266-2023 (JAKARTA) Indonesian police are intensifying their investigation into the nation’s drug regulator, the Indonesian Food and Drug Agency (BPOM), to determine if any officials may have engaged in criminal activities. The probe comes as tainted cough syrups, responsible for the deaths of over 200 children across Indonesia, have sparked concerns and heightened scrutiny. Reuters has learned from two senior inspectors that the police are expanding their inquiries and seeking accountability for the contaminated syrups, which were also linked to the deaths of numerous children in Gambia and Uzbekistan last year. Collaborating with various countries, the World Health Organization is actively investigating the global pharmaceutical supply chain for similar incidents involving compromised syrups.
In late 2022, the police arrested and charged eight individuals associated with Indonesian companies involved in the importation and distribution of raw materials to pharmaceutical manufacturers. These manufacturers were found to have produced cough syrups containing hazardous industrial-grade chemicals instead of the legitimate ingredients.
Lead investigator of the case, Andika Urrasyidin, revealed that “many” BPOM officials have been summoned for questioning, emphasizing that the investigation is still ongoing. While Urrasyidin refrained from disclosing potential charges, he acknowledged that responsibility must be assigned if any wrongful actions are identified.
To date, no BPOM officials have been implicated in any wrongdoing. The police retain the option to pursue criminal charges or close the investigation without further action.
Requests for comments from BPOM officials went unanswered.
Hersadwi Rusdiyono, Director of Indonesia’s National Police’s Crimes Detection Unit, clarified that BPOM officials were initially summoned as witnesses. However, investigators are now examining whether any regulatory misconduct occurred. “We questioned them in line with their roles as regulators, inquiring about the extent of their supervision and the nature of such oversight,” Rusdiyono informed Reuters. “They were treated solely as witnesses, and we are coordinating with the prosecutors.”
Rusdiyono added that the ongoing probe has primarily focused on lower-ranking staff, excluding BPOM’s chief, Penny Lukito. Despite a request for comment, Penny has remained silent on the matter.
BPOM had previously acknowledged a surge in cases of acute kidney injury, attributing them to the exploitation of loopholes in the safety guarantee system and insufficient scrutiny by pharmaceutical companies when examining raw ingredients.
In January, Pipit Rismanto, a senior police official, informed reporters that authorities had discovered a company selling “industrial-grade” toxins as pharmaceutical-grade propylene glycol, a crucial component of syrupy medicines.
According to several pharmaceutical experts interviewed by Reuters, unscrupulous actors may use the cheaper toxins, ethylene glycol (EG) and diethylene glycol (DEG), as substitutes for propylene glycol. The police have pressed charges against four companies implicated in the case: Afi Farma, a drug manufacturer accused of selling tainted syrups, CV Samudera Chemical, the alleged supplier of the chemicals, and two distributors, Tirta Buana Kemindo and Anugrah Perdana Gemilang.
A representative from Afi Farma, which attended its first court hearing on Tuesday, stated that the company would respect the legal proceedings.
Tirta Buana Kemindo declined to provide a comment, while CV Samudera and Anugerah Perdana Gemilang could not be reached for comment.
In addition to the ongoing criminal investigation, BPOM is currently facing a separate class-action lawsuit filed in January by parents of children who 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.
