BPOM Uncovers Reason For Blocking Ivermectin Drug Factory PT Harsen: There Is A Violation

Head of BPOM Penny K. Lukito

JAKARTA - Head of the Food and Drug Supervisory Agency (BPOM) Penny K. Lukito revealed the reason his party blocked the ivermectin production warehouse of PT Harsen Laboratories.

Penny explained that her party found the fact that PT Harsen did not produce until the distribution of the drug ivermectin, with the trade name Ivermax 12 mg, not through a good ovat production method (COPB) and a good drug distribution method (CDOB).

This is known based on the inspection contained in the minutes of inspection (BAP). This BAP has also been submitted to PT Harsen.

"There are stages of improvement that should be given. However, until now PT Harsen has not shown good intentions to correct the violations that have been obtained, related to aspects of GMP and CDOB," said Penny in a virtual press conference via the POM Agency Youtube, Friday, July 2nd.

At least, there were some violations that were found by BPOM. 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.

Penny explained that her party has a duty to protect the public by ensuring that drugs that have been given a distribution permit remain within the existing regulations. Moreover, Ivermectin is a strong drug.

"The findings (of PT Harsen's violation) can cause the quality of the drug to decrease or cannot be accounted for. Of course this has the potential to endanger the community," said Penny.

Previously, PT Harsen Laboratories admitted that the Food and Drug Supervisory Agency (BPOM) blocked the ivermectin drug from being released from the factory. This blocking has been done for three days.

Marketing Director of PT Harsen Laboratories Riyo Kristian Utomo said the blocking was carried out after BPOM conducted a sudden inspection of the factory.

"They hang out for days checking all invoices at the factory. It seems they don't want this drug to be circulated and used to fight COVID-19," said Riyo.

Riyo considered that what BPOM had done had disrupted the performance of factory employees and harmed the company. In fact, Riyo accused BPOM of hampering the government's efforts to protect the public from COVID-19.

"We question BPOM's intention to inhibit the distribution of Ivermectine as a people's weapon in the fight against COVID-19," he said.