November 10, 2022
JAKARTA – The 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.
Penny said the faulty raw materials used by Yarindo Farmatama could be traced to chemical supplier CV Samudra Chemicals. It remains unclear if the four other drug manufacturers sourced their materials from the same company.
The BPOM has no jurisdiction to impose administrative sanctions on chemical distributors like Samudra Chemicals, Penny said, and had therefore handed that portion of the investigation over to the National Police.
In tandem with the police’s Criminal Investigation Department (Bareskrim), the BPOM is investigating whether the companies intentionally produced medicine that violated its safety regulations, which would be grounds for criminal charges.
“Whether it’s intentional depends on the [findings] of the ongoing investigation,” Penny said. “But what’s clear is that there is negligence in […] ensuring the quality of medicines.”
The BPOM previously said that drug manufacturers found to have produced toxic medicines could be charged under a provision of the 2009 Health Law that carries a maximum sentence of ten years in prison.
Penny went on to say that the BPOM had also revoked the licenses of two pharmaceutical distributors (PBF), PT Megasetia Agung Kimia and PT Tirta Buana Kemindo, for failing to comply with the agency’s rules of good distribution practice (CDOB).
Health authorities have so far reported 320 AKI cases – mostly in infants – with 195 fatalities since January.
Health Ministry spokesman Mohammad Syahril said on Monday that new cases began to slow down after the government placed a temporary ban on the sale of all prescription and over-the-counter medicinal syrups on Oct. 18.
The government, he said, had imported 246 vials of fomepizole – a treatment for AKI – and the drug had shown good results.