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China fines company for illegal human rabies vaccine production

BEIJING
2018-10-17 10:40

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Chinese authorities on Tuesday handed out penalties totaling more than 9.1 billion yuan (1.32 billion U.S. dollars) to a company for the illegal production of a human rabies vaccine.

The Changchun Changsheng Life Sciences Limited violated China's laws and regulations on drug management and production supervision in producing a human rabies vaccine, according to administrative penalty decision made by national and local drug authorities.

Violations included blending different batches of vaccine fluid, falsifying dates of production and using expired fluid to produce some of the vaccine batches, the document said.

The National Medical Products Administration (NMPA) annulled the rabies vaccine approval document and the certificates for related products from the company and imposed a fine of 12.03 million yuan.

Jilin Food and Drug Administration revoked the company's pharmaceutical production license, confiscated the illegally-produced vaccines and total income of 1.89 billion yuan from defective vaccine sales and imposed a fine of 7.21 billion yuan.

The hefty fine of 7.21 billion yuan was three times the total value of the defective vaccines produced and sold by the company.

Individuals directly responsible for the violations in the case will be banned from carrying out drug manufacturing and operating activities, and those suspected of committing crimes will face criminal charges.

Li Jiang, an NMPA legal adviser, said in an interview that "maximum penalty" was imposed on the company after taking the company's violations into full consideration.
"Serious punishment for the case will serve as a warning for drug safety and shows the authorities' resolution to crack down on drug violations and protect people's health," Li said.

The China Securities Regulatory Commission said Tuesday that it plans to impose a fine of 600,000 yuan on the Shenzhen-listed parent company of Changchun Changsheng, along with planned punishments on responsible individuals.

The commission will make the decision on final penalties after fully hearing the statements and defenses from the parties involved, warning other companies to learn a lesson from the case to promote the healthy growth of the capital market.
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