New rules on pharmaceutical excipients to stem malpractice

BEIJING - A senior medical official on Friday expressed confidence that a new regulation will prevent malpractice and help regulate the pharmaceutical market.

Yin Li, director of the State Food and Drug Administration (SFDA), said the new regulation on the management of pharmaceutical excipients, or pharmacologically inactive substances used to carry the active ingredients of medication, will take effect on February 1 next year.

The SFDA issued the regulation Thursday in response to a serious scandal involving contaminated medicine capsules.

The pharmaceutical excipient industry will undergo stricter scrutiny under the new rules, Yin said.

The industry is relatively new in China. There were no suppliers specializing in excipients until the late 1970s and legislation concerning the management of the sector was not created until 2001.

The SFDA issued a guideline on quality management in 2006, but it has only been used for reference purposes, Yin said.

"The recent capsule scandal exposed loopholes in supervision. The new regulation aims to fill in the blanks," he said.

To meet the higher quality standards set by the new regulation, the country plans to increase the number of criteria for excipients in the "Chinese Pharmacopoeia" from 132 in the current version, published in 2005, to 300 in the next version to be published in 2015, he said.

Producers who fail to meet the new standards will be elbowed out of the market and those adopting better practices will remain, he said.

Since the regulation holds pharmaceutical firms responsible for quality control problems resulting from the use of illegal and substandard excipients, the firms will be forced to supervise the quality of excipients and regulate their suppliers, he said.

"We believe the regulation will be an effective warning for the whole industry," he said.

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.