Simcere Pharmaceutical Group announced Monday that Chinese officials have imposed a $3.75 million fine on its Jiangsu Yanshen unit as a result of its production of substandard rabies vaccine for humans. According to the decision by the Changzhou Food and Drug Administration, the fine consists of penalties and confiscated revenue from previous sales. Jiangsu Yanshen will also bear the cost of patient re-vaccinations up to $3.37 million.
Simcere entered an agreement to obtain a controlling stake in Jiangsu Yanshen last October and subsequently discovered quality control problems relating to the production of the vaccine, according to a statement. A week prior to the start of an SFDA investigation, Simcere says it had urged the board of Jiangsu Yanshen to replace its general manager and head of quality assurance. When the agency came to investigate, it found four batches of the rabies vaccine made between July and October 2008 with"quality problems." The agency ordered Jiangsu Yanshen to halt marketing and production of all products and organized experts to provide an assessment of risks presented by the problem vaccine.
As a result, members of Jiangsu Yanshen's management team and employees who were directly involved in the production of the substandard vaccine will be prohibited from engaging in the production and marketing of pharmaceutical products for a period of 10 years, according to a Simcere statement. In addition, a criminal investigation is under way.
Although there have been no reported adverse events related to the vaccine, Jiangsu Yanshen's operations remain suspended.
- check out the Simcere release