Pharmaceuticals/generic drugs

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Question
Hello,
       I want a response to the general question ŅHave generic pharmaceutical products bought  anywhere, perhaps an Asiatic place (say China, Russia, India) identical and absolutely equal chemical structure to ones of brand name?. I think they haven't because the synthesis is very very difficult (Cf. Pharmaceutical Manufacturing Encyclopedia, Marshall Sitting, 1988, Noyes Pub. ed.)
       Iím a family physician in task of writing a well-documented monograph (among books, manufacturing protocols, papers, reports, I could gather more than 50 of them despite anything arrives directly to the center or key of the subject) about generics in Argentina. Our government office doesnít give information. I donít ask specifically about Argentinian generics but the ones in emerging countries. The previous question may be reformulated considering this illustrative example: ŅWhat do you think prima facie (ab initio) if a pharmacy in U.S.A. sells products brought from any Asiatic market?. I donít ask in legal terms but what do you believe about efficacy and purity (the last focused in enantiomers or chiral aspects or other impurities). Nobody knows if generics are useful because clinical trials are just impossible and biodisponibility as a quality marker isnít a reliable method.
Thanks. Iíll be waiting for you response or any guidance of readings at the web, better if this critical theme would be understood from a chemical point of view.
Note: recently two chemists in the Biochemistry & Pharmacy College at the UNR (University of Rosario) answered me theyíll try to analyze generic drug in search of chirality. But say me what do you think about.
Dr. Eduardo Durigan.
Practitioner registered Nļ 8672.
Rosario. Argentina.

Answer
Eduardo:

For drugs purchased in the United States and Europe (and I assume in Argentina), the chemical must be as pure and identical as the original to the originator's specification, and meet official pharmacopoeial standards (if there are any). Whether the Active Pharmaceutical Ingredient (API) is manufactured in Argentina, India, China, or the USA is irrelevant; as is the route of synthesis (which - in order to get around patents - often differs from the originator's route of synthesis).


When it comes to the finished dosage form the generic version must demonstrate identical bioavailability and bioequivalence.

I hope this helps.

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