JAKARTA - Head of the Food and Drug Supervisory Agency (BPOM) Penny K Lukito said, there are 23 sirop drugs from 69 products consumed by patients with atypical progressive acute kidney disorders (GGAPA) that can be said to be safe.
“ Of the 23 ( sirop drugs) that have been out of 69, already. Because the process certainly takes time. It has been tested. There are 23 who use the solvent but it can be said to be safe because it still meets the threshold that our bodies can tolerate. This means it is still safe,” said Penny during a press conference in Jakarta, quoted from Antara, Thursday, October 27.
Earlier on Sunday, BPOM announced 23 products that did not use four solvent materials from 102 sirop drugs released by the Ministry of Health (Kemenkes).
The four sirop solvent materials are glycol province, glycol polyethylene, sorbitol, and/or glyceron/gliserol.
“ Of the 102 lists of drugs issued by the Ministry of Health, which are safe because they do not contain the solvent, it has been announced. The rest, there are 69 drugs containing the solvent,” said Penny.
He emphasized that the 69 sirop drugs are still being explored further by BPOM, including 23 products that are said to be safe. Even though they contain all four solvents, Penny said that it is not certain that the 69 sirop drugs contain ethilen glycol (EG) contamination and dietilen glycol (DEG).
"Even if they (69 sirop drugs) contain EG and DEG contamination, there are limits on tolerable limits, requirements, where if they are still below these restrictions, it means they are still safe based on internationally applicable experts and standards, they are still categorized as safe," explained Penny.
However, Penny said that at this time her party would not mention the name or brand of the drug considering that the government's policy was still prioritizing the element of caution. He said 69 drugs containing four solvents could not be consumed by the public.
“ I think the government is careful, so now it only allows sirop products without solvent. So it is no longer allowing sirop products, but already with the issuance of a Circular Letter from the Ministry of Health, it means that sirop products are allowed that do not use the four types of solvents,” he said.
Penny said the 69 sirop drugs were temporarily detained and her party would reconfirm the supervision of pre-markets to post-markets in the pharmaceutical industry.
In addition, he also encouraged the pharmaceutical industry that has other medicinal products outside the list released by the Ministry of Health but using four solvent materials can ensure the safety of raw materials for its products and carry out self-examination or testing and submit the results to BPOM.
"I think there are already some major pharmaceutical industries that are capable of self-examination and have submitted it to us so that it can be our data, which ones do not meet the requirements and we must immediately carry out further processes to follow up on the results of surveillance with sanctions, with careful steps," said Penny.
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