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Tighter controls on drugs firms
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Measures will be introduced before the end of the year to better control the supply of ingredients for medicines, especially those produced by chemical firms that have crossed over into the drugs market, Yan Jiangying, spokeswoman for the State Food and Drug Administration (SFDA), said yesterday.

The image of China's pharmaceutical industry overseas has been tarnished by a number of incidents involving unregistered companies, she said.

To redress the situation, the SFDA will introduce higher standards for companies involved in the production of ingredients for pharmaceuticals, Yan said.

As well as the new standards, greater efforts will be made to monitor chemical firms that use regulatory loopholes to enter the pharmaceutical ingredients market.

Several government agencies including the SFDA, the National Development and Reform Commission and the new Ministry of Environmental Protection (MEP) will be involved, she said.

The MEP will help weed out chemical firms that fail to meet environmental protection standards, she said.

"Firms that do not have a permit from the SFDA to produce drugs or drug ingredients are strictly prohibited from conducting any drug-related business," Yan said.

Currently, only approved pharmaceutical companies are regulated by the SFDA, while chemical firms are supervised by other agencies.

The problem arises when chemical firms make drug ingredients illegally.

"We have never investigated a chemical firm, as it's beyond our scope," Yan said.

An industry insider said: "Some companies don't have the resources or means to produce medicines. The bar for producing chemicals is pretty low."

Also, the large number of chemical plants in China, officially estimated at about 80,000, makes the monitoring process more difficult, the insider said.

Despite the difficulties, the government is carrying out a nationwide inspection to find out how many firms are involved in the drugs business, Yan said.

In the long term, the SFDA will include all drug ingredients within its identification and supervision system, she said.

"This will help us to monitor all aspects of the drug production process and ensure drug safety," she said.

Currently, only selected high-risk drugs such as narcotics are covered by the system. But by the end of October, it will be expanded to include blood products, vaccine and traditional Chinese medicines that are taken intravenously, she said.

Meanwhile, following a nationwide anti-doping campaign, 18 drug companies and 14 drug retailers have been punished for illegally producing and selling anabolic agents and peptide hormones, Yan said.

(China Daily April 9, 2008)

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