Drug safety watchdog has issued a new drug recall method, which encourages pharmaceutical manufacturers to recall unsafe drugs voluntarily.
The regulation, promulgated Monday by the State Food and Drug Administration (SFDA), says that enterprises, which voluntarily recall unsafe drugs, will be subject to lower, or even be exempted from, administrative punishment.
Those, who are aware of problems with their drugs but fail to issue voluntary recalls, will face heavy fines or even be deprived of drug manufacturing licenses, Yan Jiangying, spokesperson of the SFDA, told a press conference Wednesday.
China has witnessed a series of drug safety scandals over the past years. Yan said most drug recalls in the past in China were compulsory recalls issued by the government.
"The new recall methods emphasize the primary responsibility of pharmaceutical manufacturers in drug safety," Yan said.
According to the regulation, manufacturers must set up and improve their quality monitoring systems, promptly analyze information and feedback from hospitals, retailers and users, and to investigate and evaluate potentially unsafe drugs.
It classifies the problem drugs that must be recalled into three categories, with the first being potentially fatal and harmful drugs, which must be recalled within 24 hours of the recall announcement.
The second category is drugs that may cause temporary or reversible health problems and producers have two days to recall these.
The third category involves drugs that must be recalled within three days for reasons other than safety, such as improper packaging.
The move by the SFDA comes in the wake of pressure on the Chinese government to overhaul the country's food and drug safety system.
One of the most notorious cases of substandard drugs was that of Anhui Huayuan Worldbest Biology Pharmacy Co., whose antibiotic injections had been blamed for six deaths last year.
The problem injections, produced in June and July last year, was found to be not properly sterilized, with both sterilization temperature and time being below the state-required safety level. The producer was then given two weeks by the SFDA to retrieve all its problem drugs.
(Xinhua News Agency December 12, 2007)
