Fined over 300 million VND for 2 foreign pharmaceutical companies

Recently, during the post-licensing inspection and supervision process, the Drug Administration of Vietnam (Ministry of Health) discovered serious violations of drug trading regulations by two foreign pharmaceutical companies and imposed fines totaling more than VND300 million.

Illustration photo. (Source: wordpress.com)

They are two companies: Austin Pharma Specialties Company (located in Hong Kong) and CSPC Innovation Pharmaceutical Company (located in China).

Thus, both of the above companies were fined at the highest level among the fines under the authority of the drug administration agency, the Ministry of Health.

Austin Pharma Company violated the trading of omeprazole and pantoprazole raw materials of unknown origin and was administratively fined 160 million VND, and forced to return 30,625 USD obtained from trading omeprazole and pantoprazole raw materials of unknown origin.

In addition, due to the reason of providing drugs that do not meet quality standards according to the regulations on drug quality management of the Ministry of Health and trading raw materials of omeprazole and pantoprazole of unknown origin, the Drug Administration of Vietnam has decided to withdraw all drug registration numbers registered by Austin Pharma Specialties Company from the list of drugs granted registration numbers for circulation in Vietnam.

Drugs manufactured by Austin Pharma Specialties Company were also suspended from import for a period of 24 months for providing drugs that did not meet quality standards according to the Ministry of Health's regulations on drug quality management and trading in raw materials of omeprazole and pantoprazole of unknown origin.

The Ministry of Health also decided to suspend nationwide circulation and recall all drugs in the attached list; stop accepting initial registration applications, re-registration applications, and not issue drug circulation registration numbers for applications submitted by Austin Pharma Specialties Company within 24 months.

For CSPC Innovation Pharmaceutical Company, the Drug Administration has decided to impose an administrative fine of 160 million VND for violating the business of omeprazole and pantoprazole raw materials of unknown origin, and required the return of 29,750 USD obtained from trading raw materials of unknown origin.

Attached is the Decision to stop receiving and reviewing drug import dossiers for drugs registered or manufactured by CSPC Innovation Pharmaceutical Company within 24 months; Stop importing drugs manufactured by CSPC Innovation Pharmaceutical Company within 24 months for the reason of providing drugs that do not meet quality standards according to the regulations on drug quality management of the Ministry of Health and trading in raw materials of omeprazole and pantoprazole of unknown origin.

The Ministry of Health also issued a decision to suspend nationwide circulation and recall all drugs in the list issued with this decision; stop accepting first-time registration applications, re-registration applications and not issue drug circulation registration numbers for applications submitted by CSPC Innovation Pharmaceutical Company within 24 months./.

According to Vietnam+