Two foreign pharmaceutical companies fined over 300 million VND.

Recently, during post-licensing inspections, the Drug Administration of Vietnam (Ministry of Health) discovered serious violations of drug business regulations by two foreign pharmaceutical companies and imposed fines totaling over 300 million VND.

Illustrative image. (Source: wordpress.com)

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

Thus, both companies mentioned above were fined at the highest level within the scope of penalties under the authority of the pharmaceutical regulatory agency, the Ministry of Health.

Austin Pharma violated regulations by trading in omeprazole and pantoprazol raw materials of unknown origin and was fined 160 million VND, and ordered to return 30,625 USD obtained from trading in omeprazole and pantoprazol raw materials of unknown origin.

Furthermore, due to supplying substandard drugs in violation of the Ministry of Health's regulations on drug quality management and trading in omeprazole and pantoprazole raw materials of unknown origin, the Drug Administration of Vietnam has decided to withdraw all drug registrations under the name of 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 24 months due to the supply of substandard drugs as stipulated in the Ministry of Health's drug quality management regulations, and the trading of omeprazole and pantoprazole raw materials of unknown origin.

The Ministry of Health also decided to suspend nationwide distribution and recall all drugs on the issued list; stop accepting initial registration applications, re-registration applications, and not issue drug registration numbers for applications already submitted under the name of Austin Pharma Specialties Company for 24 months.

Regarding CSPC Innovation Pharmaceutical Company, the Drug Administration of Vietnam issued an administrative penalty of 160 million VND for violating regulations on trading omeprazole and pantoprazole raw materials of unknown origin, and ordered the company to return 29,750 USD obtained from trading these raw materials of unknown origin.

This is accompanied by a Decision to cease accepting and reviewing import applications for drugs registered or manufactured by CSPC Innovation Pharmaceutical Company for a period of 24 months; and to cease importing drugs manufactured by CSPC Innovation Pharmaceutical Company for a period of 24 months due to the supply of drugs that do not meet quality standards as stipulated in the Ministry of Health's regulations on drug quality management and the trading of omeprazole and pantoprazole raw materials of unknown origin.

The Ministry of Health also issued a decision to suspend nationwide circulation and recall all drugs on the list attached to this decision; to stop accepting initial registration applications, re-registration applications, and not to issue drug registration numbers for applications already submitted under the name of CSPC Innovation Pharmaceutical Company for 24 months.

According to Vietnam+