The production licenses for nearly 170,000 medicines will be
reviewed under strict quality examination procedures before they
expire at the end of the year, according to the State Food and Drug
Administration (SFDA).
The campaign will begin in the second half of the year to
re-examine drug companies who acquired a Good Manufacturing
Practice (GMP) certificate for registering new medicines in 2004
and 2005. Drugs that fail the tests will be removed from the
market.
The GMP certificate's credibility has been repeatedly called
into question by a number of health scares caused by poor-quality
pharmaceuticals. The most notorious case came to light last July
when "Xinfu" antibiotic injections, manufactured by Anhui Huayuan
Worldbest Biology Pharmacy Company, caused the deaths of at least
six patients and severe reactions in more than 80 others.
The SFDA carried out 35 unannounced inspections of drug
manufacturers last companies last September and stripped 15
companies of their GMP certificates.
Due to the lax registration system, many Chinese pharmaceutical
companies have copied existing products, registered them as new
ones and sold them at much higher prices.
By last August, the SFDA had issued licenses for 168,740 new
drugs and established a special data base for the license numbers
and the ingredients of all new drugs.
"Whether or not the pharmaceutical enterprises can have their
licenses renewed will mainly depend on the track records shown in
the database," said a SFDA statement.
China is home to nearly 5,000 pharmaceutical manufacturers but
only a few famous brands. "Redundant production has led to
oversupply and reduced competitiveness," said Liu Yanming, an
analyst with the China Galaxy Securities Co., Ltd.
Analysts say a stricter re-registration system for existing
drugs is expected to help eliminate shabby products from the
market, improve the research and development capabilities of
pharmaceutical companies and fuel mergers and acquisitions.
(Xinhua News Agency January 27, 2007)