After Binex’s voluntary change in the pharmaceutical manufacturing process, voices from inside and outside the pharmaceutical bio industry are demanding the introduction of’restriction of 1+3 consignment co-living activities’.
Currently, Binex is under suspicion that it has manipulated the dosage and manufacturing method of the main ingredient of the drug. The Ministry of Food and Drug Safety designated 6 Binex items in question and 32 items from 24 companies that Binex was consigning to produce as targets for temporary suspension of manufacturing and sales. In addition, on-site investigations are underway at the Binex Busan plant where the items were produced.
Accordingly, the Korea Pharmaceutical Bio Association (hereinafter referred to as the Pharmaceutical Association) revealed its position on the Binex incident on the 11th and suggested’restriction of 1+3 consignment co-living activities’ as an alternative.
Through the statement, the Korea Pharmaceutical Association said, “The Binex case is shocked because it is an unacceptable offense.” “It should never happen in pharmaceutical companies that produce drugs that have a profound impact on the health and life of the people. It shouldn’t happen,” he raised his voice.
The’restriction of 1+3 entrusted co-living life’ is a system with the intent of preventing generic sprawl by limiting the number of original manufacturers who conducted a bioequivalence test during the generic development process and the number of companies that can entrust their manufacturing to them.
The Pharmaceutical Association said, “In order to prevent the sprawl of generic drugs due to unrestricted consignment production, it is necessary to quickly institutionalize the’restriction of 1+3 consignment co-living life.’ To this end, we will do our best to rationalize the quality control of pharmaceutical products and the co-development system, such as actively cooperating with the legislation of the National Assembly.”
In addition, the Pharmaceutical Association announced that it plans to refer Binex to the Ethics Committee, independent of governmental actions such as further investigation by the Ministry of Food and Drug Safety. The dispositions that member companies receive from the Ethics Committee are divided into four categories, from the lowest level of’oral warning’ to’written warning’,’disqualification’, and the highest level of’dismissal’.
An official from the Pharmaceutical Bio Association said, “There is a meeting of the main board of directors and directors,” and “the agenda of the ethics committee, such as the date of the committee meeting, will be discussed.”
It seems that the political world is also interested in the Binex situation.
On the 9th, Rep.Seo Young-seok (Democratic Party) posted a post titled’Vinex Incident, Recurrence Prevention Measures can be started from ‘1+3 Regulations for Prevention of Overgrowth of Generic Drugs (Replica Drugs)’ through personal SNS. .
Rep. Seo Young-seok, a former pharmacist, is currently serving as the special chairman of the Democratic Party’s special health care committee and previously served as the head of policy planning for the Korean Pharmacopoeia.
Rep. Seo cited the passage of the Consignment Partnership 1+3 Regulation Act as the solution to the Binex incident.
Rep. Seo said, “The fact that the famous pharmaceutical company’Binex’ manipulated the dosage of antipyretic drugs, depression, and diabetes drugs was revealed, which is causing public anger.” “It was not easy for the Ministry of Food and Drug Safety to detect the arbitrary illegal manufacture of pharmaceuticals by pharmaceutical companies. “It is a very big problem that the existing surveillance system, such as quality control or follow-up management for manufacturing plants or manufactured drugs, did not work properly,” he criticized.
He added, “I think this Binex incident certainly acted as one of the main causes of the outbreak of generic drugs in Korea.”
Rep. Seo said, “Because generic drugs can be made infinitely, there are a lot of generic drugs in the market, which has led to excessive competition among pharmaceutical companies and manufacturers.” In order to grow it, I think that the temptation for abnormal cost reduction measures such as the use of low-cost raw materials and the change in the amount of raw materials for manufacturing would have been great,” he pointed out.
“In order to solve this problem, it is necessary to regulate the number of generic drugs by restricting the number of generic drugs, so that unnecessary operations can be prevented and the cost and capacity reduced by this can be devoted to the development of new drugs. He stressed that the’Consignment Joint Living Dong 1+3 Regulation Act’ must be passed as soon as possible.”
The’Consignment Joint Living Dong 1+3 Regulation Act’ was enacted in the subcommittee of the National Assembly bill in February.
Rep. Seo urged, “I hope that the National Assembly in March will discuss and deal with bills for the safety and health of the people.”