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| Center Set Up to Curb Graft in Drug Licensing |
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China launched a national center yesterday to handle applications of licences for new drugs or medical devices as part of efforts to fight corruption and increase efficiency. All drug makers should first hand in their application documents to the centre, which is under the State Food and Drug Administration (SFDA). The centre, after making sure the enterprises and their products are qualified to apply for licences, will then transfer the documents to a team of experts who will examine them. Based on the examinations, SFDA will give a final approval for the drugs or medical devices, and the centre will issue licences to the enterprises. The centre is also authorized to ask the experts and relevant SFDA departments to finish their work on time, said Zhu Guofu, director of the centre. Before the establishment of the centre, it was the responsibility of the SFDA departments to accept, examine and approve licence-related documents. However, those departments with approving authority enjoy unsupervised power. The situation has caused serious corruption and made the system inefficient in the past. In early January, Cao Wenzhuang, 44, director of the department of Drug Registration of SFDA, and five other officials were arrested and charged with taking bribes. Before Cao, Hao Heping, another SFDA official, former director of the Department of Medical Devices, was also detained last June and accused of accepting bribes. The two cases are still under investigation and the amount of money involved is not known. Apart from setting up the centre, SFDA now also forbids drug makers from seeking different registered commercial names for their drugs. The chaotic registration process for new drugs and medical devices has been cited as a major cause for the rapid increase of medicine prices in China. About 75 per cent of Chinese residents still have no medical insurance, and many can only wait for their condition to worsen when they fall ill because of hefty medical costs. One reason behind the problem is that the SFDA has approved too many so-called new medicines in the past years, said Wu Yongpei, director of the Department of Pharmacy Regulation with the National Institute of Hospital Administration. For example, the SFDA approved 10,000 new drugs in 2004, compared with 148 in the United States. With the new anti-graft measures in place, it is estimated that China will only have less than 100 kinds of registered new drugs each year, SFDA said. Almost all the western drugs registered in China are copied from other countries. All the imitated medicines that have never been used in China are regarded as the new drugs. In the past years, the National Development and Reform Commission has reduced the prices of many medicines. However, because of the abuse of power by some SFDA officials, pharmaceutical enterprises just stop producing those drugs and change their names. Then they apply to the SFDA for the approval of new medicines, which actually have the same function as the old one, and sell them at much higher prices. Bribery paves the way for these enterprises to easily get a licence to produce those drugs. Take aspirin, a pain-killer, for instance. It only costs 0.03 yuan (0.36 US cents) a piece. But now it is very hard to find it in China. Instead, other drugs with the same medical content are sold at more than 0.63 yuan (7.7 US cents) a piece. So in China, it is quite common for one drug, such as penicillin, to have dozens of names and to be produced by hundreds of factories, Wu told China Daily. China has nearly 6,000 drug enterprises. (China Daily April 4, 2006) |
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