, Jakarta - The mysterious kidney disease cases in Indonesia are revealed to be caused by drug poisoning. More than 150 children lost their lives.
The Ministry of Health confirmed that the syrup medicines contained more ethylene glycol (EG) and diethylene glycol (DEG) than allowed. The contamination could cause kidney failures.
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The limit for the contamination is 0,1 mg/ml, however the Indonesian Food and Drug Supervisory Agency (BPOM) revealed that there are three pharmacy producers whose syrups contain excessive EG and DEF.
Previously, the government restricted the selling of more than a hundred syrup medicines products after the deadly kidney disease were reported among children. 159 children died so far.
Now the blame game is starting in Indonesia.
BPOM said the drug companies will be brought the justice. Ministry of Trade is also blamed. The company, however, blames BPOM for issuing permission. Meanwhile, the Ministry of Health said BPOM has the responsibility.
The Head of BPOM Penny Lukito said already issued the relevant permit for the companies to create drugs properly (CPOB), and so her agency is free from blame.
"For this case, do not come to BPOM. We see it further. It has been given the CPOB, therefore there are responsibilities for the industry to produce according to the existing regulations as set by BPOM, thus they must be responsible," said Penny Lukito last Thursday.
More recently, Penny also blames the Ministry of Trade. She mentioned that the ministry is giving permission to import the two dangerous components: polyethylene glycol (PEG) and Propylene Glycol (PG).
EG and DEG are the results of PG and PEG which are used for solvents. Penny Lukito said her agency does not issue permission for PEG dan PG.
"The reason from the Ministry of Trade is that those solvents are used for other industries such as paint, textile, and others," said Penny at the parliament on Wednesday (2/11/2022).
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Company Blames BPOM
![Merk Obat Yang Di Klaim BPOM Menyebabkan Gagal Ginjal Akut. (Senin, 31/10/2022). (Yandhi Deslatama/).](https://cdn0-production-images-kly.akamaized.net/LrlvRQIxwP5rChZ0GgFJSKisj3Y=/0x0:4160x1952/640x360/filters:quality(75):strip_icc():format(webp):watermark(kly-media-production/assets/images/watermarks/liputan6/watermark-color-landscape-new.png,540,20,0)/kly-media-production/medias/4209762/original/020410800_1667219023-IMG_20221031_140328.jpg)
One of the pharma companies that received sanction is Yarindo Farmatama. Their medicines are found to contain excessive EG and DEG.
The manager of Yarindo Farmatama, Vitalis Jebarus, has questioned BPOM for issuing distribution permits for their syrup medicine.
Vitalis said the company has not changed the drug composition. He said BPOM should not have issued a permit if there was a mistake.
"No change in drug composition," said Vitalis during a press conference in Serang, Banten Province.
Moreover, Vitalis said his company has registered the drug three times with BPOM. The current distribution permit is for the 2020-2025 period.
"That means BPOM itself gives supervision," said Vitalis.
Vitalis said the company is actually the victim from fraud and counterfeit whether from the supplier or from the manufacturing sides.
BPOM found the contamination of EG within Yarindo's drug is 480 times more than the standard. The usage of PG from the company is also said to exceed the limit.r
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BPOM is Responsible
![Penjelasan Menkes Budi Terkait Kasus Gangguan Ginjal Akut pada Anak](https://cdn0-production-images-kly.akamaized.net/1FIvk3eI23DbBwlq5xjaD_pivNM=/640x360/smart/filters:quality(75):strip_icc():format(webp)/kly-media-production/medias/4199538/original/094555500_1666355920-penjelasan_menkes_terkait_kasus_gangguan_gijal_akut_pada_anak-ANGGA_7.jpg)
The spokesperson of the Ministry of Health, Mohammad Syahril said that the supervision for the drug syrups are under BPOM's jurisdiction.
"Actually this is the responsibility of BPOM. So, BPOM is working on the registration, testing, and supervising. That is their authority," said Mohammad Syahril during a press conference in Jakarta, Tuesday (1/11).
He declined to give further comment about the legal matters regarding the pharma companies.
There are three companies whose products are found contaminated with EG and DG, namely the Universal Pharmaceutical Industries, the Afi Pharma, and then Yarindo Farmatama.
The Ministry of Health also said that the cases of acute kidney disease are decreasing between 18 October and 28 October after they restricted the sales of drug syrup.
Previously, Syahril said the ministry could find up to 100 cases, but recently they only find five cases or fewer.
"Very, very decreasing," he said.
Fitri Haryanti Harsono, Ilyas Istianur Praditya, and Ade Nasihudin Al Ansori contributed to this report.
Terkini Lainnya
Indonesia Imports Fomepizole to Treat Mysterious Kidney Disease in Children
The Case of Mysterious Acute Kidney Injury Increased to 192, Mostly in DKI Jakarta
Company Blames BPOM
BPOM is Responsible
BPOM
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