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[e-drug] Generic quality (cont)

E-drug: Generic quality (cont)
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This idea of publishing a list of the "good manufacturers" is interesting
and has already been suggested in the past (see e-drug archives). But a
positive list is one thing, what is behind such a list is something
different and more critical.

- At first, criteria have to be precised for defining what is a "good
manufacturer" (e.g., compliance to GMP standards... etc.). WHO 
standards and expertise can be helpful to precise the technical 
framework, and
contribution of pharmaceutical manufacturers associations (e.g., generic
manufacturers) is as well needed to stick to the reality of the problem.

- Secondly, such a list will only be a snapshot at a given moment. It will
be necessary to take steps (e.g., monitoring and inspection) to check that
the so-called "good manufacturer" is still in compliance with the defined
criteria. Who can do it ? Surely, national drug regulatory authorities
(DRAs), providing they have legal and human resources to do it. Some 
DRAs do it for the proportion of production destined to their 
internal market but
not for exports (international market). The existing certificate of quality
(WHO certification scheme on the quality of pharmaceuticals) can be an
incomparable tool, as long as it is not only a sheet of paper but an
accurate reflection of the industrial reality. Once again, that means a
minimal set of control mechanism.

There is still a long way before responding to this challenge.

Anyway, as a good starting point, few years ago the NGO "ReMed" 
(network for medicines and development: www.remed.org) carried out in 
collaboration with WHO a survey on the quality of drugs in some 
countries of west Africa, but without publishing the identity of 
manufacturers. Such surveys, in a more systematic and comprehensive 
way, could be at least a first stage.

Patrice Trouiller, PharmD, MB
- Hospital Practitioner
- Consultant, MSF (Doctors without Borders)
University Hospital of Grenoble, France
Tel : +33 476 76 54 97
Fax : +33 476 76 51 09
Email: PTrouiller@chu-grenoble.fr
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