E-DRUG: RFI: Bioequivalence and generics registration (9)
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Dear E-druggers,
Thank you very much for your response on this issue!
Of course I fully agree with all of you that full bio-equivalence test
would be the best thing to establish the safety and efficacy of generics
compared to the branded.
But in reality, for most generics in use in development-countries, such
studies have NOT been performed. To be more specific, the generics used
in development-countries are mostly produced as well in other
development countries (China and India are good examples). They are
being sold at VERY low prices. Only in this way certain
third-world-countries, such as the one that I am working for, can afford
to purchase sufficient drugs at an affordable price for the local
institutions and customers.
In my particular case, the demand from the local authorities for IN VIVO
B.E. studies will mean that drug prices will rise more than 1000%. That
means that 99% of our population will have no access to drugs at all. Is
THAT ethically right?
My SOLE question is: WHAT is REALISTIC ???
I would like to avoid 100% theoretical and technical discussions. In
fact GMP, GDP, GLP are VERY relative in most third-world countries! I
would like to keep this discussion PRACTICAL.
As I understand, there are certain lists of medications that SHOULD be
tested for B.E. in vivo in any case. Those drugs will be the drugs with
a narrow therapeutic window, known absorption-problems, high risk of
toxicity etc.
Please can anyone provide me a list of those drugs as mentioned above?
And as well ...... can anyone provide me a list of oral drugs that don't
really need B.E. tests in vivo (like Paracetamol, ASA, etc.)
I would like to thank you all in advance for your contributions!
ANONYMOUS, pharmacist, consultant on regulatory affairs.
[name and email known to e-drug moderator]
[One of WHO's Expert Committee documents some 10 years ago (issued in the
TRS series) had a table comparing the requirements for in-vivo and in-vitro
tests in 3 countries: does any e-drugger remember the exact TRS issue and
page number? Or does anyone have a newer table with what countries require?
WB]
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