Riri Rahayu, Jakarta – Food and Drug Monitoring Agency (BPOM) reported new findings after investigating the source of the raw material for the solvent of medicinal syrups, which is allegedly the cause of acute kidney injury among children.
The agency head Penny Lukito said CV Samudra as a distributor of raw materials is proven to have committed violations. CV Samudra Chemical is a chemical distributor for CV Anugrah Perdana Gemilang, which is the main supplier of CV Budiarta.
"And CV Budiarta is an ineligible supplier of propylene glycol (PG) to the pharmaceutical industry of PT Yarindo, which has previously received sanctions; revocation of distribution license and revocation of CPOB (good drug distribution method), and is currently under legal process," Penny explained at a press conference, Wednesday, November 9, 2022.
She elaborated laboratory test results showed that of the 12 samples of medicinal syrups containing drug solvent PG, all of them contained ethylene glycol (EG) and diethylene glycol (DEG) which were above the safe limit.
"It (the safe limit) should have been 0.1 percent, but nine samples are detected to have up to 52 percent and some even up to 99 percent. There are also [syrup-type drugs with] nearly 100 percent EG content. So, there is indeed an alleged counterfeiting of the PG label while it actually contains EG, a suspect in acute kidney injury cases," said Penny.
Additionally, Penny went on, there were two samples of medicinal drugs containing sorbitol while they were proven to contain 1.34 percent DEG. From these findings, BPOM commanded the drug and food industry as well as large pharmaceutical companies (PBF) that have procured raw materials for drug solvents from distributors, particularly CV Samudra Chemical, to launch tests on EG and DEG contamination.
"BPOM also asked PBF to stop distributing raw materials sourced from CV Samudra Chemical," Penny underlined.