E-drug: Effectiveness of Generics compared to brands (cont'd)
---------------------------------------------
Dear all,
This is a very common fact that a physician can have doubts on generic
versions of established brand. Here I want to clarify following points to
physicians:
1. Brand is the outcome of company image linked with the product and vice
versa. If a new product in terms of new chemical entity or new dosage form
is launched by a research based company, it is only because of company's
scientific intellectuals. It requires huge investment in terms of money and
time. On the contrary, a generic version of such product requires lesser
investment on research.
2. Generic versions are always less costly as compared to Brand version.
3. Approval of Generic Version is given by the Drug control authority based
on the data submitted by the company proving therapeutic equivalence/
bioequivalence with the innovator Brand.
4. Drug Laws are the governing factors for the purity, efficacy and safety
of drug products.
5. If a Physician has doubts on the generic version, he can ask the
manufacturer to provide data related to stability study, Bioequivalence
study report and or Comparative Dissolution profiling of Brand and Generic
versions.
Rakesh Chaurasia
Dy. General Manager-Regulatory Affairs
Macleods Pharmaceuticals
Mumbai
Tel 022-5676 2800
Rakesh Chaurasia <chaurasiarakesh@macleodspharma.com>
--
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: http://www.essentialdrugs.org/edrug