TheJakartaPost
Please Update your browser
Your browser is out of date, and may not be compatible with our website. A list of the most popular web browsers can be found below.
Just click on the icons to get to the download page.
BPOM to tighten post-market inspections on medicines
As a probe continues into rising cases of acute kidney injury (AKI) that have so far killed more than 100 children, the drug regulator said it was not conducting inspections on medicinal syrups that were currently on the market, but planned on revising this stance going forward.
Change Size
An employee collects medicinal syrups that contain paracetamol at a minimarket in South Tangerang, Banten, on Oct. 19. The Health Ministry has banned the sale of all medicinal syrups following the deaths of nearly 100 children across the country from unexplained acute kidney failure. (Antara/Sulthony Hasanuddin )
A
s a probe continues into rising cases of acute kidney injury (AKI) that have so far killed more than 100 children, the drug regulator said that it was not conducting inspections on medicinal syrups that were currently on the market, but planned on revising this stance going forward.
Food and Drug Monitoring Agency (BPOM) head Penny Lukito told a press conference on Sunday that her office “is already monitoring the existence of contaminants in medicinal ingredients according to international standards. [...] But these standards do not include monitoring contaminants in finished products”.
She was referring to ethylene glycol (EG) and diethylene glycol (DEG), two dangerous compounds that the Health Ministry suspects are the causes of AKI cases that have so far affected 241 children and killed 133 of them.
“EG and DEG are inedible and they cannot be used in anything meant for human consumption. But they are impurities, resulting from several solvents used in the pharmaceutical industry like propylene glycol, glycerol, sorbitol and polyethylene glycol,” said Bandung Institute of Technology (ITB) pharmacy professor Rahmana Emran.
While Rahmana argued that it was impossible to completely get rid of these contaminants, it was BPOM’s responsibility to maintain that the levels of EG and DEG in medicinal products did not rise above safety limits.
“Going forward, we will impose stricter monitoring protocols in both pre and post-market stages and impose tighter quality control regulations on the pharmaceutical industry,” said Penny.
For the time being, the agency has listed 133 medicinal syrups – ranging from Meprofarm's Asterol for asthma to Combipar's cold syrup OBH Combi – that do not use the four listed solvents – propylene glycol, glycerol, sorbitol and polyethylene glycol – as ingredients, and therefore are completely safe to use.
Your Opinion Matters
Share your experiences, suggestions, and any issues you've encountered on The Jakarta Post. We're here to listen.
Thank you
Thank you for sharing your thoughts. We appreciate your feedback.
