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China Plans to Boost Drug Safety

The country's top watchdog for food and drug safety wants to make it mandatory for producers to recall defective, unsafe drugs and medical devices.

If producers do not carry out the recalls on their own, the government will order a recall and fine the producer up to three times the value of the products, according to a draft regulation published on the website of the State Food and Drug Administration (SFDA) on Thursday.

The regulation states that producers must inform the public and retailers if it is revealed their products are unsafe.

Retailers also must stop selling the products immediately or they will face a fine of up to 50,000 yuan (US$6,600).

If producers fail to voluntarily recall their products, which then lead to serious public harm, they will have their production licenses revoked and be subject to criminal charges, according to the regulation.

In addition, drugs and medical devices to be exported must meet the standards of the market countries.

A blacklist of the shoddy manufacturers will be made public.

The SFDA is calling for public comment on the draft regulation.

Yan Jiangying, SFDA's spokeswoman, said at a Thursday press conference that the draft regulation was designed to strengthen the State Council Special Regulations on the Safety Supervision and Administration of Food and Other Products, issued last month.

She said the Special Regulations intensified the punishment for illegal acts and reinforced the responsibility of supervisors.

"It (the Special Regulations) also introduces some new polices, such as a recall system," she said.

"In response to that, we'll issue detailed regulations and establish a management system."

Yan said China did recall unsafe drugs in the past, but it was done "case by case" without a sound system. She also revealed that the country would invest 8.8 billion yuan (US$1.2 billion) to upgrade the infrastructure of a number of drug and food safety testing centers.

The General Administration of Quality Supervision, Inspection and Quarantine earlier said it would release the country's first regulation on unsafe food recalls by the end of the year.

These latest moves follow a spate of safety scares concerning made-in-China products. Reports have revealed isolated cases of contaminated food additives, unsafe toothpaste, seafood, toys and even tires, and affected global confidence in Chinese products.

Premier Wen Jiabao said China would face the problems squarely and make consistent efforts to improve product quality. However, Wen also noted that China did not support media hype and was against trade protectionism and discrimination.

(China Daily August 11, 2007)

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