Bioequivalence and Bioavailability Forum

Dear Forum Members,

The IMPACT arm of WHO has proposed some changes in the defination of counterfeit drugs. Once implemented it could be extrapolated to genuine generics.The interpretation is bit confusing but I write the way I could interpret.

See how. IMPACT wants to see that WHO definition on counterfeiting "can apply to both branded and generic products and include products with correct ingredients/components, with wrong ingredients/components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging."

Now consider that due to patent reasons of the innovator , for a product, I may need to modify the salt of the active/s in my generic formulation and then proceed for the usual BE stuff. Due to this I may also require to change some inactives due to compatibilty reasons with the modified salt(amoprhous/hydrate, etc.)

But according to the proposed defination, I would then be producing a counterfiet generic (even with correct label claim) since it does not contain the same active/s and components (read inactives)as the innovator.

Usually counterfeit is something which is sub-standard, spurious or one where there is intentional misrepresentation of the correct facts.

Please let me know your opinion.

Best Regards,

BE