The Ministry of Food and Drug Safety converts to investigation by falsely double-writing manufacturing records…
Prevent recurrence by establishing a special GMP special planning inspection team for pharmaceuticals and strengthening penalties
[바이오타임즈] It has been confirmed that Binex and non-preservation pharmaceuticals, which are suspected of making drugs, are illegal.
The Ministry of Food and Drug Safety conducted an administrative investigation on Binex and non-preservative pharmaceuticals on the 25th, and as a result, the violation of the Pharmaceutical Affairs Act was confirmed and an administrative disposition was announced.
The violations of both companies confirmed by the Ministry of Food and Drug Safety include △voluntary use of additives without permission to change △ false double preparation of manufacturing records △ unchanged manufacturing method △ voluntary increase or decrease in the use of raw materials.
In particular, in the case of false double preparation of the manufacturing record, in preparation for inspection by the Ministry of Food and Drug Safety, all processes from raw material weighing to completion of manufacturing are falsely written using a manufacturing record in the same format as the licensed matter, and the records used for actual manufacturing are manufactured. It was confirmed to have been discarded afterwards.
Accordingly, the Ministry of Food and Drug Safety said that it was concerned about the concealment and disposal of related documents during the administrative investigation process, so it quickly switched to investigation to confirm additional violations, and that it plans to take serious administrative measures.
In addition, the Ministry of Food and Drug Safety has 29 consignment companies that manufacture and consign drugs with the same ingredients and formulations as the products that are in violation of Binex and non-conservative pharmaceuticals (24 companies related to Binex, 32 items related to non-conservative pharmaceuticals, 5 companies related to non-conservative pharmaceuticals) As a result of the inspection, it was decided to take measures such as administrative dispositions against the consignees by confirming violations of negligence in management and supervision.
However, as a result of testing the products with confirmed violations, it was determined that the content, etc., were within the test criteria and had little effect on the human body.
In addition, in order to check similar cases with Binex Co., Ltd. and Non-Preservation Pharmaceutical Co., Ltd., as a result of an additional inspection of 30 entrusted and entrusted manufacturing companies nationwide, the same violation cases were not confirmed, but one site violated the pharmaceutical manufacturing and quality control standards. We plan to confirm the matters and take administrative measures.
The Ministry of Food and Drug Safety has come up with various measures to prevent the recurrence of intentional violations of manufacturing and quality control standards in the future.
Establishment of the’Pharmaceutical GMP Special Planning and Inspection Group’ to strengthen the inspection system for pharmaceutical manufacturing and quality control △conveniently conduct unannounced inspections △Establish and operate a’report center’ for violations △Improve the effectiveness of punishment and a related permit system Responsible for improving the structure of the company.
Among them, the’Clean Report Center for Drug Manufacturing and Quality Illegal Activities’ is a hotline that allows all citizens to easily report intentional and illegal activities anonymously, and will be operated from April.
The policy is to strengthen punishment. Deliberately changing the manufacturing method For illegal acts such as manufacturing and creating false or double records, the GMP conformity determination will be canceled, and a punitive penalty will be imposed on the unjust profits obtained through the violation.
In addition, in order to reinforce the quality responsibility of the entrusted and entrusted companies, the administrative disposition for non-compliance with the entrusted and entrusted companies is raised.
The Ministry of Food and Drug Safety stated that “the ongoing investigation of Binex Co., Ltd. and Non-Preservation Pharmaceutical Co., Ltd. will be conducted thoroughly and promptly, and the results will be transparently disclosed and necessary measures will be taken.” “We will do our best to strengthen the level of drug safety management, such as actively promoting effective system improvement measures such as limiting the number of live products permitted.”
Previously, the Ministry of Food and Drug Safety temporarily stopped manufacturing, selling, and recalling the relevant items of Binex, which has arbitrarily changed the dosage and manufacturing method of pharmaceuticals, and non-preservative pharmaceuticals that manufactured pharmaceuticals differently from approval.
On the 8th, Binex took the same measures on six products, including Amorin Tablet, a diabetes drug produced by Binex, Selectin Tablet, a depression drug, Daxfen Tablet, an arthritis drug, Ropesin Tablet, a treatment for inflammation, and Cadillac Tablet, a high blood pressure drug.
At the time, Binex said, “Contrary to what is known, it is a misunderstanding caused by the process of manufacturing synthetic drugs at the Busan plant, and Binex has voluntarily reported to the Ministry of Food and Drug Safety of any change in the pharmaceutical manufacturing process.”
In addition, in accordance with the voluntary report of non-preservation pharmaceuticals, the company confirmed that the company’s 4 products and 5 products manufactured by consignment were illegally manufactured, and suspended the sale and disposed of withdrawal.
Regarding this, the non-conservation group completely denied that, in a statement regarding the illegal manufacturing of pharmaceuticals by non-conservation pharmaceuticals on the 19th, “there is no doubt about concealment.”
According to the non-preservation group, the company took over the business after taking over the non-preservation pharmaceutical (formerly Enist Bio Pharmaceutical) in September last year, and in the process of verifying the business,’J-Octin tablet (thioctic acid)’ is manufactured differently from the contents originally licensed. After receiving a report, I went to the investigation. There were no employees currently working, and related documents were also discarded due to the expiration of the storage period. In response to this, the company is in a position that it has immediately made a decision to stop manufacturing and voluntarily withdraw and proceed with the reporting process in order to solve the problem normally even if it suffers damage right away.
As a result of an investigation by the Ministry of Food and Drug Safety, Binex’s stock price fell by nearly 10% as the two pharmaceutical companies were found to be illegal. Binex closed the market at 17,900 won, down 9.6% (1,900 won) from the previous trading day on the 25th.
Meanwhile, the Korea Pharmaceutical Bio Association plans to take decisive measures such as referral to the Ethics Committee in the near future, separate from the measures taken by the government authorities.
[바이오타임즈=정민구 기자] [email protected]
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