Indonesia’s drugs regulator said Monday it had revoked licenses allowing two pharmaceutical firms to produce syrups that were linked to cases of fatal acute kidney failure in children, with the agency alleging they had violated manufacturing protocols.
Police are investigating the companies, PT Yarindo Farmatama and PT Universal Pharmaceutical Industries, for possible criminal offenses because they may have used industrial-grade chemicals instead of pharmaceutical-grade substances to cut costs during the COVID-19 pandemic.
“Their distribution permits have been withdrawn. We have to do it immediately [because] the compositions in their products are very worrying,” the head of the Drug and Food Monitoring Agency, Penny Lukito, told reporters without saying when the permits were withdrawn.
Suspected violations committed by the companies included the use of two toxic industrial compounds, ethylene glycol and diethylene glycol, above safe thresholds and their failure to report changes in raw materials to the authorities, Penny said.
She said that PT Yarindo’s product, Flurin DMP Syrup, allegedly contained 48 milligrams of ethylene glycol per milliliter, when the safe threshold is less than 0.1 mg/ml.
“This is tantamount to a poison,” Penny said.
Indonesia’s Health Ministry has reported 269 cases of acute kidney failure since January, including 157 that led to deaths.
On Friday, Penny said the two companies might have cut corners by using industrial-grade chemicals instead of pharmaceutical-grade substances because of higher prices for raw materials during the COVID-19 pandemic.
“Maybe because of the pandemic and prices have increased, they turned to suppliers that provide industrial-grade ingredients instead of pharmaceutical-grade ones,” Penny said during an online discussion.
Yarindo imported propylene glycol – used as a solvent in medicinal syrup production – from Thailand, she said.
Yarindo officials could not immediately be reached for comment.
Temporary bans
The food and drug agency also temporarily banned the use of propylene glycol, polyethylene glycol, sorbitol and glycerol in the production of liquid medicine as a precaution because of concerns over possible contamination.
The agency has tested and determined that 23 medicinal syrups are safe to use, Penny said last week, adding a total of 69 syrups were to be tested.
Meanwhile, Brig. Gen. Pipit Rismanto, who directs the special crimes unit at the national police, said no charges had been filed against any company because investigators were collecting evidence, including results of patients’ lab tests.
“We are waiting for the results to proceed with the cases together,” Pipit told reporters.
Pipit said the companies could also be charged under consumer protection and trade laws.
Hermansyah Hutagalung, a lawyer for Universal Pharmaceutical Industries, blamed the company’s supplier for the presence of toxic substances, and said a police complaint had been filed against the company. Police confirmed they received the complaint.
“They sold raw materials that did not comply with the certificate analysis,” Hermansyah told BenarNews, adding the company had reassured his client that the raw materials were free from contamination.
Dicky Budiman, a global health security and resilience analyst at Griffith University in Australia, urged the Indonesian government to declare the outbreak as an “extraordinary event” so as to allow it to mobilize more resources.
“An extraordinary event status will prompt greater involvement of health authorities and other strategic stakeholders,” Dicky told BenarNews.
But Health Minister Budi Gunadi Sadikin said the designation was unnecessary because cases had declined and the illness was not transmissible.
He said Fomepizole, a drug used to treat methanol and ethylene glycol poisoning, had been found to be effective against the disease.
“We are making sure that the drug is available,” Budi said on Kompas TV on Monday.
The ministry has imported the drug from Singapore and Australia and has ongoing talks with Japan to import 100 to 200 doses, he said. Some of the doses arrived on Saturday.
The first two cases of acute kidney injury were reported in January, but the number rose sharply since August. The health ministry recorded two cases in March, six in May, three in June, nine in July, 37 in August and 81 in September.
It said children between the ages of 1 and 5 were most affected and had symptoms including fever, loss of appetite and a low output of urine.
By Arie Firdaus and Pizaro Gozali Idrus / BenarNews
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