# \[e-drug\] Re: WHO prequalification withdrawals and bio-tests (cont'd) **URL:** \ **Category:** e-drug\ **Created:** [September 2, 2004, 7:17pm UTC](https://talk.edrugplus.org/t/e-drug-re-who-prequalification-withdrawals-and-bio-tests-contd/20379 "2004-09-02T19:17:49Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![Francisco\_Rossi](https://avatars.discourse-cdn.com/v4/letter/f/50afbb/32.png) [@Francisco\_Rossi](https://talk.edrugplus.org/u/Francisco_Rossi)\ **Post date:** [September 2, 2004, 7:17pm UTC](https://talk.edrugplus.org/t/e-drug-re-who-prequalification-withdrawals-and-bio-tests-contd/20379/1 "2004-09-02T19:17:49Z")
E-drug: Re: WHO prequalification withdrawals and bio-tests (cont'd) ------------------------------------------------------------------------ --- [The message to which Francisco responds never reached the moderator although he had sent it both to E-drug and to Francisco so you can find it below. KM] I'm not sure if it will be useful to go deeper in this debate. It will be a decision of the moderators. But I think this message gave me an opportunity to more clarification about this uncomfortable issue. I think it is important to precise some points. 1.- Why, when one ask about pertinence of bioequivalence tests for ARV, or any other drugs, automatically somebody assume that one are against the duty of demonstrate quality of generic drugs? So, quality is only, bioequivalence? In other words, the only one and unavoidable way to demonstrate the quality of a generic version of any drug is bioequivalence? (What about intravenous drugs?) 2. Pertinence means that you do some test only when it is really necessary. You can ask all producers of generic drugs for radioactive residues tests , but I think it is easy to reach an agreement about pertinence. These tests are pertinent only in very small, well defined cases. We can add some examples: potency (antibiotics), crystallography (crystals), etc. It is a joke to make a dissolution or disintegration test for an inhaler. 3. Bioequivalence means similar bioavailability between two formulations. No more. No less. In which drugs, for which therapeutic indications, is it relevant? Is anyone interested in bioequivalence for "memory and concentration improvers? Is it not true that, for chemical and physical reasons, most of molecules are not expected to have significant bioavailability differences? What is the main intention of the biopharmaceutical classification of the FDA? 4. In this order of ideas, every generic drug must demonstrate quality by the pertinent test of the molecule, dosage form and other specifications. Don't forget the importance of package and labeling about quality. Sometime health authorities reject products due to critical defects on labeling. And of course it is relevant I think. 5. So, the question is: Oral dosage forms of ARV need bioequivalence test? While this point is properly discussed, let me try to clarify other issue. Safety and efficacy are demonstrated by pre-clinical and clinical tests. No more. No less. Bioequivalence tests are really far from this kind of tests. So, a generic version of any drug must repeat pre-clinical and clinical tests? The answer is no. Especially, for ethical reasons. Safety and efficacy need demonstration for a chemical entity, a molecule, and a particular dosage form. And when safety and efficacy where demonstrated, it is necessary to establish a quality standard, both for innovator and generic versions. Then, health authorities must decide if a generic version of a specific drug, need bioequivalence test as a quality assurance requirement. Or not. So, generics do not demonstrate safety and efficacy, and they are not guilty about it. Particular conditions of drugs are the reason. Maybe one can argue that it is not fair with innovators...but I think it will open other discussion. Very relevant I'm afraid, but not now. Thanks Francisco A. Rossi. B. IPR and access to drugs project. International Poverty Center. UNDP - IPEA. SBS. Ed BNDES, 10 andar. 70076-900 Brasilia D.F. Brazil. (55 61) 2105 -5005 francisco\_rossi@hotmail.com > This issue is crucial. > We are talking about: Efficacy, Safety and Quality, > For generics this standards are also required. > If you have chemical formulary - it can be reproduced by dozens of > professionals. Does it mean that reproduced formulary would have the > same efficacy, safety and quality? > Of cause - no! Somebody have to prove that reproduced (generic) formulary > fulfil all three standards. > Chemical equivalent is not usually equivalent therapeutically. > We are talking about ARVs. > For everybody (mean who pay for ARVs) very important is to have not only > GMP (quality). > If ARV is not effective (GCP) we will face resistance. Who would be happy > with this? > Quality can not be assessed, tested or inspected into the product. It has > to be built into it. > With limited resources WHO pre-qualification project make a very important job. > Somebody has to be responsible to prove that product meat international/WHO > standards (GLP, GCP, GMP). > Suppose, I am person/investor/donor/NGO/etc. I need somebody to prove, that > my investments would be spend more effectively. > Who will assess evidence.. > For local government/budget it can be local regulatory authority. > Internationally I would like to have WHO in this case. > Especially when we are talking about HIV/AIDS in developing world with weak > regulations, leak of professionals etc. > Those countries need such approval until they would create own expensive > agencies as FDA or MCA. > Only then local agencies would guarantee on the local/international level > that quality is built into a product. > Finally. CIPLA and Ranbaxy are good enough. > Generic substitution is very important to accelerate access to drugs. > And at the same time to be sure that generics meet the same requirements > (in terms of Efficacy, Safety and Quality) > I prefer to use WHO PQ list rather than results of assessment/registration > of products especially in developing countries. > > Dr Alexander Polishchuk > 22 Volynska street, #24, > 03151, Kiev, Ukraine > Tel: +38044 2429040 > [Mailto:alexpoly@ln](Mailto:alexpoly@ln).ua -- To send a message to E-Drug, write to: e-drug@healthnet.org To subscribe or unsubscribe, write to: majordomo@healthnet.org in the body of the message type: subscribe e-drug OR unsubscribe e-drug To contact a person, send a message to: e-drug-help@healthnet.org Information and archives: [Essentialdrugs.org](http://www.essentialdrugs.org/edrug)