Penalties and bans for defective vaccines

Chinese authorities have penalized Changchun Changsheng Life Sciences Limited and its executives over illegalities related to making defective human rabies vaccine.

Penalties include a delisting warning, fines, and lifetime market access bans for executives of the company.

The company said yesterday it had received notice of its compulsory delisting from the Shenzhen Stock Exchange over its major violations of the law. The bourse will continue to weigh its removal decision in accordance with related regulations.

The vaccine-maker said Gao Junfang and three other executives have been given administrative penalties including a lifetime ban from the securities market by the China Securities Regulatory Commission, the top industry watchdog.

They have also received warnings and fines of 300,000 yuan each (US$43,400).

Another three executives were fined 200,000 yuan each and banned from the securities market for five years. Ten others were warned and fined 50,000 yuan each.

The company was warned and fined 600,000 yuan by the CSRC.

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

The National Medical Products Administration annulled the company’s rabies vaccine approval document and certificates for related products.

It imposed a fine of 12.03 million yuan.

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

It imposed a fine of 7.21 billion yuan, three times the value of the defective vaccines produced and sold by the company.

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

Li Jiang, an NMPA legal adviser, said: “Serious punishment for the case will serve as a warning for drug safety.

“It shows the authorities’ resolution to crack down on drug violations and protect people’s health.”

The CSRC warned other companies to learn a lesson from the case to promote healthy growth of the capital market.