Details of the licensing process in the VN Pharma fake drug case have been released.

On the morning of August 29th, the Ministry of Health officially reported on the handling of imported drugs from VN Pharma Joint Stock Company. According to the report, the documentation for H-Capita 500mg was so sophisticatedly forged that even 10 pharmaceutical experts could not detect the deception with the naked eye.

Former CEO of VN Pharma on trial.

So sophisticated was the counterfeiting that 10 pharmaceutical experts couldn't detect it with the naked eye.

Regarding the licensing process for H-Capita 500mg, the Ministry of Health stated that on October 16, 2013, the Drug Administration of Vietnam (Ministry of Health) received order number 225/DH/VNP-XNK from VN Pharma Joint Stock Company requesting permission to import H-Capita 500mg Caplets manufactured by Helix Pharmaceuticals Inc, Canada.

As with other import orders for unregistered drugs, based on current regulations, the Drug Administration of Vietnam organized an assessment with the participation of 10 expert assessors from Hanoi University of Pharmacy, the Central Institute for Drug Testing, and the Drug Administration of Vietnam.

“The assessment was conducted in accordance with regulations, procedures, and the operating rules of the assessment team. On December 30, 2013, the Ministry of Health (Drug Administration Department) granted permission to import the drug according to Official Letter No. 22113/QLD-KD. The granting of permission was entirely in accordance with current regulations and there was no favoritism,” the Ministry of Health affirmed.

However, upon reviewing the case, the Ministry of Health stated that the relevant documents submitted by VN Pharma Joint Stock Company with the aforementioned order (including the Free Sale Certificate (FSC) and the Good Manufacturing Practice (GMP) certificate) were later determined by investigators to be sophisticatedly forged, undetectable by pharmaceutical experts with the naked eye.

The problem stems from the unusually low drug prices.

The Ministry of Health stated that another "irregularity" was later discovered, raising suspicions: the declared price of drugs from 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 similar drugs produced in countries belonging to the Pharmaceutical Cooperation System on Good Manufacturing Practice (POC/s), of which Canada is a member.

Following these suspicions, on July 31, 2014, the Ministry of Health (Drug Administration Department) requested the director of VN Pharma to provide an explanation at a meeting.

Finding the company's explanation unsatisfactory, on August 1, 2014, the Drug Administration of Vietnam issued công văn (official letter) No. 13134/QLD-KD requesting the company to temporarily suspend the import and distribution of the aforementioned drug.

The imported batch of medicine has not yet been released onto the market.

Due to suspicions regarding the drug's price and unsatisfactory explanations, the Drug Administration of Vietnam decided on August 1, 2014, to prohibit the sale of H-Capita on the market. In fact, not a single H-Capita tablet from the imported batch was sold on the market.

Immediately following this decision, on August 8, 2014, the Ministry of Health (Department of Pharmaceutical Management) issued công văn (official letter) No. 13499/QLD-KD dated August 8, 2014 to the General Department of Security II - Ministry of Public Security and other letters to the Consular Department of the Ministry of Foreign Affairs, the Canadian Ministry of Health, and the Vietnamese Embassy in Canada requesting cooperation to verify and clarify the relevant information.

To further strengthen the information, on August 13, 2014, the Drug Administration of Vietnam continued to invite the representative in Vietnam of Helix Pharmaceuticals Inc, Canada, for a meeting.

Over 278,000 H-Capita pills were sealed.

Immediately after the meeting, the Drug Administration of Vietnam issued Decision No. 438/QD-QLD dated August 13, 2014, establishing an inspection team. On August 14, 2014, the team conducted an unannounced inspection of VN Pharma Joint Stock Company's compliance with legal regulations on import, export, and drug trading, with the participation of the Ho Chi Minh City Institute of Drug Testing. Simultaneously, they sealed all H-Capita tablets (278,670 tablets) at the company, prohibited the circulation of the entire imported batch, and took samples for quality testing at the Ho Chi Minh City Institute of Drug Testing.

With the assistance of the Consular Department of the Ministry of Foreign Affairs, in official letter No. 2824/CV-LS-HPH dated September 17, 2014, notifying that the consular legalization on the documents of Helix Pharmaceuticals Inc, Canada, was forged, the Ministry of Health forwarded all information to the General Department of Security II for consideration and handling within its authority.

Reportedly, before initiating legal proceedings, at the request of the police, the Ministry of Health (Department of Pharmaceutical Management) summoned Mr. Nguyen Minh Hung and Mr. Nguyen Manh Cuong for questioning at the Department of Pharmaceutical Management; based on the evidence of violations, the police carried out an on-the-spot arrest.

According to the Ministry of Health, during the period before and after the prosecution and investigation of the case, officials of the Ministry of Health (Drug Administration Department), upon discovering suspicious signs, proactively requested the authorities to conduct an investigation and actively cooperated by providing documents and expert opinions to support the investigation, aiming to bring the fraud regarding the origin of goods and the falsification of documents to light.

In addition, the Ministry of Health has taken administrative action and rectified the situation as recommended by the Security Investigation Agency of the Ministry of Public Security to adjust regulations on drug import licensing to prevent such situations from occurring, specifically:

Administrative measures require relevant officials and appraisal experts to report, explain, and draw profound lessons learned; implement leadership rotation, replace and supplement appraisal experts; and adjust legal regulations, including supplementing and amending legal provisions related to drug import and bidding... in a very detailed and strict manner in the 2016 Pharmaceutical Law.

Because the process of reviewing legal documents is not simple, the Drug Administration Department invited experts from the Ministry of Foreign Affairs and the Ministry of Justice to train its staff and experts in consular legalization, serving their operational work and document review.

Thus, in its capacity as the pharmaceutical regulatory authority, the Ministry of Health has granted import licenses for the drug in accordance with current regulations. It has proactively and actively coordinated with relevant agencies to initiate legal proceedings and bring the case to trial; promptly sealed and prevented the entire batch of substandard imported drugs from reaching the market, ensuring that not a single H-Capita tablet entered the market.

According to Dan Tri