The Drug Administration of Vietnam (Ministry of Health) has officially issued a document to the Departments of Health of provinces, cities and drug import-export enterprises regarding the updated list of foreign production facilities with drugs that violate quality according to the provisions of Circular 30/2025/TT-BYT.
According to the Drug Administration of Vietnam, based on monitoring the quality of drugs in circulation and reviewing the records of foreign production facilities, the unit decided to remove the name of a company from the list to check 100% of imported drug lots. The company was renamed: Zee laboratories - India. The Department said that this enterprise has completed the collection of quality control samples for all imported drug lots during the period under supervision. The results showed that no batch of drugs violated the quality, meeting the conditions according to Clause 2, Article 9 of Circular 30/2025/TT-BYT.
In the list of foreign enterprises with drugs violating quality, India continues to be the leading country in terms of the number of violations, with many enterprises being subject to supervision since 20132015 and have not yet been removed from the list. Many establishments such as ACI Pharma, All Serve Healthcare, altomega Drugs, AMN Life Science, Chemfar Organics, Elegant Drugs, Euro Healthcare, Fine Pharmachem or Mediwin Pharmaceuticals have violated for many years.
Notably, some manufacturers violated both pre-inspections and post-inspections, including: AMN Life Science, Medico Remedies, Syncom Formulations, Minimed Laboratories and marksans Pharma.
Not only concentrated in India, businesses from Bangladesh, China, Indonesia, South Korea, Pakistan, the US, Italy and Romania continue to be on the watch list. Names such as Reman Drug laboratories, CSPC Zhongnuo, PT. Merck Tbk, Crown Pharm or Yuyu Inc. were listed very early but have not yet met the conditions to be removed from the pre-inspection. Some US businesses such as ADH Health Products, Robinson Pharma also appeared on the list, showing widespread violations in many countries.
A total of 46 enterprises with imported drugs that do not meet standards are forced to continue taking samples to check 100% of the batch before circulating.
The Drug Administration emphasizes the periodic issuance to ensure transparency, while supporting authorities and pharmaceutical enterprises to effectively implement the work of controlling the quality of imported drugs.
The Department requests the Department of Health of provinces, cities and health sector units to: Direct the forces of pharmaceutical management, drug inspection and testing in the area. Strengthen supervision of compliance with regulations on quality control of imported drugs. Strictly handle organizations and individuals who violate the law according to current regulations.
