Bioequivalence and Bioavailability Forum

Dear ElMaestro,

❝ FDA has recently had some beef with Indian generic drug makers and their subcontractors, and due to those worries FDA are increasing their oversight in the country. A worst case scenario is a generalised import ban that targets not drug makers but an entire country.

I'm not sure I could totally blame them considering the recent accumulation of data integrity issues reported in warning letters. See the latest posted this week. Jugaad...

❝ It could potentially lead to a complete collapse of India's pharma industry.

It surely could. Pity for those people doing a good job. I wouldn't cry for the rest.

(Don't misunderstand me: what I just wrote is not targeted against India, I would react the same way whatever the country. But this accumulation of fraudulent behavior is just too much).