China’s Crackdown On Bad Drugs Inches Forward

Listening to the deputy commish of the State FDA, one could get the impression that Chinese pharmaceutical manufacturers are developing a greater sense of self-awareness, or fear. Supposedly, more than 7,300 drugmakers withdrew applications for drug approvals under new rules that include improved drug registration, and more oversight of manufacturing and marketing, Reuters reports.

“The withdrawals have shown that the pharmaceutical companies are examining themselves in this special campaign and their awareness for drug safety has been greatly enhanced,” Wu Zhen, deputy commissioner of the State Food and Drug Administration, told a news conference. The 7,300 withdrawn applications account for 24 percent of those investigated, suggesting the magnitude of the problem.

The agency is trying to restore its reputation after its previous head was executed this summer on charges he took bribes to approve untested medications. “I can tell you that our team has an arduous task, and it is true that we face huge pressure,” Wu told a news conference. “To some extent our personnel and our team is inadequate both in terms of the size of our staff and the resources to fulfil their tasks.”

A nationwide campaign to regulate the drug market was started in July. About 180 drugs have been banned from sale due to false advertisements, Wu said, and 300 drug and medical device manufacturers have been shut down for bad-quality products.

But the problem of fake drugs in China is still a sizable one, with 1,100 drugs that were approved later found to have problems. Hundreds of illegal manufacturing sites have also been busted, the administration said in a statement. Wu said China has exercised “stringent management” of its pharmaceutical exports, with only approved companies being allowed to export their products.

Wu said any export problems lie with the importers who do not have strict enough rules and regulations. We are strict in the regulation of imported drugs, but some other countries do not have such strict regulations and rules. Therefore, there will always be some gaps and some vacuum in regulations and management,” Wu said.