"With this incident, there is a positive impact on improving the drug control system," he remarked during a press conference on acute kidney injury on videoconferencing platform Zoom, which was accessed from here on Tuesday.
He said that the ministry and the National Food and Drug Supervisory Agency (BPOM) worked together to determine the cause of acute kidney injury (AKI) by testing a mix of syrup drugs consumed by victims for prohibited compounds.
The Health Ministry prepared a list of 102 syrup drugs that were strongly suspected of containing propylene glycol (PG) above the safe threshold of 0.1 percent and sent it to the agency for investigation.
The agency's search with the Criminal Investigation Unit of the National Police revealed that three private drug manufacturers in Indonesia were using PG solvent as a raw material and their finished products were found to contain ethylene glycol (EG) and diethylene glycol (DEG) in amounts exceeding the safe threshold.
At the first company, PT Yarindo Farmatama, the investigators seized 2,930 bottles of Flurine DMP Syrup, 44,992 kg of PG raw material produced by DOW Chemical Thailand, 110,776 pieces of packaging material for Flurine DMP Syrup, a number of batch records for Flurin DMP Syrup production, and certificates of PG raw material analysis as evidence.
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At the next company, Pharmaceutical Industries, they seized 13,409 bottles of 60 ml Unibebi Fever Syrup, 25,897 bottles of Unibebi Fever Drops, 25,897 bottles of 15 ml Unibebi Cough Syrup, 588,673 bottles of PG raw material from DOW Chemical Thailand, 18 drums, and a number of production batch documents as evidence.
The agency also conducted extensive sampling and testing of medicinal syrup products that had the potential for EG and DEG contamination. "As a result, there are three products that exceed the safe threshold, those being Paracetamol Drops, Paracetamol Peppermint Syrup, and Vipcol Syrup produced by PT Afi Farma," Syahril informed.
Upon further investigation, the agency found similar contamination in all of PT Afi Farma's liquid syrups, which used four solvents PG, polyethylene glycol, sorbitol, and glycerin/glycerol.
"The cooperation between the Health Ministry and the National Food and Drug Supervisory Agency is very (tight). Of course, after the investigation there were allegations of intoxication, we gave information to the National Food and Drug Supervisory Agency and those who have the task of investigating what the threshold is," he said.
The search for the cause behind cases of acute kidney injury has led to the conclusion of syrup poisoning, he added.
"(For) our examination, we carried out a biopsy on the kidney of a child who had died, and found oxalate crystals, and this was the final result of EG and DEG. This is what causes crystals that damage the kidneys," he informed.
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Translator: Andi Firdaus, Mecca Yumna
Editor: Suharto
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