Indonesia revokes drug companies’ licenses after 159 deaths

JAKARTA, Indonesia — Indonesian authorities have revoked the licenses of two pharmaceutical companies to produce syrup-type medicines following the deaths of 159 children due to acute kidney injury, officials said Tuesday.

Penny Lukito, chief of the Food and Drug Monitoring Agency, known as BPOM, said it found that PT Yarindo Farmatama and PT Universal Pharmaceutical Industries had changed suppliers of propylene glycol, a component of the syrups, and the type they were using was contaminated with other chemicals.

“If there is a change, it should be reported to BPOM,” Lukito said. In cases of non-compliance, pharmaceutical companies are “subject to administrative sanctions in the form of cessation of production, distribution, recall and destruction,” Lukito said.

The agency and the National Police found that the two companies used propylene glycol as a raw material in the production of medicinal syrups. The syrups, often used by children, contained excessive amounts of ethylene glycol and diethylene glycol. The findings were based on interviews with employees and an examination of documents, facilities and products of the companies.

The two chemicals are often used in industrial applications and in antifreeze and brake fluids.

Lukito said BPOM is pursuing criminal charges against the companies.

“Perpetrators face a maximum prison sentence of 10 years and a maximum fine of 1 billion rupiah ($64,000),” Lukito said.

The contamination is suspected of being the cause of a spike in cases of acute kidney disorders in children since the end of August.

The Health Ministry reported on Tuesday that there have been 304 cases of acute kidney injury in 27 provinces. Most of the patients were under age 5. The ministry said it has distributed 146 vials of antidotes to 17 hospitals across the country.

Ministry spokesperson Mohammad Syahril said the number of new cases and deaths has decreased since the government announced a temporary ban on the use of syrup medicines until the completion of its investigation.

Source ABC

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