JAKARTA: Indonesia's food and drug agency (BPOM) said on Monday it had revoked licenses of syrup-type drug production of two local firms for violating manufacturing rules, as it probes the deaths of more than 150 children due to acute kidney injury (AKI).
The decision comes after Indonesia temporarily banned sales of some syrup-based medications and identified the presence in some products of ethylene glycol and diethylene glycol as possible factors in the AKI deaths, most of which were of children under five.
The two are used in antifreeze and brake fluids and other industrial applications but also as a cheaper alternative in some pharmaceutical products to glycerine, a solvent or thickening agent in many cough syrups. They can be toxic and lead to acute kidney injury.
BPOM chief Penny K. Lukito told reporters "oral liquid" manufacturing licences of the two companies, PT Yarindo Farmatama and PT Universal Pharmaceutical Industries, has been revoked, adding BPOM are pursuing criminal action against them.
The two firms produced drugs with substandard raw materials, failed to report a change in ingredients and used some materials in excess of guidelines, Penny said.
PT Yarindo Farmatama did not immediately respond to Reuters' requests for comment. A lawyer with PT Universal Pharmaceutical Industries declined to comment, citing the ongoing investigation.
Indonesia has seen a surge in AKI cases among children since August, which its health minister said was most likely due to changes in the raw ingredients used in cough and fever syrups.
Indonesia imports its raw ingredients for medicine mostly from China and India, according to the health ministry.
Authorities said solvents used in the syrups from the two companies contained impurities.
BPOM said on Monday one of these solvents, propylene glycol, was made by Dow Chemical Thailand. The company did not immediately respond to a request for comment.
BPOM said it would look into distributors of the two drug makers to see if they supplied materials to other pharmaceutical firms.
Indonesia has been investigating AKI cases in consultation with the World Health Organization (WHO) following a similar incident in Gambia earlier this year, which has seen at least 70 deaths related to syrup medications made by India's Maiden Pharmaceuticals.
Dow's statement for Indonesia case
According to the BPOM's press conference, BPOM found drums from the pharmaceutical companies that have tested for high levels of ethylene glycol (EG) and Diethylene Glycol (DEG).
Mr. Riswan Sipayung, Dow Indonesia Country President’. Said Dow took immediate actions to work with BPOM and provided all the data and information we have to BPOM. After a thorough internal review, we found that none of the suppliers mentioned by BPOM are our customers.
Dow is confident and can confirm that PG USP supplied by Dow in its sealed form does not containany EG or DEG. Detailed analytical results and related documents have been submitted to BPOM.We intend to cooperate with BPOM to the fullest extent possible and we are ready to assist with anytests of the products as maybe required by BPOM.
Dow continues to comply with all applicable laws and regulations wherever we operate, including Indonesia, and supports government efforts to maintain public safety and health. As a materials science company, Dow takes a very serious view on its product integrity and is committed to ensuring safety in all its products. Dow's brand products are used to ensure quality and compliance in drug formulations and have been tested to meet the applicable regulatory requirements.
About Dow
Dow (NYSE: DOW) combines global breadth; asset integration and scale; focused innovation and materials science expertise; leadingbusiness positions; and environmental, social and governance (ESG) leadership to achieve profitable growth and deliver a sustainablefuture. The Company's ambition is to become the most innovative, customer-centric, inclusive, and sustainable materials science company in the world. Dow's portfolio of businesses delivers a broad range of differentiated, science-based products and solutions for its customersin high-growth market segments, such as packaging, mobility, infrastructure, and consumer applications. Dow operates 104 manufacturing sites in thirty-one countries and employs approximately 35,700 people. Dow delivered sales of approximately $55 billion in 2021. References to Dow or the Company mean Dow Inc. and its subsidiaries. For more information, please visit www.dow.com or follow @DowNewsroom on Twitter.