[사회]Ministry of Food and Drug Safety, YTN reported’Binex Incident’ illegal conclusion…”Intensifying unannounced inspection”

[앵커]

The KFDA, which investigates the’raw material manipulation situation’ of the pharmaceutical company Binex, reported solely by YTN, announced the results of the investigation after 15 days of seizure and search.

It was revealed that the company not only manufactured raw materials arbitrarily, but also made false documents to cover up.

It also came up with measures to prevent recurrence of similar events.

Reporter Kim Woo-jun’s report.

[기자]

The case of manipulating the raw material capacity of the pharmaceutical company’Binex’ reported by YTN on the 8th.

Immediately after the report, the Ministry of Food and Drug Safety conducted an administrative investigation of the company, and two days later, it was searched for seizure.

[식약처 관계자 : 자료는 다 폐기한 것들이 많아서, 조사해보니까 이런저런 정황들이 있고 그래서….]

The results of the investigation were also announced after 15 days of switching to forced investigation.

First of all, it was concluded that Binex had arbitrarily adjusted the amount of raw materials and used unauthorized additives.

In addition, in preparation for the inspection by the Ministry of Food and Drug Safety, it was revealed that it was understood that the actual production record was destroyed after falsely creating a manufacturing record.

All suspicions of manipulation and concealment of raw materials have been confirmed.

The Ministry of Food and Drug Safety also released the results of a special inspection of 30 pharmaceutical companies nationwide that make generic drugs for a week starting on the 15th.

One company did not test raw materials for finished products, and the quality control was insufficient, and the rest were found to have no problems.

However, it seems that it was not possible to confirm whether or not raw materials were tampered with, focusing on document review.

As the possibility of a second’Binex Incident’ is still there, the Ministry of Food and Drug Safety has also introduced measures to improve the system.

First, the’Pharmaceutical GMP Special Planning and Inspection Group’ is newly established.

In addition to regular audits that are conducted every three years, it is essential to strengthen regulations through frequent irregular inspections.

It is difficult to detect illegal capacity manipulation without internal information.

We have decided to operate a’hotline’ where you can report anonymously, and establish a’permanent clean report center’.

The policy is to increase the sentencing of administrative disposition by accepting the criticism of’penalty of a cotton bat’, and a punitive penalty for unfair gains.

[이동근 / 건강사회를위한약사회 사무국장 : 현재 징벌적 과징금이나 ‘GMP 특별 점검 기획단’을 꾸려서 이런 처벌을 강화하고, 감시를 수시로 하는 방향으로 식약처가 개선하겠다는 방향에 대해선 적절하다고 생각하고 있습니다.]

In addition, we plan to discuss with the National Assembly the revision of the Pharmaceutical Affairs Act, which limits the number of companies that can be produced on consignment for each generic drug.

YTN Kim Woo-jun[[email protected]]is.

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