Indonesia Investigates Drug Regulators Over Cough Syrup Linked to Child Deaths

Mon Jun 26 2023
icon-facebook icon-twitter icon-whatsapp

JAKARTA: Indonesian police have launched preliminary inquiries into the actions of officials at the country’s food and drugs agency (BPOM) to determine if any criminal wrongdoing was involved in the distribution of tainted cough syrups.

The investigation comes as the death toll of more than 200 children across the nation has been linked to the contaminated syrups. Last year, similar incidents in Gambia and Uzbekistan resulted in the deaths of dozens more children, prompting global efforts to investigate the pharmaceutical supply chain for such products.

The police investigation, led by Andika Urrasyidin, has called in several BPOM officials for questioning, though no accusations of wrongdoing have been made against them. Urrasyidin stated that responsibility would be determined if any improper actions were found. The investigation is ongoing, and it is unclear what charges, if any, may be brought against the individuals involved.

Hersadwi Rusdiyono, the director of Indonesia’s national police’s crimes detection unit, clarified that BPOM officials were questioned as witnesses, and the investigation is now examining whether any wrongdoing occurred among drug regulators. The focus thus far has been on lower-level staff, and BPOM’s chief, Penny Lukito, has not been implicated in the investigation.

Investigation into Tainted Cough Syrup

BPOM previously acknowledged that a rise in cases of acute kidney injury resulted from parties exploiting gaps in the safety guarantee system, and pharmaceutical companies failing to adequately screen the raw materials used in the production of cough syrups. In January, police revealed that one company had sold industrial-grade toxins as pharmaceutical-grade propylene glycol, a crucial ingredient in syrupy medicines. Unscrupulous actors often use cheaper toxins such as ethylene glycol (EG) and diethylene glycol (DEG) as substitutes for propylene glycol, as they cost significantly less.

Authorities have pressed charges against four companies involved in the case: Afi Farma, the drugmaker allegedly responsible for selling tainted syrups; CV Samudera Chemical, the supplier of the chemicals; and two distributors, Tirta Buana Kemindo and Anugrah Perdana Gemilang. Afi Farma attended its first court hearing on the case, expressing its commitment to abide by the law. Tirta Buana Kemindo declined to comment, while CV Samudera and Anugerah Perdana Gemilang could not be reached.

Additionally, BPOM is named in a separate class-action lawsuit filed by parents whose children died or suffered long-term complications from acute kidney injury. The trial date has yet to be scheduled, and a recent mediation process has just concluded, according to the families’ lawyer.

icon-facebook icon-twitter icon-whatsapp