Bioequivalence and Bioavailability Forum

drshayana ☆ 2007-03-02 09:13 (6648 d 11:40 ago) (edited on 2007-03-02 11:54) Posting: # 553 Views: 4,912	reg approval of DCGI for every BA/BE study [Regulatives / Guidelines] Post reply
	Sir, is it necessary to take approval from DCGI for conducting each and every BA/BE study in a CRO on generic drugs. If it is required only once and not every time please mail me the name of regulatory guidelines which we have to go through to get this point {i.e DCGI approval is not required to conduct ba/be study on generic drugs} Edit: Entire message in capitals reformated. [HS]

drshiv
★

India,
2007-03-04 19:56
(6646 d 00:58 ago)

(edited on 2007-03-06 11:25)
@ drshayana
Posting: # 557
Views: 4,038

reg approval of DCGI for every BA/BE study

Post reply

Hi,

It is necessary to take DCGI (Drugs Controller General [India]) permission to conduct all BA/BE studies in India. Also it is a requirement to get the permisssion from DCGI to import study drugs (reference drugs) and in case you need to export plasma samples for analysis out side the country, you will not get DGFT (Directro General of Foreign Trade) clearance (which is a must) without DCGI permission letter.

Dr. Shiv

Edit: Full quote removed. [HS]

drshayana ☆ 2007-03-06 08:16 (6644 d 12:38 ago) @ drshiv Posting: # 558 Views: 3,938	reg approval of DCGI for every BA/BE study Post reply
	Dear Dr Shiv Thanks for the information Regards Dr. shayana

reg approval of DCGI for every BA/BE study [Regulatives / Guidelines]

reg approval of DCGI for every BA/BE study

reg approval of DCGI for every BA/BE study