Wednesday, September 27, 2023

BPOM Revokes Licenses of Two Pharma Distributors over Dangerous Chemicals

November 9, 2022 | 7:55 pm
Drug and Food Supervisory Agency (BPOM) Head Penny Lukito, left, speaks at a news conference in Depok, West Java, on November 9, 2022. (Herman)
Drug and Food Supervisory Agency (BPOM) Head Penny Lukito, left, speaks at a news conference in Depok, West Java, on November 9, 2022. (Herman)

Depok. The Drug and Food Supervisory Agency, or BPOM, announced on Wednesday it has revoked licenses of two “major pharmaceutical traders” for allegedly supplying dangerous chemicals to drug makers.

The two companies are identified as Megasetia Agung Kimia and Tirta Buana Kemindo.

Both are accused of supplying propylene glycol which is used as a solvent in the making of cough and paracetamols syrups but it may result in a high concentration of harmful chemicals ethylene glycol (EG) and diethylene glycol (DEG), which have been widely blamed for the surge in acute kidney injury cases among children -- many ending up with fatalities.

"For the two major pharmaceutical traders, we have revoked their licenses on proper drug distribution,” BPOM Head Penny Lukito said at a news conference in the Jakarta suburb of Depok.


The agency also brought criminal charges against the two companies, which are currently under police investigation, she added.

"We revoked their licenses and the Bareskrim [the National Police's criminal investigation agency] followed up with an investigation. We also have a deputy in charge of law enforcement who is assessing the criminal aspects,” she said.

The latest news brought the total number of companies under criminal investigation for alleged distribution of harmful chemicals and drugs to five.

In another development, the BPOM has uncovered the distribution of chemicals with high concentration of EG and DEG by a company named Samudera Chemical, Penny said.

Through a supply chain involving at least two other distributors, the chemicals ended up at Yarindo Farmatama, one of the first three companies charged under the Criminal Code for selling paracetamol syrups tainted with EG and DEG.

Samudera Chemical has sold chemicals labeled as propylene glycol but investigation revealed that they are actually EG and DEG, Penny said. Accordingly, the criminal charges against Samudera may also include deception, she added.

“Any pharmaceutical company or distributor who has been involved in a business with Samudera Chemical to obtain propylene glycol must check their supplies because there is a high probability that they are tainted with a high concentration of EG and DEG,” Penny said.

Two more companies identified as Samco Farma and Ciubros Farma have been found of breaching the proper drug making procedures in the production of syrup medicines, she told the conference.

Earlier this month, the BPOM said it had brought criminal charges against three companies -- Yarindo Farmatama, Universal Pharmaceutical Industries, and Afi Farma Pharmaceutical Industries -- for allegedly producing and distributing tainted syrup medicines.

According to the latest Health Ministry data, Indonesia has recorded 324 cases of acute kidney injuries among children and 190 deaths.

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