China may blacklist substandard drug manufacturers

If the FDA finds that a drug manufacturer is faking results and blatantly flaunting good manufacturing standards, it may ban anything coming out of the plant. If it is bad enough, there can be criminal charges.

In China, regulators are considering something a little less punitive. They might put those kinds of companies on a blacklist, with the hope that the bad publicity will get them to shape up, reports China Daily. The list, which would be posted through news releases and government websites, will tally up companies that "severely" violate safety and manufacturing rules, according to a draft posted on the State Food and Drug Administration (SFDA) site last week. The state agency is soliciting feedback through tomorrow, the report says.

Those who make the list will be monitored, Wang Lianglan, an SFDA spokesperson, told the paper. That can include more frequent inspections and demands for quality reports, China Daily says.

An expert associated with the Ministry of Health says he believes that the publicity would cost drugmakers lots of sales and motivate them to do a good job. He did indicate a need to step up the penalties for companies who persist in turning out bad products. "Those who continue with their bad practices should be expelled from the trade forever," said Sun Zhongshi of the National Rational Drug Use Monitoring System.

The proposal comes after media reports led to a government investigation that found nearly 250 capsulemakers were using industrial grade gel made from leather scraps in their products, reports Pharmalot. Chinese drugmaker Biostar Pharmaceutical ($BSPM) said last week that tests it did since the revelations found about 5 million of its capsules contained excessive levels of chromium. 

Chinese regulators have had difficulty keeping close oversight on the burgeoning drug industry, but then so have regulators in the U.S. The FDA was castigated in 2008 when substandard heparin from Chinese API makers made it into blood thinner products here and led to dozens of deaths. The agency intends to use some of the additional funding that would come from its pending congressional reauthorization to crank up inspections in China. The reauthorization also would give the FDA new powers to stop at the border drugs made by foreign manufacturers on its own blacklist.

- read the China Daily story
- see PBR's story
- get Pharmalot's take
- here's the SFDA proposal

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