Indonesia’s food and drug agency, known as BPOM, has revoked manufacturing licenses for syrup-type medicine production by two local firms for failing to meet its standards on safety, efficiency, and quality.
PT Yarindo Farmatama (PT Yarindo) and PT Universal Pharmaceutical Industries (PT Universal) have had their “oral liquid” manufacturing licenses revoked, officials BPOM said, adding that the agency is now investigating the companies over possible criminal offenses.
BPOM chief Penny K. Lukito stated the two firms used substandard raw materials when making the drugs, did not report a change in ingredients, and used some materials in excess of safety guidelines.
Specifically, an investigation found that propylene glycol was used as a raw material in production of the medicinal syrups, while the finished product contained levels of ethylene glycol (EG) and diethylene glycol (DEG) that exceeded the threshold of safety.
The findings are based on the results of a probe into employees, documents, facilities, and products of the two pharmaceutical companies, officials said.
PT Yarindo and PT Universal face a maximum prison sentence of 10 years and a maximum fine of 1 billion rupiah ($64,000) if found guilty.
The move by the agency comes amid an ongoing investigation into the deaths of more than 150 children in Indonesia, the majority of whom were under the age of five, due to acute kidney injury (AKI) which has been linked to syrup-based medications.
Indonesia’s health ministry has reported 269 cases of acute kidney failure since January, which includes the deaths of 157, according to local outlets.
Last week, the Indonesian ministry of health temporarily banned sales of all syrup-based medications as it looks into the presence of ethylene glycol and diethylene glycol in the products.
Ethylene glycol is mainly used in the manufacturing of polyester fibers and for antifreeze formulations, while diethylene glycol is a widely used solvent and also used in the preparation and production of antifreeze formulations, brake fluid, cigarettes, and some dyes.
The two suspect ingredients can be toxic when consumed in high doses and can lead to AKI. Indonesia has seen a surge in AKI cases among children since August.
“Some syrups that were used by AKI child patients under five [years old] were proven to contain ethylene glycol and diethylene glycol that were not supposed to be there, or of very little amount,” Indonesian Health Minister Budi Gunadi said late in October, The Guardian reported. Sadikin did not specify how many cases involved the toxic syrups.
PT Yarindo Farmatama in a statement denied the allegations that it used substandard raw materials in products and said that BPOM had approved changes in its ingredients in 2020 and that there were no issues with its distributor.
A lawyer with PT Universal Pharmaceutical Industries declined a Reuters request for comment, citing the ongoing investigation.
Indonesia’s ban on the syrup medications came shortly after the World Health Organization (WHO) in September issued a global alert over four specific cough syrups that were linked to the deaths of almost 70 children in Gambia. The country’s Medicines Control Agency said on Monday that it has not yet confirmed that toxic cough syrup was linked to the deaths.
WHO said that laboratory analysis of samples of each of the four substandard products—Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup—found that they contained “unacceptable amounts” of diethylene glycol and ethylene glycol as contaminants.
The Epoch Times has contacted PT Yarindo and PT Universal for comment.
Reuters contributed to this report.
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