC tests, which aim to ensure the quality of the products produced meet the established
Meanwhile, when had the opportunity to visit the SOHO factory in early January 2023, Imboost Brand Ambassador Titi Kamal said she was very glad to know that Imboot Kids Syrup has been declared SAFE to use by BPOM RI, which is also definitely a reflection of the relief feeling from mothers throughout Indonesia.
"Thank God, I feel very relieved after knowing that Imboost Kids Syrup has been officially declared safe for consumption for children according to recommendations for use by BPOM RI, so I can give them Imboost Kids Syrup again to maintain their daily immune system. Moreover, their current activities are quite busy, of course they need extra protection," said Titi.
As a mother, Titi acknowledged, of course she wants to provide the best for her family and children, including in choosing immune supplements. "For many years, I have entrusted the protection of my body immune and my family's immunity to Imboost, as the number 1 Immune System supplement in Indonesia, whose quality is guaranteed and there is no doubt about it. So, for moms, don't forget to protect your little one's immune system by routinely giving Imboost Kids Syrup which has been proven safe and verified by BPOM RI," concluded Titi.