The Ministry of Food and Drug Safety is Binex(18,150 -8.33%)It was announced on the 25th that W and Non-Preservation Pharmaceuticals have confirmed that they have violated the Pharmaceutical Affairs Act, such as randomly using unlicensed additives and falsely writing manufacturing records when manufacturing pharmaceuticals.
Previously, the Ministry of Food and Drug Safety confirmed that the two companies manufactured drugs illegally, and conducted an emergency special inspection at 30 consignment and consignment drug manufacturing sites nationwide.
It turned out that Binex and non-preservative pharmaceuticals used the additives used in pharmaceuticals at random without obtaining permission to change them. In addition, in preparation for the inspection by the Ministry of Food and Drug Safety, the manufacturing record was falsely written, and the records used in actual manufacturing were discarded after manufacture. It was also confirmed that the use of raw materials was arbitrarily increased or decreased without changing the manufacturing method.
The Ministry of Food and Drug Safety switched to investigation due to concerns about concealing related documents during the administrative investigation process. It is scheduled to take measures such as administrative disposition.
In addition, as a result of checking 29 consignment companies consigning drugs with the same ingredients and formulations as the products with confirmed violations, violations of negligence in management and supervision of consignees were also confirmed. These are 32 items from 24 companies entrusted to Binex, and 5 items from 5 companies entrusted to non-preservative pharmaceuticals.
However, as a result of collection and inspection of these products, the content, etc., are within the test standards, so it is believed that there will be little harm to humans.
In addition, it was confirmed that one out of 30 pharmaceutical manufacturing establishments violated the pharmaceutical manufacturing and quality control standards (GMP). Although the test for finished products and raw materials has not been conducted, and some product standards have not been prepared, it was manufactured in accordance with the permission requirements and no intentional offenses were found.
The Ministry of Food and Drug Safety plans to establish a’Pharmaceutical GMP Special Planning and Inspection Team’ to prevent the recurrence of intentional GMP violations, and conduct irregular inspections at all times in addition to the current three-year periodic factory monitoring.
In addition, a reporting center for violations will be operated, allowing all citizens to report intentional and illegal activities anonymously starting next month.
For illegal acts, the GMP conformity determination is canceled, and punitive penalties are imposed on unjust profits obtained from the violation. In addition, the sentencing for administrative disposition for non-compliance with the matters to be observed by the entrusted or consignee will be upgraded.
An official from the Ministry of Food and Drug Safety said, “We will thoroughly and promptly proceed with the investigation on the current Binex non-preservation pharmaceuticals.” said.
Reporter Kim Ye-na [email protected]
Ⓒ Hankyung.com prohibits unauthorized reproduction and redistribution