Bioequivalence and Bioavailability Forum

Dear Osama,

❝ what is new is the increasing frequency of discovery of many cases of fraud in the clinical trials & BE in the past few years, starting with GVK [...]

Before that you had the generic drug scandal in the US in the '80s, the WHO removing multiple products from Cipla, Ranbaxy and Hetero from the prequalification list in 2004, Cetero in the US... What may be new is that you now hear of such cases (much more media buzz, and amplification by social media) and the "if we ever catch you, we'll just reject everything you ever did" attitude from regulators, trying to have a deterrent effect.

❝ [...] that brings me to a real story I have heard that the sponsor refused to pay the remaining amount to the CRO because the BE study was failed!!

Yes, there are a number of things that the Man in the Armani suit would need to be explained, if one of his underlings dares to speak. Such attitude is pushing for fraud.

❝ Recently, we discussed the matter of accepting BE studies that are performed in CRO belonging to the pharmaceutical companies if this contradicts the principles of COI and therefore the files of these studies should not be received or accepted.

Yes, in such situations you indeed have a higher risk of internal pressure, pushing to do stupid things. But this is not limited to BE, and you have the same problem with pharmaceutical development, finished product stability studies and so on. Look at what happened at Ranbaxy in the past. Did you read Katherine Eban's "Bottle of lies" ?