Ministry of Health fines Messi-10 drug manufacturing company over 300 million VND

Dat Vi Phu Pharmaceutical Joint Stock Company, located in Thoi Hoa ward, Ben Cat town, Binh Duong, has just been fined 340 million VND by the Drug Administration of Vietnam (Ministry of Health) for 5 violations in the pharmaceutical field.

Specifically, this company did not have a document requesting to supplement or change the information of the declared drugs, or to re-declare the drug price in case of changes compared to the announced information but the drug price did not change, for 3 drugs:Aluminium phosphate gel, registration number VD-28444-17 (treatment of stomach and duodenal diseases);Orlitax(registration number VD-25454-16, treatment of obesity and prevention of weight regain);Najen(registration number VD28920-18, helps relieve pain and inflammation in osteoarthritis and rheumatoid arthritis).

In addition, this company sells drugs.Zlatko-50(registration number VD-21484-14, diabetes treatment) for a facility that is not in accordance with the business scope in the certificate of eligibility for pharmaceutical business.

The company did not carry out the registration procedure for changes and additions to the circulation registration certificate with the competent state agency and obtain approval before 3 drug circulation:Zuryk(registration number VD-29728-18, treatment of gout and metabolic disorders);Messi-10(registration number VD-27445-17, drug for the treatment of osteoporosis);Kagawas-150(registration number VD-30342-18; treatment of gastric ulcers, gastroesophageal reflux...);Malag-60(registration number VD-26499-17, used to treat seasonal allergic rhinitis, urticaria).

Messi-10 medicine is indicated for the treatment of osteoporosis and is manufactured by Dat Vi Phu Pharmaceuticals.

Dat Vi Phu Pharmaceutical Company does not carry out the procedure of notifying the competent state agency for minor changes that require notification before circulation:Kagawas-150(registration number VD-30342-18);Schaaf(GDKLH number VD-30348-18). Schaaf is indicated in the treatment of hypertension and prostate enlargement.

In particular, Dat Vi Phu Pharmaceuticals imported pharmaceutical ingredients that must be specially controlled without an import license for pharmaceutical ingredients.Pyridostigmine HBr(commonly used in myasthenia gravis drugs...).

In addition to the administrative fine of VND340 million for 5 violations, the Drug Administration also revoked the right to use the pharmacy practice certificate of pharmacist Nguyen Tan Loi, who is responsible for the company's pharmaceutical expertise, for 7.5 months.

Also during this time, the company was suspended from importing drugs and pharmaceutical ingredients. At the same time, the Ministry of Health requested that the raw materials be removed from Vietnam or re-exported.Pyridostigmine HBrBecause Dat Vi Phu Pharmaceutical Joint Stock Company imported without an import license. If this measure cannot be applied, it must be destroyed.