# \[e-drug\] Generic quality (cont) **URL:** \ **Category:** e-drug\ **Created:** [March 4, 2001, 5:23am UTC](https://talk.edrugplus.org/t/e-drug-generic-quality-cont/10567 "2001-03-04T05:23:46Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![ptrouiller](https://avatars.discourse-cdn.com/v4/letter/p/bc79bd/32.png) [@ptrouiller](https://talk.edrugplus.org/u/ptrouiller)\ **Post date:** [March 4, 2001, 5:23am UTC](https://talk.edrugplus.org/t/e-drug-generic-quality-cont/10567/1 "2001-03-04T05:23:46Z")
E-drug: Generic quality (cont) --------------------------------------------- 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 -- Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'. Mail administrative requests to `majordomo@usa.healthnet.org'. For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.