Decisions were made at the State Council’s executive meeting on Aug 16 chaired by Premier Li Keqiang, following a report on the findings of investigations into the case of substandard vaccine producer Changchun Changsheng Life Sciences Ltd.
Mandated by the Party Central Committee and the State Council, the investigation team 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 grave unlawful acts. 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 failed to fulfill their duties in supervision. These include, in particular, the failure to report major risks and potential risky conditions, and improper contingency management, pointing to serious dereliction of duty and nonfeasance.
So far, Public Security authorities have finished the investigation into the Changsheng case, and those suspected of breaking the law have all been handed over to judicial authorities for prosecution. Competent departments will also deal with substandard vaccines that have been sold overseas.
The meeting demanded that those who engaged in lawbreaking and criminal activities be severely penalized and strictly track the responsibility and hold them accountable. The company will be punished according to the Drug Administration Law, and all illegal profits of Changchun Changsheng Life Sciences will be confiscated, and the maximum fine will be imposed.
At the same time, local governments and regulatory agencies will be strictly held accountable for misconduct, as a warning to others.
In the meantime, drug safety and quality checks will be carried out for vaccine producers across the country. Any misconduct and problems should be made public and addressed in a timely manner.
“Our investigation findings and safety checks must stand the test of history,” Premier 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 putting in place the most rigorous drug regulatory mechanism and improve the supervision of the entire chain of vaccine production, as well as a related electronic tracking system, and promote domestically produced vaccines for quality upgrading, in order to ensure the safety of drugs for the people.