The State Council has finally decided to launch a year-long
campaign to crack down upon fake and poor quality drugs and
introduce order to the drug market, according to a national working
conference for the watchdog food and drug administration
yesterday.
A fake drug claimed 11 lives in May, and poor quality medicine
killed three early this month.
In the latest case, the Anhui Huayuan Worldbest Biology Pharmacy
Co in east China's Anhui Province was confirmed to have violated
the rules by simplifying its production procedures, which has
affected the quality of the clindamycin phosphate glucose it has
produced.
The old version of this drug was used for muscle injections, but
its new version is for dripping directly into the blood vessel. The
price for the latter is several times that of its predecessor.
Experts say this is a typical way for drug producers to make
money. Instead of putting in a large sum of money conducting
research on new drugs, they prefer to make some changes in the
ingredients of old drugs and then give them a new name. Such a
trick can bring them profits with a very low cost.
This is one of the practices that this overhaul will crack down
on in the one-year campaign. All the registered drugs will be
checked and re-registered to see whether they are such new versions
of old drugs.
Watchdogs at various levels will go down to the pharmaceutical
plants to check whether their drug production procedures are
strictly following required rules.
Such a campaign is indeed necessary and it will no doubt get
somewhere. But can we guarantee that the same problems will not
relapse after the campaign? In addition, we doubt whether we have
traced down to the very root of the problems.
The latest poor quality drug case has shown that the problematic
drug is just a new version of an old one. How can this drug, on the
basis of minor changes in the recipe of its predecessor, be
approved and registered as a new one?
An inspection team of the State Food and Drug Administration
(SFDA) checked 130 different drugs by 14 pharmaceutical companies
in the first six months of this year and found many to be
problematic. When the SFDA started to re-examine the applications
for new drug registrations during this period, 2,320 applications
were revoked by drug producers who feared the applications' unreal
content might be discovered.
The conclusion of the investigation of the Huayuan case
attributes the problem to the producer. But we should not pretend
nothing was wrong besides that.
The campaign may ferret out more rule breakers and restore order
to some extent. But unless we make sure the supervisors work
faithfully on a regular basis, there is no guarantee we will not
see such tragedies replay themselves in the future.
(China Daily August 17, 2006)