Bioequivalence and Bioavailability Forum • CDSCO, India: PI can do 3 trials at a time

ElMaestro
★★★

Denmark,
2014-07-15 19:17
(4366 d 12:50 ago)

Posting: # 13268
Views: 2,563

CDSCO, India: PI can do 3 trials at a time [Regulatives / Guidelines]

Hi all,

new regulation from CDSCO: Link here.

This could quickly get complicated to the point where companies are seeking ways to game the system. When is a PI involved in the conduct?

If (s)he delegates a task to sub-investigators is (s)he then involved (I'll vote yes)?
Does involvement stop at the point the last plasma sample is sent away for analysis (in case no follows-ups are needed)?

If PI involvement correlates with PI responsibility then I guess the PI is involved until the time (s)he has put her/his signature on the final study report.

If an Indian generic company conducts a trial outside India, must the Indian company then ensure that the PI wherever (s)he works is still observing this regulation?

:confused:

—
Pass or fail!
ElMaestro

Ohlbe
★★★

France,
2014-07-15 19:52
(4366 d 12:15 ago)

@ ElMaestro
Posting: # 13269
Views: 2,135

CDSCO, India: PI can do 3 trials at a time

Post reply

Dear ElMaestro,

It is indeed very unclear to me and raises tons of questions:

what is the legal value of this "order" ?
does it apply to BE trials (which I understand are excluded in their vast majority from the scope of Schedule Y as they are not "new drugs") ?
if it applies to BE trials: are 3 trials considered to be run at the same time only if subjects from the 3 trials are in-house at the same time ? Could the PI have the period 1 of 2 trials running during the wash-out period of 2 other trials ?

—
Regards
Ohlbe