Simcere Pharmaceutical said that as a result of the investigation conducted by the local food and drug regulatory authority and local police department the SFDA found that the four batches of human use rabies vaccine, which were manufactured by Jiangsu Yanshen and released into the market between July and October 2008, had an insufficient amount of active compound.
It was found that inadequate quality control processes were in place, and there was misrepresentation and avoidance of regulatory inspection, which caused substandard vaccine to be released into the market.
The situation arose before Simcere took an equity position in Jiangsu Yanshen. However, as an ongoing business entity, Jiangsu Yanshen may be subject to administrative penalties and criminal prosecution.
Earlier, on November 23, 2009, Simcere urged the board of Jiangsu Yanshen to replace its general manager and head of quality assurance and demanded that Jiangsu Yanshen implement a total suspension of production effective on November 30, 2009 to facilitate internal inspection and rectification of its quality control systems.
Jiangsu Yanshen subsequently reported the suspension to the relevant regulatory authorities and has been actively cooperating with them on their investigation. To date there have been no reported adverse events as a result of the vaccine batches in question. The authorities and Simcere are monitoring the situation closely.
Jiangsu Yanshen operations remain suspended and it is uncertain whether or when it will resume vaccine production. Simcere will closely watch the outcome of the investigation and intends to pursue all available legal options against the selling shareholders of Jiangsu Yanshen.
Simcere specializes in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China.