A. Muh. Ibnu Aqil, Jakarta – Authorities have named three pharmaceutical companies and a chemical distributor as suspects in cases of acute kidney injury and associated fatalities stemming from contaminated children's medicinal syrup.
Food and Drug Monitoring Agency (BPOM) head Penny Lukito said on Thursday that PT Yarindo Farmatama and PT Universal Pharmaceutical Industries were under investigation and have been named suspects.
She did not elaborate on the criminal charges pressed against the two companies.
Separately, National Police Spokesman Insp. Gen. Dedi Prasetyo said that PT Afi Farma and CV Samudra Chemical had also been named as suspects.
"These two corporations are suspected to have conducted the crimes of producing medicines or distributing pharmaceutical raw materials that are not up to standards and/or safety requirements, beneficial requirements and quality," Dedi said on Thursday, as quoted by Kompas.
Dedi said that PT Afi Farma did not conduct proper testing and quality control for the propylene glycol the company used as a solvent for their products, which was later found to have been contaminated with ethylene glycol and diethylene glycol.
PT Afi Farma allegedly obtained their supply of propylene glycol from CV Samudra Chemical, he added.
PT Afi Farma is charged for violating the 2009 Health Law and 1999 Consumer Protection Law, which carried a sentence up to 10 years' imprisonment and Rp 2 billion (US127,526.45) in fines.
Chemical distributor CV Samudra Chemical was found to manufacture counterfeit propylene glycol, commonly used as solvent in pharmaceutical products.
CV Samudra Chemical is charged for violating the Health Law, the Consumer Protection Law, the 2020 Jobs Creation Law and the Criminal Code (KUHP), which carried a sentence of up to 15 years' imprisonment and Rp 2 billion in fines.
BPOM has revoked five pharmaceutical companies' licenses to produce medicinal syrups as well as ordered the withdrawal and destruction of their products from circulation.
The five companies include the three that have been named suspects, PT Samco Farma and PT Ciubros Farma.
The five companies were discovered to have produced medicines containing dangerous levels of ethylene glycol and diethylene glycol from 433 to 702 times over the safety standards. The two substances were linked as the main factors in the cases of acute kidney injuries in children.
The Health Ministry spokesman Mohammad Syahril reported that there had not been any new recorded cases of acute kidney injury in the last two weeks. As of Nov. 15, the ministry recorded the total cases of acute kidney injury at 324.
Syahril said in the Indonesian Medical Association (DI) Instagram Live post that as of Friday there had been 200 deaths from acute kidney injury. Of the total cases, 111 patients recovered and currently 13 patients are still receiving treatment. The cases were predominantly in children aged 1-5 years old.
He said that the patients who were still receiving treatment were currently in stage three of kidney injuries, which signified that there had been quite a lot of damages to the patients' kidneys.
"The patients are still being intensively treated at Pediatric Intensive Care Units. We are also treating them using fomepizole [antidote injections for ethylene glycol poisoning]. We hope that it will help," Syahril said in a statement on Wednesday.
He said none of the patients that were still being treated had comorbidities, and that their kidney injuries were caused by poisoning from ethylene glycol and diethylene glycol from syrup medicines.