China Drugmakers Face U.S. Scrutiny on Investigator Bump

Lock
This article is for subscribers only.

U.S. regulators are more than tripling to 27 the number of workers they’ll have in China to inspect pharmaceutical plants and products, a move that may spur a wave of enforcement similar to what’s happening in India.

An increased number of Food and Drug Administration investigators in India this year led to import bans against some generic drugs from Ranbaxy Laboratories Ltd. and Wockhardt Ltd. for failure to meet U.S. standards. The China expansion is the culmination of almost two years of negotiations with government officials, Christopher Hickey, director of the FDA’s China office, said in a telephone interview from Beijing.