“I need to check the quality control of all factories…Pharmaceutical companies are only pursuing money with’Paper Item Permit'”
When the Ministry of Food and Drug Safety took measures to suspend the sale and withdrawal of Binex, a drug consignment manufacturing company that manufactured drugs that were different from the license requirements, the Korean Pharmacopoeia expressed concern, saying that it was a “breakthrough”.
The pharmacy society also raised voices of criticism against domestic pharmaceutical companies that are entrusting the manufacture of drugs to Binex.
On the 9th, the pharmacy society urged, “(The Ministry of Food and Drug Safety) should face the public’s anxiety over the overall pharmaceutical products and check the quality control of pharmaceutical products at all manufacturing sites.”
The pharmacy society pointed out that “the reason for the existence of the Ministry of Food and Drug Safety, which neglects quality control by operating an unlimited commissioned livelihood (biological equivalence) and joint development system under the name of fostering’K Pharmaceuticals’,” pointed out.
The pharmacist society also said, “Many of the leading pharmaceutical companies in Korea that are entrusting the manufacture of drugs to Binex say they did not know anything at all,” and said, “This case shows a cross-section of the Korean pharmaceutical industry that is busy pursuing only money with paper licenses.”
Consignment production of pharmaceuticals is a method in which a pharmaceutical company that has obtained an item license entrusts the production of a product to a consigned manufacturer.
In Korea,’Gongdongsaengdong’ is possible in which a number of pharmaceutical companies jointly conduct bioactivity tests with original drugs of the same generic (replica drug) with the same consignment factory, raw material, and manufacturing method, except that the product name is different.
Because of this, pointed out that virtually the same drugs are released in a pile, steadily raised.
The pharmacist society emphasized, “It is unreliable not only for the six Binex products that have already been disposed of, or the products that are consigned to the first factory in Busan, which is considering disposal, but all the 194 products that Binex is consigning to.”
The pharmacy society asked the Ministry of Food and Drug Safety to “redesign the consignment biotechnology and co-developed item permission system, such as thoroughly reviewing the domestic manufacturing plant pharmaceutical manufacturing and quality control standards (GMP), and strengthening the obligations of product license holders.”
The day before, the Ministry of Food and Drug Safety initiated an investigation into the first factory in Busan after temporarily suspending manufacturing, selling, and recovering six items, including Binex’s diabetes treatment, which manufactured drugs differently from the license requirements.
/yunhap news
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