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)