E-drug: Generic quality (cont)
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Mohga,
I do agree it is worrisome, but both ways, i.e.
- it is originators' brands (patented products) that most frequently are
being counterfeited.
- some generic companies might not have acceptable standards
How to tackle the issue of generic quality I do not know. I do not know
either if it is more worrisome than the counterfeiting. Government
should of course inspect and approve all manufacturers in their
countries, but we all know that this is not always enforced strongly
and there are other reasons why this might be a weak point. I also
know that in the US and Canada there is no requirement in legislation
to inspect manufacturers which only manufacture for export. And we
have distributors such as Helm Pharmaceuticals in Germany which calls
themself a manufacturer, has the German authority papers in order,
but buy from the cheapest source they can find and repackage. So
please, this might not only be a developing country manufacture
issue! Our inspectors have participated in inspections in Central
and Eastern Europe and found manufacturers that were better than many
European.
I was also sort of fascinated last year when there was a recall in the US
for a drug containing etodolac. This drug is from Lederle. It was
withdrawn because it was found to be have been contaminated during
manufacture with another drug, a beta-blocker called acebutolol and
this could cause problems in certain patients. 4.2 million capsules
had to be withdrawn. Now you wonder how this could happen in one of
the world's large multinationals, probably one of those trying to put
generics in a negative light?
The number of manufacturers are of course huge, in the study I
mentioned on the quality of clarithromycin products only Turkey had
at least 7 manufacturers of this particular antibiotic (very
worrisome from a treatment point of view as well as overuse might be
rampant with so many products competing). The reference for this
study is Nightingale CH. A survey of the quality of generic
clarithromycin products from 13 countries.
Clin Drug Invest 2000; 19(4): 293-305.
This article paints a very negative picture, but I find the
conclusions biased and will publish comments soon.
Astra once did a study comparing omeprazole products from 13 countries.
Reference: Karlsson A et al. An investigation of the pharmaceutical
quality of non-Astra authorised omperazole products - a comparative
study. Int Pharm J. 1996; 10(6): 210- . Quoted in Scrip 7 February
1997.
In conclusion, I think for many reasons there are very few studies,
If you are not convinced that a generic manufacturer has been
properly inspected by the national regulatory authority or has been
inspected by an international licensed inspector/group of inspectors,
you should probably require the manufacturer to undergo such
inspection. If we have an E-drug member who is an inspector, he/she
could elaborate more on this - my knowledge is rather limited on the
more technical things such as requirements. But I have seen some
manufacturers, also manufacturers doing contract manufacturing for
large multinationals, in my lifetime with rather doubtful facilities
and quality assurance procedures. And I have experienced buying bad
quality products from Helm Pharmaceuticals.
Regards
Kirsten
Kirsten Myhr, MScPharm, MPH
Bygdoy alle 58B
0265 Oslo, Norway
Tel.: +47 22 56 05 85
myhr@online.no
[Do we have an e-drug member who is an inspector? If so we would love
to hear from you. BS]
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