State Council: guilty producers to be severely punished, officials held accountable for substandard vaccines

Decisions were made at the State Council's executive meeting chaired by Premier Li Keqiang Thursday, following a report on the findings of investigations into the case of substandard vaccine producer of Changchun Changsheng Life Sciences Ltd..

Chinese Premier Li Keqiang. [File Photo: gov.cn]

Mandated by the Communist Party of China Central Committee and the State Council, the investigation team has established the basic facts involving the breaching of laws and regulations in rabies vaccine production and the production of substandard DPT vaccines by Changchun Changsheng.

In its reckless pursuit of profits, the company committed unlawful acts of grave nature. The case has exposed supervision failures on the part of local governments and regulatory agencies in implementing their overall responsibility in ensuring food and drug safety, and the fact that state and local supervision authorities lacked severely in lawfully fulfilling their duties of supervision.

These include particularly the failure to report major risks and potential risky conditions, and improper contingency management, pointing to serious dereliction of duties and nonfeasance.

Up to now, public security authorities have finished the investigation of the Changsheng case and those suspected of breaking the law have all been handed over to judicial authorities for prosecution.

Competent department will also properly deal with the substandard vaccines that have been sold overseas.

The meeting demanded that those who engaged in law-breaking and criminal activities be severely penalized and those who neglected their duties be held accountable. The company will be punished according to the Drug Administration Law, and all illegal profits of Changchun Changsheng Life Sciences Ltd. will be confiscated, and a maximum of fine will be imposed.

At the same time, local governments and regulatory agencies be strictly held accountable for misconduct, as a warning to others.

Drug safety and quality checks will also be carried out for vaccine producers across the country. Any misconduct and problems should be made public and addressed in time.

"Our investigation findings and safety checks must stand the test of history," Li stressed at the meeting. "We must conduct thorough safety checks on vaccine production both by producers themselves and competent authorities and close all loopholes in the vaccine regulatory mechanism. Efforts should be made to build public confidence in the safety and effectiveness of vaccines made in China."

The meeting urged for putting in place the most rigorous drug regulatory mechanism and for improving the supervision of entire-chain vaccine production as well as related electronic tracking system, and for promoting domestically produced vaccines for quality upgrading so as to ensure drug safety.