[이코노믹리뷰=황진중 기자] Unlike the matters approved by the Ministry of Food and Drug Safety, the discovery of Binex (053030) and non-conservative pharmaceuticals, which manufactured pharmaceuticals, has a ripple effect on the reliability of chemically synthesized generic drugs (generics). The Ministry of Food and Drug Safety is planning to conduct an emergency special inspection of about 30 pharmaceutical manufacturing facilities nationwide. The pharmaceutical industry is concerned about this situation while continuing efforts to improve the reliability of generics.
Food and Drug Administration, Binex/Non-preservation Pharmaceuticals Found… Emergency inspection at 30 locations nationwide
According to the pharmaceutical industry on the 12th, the Ministry of Food and Drug Safety initiated an investigation and seizure search for the factory after submitting a voluntary recovery plan for six items manufactured by Binex to the Busan Regional Food and Drug Administration.
The Ministry of Food and Drug Safety has six products manufactured by Binex ▲ Amorin tablet (ingredient name glimepiride) ▲ Selectin capsule (fluoxetine hydrochloride) ▲ Daxfen tablet (dexibuprofen) ▲ Ropsin tablet 250 mg (ciprofloxacin hydrochloride hydrate) ▲ Selectin capsule 10 mg ( Fluoxetine hydrochloride) ▲Cadyl tablets 1 mg (doxazosin mesylate) were temporarily suspended in manufacturing and sales.
According to an investigation by the Ministry of Food and Drug Safety, the number of illegally manufactured drugs by Binex increased to 32 items from 24 companies, including consignment products. The Ministry of Food and Drug Safety is a consignment of Binex ▲Kyungbo Pharmaceutical’s Decpen Tablet ▲Ildong Pharmaceutical’s Dicarol Tablet ▲JDW New Drug Sonny Pen Tablet 300mg ▲Hanall Biopharma Excipen Tablet ▲Guju Pharmaceutical’s Neuroxashin Tablet ▲Joa Pharmaceutical’s SiflocQ Tablet 250mg ▲Jinyang Pharmaceutical’s Cirok Shinjeong 250mg ▲Icure Siroctan Tablet 250mg ▲Hana Pharm Cipron Tablet 250mg ▲Punglim Mujak Poonglim Siprofloxacin Hydrochloride Hydrate Tablet ▲Lite Pharmtech Dipmax Capsule 20mg ▲Dongkuk Pharmaceutical Slycetin Capsule ▲Young Poong Pharmaceutical Youngproctin Capsule ▲Cho-A Pharmaceutical Oxetine Capsule ▲Mothers Pharmaceutical Oxygreen Capsule ▲ Wooridul Pharmaceutical Wellfit Capsule ▲ UniMed Pharmaceutical Unizac Capsule 20mg ▲ JDouble Yushin Pharmaceutical Ponoxetine Capsule 20mg ▲ Mirae Pharmaceutical Furucetine Capsule 20mg ▲ Hwail Pharmaceutical Phloxen Capsule ▲ CMG Pharmaceutical Pronin Capsule ▲ Dongkuk Pharmaceutical Slee Cetine Capsule 10mg ▲Young Poong Pharmaceutical Young Proctin Capsule 10mg ▲Introbio Pharma Obetin Capsule ▲Joa Pharmaceutical Oxetine Capsule 10mg ▲Woolfit Capsule 10mg ▲Unimed Pharmaceutical Unizac Capsule 10mg ▲CMG Pharmaceutical Pronin Capsule 10mg ▲Preparation New One Science Phloxine Capsule 10mg ▲Taegeuk Pharm Flumin Capsule 10mg ▲SPC Grill Tablet ▲Alvogen Korea Gluvi Tablet, etc., also temporarily stopped manufacturing and selling.
An official from the Ministry of Food and Drug Safety explained, “The products subject to this measure are not expected to affect domestic supply and demand as the proportion of production performance is not high.”
The detection of illegal manufacturing continues. The Ministry of Food and Drug Safety discovered pharmaceuticals manufactured differently from those approved and reported by non-preservative pharmaceuticals through regular inspections. The items are ▲Non-preserving pharmaceutical distrin capsule (diacerein) ▲Non-preserving pharmaceutical ready thin capsule ▲Non-preserving pharmaceutical mucolide capsule 200 mg (acetylcysteine) ▲Non-preserving pharmaceutical J-octin tablet (thioctic acid) ▲Nugen Pharm Diagen capsule (Dasserein) ▲ Huvist Pharm Atroserine Capsule (Dasserein) ▲ Nexfam Korea Mucoban Capsule 200mg (Acetylcysteine) ▲ Dasan Pharmaceutical Mucotia Capsule 200mg (Acetylcysteine) ▲ Medics Pharmaceuticals Thioxin Tablet (Tiok The company’s 4 items and 5 consignment items, including Tsan).
As illegal manufacturing has been continuously detected, the Ministry of Food and Drug Safety is planning to conduct an emergency full inspection of 30 pharmaceutical consignment and consignment factories nationwide. An official from the Ministry of Food and Drug Safety said, “We plan to quickly prepare and promote comprehensive system improvement measures to prevent recurrence, such as expanding the inspection of the entire pharmaceutical manufacturing plant in the future, taking into account the results of the inspection.”
Korea Pharmaceutical Bio Association’Take prompt action’
The Korea Pharmaceutical Bio Association plans to take prompt action as the illegal manufacturing situation is very serious.
The Pharmaceutical Bio Association said, “The Binex case is shocked because it is an unacceptable crime,” he said. “We are taking it very seriously and seriously.” With this incident as an opportunity, we will take prompt action, such as checking the overall status of the consignment production process and quality control of member companies.
Apart from the measures taken by the authorities, the Pharmaceutical Bio Association plans to thoroughly grasp the truth and take decisive measures against workers such as referral to the ethics committee against Binex.
In order to prevent recurrence, the company plans to promote the rapid institutionalization of the ‘1+3 restriction’ of the consignment and joint bioequivalence test to prevent the production of unrestricted consignment of generic drugs. In 2017, the association also promoted a plan to limit the number of consignment and co-living items to four.
Cold water in the effort to improve the quality of generics in the industry
According to the industry, generics are mostly produced in Korea through consignment production. The industry sees that the problem caused by the’generic mess’ needs to be solved, and related issues are being discussed and underway. The detection of NDMA, a carcinogenic substance related to valsartan, a high blood pressure drug in 2018, is also considered an incident related to’infinite generics’.
When a large number of generics are released, the same effects as expensive original drugs can be enjoyed at an affordable price, which can benefit patients and drug consumers. However, it is pointed out that if the product is released over a certain limit, it can produce products using cheap raw materials (APIs) or excessive sales competition in order to make a profit through price and sales competitiveness.
A person in the pharmaceutical industry said, “After the Balsartan incident, it is a pity that the industry is considering and implementing measures to increase the reliability of generics. As it has been recognized as an advanced country in drug regulation, such as signing up for the first time, we will need to make more thorough efforts in drug quality control.”
Some point out that it is necessary to further increase the number of manpower from the Ministry of Food and Drug Safety. Pharmaceutical industry official B said, “The more scientific and rational regulations are, the more competitive the pharmaceutical industry can gain.” “The work of the Korea Food and Drug Administration, which is a regulatory body for the pharmaceutical industry, is heavy. We need to increase our manpower to secure more regulatory capabilities.”