E-drug: Re: Problem manufacturers (cont'd)
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Dear Chiel,
It would be a real challenge to deal with this sensitive and complex issue
(I am not surprised that there had been (if any) an effort to initiate the
discussion on this but, as you said, with no success). A list - based on
the test results performed during pre-import and on-the-market sampling) of
"underperforming" drug manufacturers, including those of non-GMP, and
suppliers could be established for use only within a particular country for
the procurement of acceptable standard pharmaceuticals (even so, the names
of the manufacturers may not be publicly made available due to the
technical and politico-economical nature of the matter). Things to be
considered (I raise only two here).
1. the term underperforming is relative: If I am very sceptical I would say
almost (if not all) manufacturers/suppliers at a certain point of times (in
production of their products) were underperforming believing that "not all"
of their products to the market were 100% met safety, efficacy and quality
standards. To prove it is difficult and very costly task for any drug
regulatory authorities.
2. Up-dating the data bank and website: One manufacturer/supplier could not
be on the list as "underperforming" resulting from, say, one of its
products was caught by a drug regulatory authority in country A. The same
product is not necessarily be tested or caught in country B or C (as double
standard drug products are available). In this case the
manufacturer/supplier could be in the "underperforming" list of country A
(until it improves and meets the set manufacturing standards), but not in
the B or C.
To keep the data/website up-to-date would require, I would say, a constant
monitoring and auditing process and an effective coordination mechanism
among drug regulatory authorities regionally and internationally. This
issue involves, again, a very complex and costly experiment.
3. I do not think the drug industry is happy to see or visit the data
bank/website.
Souly Phanouvong
(former drug inspection and quality control, MOH, Laos)
S.Phanouvong@latrobe.edu.au
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