The State Drug Administration issued a new civil measure Wednesday
to better protect people against fake and shoddy drugs.
The new regulation is expected to go into effect on September 15 in
support of the revised Law on Drug Management, which became
effective on December 1 last year.
Zhen Xiaoyu, director of the administration, said the regulation
strives to watch closely every link in the production and sale of
drugs for the sake of guaranteed quality, while endeavors continue
to build a more market-oriented distribution system.
For instance, the regulation endows drug authorities at the
provincial level with the same rights as the State Drug
Administration to examine and authenticate the production quality
of drug manufacturers.
A
source within the administration, who declined to be identified,
said the change will quicken the process of examination and
certification.
"The faster the manufacturers are examined, the earlier the people
will be supplied with safer drugs," said the official.
The administration has demanded that all of the country's 6,731
drug manufacturers pass the examinations by June 30, 2004. So far
30 percent of them have made it.
And even though the regulation recognizes the practice of "trust
production," it says the parties entrusted must have the
corresponding production qualification.
Otherwise, both the consignor and the entrusted party will be
punished for producing "fake" drugs.
As
for retail, the regulation stipulates that every drug retailer be
staffed with professional pharmacists, who can help ensure people
get the right medicine.
The administration will no longer interfere with the pricing of
drugs, except for those listed for use in the country's basic
medical insurance program that satisfy the daily medical needs of
ordinary employees. Price controls will also continue to apply to
drugs with monopolized production and sale.
The regulation vows to punish severely those selling fake and
shoddy drugs to pregnant women and children, those selling fake or
shoddy biological and blood products, those passing off products
like anesthetics as ordinary drugs (and vice versa), those who
cause severe results by selling unqualified drugs, or those caught
committing a second offence.
The designated punishments consist mainly of fines, confiscation
and administrative penalties, except that every severe case will be
punishable under criminal law.
(China
Daily August 15, 2002)