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China Daily Website

China to enforce blacklist for unsafe drugs

Updated: 2012-08-16 09:15

Regulations that call for the blacklisting of manufacturers of unsafe medication will go into effect in October as part of nationwide efforts to enhance medical safety.

According to rules issued Wednesday by the State Food and Drug Administration (SFDA), information regarding the manufacturers and those found responsible for severe violations of relevant laws will be included in a blacklist that will be posted on government websites for public supervision.

The blacklist will include those involved in the production and sale of counterfeit or inferior drugs, as well as those who have produced uncertified medical equipment or who have caused accidents by producing substandard equipment, the regulations state.

The regulations also call for the revocation of licenses granted to companies on the blacklist, as well as a 10-year suspension of their operations.

The blacklist should appear in a conspicuous place on the websites of local drug safety regulators and should be maintained by designated personnel in a timely fashion, the regulations state, adding that major drug safety cases will also appear on the list.

A SFDA official said the blacklist will further enhance supervision and management concerning drugs and medical equipment, as well as perfect the industry's prohibition and withdrawal mechanism and deter violators.

The unnamed official said regulators welcome supervision from social organizations and members of the public concerning companies and people on the blacklist.

China has launched several nationwide crackdowns on counterfeit drugs in recent years after major cases in which the use of the drugs resulted in deaths. The former director of the state food and drug regulatory body was executed in 2007 for abusing his position by approving lethal counterfeit medicine in exchange for money.