Changchun Changsheng Life Sciences came to the attention of authorities at the end of July this year, when the State Drug Administration (SDA) announced the company had falsified data during the production of its human rabies vaccine.
The case has now culminated in a total fine of ¥9.1bn ($1.31bn), delivered through action taken by the SDA and the Jilin Food and Drug Administration. The latter ordered the bulk of the fine, by demanding the company pay three times the total value of defective vaccines produced and sold (¥7.21bn), a separate fine for the “illegal proceeds” made on the vaccines (¥1.89bn) and the revocation of the company’s pharmaceutical license.
In addition, the SDA imposed a fine of ¥12m and removed the company’s drug approval certificate for the vaccine, according to an announcement from the government (available here in Mandarin).
The affair has also claimed a number of officials’ positions, with the government noting that 14 personnel directly involved in the case could have criminal cases launched against them.
The overall action against the company was reached after the SDA found that Changchun Changsheng had made eight illegal infractions in the production of the rabies vaccine, which had been used in children.
The notable instances within these being the company’s decision to blend different batches of vaccines, with some batches that were later discovered to have expired, and falsifying production dates. It was also revealed that the company destroyed hard drives and other data related to the case.
The fine follows public outcry in China over the investigation’s findings, widely reported in local media, and a reaction from the top levels of China’s government – the country’s premier, Li Keqiang, stated that Changchun Changsheng had “crossed a moral line” with its actions when the investigation first began.