Korean pharmaceutical companies have received a heap of administrative penalties from the Ministry of Food and Drug Safety (MFDS), causing a stir.
On Monday, GC Wellbeing, a subsidiary of the GC Group, received a one-month suspension of manufacturing four specialized drugs from the MFDS. As a result, GC Wellbeing cannot manufacture the items from Sept. 25 to Oct. 24.
The manufacturing suspension applies to GC Vita O Inj. (D-panthenol), Meganesium Inj. 10 percent (magnesium sulfate hydrate), GC Wellbeing Magnesium Chloride Inj., and GCB Bone Inj. (sodium bicarbonate).
According to the ministry, GC Wellbeing was found to have failed to comply with its standards for “Manufacturing Environment Management” and “Manufacturing Environment Microbiological Test” during the manufacturing the GC Vita O Inj. and three other products.
Unimed Pharm and Firson also received one-month manufacturing suspensions from the MFDS recently.
Unimed was found to have failed to comply with the provisions of the 'Complaint Handling Regulations' related to complaint procedures, even after receiving complaints about the anti-inflammatory drug Dibrufen Tab. 400mg.
Firson did not comply with the provisions of its Standard on Change Management (SS0015) for changes in the manufacturing method of Sweatrol Pad Soln. (glycopyrrolate), a treatment for hyperhidrosis. Sweatrol Pad Soln. is an over-the-counter drug that can be purchased at pharmacies and is sold by Dong-A Pharmaceutical.
Jungwoo Shinpharm, a herbal medicine manufacturer, also faced a one-month manufacturing suspension for two items due to GMP violations.
Jungwoo Pharma and Healing did not comply with the company's standard “Change Management Regulation” provisions while manufacturing Ssangpaewon Cough Soln. and did not comply with implementing the quality assurance department in the company's standard “GMP Organization and Division of Duties Regulation” for Jungwoo Licorice Extract.
Last Friday, Huons received a three-month suspension of its advertising business from the ministry. The administrative penalty period is from Sept. 22 to Dec. 21.
The penalty was imposed after the company advertised the type 2 diabetes drug Huxiga Tab. 10 mg (dapagliflozin propanediol hydrate) with claims that deviated from the approved efficacy and effectiveness.
Huxiga is a generic version of AstraZeneca's SGLT-2 inhibitor, Forxiga (dapagliflozin). In addition to type 2 diabetes, Forxiga is approved for chronic heart failure and chronic kidney disease, while the generic version of Forxiga in Korea is only approved for type 2 diabetes.
In addition to Huon's, some pharmaceutical companies that have launched generic versions of Forxiga, including HK inno. N, have promoted their effectiveness in treating heart failure and heart disease through symposiums.
The regulator agency is considering administrative penalties after investigating through the regional food and drug safety agencies.
"In the case of a first offense, the penalty is a three-month advertising suspension," the MFDS said while explaining the level of punishment.