China revamped, renamed and promoted its drug regulator recently after a series of embarrassing disclosures last year by Chinese media about toxic capsules and cooking oil used in antibiotics. But no sooner had the new ministerial-level agency made its debut than state TV in China reported a new scandal that affected one of its larger drugmakers.
Guangzhou Pharmaceutical had to recall a popular flu treatment after CCTV reported that herbs from one of its suppliers contained unhealthy levels of mercury and arsenic, the South China Post reports. Authorities pulled the license of Baoshantang Pharmaceutical saying the supplier faked records to cover up the fact that the "non-medicinal" herbs might be tainted because farmers had been using sulfur to steam them. A manager told the newspaper that Baoshantang had stopped production and was cooperating. He said the company was not trying to hide the issue, blaming it on "chaotic management."
Seven people were recently sent to prison after authorities, following media reports, shut down factories last year that had been making chromium-tainted drug capsules. It turned out they were using cheap waste leather from tanneries to make their gelatin. There were also reports of an API maker buying so-called "gutter oil"and using it to make intermediate 7-aminocephalosporanic acid (7 ACA).
China recently consolidated a number of food and drug oversight responsibilities into a new agency, the China Food and Drug Administration (CDFA), and handed responsibility to the head of the food safety commission, Zhang Yong. China several years ago set an example by executing the former head of the State Food and Drug Administration for taking bribes to license unqualified drug companies.
The U.S. FDA has been paying closer attention to drugmakers in China that export to the U.S. In a recent consumer update, Christopher Hickey, who heads the FDA's 13-person operation there, said China was cooperating with the FDA to improve quality. He said in the last two years his office had trained more than 1,600 manufacturers and regulators on U.S. safety standards.
- read the South China Post story
- here's the FDA consumer update
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