Many People Buy Ivermectin Without A Doctor's Prescription, PT Harsen, The Maker Of Ivermax 12, Apologizes

JAKARTA - After arguing about the issue of production and distribution of the drug ivermectin with the Food and Drug Supervisory Agency (BPOM), PT Harsen Laboratories apologized.

Initially, BPOM temporarily blocked the production and distribution of the drug ivermectin under the trade name Ivermax 12. Representatives of PT Harsen Laboratories did not accept and said that BPOM was hampering the community's efforts to recover from COVID-19 due to the blocking.

In his official statement, the President Director of PT Harsen Laboratories Haryoseno apologized to BPOM for the statements made by his company.

Haryoseno realized that this statement caused people to buy Ivermax 12 in droves rashly. In addition, the statements of the three have also harmed the integrity and good name of the POM RI Agency.

"We, the directors of PT Harsen Laboratories, apologize profusely to BPOM, where in various mass media, Sofia Koswara, Iskandar Purnomo Hadi, and Riyo Kristian Utomo, who refer to themselves as Vice President, Director of Communication, and Director of Marketing. PT Laboratories has led public opinion to self-medicate and resulted in people buying Ivermax 12 without a prescription and supervision from a doctor," said Haryoseno, quoted on Monday, July 19.

Haryoseno admitted that there were indeed critical findings when BPOM conducted an inspection of PT Harsen Laboratories' facilities regarding the production and distribution of Ivermax 12.

In its inspection, BPOM has given sanctions to PT Harsen Laboratories in the form of temporary suspension of Ivermax 12 production facility activities, and an order to recall Ivermax 12 products.

Furthermore, Haryoseno admitted that he would completely resolve the findings of the violation and immediately report it to BPOM.

"We, PT Harsen Laboratories, promise to make improvements in accordance with the constructive suggestions and the said BPOM. In the future, we will make consistent efforts to produce and distribute Ivermax fully in accordance with applicable laws and regulations," he said.

"PT Harsen Laboratories apologizes to the public for the excessive information (over claim) about the Ivermax 12 product that we produce and distribute," he continued.

Previously reported, Marketing Director of PT Harsen Laboratories Riyo Kristian Utomo at that time admitted that he did not accept BPOM forbidding companies to produce and distribute the drug ivermectin.

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 hinder the distribution of Ivermectine as a people's weapon in the fight against COVID-19," said Riyo in his statement, Friday, July 2.

Then, the Head of BPOM Penny K. Lukito revealed the reason his party blocked the warehouse for the production of ivermectin drug 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).

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.