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Two more drug companies have medicinal syrup licenses revoked
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Police officers visit a drug store to inspect medicinal syrups in Banda Aceh on Oct. 24, following numerous child deaths from kidney injuries attributed to harmful substances in such medications. (AFP/Chaideer Mahyudin)
T
he Food and Drug Monitoring Agency (BPOM) revoked two more pharmaceutical companies’ licenses to produce medicinal syrups on Wednesday, bringing to five the total number of firms sanctioned for the manufacture of toxic medicines linked to deadly cases of acute kidney injury (AKI).
Indonesia has seen a spike in AKI cases that has left nearly 200 children dead so far this year.
Health authorities have attributed the deaths to the circulation of medicines containing dangerous levels of ethylene glycol (EG) and diethylene glycol (DEG).
While the BPOM has outlawed the use of EG and DEG in medicines, the drug regulator allows their trace presence in the solvents of syrup-based medicines, provided it does not exceed 0.1 percent.
BPOM head Penny Lukito said on Wednesday that the agency had found “sufficient evidence” that two pharmaceutical companies, PT Samco Farma and PT Ciubros Farma, had used substandard raw materials and produced drugs with EG and DEG levels that exceeded the BPOM’s safety standards.
“The BPOM has ordered the withdrawal of all medicinal syrups [produced by the two companies] from circulation throughout the country and the destruction of all the batches that […] exceed [permissible] levels of EG and DEG contamination,” Penny said.
Samco Farma and Ciubros Farma have joined three other pharmaceutical companies that have received administrative sanctions from the BPOM for producing medicines tainted with EG and DEG. They are PT Yarindo Farmatama, PT Universal Pharmaceutical Industries and PT Afi Farma.
