China Launches Drug Recall System After Push By U.S.

Wednesday, December 12th 2007, 7:42 am

By: News On 6

BEIJING (AP) _ China launched a nationwide recall system Wednesday that shifts responsibility to companies to recall harmful drugs, a day after U.S. and Chinese officials signed an agreement on the safety of medicine and medical devices.

The recall plan will place Chinese-made drugs and imported drugs in three classes according to their possible danger to people's health, a State Food and Drug Administration official said at a news conference.

Each will have to be recalled within different timeframes, ranging from 24 hours for the most serious drugs, to 72 hours for those deemed less life-threatening.

The global pharmaceutical industry increasingly uses drugs either made or containing ingredients sourced in China. That has put more attention on China to restore confidence in its manufacturing capabilities after a series of products ranging from toys to toothpaste to a pet food ingredients were found to contain poisonous products earlier in the summer.

The new recall rule puts the onus on companies to have systems in place to recall bad drugs within the set time period and take responsibility to alert the government of any noticeable bad reactions on patients that are caused by their drugs. They are also encouraged to carry out voluntary recalls and may be excused punishment if they do.

Drug distributors and medical institutes must also notify authorities of any safety risk to a particular drug.

Unlike in the U.S. where drug recalls by companies are voluntary, the Chinese government can also order a compulsory recall of bad drugs. A fine three times the total value of the recalled drugs will also be levied on a company which did not voluntarily recall a bad drug.

``We hope that government and companies can cooperate to enhance and perfect the establishment of the system and not just rely on the government's information. The companies should make efforts to monitor drug reactions,'' State Food and Drug Administration Deputy Director Yan Jiangying said.

The recall doesn't deal with counterfeit drugs, which are covered under a different law.

Under the agreement made with the U.S. Tuesday, the State Food and Drug Administration will require firms manufacturing specific drugs and medical devices to register with it.

The agreement covers 10 exports to the U.S., and eight products the Chinese want to import. This is just a sliver of China's health-related exports to the U.S. but the list may be expanded, Yan said.

The list for the U.S. includes drugs to treat impotence, dietary supplements, glucose test strips and condoms.

On China's list is drugs to treat AIDS, hepatitis and insulin, as well as pacemakers.