CHINA China's second-largest rabies vaccine maker to stop output after drug safety scandal

CHINA

China's second-largest rabies vaccine maker to stop output after drug safety scandal

CGTN

13:26, July 22, 2018

长生生物.jpg

File Photo

China Food and Drug Administration (CFDA) has issued an announcement asking Changchun Changsheng Life Sciences, China’s second-biggest rabies vaccine maker, to terminate the production of its Vero-cell rabies vaccines.

The announcement came after authorities carried out a snap inspection and found the company forging production data and violating the country’s drug production quality management protocols.

药监局.jpg

CFDA's investigation annoucement against Changchun Changsheng's ravies vaccines. (Screenshot via CFDA)

CFDA has asked the provincial food and drug administration of Jilin, where the company bases, to revoke Changchun Changsheng’s Good Manufacturing Practice (GMP) certificate, an international recognized license for drug production.

CFDA stated that the batch of rabies vaccines involved in the inspection had not been put on the market and had been “effectively controlled.” Inspectors from both state and provincial food and drug administrations have been stationing at the company for further investigation.

Changchun Changsheng’s parent company, Shenzhen-listed Changsheng Biotechnology, has made a public apology and voluntarily recalled all their rabies vaccines available at the market. 

冻干人.jpg

The investigated rabies vaccine produced by Changchun Changsheng Life Sciences. (Screenshot via Changchun Changsheng's official website)

The company stated the recall would cost over 200 million yuan (approximately 30 million US dollars) of the company’s business income. Zhao Chunzhi, secretary to the president at Changsheng Biotechnology, told China Securities Journal that sales revenue from rabies vaccine products counted for half of Changchun Changsheng’s gross revenue.

This is not the first time Changsheng Biotechnology and its subsidiaries got involved in drug safety scandals. On July 18, Jilin provincial food and drug administration announced the investigation result into Changchun Changsheng’s DTaP vaccine. 

Last year, a batch of the vaccines immunizing children against whooping cough, diphtheria and tetanus was found failing to conform to standards for biological potency. According to the report, 252,600 vaccines in the batch had been sold to disease control and prevention centers throughout east China’s Shandong Province.

Related Stories

Terms of Service & Privacy Policy

We have updated our privacy policy to comply with the latest laws and regulations. The updated policy explains the mechanism of how we collect and treat your personal data. You can learn more about the rights you have by reading our terms of service. Please read them carefully. By clicking AGREE, you indicate that you have read and agreed to our privacy policies

Agree and continue