China launched a national center yesterday to handle license
applications for new drugs and medical devices as part of a
campaign to fight corruption and increase efficiency.
Prior to embarking on projects all drug makers must first submit
application documents to the center, which comes under the State
Food and Drug Administration (SFDA).
The center, after ensuring the enterprises are legitimate and
their products authentic, will then transfer the documents to a
team of experts for close examination.
Based on this the SFDA will give final approval for the drugs or
medical devices, and?licenses would be issued by the
center.
The center is also authorized to ask the experts and relevant
SFDA departments to complete their work to a schedule, said Zhu
Guofu, director of the center.
Before the establishment of the facility it was the
responsibility of the SFDA departments to accept, examine and
approve license-related documents. However, those departments with
approving authority had unsupervised power. This situation led to
corruption.
In early January, Cao Wenzhuang, 44, director of SFDA's Drug
Registration Department, 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 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 center SFDA now also forbids drug
makers from seeking different registered trade names for their
products.
The confusing registration process for new drugs and medical
devices has been cited as a major cause for the rapid increase in
the price of these goods in China.
About 75 percent of Chinese people do not have medical insurance
and many can do very little when they fall ill because of the hefty
medical costs.
One reason for the difficulties is that SFDA has approved a
large number of so-called new medicines in recent years, said Wu
Yongpei, director of the Pharmacy Regulation Department with the
National Institute of Hospital Administration.
SFDA approved around 10,000 new drugs in 2004 compared with just
148 in the US.
With the new anti-graft measures in place it is estimated that
China will now have less than 100 new drugs coming onto the market
each year, SFDA said.
In the past the National Development and Reform Commission
reduced the prices of many medicines. However, because of the abuse
of power by some SFDA officials pharmaceutical enterprises have
simply changed the names of certain drugs.? They then apply to
SFDA for approval for the 'new' medicines and they're sold at much
higher prices.
It seems that bribery permits these enterprises to get licenses
to produce these drugs.
One example is aspirin, an everyday pain-killer. It costs just
0.03 yuan (0.36 cents) to produce one tablet. But the product is
difficult to find in China. Instead, other drugs with the same
elements are sold at more than 0.63 yuan (7.7 cents) each.
Therefore, it is common in China for one drug, such as
penicillin, to have dozens of names and to be produced by many
factories, Wu told China Daily.
China has nearly 6,000 drug enterprises.
(China Daily April 4, 2006)