China's 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, according to the regulation.

 

"Fines will be three times the value of the recalled drugs," Yan Jiangying, spokeswoman of the SFDA, told a press conference Wednesday.

 

China has witnessed a series of drug safety scandals over the past years. 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, were 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.

 

Yan said most drug recalls in the past in China, like the substandard injection case, 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.

 

Yan said the new regulation also applies to overseas pharmaceutical enterprises, which export drugs to China. "Their legal obligations are the same as domestic drug makers," said Yan.

 

To improve risk control on imported drugs, Yan said the regulation also requires overseas manufacturers to report promptly to the SFDA when they decide to recall products outside China.

 

The new regulation also requires that drug retailers and users cooperate with manufacturers in retrieving drugs.

 

Drug retailers and users should stop using the drugs once problems occurred, inform producers and suppliers of the problems promptly and report to drug safety administrations, according to the regulation.

 

Drug safety administrations at all levels should improve monitoring capacity, publicize drug safety information regularly and make sure that such information could reach the public, the regulation says.

 

"Compared with previous drug recall rules, which were rather general in wording, the new regulation is more specific, scientific and applicable," Yan said.

 

(Xinhua News Agency December 13, 2007)