Indonesian authorities revoke licenses from two drug manufacturers after children’s deaths

Indonesian authorities have revoked the licenses of two pharmaceutical companies for the production of syrups after the death of 159 children from acute kidney failure.

Penny Lukito, head of the Food and Drug Administration known as BPOM, said she found that PT Yarindo Farmatama and PT Universal Pharmaceutical Industries had switched suppliers of propylene glycol, a component in syrups, and that the type they were using was contaminated. with other chemicals.

“If there are changes, they need to be reported to BPOM,” Lukito said. According to Luquito, in case of non-compliance with the requirements, pharmaceutical companies “are subject to administrative sanctions in the form of cessation of production, distribution, collection and destruction.”

The agency and the National Police found that both companies used propylene glycol as a raw material for the production of medicinal syrups.

Syrups commonly used by children contained excessive amounts of ethylene glycol and diethylene glycol. The results were based on interviews with employees and a study of company documents, facilities and products.

Both chemicals are often used in industry and in antifreeze and brake fluids.

Luquito said that BPOM would take criminal action against the companies.

“Criminals face a maximum prison term of up to 10 years and a maximum fine of 1 billion rupees ($64,000),” Luquito said.

Pollution is thought to have been responsible for the spike in cases of acute kidney disease in children since late August.

The Ministry of Health reported today that 304 cases of acute kidney failure have been reported in 27 provinces. Most of the patients were under the age of five. The ministry said it had distributed 146 vials of antidotes to 17 hospitals across the country.

Ministry spokesman Mohammad Siahril said the number of new cases and deaths had dropped as the government announced a temporary ban on the use of syrups pending an investigation.