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Tightening drug control
2006-08-17
China Daily
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.
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