Some 2,000 pharmaceuticals makers will be shut down as they are almost certain to fail the Good Manufacturing Practice (GMP) authentication inspection by July 1, said an official from the State Food and Drug Administration (SFDA).
More than 2,800 drug manufacturers out of 6,000 have received GMP authentication so far. Another 1,000 or so are in the process of upgrading technology, but most of the remaining 2,000 are expected to fail.
"Drug producers that fail to pass the authentication inspection will be closed down," said Bai Huiliang, director of the SFDA's safety supervision department, at a recent seminar on China's production of pharmaceuticals and related health goods.
The SFDA will give a six-month grace period to the companies upgrading technology. If they cannot pass the inspection by the end of the year, they too will be closed down.
China introduced in the GMP authentication, an international standard for pharmaceuticals production, in 1998. In 2003, to ensure the safety and effectiveness of medicines the SFDA made GMP authentication compulsory for all drug enterprises and manufacturers. The deadline was set at July 1, 2004.
Bai noted that the adoption of the GMP standard has helped the pharmaceuticals industry to make structural improvements as well as to upgrade production. In 1998, only 87 manufacturers were able to pass the GMP inspections. Now all makers of blood products and liquid and powdered injectable drugs have obtained GMP authentication. In 2003, 97 of the drugs surveyed passed muster, up from 89 percent five years earlier.
(Xinhua News Agency May 8, 2004)
