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China shuts down 300 drug & medical instrument manufacturers
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China has shut down 300 drug and medical instrument manufacturers for inferior quality products during a national campaign that has been ongoing since last July, said China's drug watchdog in Beijing on Monday.

"The campaign to correct malpractice in the pharmaceutical industry is showing results," said Wu Zhen, deputy director of the State Food and Drug Administration (SFDA), at a press conference.

By October, about 900 fake drug producers were dug out and 440 cases were handed over to the prosecutors while 279 persons faced criminal charges, he said.

During the campaign, inspectors have examined more than 29,000 types of drugs and examined over 148,000 drug registration files and 26,000 files for medical instruments.

About 7,300 pharmacy companies withdrew their application for drug approvals during the campaign, Wu said, adding that the quality of drugs, waiting for approval, has greatly improved although the number of applications has dropped.

The inspectors also found 1,100 already approved drugs and medical appliances that had been illegally approved.

"Producers of blood products and vaccines were high on the inspection agenda," Wu said. About 1,300 inspectors were sent to specific pharmaceutical firms to tighten supervision.

The administration also verified the companies winning certificates of Good Manufacturing Practice (GMP) and withdrew 150 such certificates, he said.

To regulate the medicine distribution, more than 900 drug retailers and wholesalers' sales licenses were withdrawn for selling drugs they should not sell.

Meanwhile, around 180 drugs and medical instruments were banned from sale after being advertised illegally.

The Panama medicine deaths have reflected managerial differences between different countries, Wu Zhen also said.

"Management on imported drugs varies among different countries, " said Wu.

"This will inevitably result in blank points in management that may enable some companies to take advantage of the loophole," he added.

China has been strict with management regarding chemical medical materials, said Wu.

According to China's law on drug management, Chinese companies are not allowed to produce medical materials that could be directly used in medicine unless they have got a license and a certificate number from the proper drug authorities.

And China has set down specific regulations regarding imported drug management, Wu said, noting that no drug would be admitted into the country before it is proved to be safe.

In some countries, however, imported drugs need not be approved, the official said.

To address the differences, Wu said that the SFDA has signed an agreement with pertinent organizations inside the European Union focused on strengthening drug management, and has reached consensus with the Food and Drug Administration (FDA) of the United States in areas of drug and medical apparatus safety.

China's actions follow the deaths of dozens of people in Panama after taking medicine that was made in China. A Chinese company shipped 11,349 kg of "TD glycerin" to Spain in 2003, where it was then sold on to Panama.

The product, "TD glycerin" is an industrial solvent containing the toxic diethylene glycol. It was later found to be linked to dozens of deaths in Panama from tainted medicine.

Chinese quality officials have said that "TD glycerin" is a misleading label because it could be mistaken for glycerin, a sweetener commonly used in drugs. China has shut down the Taixing Glycerin Factory, the producer of "TD glycerin."

But Chinese quality officials stressed that the Panamanian merchants were mainly responsible for the tragedy because they changed the scope of use and shelf life of this product.

The Chinese company confirmed with the Spanish company that the product could not be used as a pharmaceutical in China and that the product's shelf life was one year rather than four years, according to Chinese officials.

At the press conference, Wu also warned both domestic and foreign drug trading companies not to import from illegal Chinese exporters or drug producers in order to ensure drug safety.

(Xinhua News Agency December 4, 2007)

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