Indonesia revokes drug companies' licenses after 159 deaths
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
JAKARTA, Indonesia (AP) — 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.