Chinese regulators do not inspect plants exporting to the US and other countries, so I guess this leaves the burden to the currently understaffed FDA, who also needs some technology help with their services, hardware, etc. BD
Pharmaceutical companies and medical device makers are in no mood to break their China habit, as several life sciences companies are planning on expanding manufacturing operations in that country. That, despite 21 deaths and a staggering number—over 700—of reported adverse reactions linked to contaminated Baxter Heparin, the main ingredient of which was imported from China. And the Baxter Heparin debacle hasn’t even been the worst scandal resulting from Chinese drug manufacturing. Last year, in Panama, dozens of deaths were traced to Chinese-made medicine tainted with an ingredient found in antifreeze. In China itself, hundreds of people were reportedly injured by a contaminated leukemia drug.
But even the FDA says many of those Chinese manufacturers are not up-to-snuff. “While some Chinese [drug] companies are state-of-the art in technology and manufacturing expertise, many are at the opposite end of the spectrum,” FDA deputy commissioner Murray Lumpkin told Congress last year
Despite Tainted Heparin, US Drug and Medical Device Companies Still Like China
0 comments :
Post a Comment