China beefs up pharmaceutical regulation

BEIJING -- The Chinese government Thursday introduced tougher measures concerning the production of pharmaceutical excipients following a scandal involving contaminated medicine capsules.

According to a new regulation on the management of pharmaceutical excipients, or pharmacologically inactive substances used to carry the active ingredients of medication, the State Food and Drug Administration and its branches will raise standards for excipients when approving new medicines.

Excipients that are new on the market or contain greater safety risks should be registered and approved and their producers will have to obtain production licenses from authorities, the document says.

Other excipients and their producers will be monitored, the document says.

The SFDA will set up a national database to monitor the production and application of all pharmaceutical excipients, as well as a credit reporting system for producers, said Zhang Wei, head of the registration division under the SFDA.

The regulation says pharmacy firms should be held responsible for quality control problems resulting from the use of illegal and substandard excipients. The firms should also supervise the quality of excipients and regulate their suppliers, the regulation says.

A China Central Television report delivered in April stated that several companies had manufactured drug capsules with industrial gelatin, which contains excessive levels of chromium and is illegal to use for making drug capsules.

The industrial gelatin was made from leather scraps, according to the report.

The SFDA announced in May that 254 pharmaceutical enterprises, or 12.7 percent of all capsule makers in the country, were found to be producing unsafe drug capsules after a month-long inspection, with 5.8 percent of tested drugs found to contain excessive levels of chromium.