The Vietnamese Ministry of Health has denied any wrongdoing in the licensing of substandard cancer medicine imported by VN Pharma JSC, whose leaders are being tried for their alleged role in the high-profile scandal.
In a dispatch signed and presented to the High Court of Ho Chi Minh City on Monday by Do Van Dong, deputy director of the ministry’s Department of Drug Administration (DDA), the ministry insisted that it abided by all regulations in the licensing of VN Pharma’s imports.
The pharmaceutical firm, headed by its former chairman and general director Nguyen Minh Hung, imported 9,000 boxes of H-Capita 500mg in 2013 without proper proof of origin or quality.
H-Capita 500mg is used to treat cancer.
To legalize the distribution of the product, Hung and his accomplices forged importation documents stating that the drug had been manufactured by a company named Helix Canada.
The fake documents were then submitted to the DDA.
An investigation later revealed that Canadian authorities had never licensed Helix to produce medicine.
Meanwhile, other documents relating to the drug’s origin, specifications, and quality assurance were falsified by VN Pharma employees and several pharmacists under Hung’s direction.
A test by the health ministry also showed that H-Capita 500mg contained 97 percent of capecitabine, an active ingredient that is poor in quality and should not be used for human medical treatment.
In its dispatch on Monday, DDA said it followed established regulations in licensing VN Pharma’s imports by requiring an evaluation of results from a team of four experts who reviewed the legality of the drug’s papers, the validity of its testing methods, and its clinical pharmacology.
“All papers and certificates in the company’s application were notarized by the Justice Office of District 10, Ho Chi Minh City, and were only proven to have been forged following investigations by the Institute of Criminal Science under the Ministry of Public Security,” the dispatch read.
Regarding the fact that Austin Pharma Specialities Co., the supplier of the H-Capita 500mg imported by VN Pharma, had no valid business license in Vietnam at the time of licensing, the ministry stressed that the paper was not required for approving the importation of a drug.
“Such papers are only required when the actual shipment arrives in Vietnam,” the dispatch explained.