PT Harsen Violates Ivermectin Drug Production And Distribution Rules, BPOM Threatens Criminal Sanctions

DOC ANTARA/Head of BPOM Penny K. Lukito

JAKARTA - Head of the Food and Drug Supervisory Agency (BPOM) Penny K. Lukito warned that PT Hersin Laboratories had been sanctioned for violating the rules.

PT Hersin is known to have violated the principles of good drug manufacturing practices (GMP) and good drug distribution methods (CDOB) for ivermectin.

This is known based on the inspection contained in the minutes of inspection (BAP). This BAP has also been submitted to PT Harsen. However, no improvements have been made.

"Guidance steps have been taken but there has been no response or goodwill from PT Harsen. So, of course, there are follow-up steps that we provide in the form of sanctions that can be given," said Penny in a virtual press conference, Friday, July 2.

Penny explained that the sanctions imposed could range from administrative to criminal.

"BPOM has also mentioned the sanctions, whether they are administrative sanctions and can even continue to criminal sanctions, based on the evidence that has been obtained," said Penny.

Administrative sanctions have several stages. Ranging from stern warnings, to cessation of production and revocation of distribution permits. Penny said that the threat of sanctions should have been known by business actors.

At least, there were several violations that were found by BPOM in the manufacture of drugs with the trademark Ivermax 12 mg made by PT Harsen. First, the use of ivermectin raw materials with imports that are not through official channels.

"So, the category does not meet the provisions or is illegal," said Penny.

Second, PT Harsen distributes Ivermax 12 drugs not in ready-to-distribute packages. "I think the packaging boxes that have been approved in the distribution permit are provisions that must be followed by compliance," he said.

Third, PT Harsen distributes Ivermax 12 drugs not through official distribution channels. Fourth, the inclusion of the Ivermax expiration period is not in accordance with what has been approved by BPOM.

"Supposedly, with the stability data we received, the drug would be able to be given 12 months after the production date. However, it was listed by PT Harsen for 2 years after production. That is a critical thing on the expiration date," said Penny.

Fifth, PT Harsen distributes drugs that have not yet been confirmed for the quality of their products. In fact, the promotion of hard drugs is only allowed in health worker forums, and it is not allowed to promote them to the general public.

"Direct promotion by the pharmaceutical industry is a violation," he stressed.

As a result, BPOM is now blocking drugs that come out of PT Harsen's ivermectin production warehouse. This blocking has been done for three days.