E-DRUG: Definition of country of origin

Dear Joseph Kwong:
Thanks for such a challenging question. As a drug Regulatory officer, I have
always faced the same question.Let's understand the basic principles:
Manufacture is the sum total of all activities from receipt of raw materails
to packing/labelling of finished product.The critical steps are fromulation,
weighing, blending/granulation & tableting/capsulation.
The country of origin in my own opinion is where critical steps are done.
Remember the quality of a drug (generics)depends on the critical steps in
production stage.Packing is not a very critical step. For the case of my
country, Uganda, alot of drugs are manufactured in India re-labeled in
Europe & sent to Uganda.
We consider, India to be the country of origin. In carrying out drug
registraion, we assesse the GMP performance of the "Actual" manufacturer(
critical steps). Now we even insist that the actual maunufacturer's full
address appear on the labels.You should also know that most countries with
drug registration system in place do not rely on certification scheme as
there are many other important points to look at from manufacturers.

Francis Otim
National Drug Authority.