E-DRUG: RFI: Bioequivalence and generics registration (7)
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dear E-druggers,
I totally agree with Milind that the Quality of Pharmaceutical products is
more important than just the Retail price of Drugs. Why , we have price
variances of the same product upto to 400% in some cases. The important
issue is that the tablet/capsule contains the drug as per Label claim in the
range of 80-120/125 %. Apart from this the GMP manufactured drugs would be
more reliable than non-GMP drugs because of contamination, storage and
handling issues. Online QC and QA procedures during raw material procurement
to manufacturing take up a lot of resources, time, energy and money, which
pushes up the prices of drugs. Market forces can only pull down the margins,
but there is always a ceiling to price cuts. After all, manufacturing drugs
is a business, and as all businesses needs a profit to survive and grow.
Bio`s( in vivo tests) are the only means to assure that a formulation would
behave in a way they are intended to inside the body. all the three
parameters mentioned (Cmax, T 1/2 and AUC) are important parameters in a bio
and should be asked for from any Pharma company for registration by any
regulatory agency, be it a third world or the west.
kind regards,
Lakhvinder.
Clinical Research Scientist
Ranbaxy
India
lakhvinder@email.com
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