Guilty producers of substandard vaccines to be severely punished: State Council

Grave unlawful acts were committed by Changchun Changsheng Life Sciences Ltd in the production of what turned out to be substandard vaccines, a State Council committee has announced.

An executive meeting chaired by Premier Li Keqiang was held on August 16 to follow up the findings of an investigative team's report into the production of substandard DPT and rabies vaccines.

The report said the company had behaved unlawfully in its "reckless pursuit of profits" and that the case had also highlighted supervisory failures on the part of local government and regulatory agencies in implementing food and drug safety rules.

State and local supervision authorities were also criticized for their failings, including a failure to report major risks and potential risky conditions and poor contingency management, leading to a serious dereliction of duty.

Public security authorities have finished the investigation into the Changsheng case, and those suspected of breaking the law have been handed over to judicial authorities for prosecution.

The State Council said that those who engaged in law-breaking and criminal activities will be held accountable and severely penalized. The company will be punished according to the Drug Administration Law, with all illegal profits of being confiscated, and the maximum fine possible imposed.

Local government and regulatory agencies will also be held accountable for their misconduct, as a warning to others.

In the meantime, drug safety and quality checks will be carried out for vaccine producers nationwide. Any misconduct or problems should be made public and addressed urgently.

"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 the implication of a rigorous drug regulatory mechanism and improvement of the supervision of the entire chain of vaccine production.

Other proposals included a related electronic tracking system, and upgrading the quality of domestically produced vaccines to ensure patient safety.