Bioequivalence and Bioavailability Forum • DCGI BE NOC

DCGI BE NOC [Regulatives / Guidelines]

posted by RVR – India, 2012-08-17 10:01 (5062 d 21:46 ago) – Posting: # 9075
Views: 9,808

Dear Kaushik,

❝ What if the molecule is modified release dosage form?

If a drug/molecule is MR formulation we have to get BE-NOC for conducting the study.

BE-NOC is not required for IR drugs approved in India for more than/equal to 4 years from the date of approval for marketing in India (can be checked from reference 1 link).

For ER/MR/XR/CR/SR products BE-NOC is to be filled irrespective of their date of approval for marketing in India. reference page 12...

Approval status irrespective of type of fromualtion can be checked in CDSCO web site for applying BE-NOC. reference">http://cdsco.nic.in/listofdrugapprovedmain.html]reference 1

A Clear list of documents for obtaining BE-NOC were given in CDSCO web site. BA/BE NOC for export purpose reference 2
• For new molecule not approved in India
• New drugs approved in India with in a period of 1 year
• New drugs approved in India with in a period of 1 year and 4 years
• Drug product in modified release form irrespective of their approval status

Regards,
RVR

Complete thread:

DCGI BE NOC VG 2012-07-18 11:11
- DCGI BE NOC drgunasakaran1 2012-07-19 07:07
  - DCGI BE NOC kaushik089 2012-08-15 18:30
    - DCGI BE NOC navoday 2012-08-15 20:24
    - DCGI BE NOCRVR 2012-08-17 08:01