Announcing details of the licensing process of VN Pharma's counterfeit drugs case

On the morning of August 29, the Ministry of Health officially reported on the handling of imported drugs of VN Pharma Joint Stock Company. Accordingly, the documents on the drug H-Capita 500mg were forged so sophisticatedly that 10 pharmaceutical experts could not detect it with the naked eye.

Former General Director of VN Pharma appeared in court.

Sophisticated counterfeiting, 10 pharmaceutical experts cannot detect with the naked eye

Regarding the licensing of H - Capita 500mg, the Ministry of Health said that previously, on October 16, 2013, the Drug Administration of Vietnam (Ministry of Health) received order No. 225/DH/VNP - XNK from VN Pharma Joint Stock Company requesting a license to import H - Capita 500mg Caplet manufactured by Helix Pharmaceutiacals Inc, Canada.

As with other drug import orders without registration numbers, based on current regulations, the Drug Administration of Vietnam has organized an appraisal, with the participation of 10 appraisal experts from Hanoi University of Pharmacy, the Central Institute for Drug Testing, and the Drug Administration of Vietnam.

“The appraisal was carried out in accordance with regulations, procedures, and operating regulations of the appraisal team. On December 30, 2013, the Ministry of Health (Department of Drug Administration) granted permission to import the above drug according to Official Dispatch No. 22113/QLD - KD. The granting of the license was completely in accordance with current regulations, without preferential treatment,” the Ministry of Health affirmed.

However, reviewing the case, the Ministry of Health said that the relevant documents submitted by VN Pharma Joint Stock Company with the above order (with full free circulation certificate (FSC) and factory certificate meeting good manufacturing practice (GMP) standards) were later determined by the investigation agency to be sophisticatedly forged, pharmaceutical experts could not detect with the naked eye.

Seeing the problem because of the unusually “low drug prices”

The Ministry of Health said that another "abnormality" was discovered later, causing the Ministry of Health to raise questions, because the declared drug price of VN Pharma Joint Stock Company and the winning bid price at the Ho Chi Minh City Department of Health's Drug Bidding Council were lower than those of similar drugs produced in countries belonging to the Good Manufacturing Practices Inspection Cooperation System (POC/s) of which Canada is a member.

Faced with this suspicion, on July 31, 2014, the Ministry of Health (Department of Drug Administration) requested the director of VN Pharma company to explain at a meeting.

Considering the company's explanation unsatisfactory, on August 1, 2014, the Drug Administration of Vietnam issued Official Letter No. 13134/QLD-KD requesting the company to temporarily stop importing and circulating the above drug.

Imported drug batches have not been circulated on the market.

Faced with doubts about the drug price and unsatisfactory explanations, since August 1, 2014, the Drug Administration has decided not to allow H-Capita to be sold on the market and in fact, not a single H-Capita pill in the imported batch of drugs has been sold on the market.

Immediately after this decision, on August 8, 2014, the Ministry of Health (Department of Drug Administration) issued Official Dispatch No. 13499/QLD-KD dated August 8, 2014 to the General Department of Security II - Ministry of Public Security and official dispatches to the Consular Department of the Ministry of Foreign Affairs, to the Canadian Ministry of Health, to the Vietnamese Embassy in Canada requesting coordination to verify and clarify related information.

To further consolidate the information, on August 13, 2014, the Drug Administration continued to invite the representative in Vietnam of Helix Pharmaceuticals Inc, Canada to work.

More than 278 thousand H pills - Capita forced to seal

Immediately after the meeting, the Drug Administration of Vietnam issued Decision No. 438/QD-QLD dated August 13, 2014 to establish an inspection team and on August 14, 2014, sent a surprise inspection team to inspect the implementation of legal regulations on import-export and drug trading of VN Pharma Joint Stock Company with the participation of the Ho Chi Minh City Drug Testing Institute, and at the same time sealed all H-Capita drugs (278,670 tablets) at the company and did not allow the entire imported batch to be circulated and took samples for testing at the Ho Chi Minh City Drug Testing Institute to check the quality.

With the help of the Consular Department, Ministry of Foreign Affairs in Official Dispatch No. 2824/CV-LS-HPH dated September 17, 2014 announcing that the consular legalization content on the documents of Helix Pharmaceuticals Inc, Canada is fake, the Ministry of Health has transferred all information to the General Department of Security II for consideration and handling according to authority.

It is known that before initiating the case, at the request of the police, the Ministry of Health (Department of Drug Administration) invited Mr. Nguyen Minh Hung and Mr. Nguyen Manh Cuong to work at the Department of Drug Administration; based on signs of violations, the police executed an on-site arrest warrant.

According to the Ministry of Health, during the process before and after the prosecution and investigation of the case, when detecting suspicious signs, officials of the Ministry of Health (Department of Drug Administration) proactively requested the competent authorities to conduct an investigation and actively coordinated to provide documents and professional opinions to serve the investigation in order to bring the case of fraud regarding the origin of goods and falsification of documents to light.

In addition, the Ministry of Health has handled administrative procedures and taken corrective actions according to the recommendations of the Ministry of Public Security's Investigation Security Agency to adjust regulations on drug import licensing to avoid the above situation, specifically:

Administrative handling requires relevant officials and appraisal experts to report, explain and draw profound lessons, carry out rotation of leaders, responsible experts, replace and supplement appraisal experts. Adjust legal documents, including supplementing and amending legal regulations related to drug import and bidding... very detailed and strict in the 2016 Pharmacy Law.

Training staff because the appraisal of legal documents is not simple, the Drug Administration of Vietnam invited experts from the Ministry of Foreign Affairs and the Ministry of Justice to train the Department's staff and appraisal experts on consular legalization, serving the work of operations and appraisal of documents.

Thus, with the responsibility of the drug management agency, the Ministry of Health has issued import licenses for drugs in accordance with current regulations. It has actively and proactively coordinated with competent authorities to prosecute the case and bring it to trial; promptly sealed and prevented the entire batch of imported drugs of poor quality, not allowing a single H-Capita pill to enter the market.

According to Dan Tri