Premier Li Keqiang underscored improving the country’s full-cycle supervision system for vaccines at a State Council executive meeting.
Li made the remarks after hearing a report from a State Council investigation team which shed light on the illegalities of Changchun Changsheng Bio-tech Co. in making rabies vaccines for human use.
Investigators have found “extremely severe” violations by the vaccine-maker, who had arbitrarily altered the production process, fabricated production and product inspection records, and destroyed evidence, according to a statement released after the meeting.
Police have requested approval to arrest the suspects involved in the vaccine case, according to the statement.
Those held responsible should be given higher penalties and hefty fines, while those who have committed felonies should get jail sentences and a lifetime ban from working in the pharmaceutical industry, the statement said.
Monitoring of research and development, production, circulation, and usage of vaccines should be improved, and a long-term mechanism should be built to ensure the safety of medications, according to the statement.
The meeting called for accelerating the investigation into the entire chain of vaccine production of all 46 vaccine producers in China.
A thorough investigation into related regulators will also be conducted with no leniency, according to the statement. Officials found guilty of dereliction or misconduct will be probed thoroughly, those taking bribes will be dealt with seriously, and those who bear leadership responsibility should also be held strictly responsible according to the law.
Local authorities will receive help in recalling and destroying all affected vaccines, and the exported defective vaccines will be recalled under supervision with timely briefings to the World Health Organization and related countries, the statement said.
The State Drug Administration said yesterday that Wuhan Institute of Biological Products Co. made the substandard diphtheria, tetanus and whooping cough vaccine (DTaP) for infants by accident. The manufacturer has recalled all unused substandard doses and destroyed them.
400,520 doses of substandard vaccine produced by the manufacturer were sold to Chongqing municipality and Hebei Province.