[사회]Binex orders illegal drug manufacturing…

[앵커]

YTN continues to report on the manipulation of the raw material capacity of the pharmaceutical company Binex.

Immediately after the first report yesterday (8th), the Ministry of Food and Drug Safety initiated an on-site investigation and ordered the sale of Binex’s six products to be suspended and recalled.

The Ministry of Food and Drug Safety considers the seriousness of the case and is also investing an additional investigator at the headquarters, looking closely at the case.

Let’s talk with the reporter who covered the detailed story. Reporter Kim Woo-jun!

Let’s go back to what YTN reported on its own yesterday.

So, is it that the pharmaceutical company Binex made drugs, while making the amount of raw materials and manufacturing them?

[기자]

Yes, it is.

There are more than 70 drugs produced by Binex and sold on the market.

He pointed out that some of these drugs were manufactured illegally.

I pointed out three major drugs.

It is a cure for hypertension, depression, arthritis, and antipyretic made by Binex.

When making medicines, they must be manufactured according to the dosage and manufacturing method approved by the Food and Drug Administration.

It was revealed that Binex did not make the above three products as approved by the Ministry of Food and Drug Safety, and used the raw material capacity and manufacturing method arbitrarily during the manufacturing process.

On that basis, the reporters disclosed some of the internal documents that were distributed to Binex employees.

In the internal document containing the manufacturing method, the’Separate Paper Manufacturing Method’ was written next to the’Permitted Manufacturing Method’.

Employees called this document a so-called’attachment’.

In the’Attachment’, the matters approved by the Ministry of Food and Drug Safety and other manufacturing methods were presented.

For example,’Glimepiride’, the main ingredient in hypertension drugs, had to contain 1,000g in the first mixing step, but only 100g was added.

In response, the company defended that it did not subtract the remaining 900g, but added an additional input at a later stage.

As a result of inquiries to the Ministry of Food and Drug Safety, it was pointed out that due to the nature of sensitive drugs, the order of manufacturing methods must also be clearly observed, and that even if the order of manufacture and mixing method are changed, it is a problem and can be viewed as illegal drugs.

In fact, according to a separate paper secured by the reporters, it was confirmed that in addition to diabetes treatment, unlicensed ingredients such as depression treatment were added or the active ingredient was arbitrarily increased.

[앵커]

I am curious about the reaction of Binex. Did you admit your fault?

[기자]

When I first contacted Binex for coverage, I drew a line saying that there may be mistakes in the process of some on-site processes, but there was no illegality.

He protested that the mistake was within the scope that the KFDA could fully admit it.

However, when the reporters presented’Attachment’ and asked a question, they suddenly changed their attitude.

Let’s listen to the story of the company’s officials.

[‘바이넥스’ 관계자 : 식약처에 자진신고 하겠습니다. 해당 품목에 대해서 식약처 처분은 당연할 것 같습니다만 아마 해당 품목은 제조 정지나 허가취소가 될 것 같고요.]

Most of them admitted that it was correct that unauthorized raw materials were used, and that the manufacturing process was arbitrarily changed.

At the same time, he replied that he would report himself to the Food and Drug Administration through a total investigation of its products.

The time of reply was on the last 4 days, and after investigating the company’s medicines over the weekend, it is said that about 10 products that have been regularly manufactured illegally or manufactured separately for some time were found, and that the product in question was reported to the Ministry of Food and Drug Safety. Explained.

[앵커]

Shortly after the report, the Ministry of Food and Drug Safety put an investigator on the site.

[기자]

Yes, it is.

Shortly after yesterday’s report, the Ministry of Food and Drug Safety dispatched an investigator to the Binex headquarters and factory in Busan.

It was an on-site investigation of practitioners.

As a result of the contents of Binex’s self-report and on-site investigation, the Ministry of Food and Drug Safety decided that the matter was serious and immediately ordered a temporary suspension of sales.

The products ordered to stop selling by the Ministry of Food and Drug Safety are 6 Binex medicines, including Amorine tablets for diabetes treatment, Selectin tablets for depression and 10 mg of selectin capsules, Daxfen tablets for arthritis, Ropesin tablets for inflammation, and Cadillac tablets for high blood pressure.

An official from the Ministry of Food and Drug Safety is checking whether it is illegal not only to manipulate raw materials, but also to the entire manufacturing plant.

In particular, it is reported that there is a systematic concealment attempt by the company to avoid regular inspections of the Ministry of Food and Drug Safety, which are conducted every three years.

In addition to the Busan Regional Food and Drug Administration, an additional headquarter investigator was also added.

[앵커]

In fact, there was a specific testimony from an insider to avoid the KFDA audit?

[기자]

Yes, it is.

An employee who has worked at the Busan manufacturing plant for more than 10 years since 2010 said that there was a systematic cover-up order to avoid audits.

Regular audits by the Ministry of Food and Drug Safety are conducted every three years, and if the audit schedule comes out in advance, all employees are mobilized to cover up illegal evidence.

[박 모 씨 / ‘바이넥스’ 출신 직원 : 일단 감사 날짜가 정해지면, 하도 오래된 관행이니까 관리자부터 알아요. 별지부터 일단 정리하고.]

As the basic manufacturing process changed, I confessed that there were not just one or two documents that had to be faked, such as attendance/commuting records and manufacturing machine management books.

In particular, it was known that important documents were kept in a separate, secret place.

Mainly, an executive locker or the trunk of a vehicle was used as a storage place.

It was revealed that the documents that were likely to be problematic were destroyed, and those that did not were collected separately, and that they were taken out and used again after the audit.

In response, Binex also acknowledged most of the concealment, and said that it was viewed as ordered by the working-level staff at the time.

The Ministry of Food and Drug Safety is conducting field investigations today, following yesterday (8th).

The Ministry of Food and Drug Safety confirmed that many of Binex’s six drugs that had been suspended from sales were identified as generic drugs, so-called generic products, entrusted by other pharmaceutical companies.

Due to the nature of generic drugs, they explained that they are considering additional administrative measures as they are sold on the market with different names and packaging.

So far, the Ministry of Social Affairs has delivered it.

Woojun Kim [[email protected]]

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