TEMPO.CO, Jakarta - The National Police's Criminal Investigation Agency examined 28 witnesses in the case of acute kidney injury involving PT Afi Farma who were proven to have violated the regulations for using raw materials for chemical compounds exceeding the safety threshold. "There are 28 witnesses (who have been questioned)," said the Director of Specific Crimes of the National Police's Criminal Investigation Department, Brigadier General Pipit Rismanto, Wednesday, November 9, 2022.

Pipit explained that the 28 witnesses included the Director of PT Afi Farma.

Demanding Explanation from the Ministry of Health and BPOM

In development regarding the case, he said, investigators also seek clarification from the Ministry of Health (Kemenkes), Indonesia Food and Drug Monitoring Agency (BPOM), and importers of medicinal raw materials.

He explained that investigators need to ask for clarification from authorized BPOM officials regarding technical languages in investigating cases of contamination of chemical compounds in medicinal raw materials exceeding the safety threshold.

"As to what clarification occurs regarding a problem like this, there are employees in respective fields and officials (BPOM) in charge of what we clarify on the problems we find," said Pipit.

Investigators are currently waiting for BPOM's willingness to provide clarification. The National Investigation Agency has sent a letter related to the case and is preparing investigators for BPOM. "We have to be objective and all have to be transparent regarding this problem so that the source of the issue could be discovered," said Pipit.

In addition to PT Afi Farma, Investigator developed an investigation into the supplier of medicinal raw materials to PT Universal Pharmaceutical Industries (UPI). There are three companies supplying medicinal materials to PT UPI, namely PT LS, PT BA, and PT MSAK.

Investigators are also developing their investigation by examining suppliers of medicinal materials for PT Afi Farma, namely PT Tirta Buana Kemindo and CV Mega Integra.

Pipit added that the coordinated investigation between the National Police, the Ministry of Health, and BPOM was one of the factors that led to the decrease in the number of cases of acute kidney injury, as stated by the Coordinating Minister for Political, Legal and Security Affairs, Mohammad Mahfud Mahmodin, some time ago.

In addition to investigations, he mentions there are preventative measures made by the Ministry of Health and BPOM, including the National Police on how to prevent, reduce, and ease the cause, including bringing in medication to cure the condition.

"Withdrawing products that are allegedly produced using additional ingredients identified as EG and DEG is one of the prevention efforts," said Pipit.

Revoking the Marketing License of Three Companies

Meanwhile, BPOM has revoked the Good Manufacturing Practices certification and distribution permits from three private pharmaceutical companies in Indonesia after being proven to use medicinal raw materials for chemical compounds exceeding the safety threshold.

The three companies that received the administrative sanctions are PT Yarindo Farmatama, PT Universal Pharmaceutical Industries, and PT Afi Farma.

The three pharmaceutical companies are related to the findings of syrup medicine that use PG solvent as raw materials and finished products containing EG that exceed the safety threshold.

Then on Wednesday (November 9), BPOM announced the addition of two private pharmaceutical industries in Indonesia that violated the use of syrup medicinal material beyond the safety threshold, namely PT Samco Farma and PT Subros Farma.

ANTARA | IMAJI LASAHIDO (INTERN)

Click here to get the latest news updates from Tempo on Google News