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Simcere Says Rabies Shot Lacked Active ingredient

From Associated Press (April 5, 2010)

NEW YORK -- Simcere Pharmaceutical Group said Monday that Chinese state regulators determined that four batches of a rabies vaccine made by one of its subsidiaries did not have enough active ingredient because employees broke the law and avoided inspections.

The division could face administrative penalties and criminal prosecution, which Simcere said may hurt its financial results.

The investigation concerns four batches of human use rabies vaccine made by Jiangsu Yanshen Biological Technology Stock Co. Simcere said the China State Food and Drug Association determined the non-working vaccine reached the market because laws were broken, quality controls were not sufficient, and regulatory inspection was misrepresented and avoided.

The four batches which were sold between July and October 2008. Simcere, a generic drug developer, bought a controlling stake in the company in October 2009.

Simcere said the Jiangsu Yanshen employees who were responsible for those activities are under criminal investigation.

The SFDA’s conclusions were based on investigations by local regulators and police. Simcere said no negative effects from the vaccine have been reported.

Simcere said it discovered the problem shortly after buying Jiangsu Yanshen. In November 2009, Simcere says it urged the board of Jiangsu Yanshen to replace its general manager and head of quality assurance, and stop all production to allow for an inspection and improvement of quality control. It said Jiangsu Yanshen reported the suspension to regulators and has been cooperating with them.

Jiangsu Yanshen has still not restarted production, and Simcere said it does not know when or if operations will resume. Simcere said it will monitor the investigation and intends to pursue all available legal options against the selling shareholders of Jiangsu Yanshen


Posted: April 2010