# E-DRUG: GMP and how to get the reliable suppliers **URL:** \ **Category:** e-drug\ **Created:** [January 31, 1998, 11:44pm UTC](https://talk.edrugplus.org/t/e-drug-gmp-and-how-to-get-the-reliable-suppliers/2038 "1998-01-31T23:44:32Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![GERRIT\_WEEDA](https://avatars.discourse-cdn.com/v4/letter/g/a9a28c/32.png) [@GERRIT\_WEEDA](https://talk.edrugplus.org/u/GERRIT_WEEDA)\ **Post date:** [January 31, 1998, 11:44pm UTC](https://talk.edrugplus.org/t/e-drug-gmp-and-how-to-get-the-reliable-suppliers/2038/1 "1998-01-31T23:44:32Z")
E-drug: GMP and how to get the reliable suppliers --------------------------------------------- A New Approach to GMP (?), how to beat the unreliable producers (?). Can we do something together (?) We are restarting the Essential Drugs Programme in the Republic of Yemen, once an exemplary programme with the support of WHO in the former Southern Republic, but unfortunately destroyed during the civil war. The war also resulted in a total breakdown of infrastructure. Medicines and medical appliances were hardly available for a number of years through the official channels. Smugglers and traders stepped in and supplied what was needed or perceived to be needed. Fortunes were made overnight. Now the government wants to put order in this chaos again and is passing strict laws regulating all elements of the drug supply chain (we can send you documentation if you are interested). One element is of course which supplier can be trusted to provide safe, effective, good quality and affordable (this is a poor country) essential pharmaceutical products. The answer should be every company that can hand over a GMP certificate of its country and a Free Sale Certificate. However everyone who is buying and selling drugs knows that it is not that simple. Some countries only pay lip-service to the heavy responsibilities following these requirements; in some countries one can buy certificates etc. Several production and trading companies make good use of this situation and buy drugs from these countries (good and bad) and stick a label from a well-trusted country on it. Unfortunately WHO cannot make the GMP regulations stick due to the way it is organised and we are all the lesser for it. So is there a way we can know those companies that can be relied upon? (within all limits of reason as even the biggest and most state of the art companies can make mistakes). Over the years I have listened to several arguments from all sides; also in various forums. None of them satisfied me as in one way or the other they all seem to be initiated by some interest group. A sample of these arguments is:   \* Don't buy generic: you don't know what you get;   \* Don;t buy from country A or B as their drugs are all       sub-standard (laughter and yeah-yeah);   \* Essential drugs are sub-standard;   \* Only the inventor companies have the know-how to develop and       therefore produce drugs at the required standards, and to buy       otherwise is close to criminal as the population is put at risk.   \* Only companies with ISO 9000 (etc.) are safe. I was fortunate enough to visit over the years a number of good countries and an equal number of bad counties and although I am not a qualified auditor on these matters my personal conclusion is that there are good companies in the bad counties and some doubtful companies in the good countries. With this in mind Yemen is now requiring that every company from every country (we should not ignore the politics that is involved in such a move) will be audited (we call it international inspection) by qualified auditors, to verify the GMP claims made by the company. We appointed 10 of these on the basis of recommendation by certain national Health, Medicine control agencies and Inspectorates. We have asked the inspectors not to audit to a level as if the company inspected should meet standards based on the latest designs of the latest brand name company, but to inform us whether the company is able to meet our requirements to provide safe, effective, good quality and affordable essential pharmaceutical products. This is now going on for the first year, and we get, of course, various responses. Some companies are happy to cooperate; some say their country's GMP should be sufficient. Some grumble about the cost as these inspections are not cheap and the impact of inspection for Yemen only, is of course limited. For the time being the way we are working seems to be the only way to clean out our file of registered companies (there are many). On the other hand, since I know that the problem is present in many countries, one cannot help wondering whether others would like to obtain our results or would like to adopt the method and exchange information. A type of international consumers organization for drugs and medical supplies? It would certainly save everyone a lot of time, headache and sleepless nights. And we could lay to rest a lot of myths and accusations. I would like to receive response on this approach from concerned national consumers to see whether we could organism this professionally and internationally. It could bring great export opportunities for serious third world producers. Regards, Gerrit Weeda Yemen Drugs Action Programme P.O.Box 16033 Sanae, Republic of Yemen tel.: 967.1.414661 fax. 967.1.415144 e-mail: yemdapmoph@y.net.ye -- 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'.