Bioequivalence and Bioavailability Forum • DCGI BE-NOC

DCGI BE-NOC [Regulatives / Guidelines]

posted by Vardhan82 – India, 2012-02-03 07:57 (5243 d 17:32 ago) – Posting: # 8045
Views: 6,050

Dear Rave04,

❝ I am applying to DCG India to get BE-NOC for products which we are selling for more than 4 years but still our two products are not found in the approved list of the DCGI. please help as we are going to conduct BE study in India.

Approval details have been available only from 1999 in CDSCo site, which is not covering complete FDC list. if your formulation is IR, you can conduct the study without NOC as you may have form 46 for the same.

Regards,

vardhan

Complete thread:

DCGI BE-NOC rave04 2012-02-03 06:10 [Regulatives / Guidelines]
- DCGI BE-NOC drgunasakaran1 2012-02-03 06:45
  - DCGI BE-NOC rave04 2012-02-03 07:23
    - DCGI BE-NOC drgunasakaran1 2012-02-03 13:19
- DCGI BE-NOCVardhan82 2012-02-03 06:57
  - DCGI BE-NOC rave04 2012-02-03 07:31