China stops imports of Fluconazole injection

Published: 17-Jan-2014

Pfizer says problem is not related to safety or quality


China's drug watchdog has decided to stop importing an injection from Pfizer, as the US pharmaceutical manufacturer failed a supplementary application for drug exports. It has decided not to import Pfizer's Fluconazole injection, used to treat monilial infection, until the company makes a correction, according to the State Food and Drug Administration (SFDA).

The SFDA said it recently inspected Pfizer's Amboise plant in France and found that the factory did not submit relevant supplementary applications in accordance with Chinese law and regulations. , Pfizer said in a statement that the problem did not involve safety and quality.

China has been trying to maintain high manufacturing standards; it also launched a drive against drug counterfeiters last year. This year, the focus is meant to be on companies that fail to make the grade. The new programme is part of a larger effort by Chinese regulators to maintain high manufacturing standards within the country's drug production industry.

 

Earlier, Shanghai Pharmaceuticals Holding was accused of bribing doctors to improve its sales. The company has allegedly given kickbacks to doctors in 31 hospitals in Qingdao, Shandong province, for prescribing an anaemia treatment produced by its subsidiary Qingdao Growful Medicine. Hospitals involved include top level public ones in the city, including the Affiliated Hospital of the Qingdao University and the Qingdao Municipal Hospital Group.

The subsidiary company allegedly received US$478,000 from selling the medicine to the 31 hospitals from January to June 2013, while also giving some kickbacks to doctors. The disciplinary committee of the Qingdao health bureau has begun investigating the incident. 

Regulators in China probed numerous domestic and international drug firms in 2013. The most high profile investigation involved GlaxoSmithKline. GSK has said it would stop paying doctors to promote its products.

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