PharmPK Discussion - DCGI approval procedure-BA/BE studies

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On 18 Dec 2012 at 11:10:52, Lalit Gore (lalit.gore.aaa.indoco.com) sent the message


Dear All,

This refers to discussion on BE-NOC application in DCGI. Yes, I agree on
above requirements.

Please clarify on below points in conducting BE study in India.

For Pilot Study.
Import license application in DCGI for New Molecules and Old Molecules

For Pivotal Study.
Import license application in DCGI for New Molecules and Old Molecules.

Mr. Lalit Gore
Assistant Manager-Medical Services
Indoco Remedies Limited
R & D Centre, R-92-93, T.T.C Industrial Area
Thane Belapur Road, Rabale MIDC
Navi Mumbai - 400701

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