China rejects 11 drug applications over inadequate trial data

The quality of medicines produced in China is a growing focus both for Beijing, which is pushing an ambitious programme of healthcare reform, and for foreign countries that rely on China and India for pharmaceutical ingredients and finished drugs.

India's long-established generic drugs industry has run into a series of high-profile quality problems with the U.S. Food and Drug Administration in recent years.

"The CFDA seems very, very determined on this quality issue and that could change the Chinese pharmaceutical industry in a big way," said one senior executive with a multinational drugmaker.

Deutsche Bank analyst Jack Hu said that the CFDA's action was a short-term setback for the Chinese industry but should be of long-term benefit to companies with high quality standards, such as Sino Biopharmaceutical, Shanghai Fosun and 3SBio.

The eight companies to have drugs rejected were named by the CFDA as Hainan Pharmaceutical, Zhejiang Huahai Pharmaceutical , Hebei Pharmaceutical, Qingdao Bai Yang Pharmaceutical, Zhejiang Angli Kang Pharmaceutical, Hainan Kang Chi Pharmaceutical, Guangdong Pharmaceutical and Shandong Da Yinhai.