E-DRUG: Ranbaxy withdraws all generic ARVs from WHO Prequalification(3)
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Dear friends:
Bad news I agree. But I just want to put on the carpet some questions regarding (again and again) the real quality implications of Bioequivalence tests for ARVs.
Why when WHO reject bioequivalence tests (because of good clinical practices mistakes) did not recommend the immediate suspension on use of these drugs? (Recommendations of WHO moved in a very wide spectrum from not to do anything, to retire the products from the market, as I can remember).
Why did Ranbaxy, facing evidence of no (insufficient?) bioequivalence demonstration, not remove the products from the market?
When any product anywhere doesn’t fulfil one quality requirement, is usually withdrawn of the market. If Bioequivalence tests were truly necessary for quality assurance, and it was not properly fulfilled by Ranbaxy (and Cipla before), why withdrawal of all the products was not the "compulsory" recommendation?
Is the WHO conducting (without the necessary close follow up I’m afraid) an experimental survey about quality of generics drugs? Is it a Natural experiment versus a clinical trial?
Certainly, when you decide to introduce a requirement in your quality system, and some provider do not fulfil it, you must withdraw the product of the market. So, WHO prequalification system is not an international quality assurance system. The systems was born as a scheme to select providers for international drug purchases, for UN organizations, but when this kind of problems appear, all of the people are assuming that we are talking about quality of generics. Specially big farma I’m afraid.
Let the debate continue!
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
[Moderator’s comments: WHO is not a drug regulatory authority, and cannot recommend withdrawals from the market. That’s up to the company and the national DRAs. Ranbaxy did recall its products from the South African market, and the South African Drug Regulatory Authority withdrew marketing authorisation (pending a 30 days notification period). Whether Ranbaxy actively withdrew from other markets is unclear: there is nothing on the Ranbaxy website (www.ranbaxy.com). WB]