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Substandard drug firms face shutdown
(China Daily)
Updated: 2004-05-08 00:22

Some 2,000 drug manufacturers may be shut down if they fail the Good Manufacturing Practice (GMP) authentication by July 1, said an official from the State Food and Drug Administration (SFDA).

The most recent statistics show that more than 2,800 drug manufacturers out of 6,000 have passed the GMP authentication so far. Some 1,000 companies are upgrading their technology to conform to the standard, and another 2,000 look certain to fail, SFDA sources said.

"Medicine producers which fail to pass the authentication will be closed down," said Bai Huiliang, director of safety supervision under the SFDA. He was speaking recently at a seminar on China's Medicine and Health Production.

Companies upgrading their technology will have a six-month grace period. By the end of this year, if they still do not pass, they will be closed down.

China introduced the GMP authentication, an international standard of medicine production, in 1998. In 2003, as a measure to ensure medicine safety, the SFDA regulated that all drug enterprises and workshops would have to pass the GMP authentication by July 1, 2004 to continue operating.

Bai noted that the adoption of the GMP has helped promote the structure and production upgrading of the medicine industries. In 1998, only 87 medicine manufacturers passed the GMP inspection. Now producers of all blood products, injections and powder injections have all passed the GMP authentication. The rate of qualified medicine reached 97 per cent in a survey in 2003 from 89 per cent five years ago.

The pharmaceutical industry revenue in China was about US$20 billion, of which 48, 30, and 22 per cent comes from the sales of joint venture, domestic, and imported products respectively.

The Pharmaceutical Control Law, which was promulgated on December 1, 2001, stipulates that domestic pharmaceutical manufacturers must abide by international rules, laws, and practices. GMP is part of them.

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