Bioequivalence and Bioavailability Forum

❝ What does this mean for products for the Indian market? No need for making up studies any more?

At least this is what I understand as well.

Remember the Ranbaxy Story and one of the official statements?

Backing pharma major Ranbaxy, who has been accused of marketing sub-standard medicines, the health ministry Friday said there was nothing wrong with the quality of its drugs.
“There are misconceptions about Ranbaxy producing sub-standard drugs. There was something wrong with the manufacturing process, but the quality of the drugs was fine,” said Jagdish Prasad, Director General of Health Services.
“In the production of the medicines, the company may have forgotten to follow one or two steps prescribed by the US FDA (Food and Drug Administration), but that does not mean that the drugs are sub-standard,” he added.

I translate from Newspeak:

Cmon, they have tested TT|RR instead of RT|TR. So what? That’s just a super­fluous, nit­picking require­ment of the damn arrogant Americans our boys may [sic] have forgotten [sic] to follow. Of course, drugs marketed in India are excellent!

Given that, the recent statement doesn’t surprise me at all.