Bioequivalence and Bioavailability Forum • BENOC-DCGI

accutest
☆

India,
2015-07-28 09:12
(3984 d 06:54 ago)

Posting: # 15158
Views: 3,799

BENOC-DCGI [Regulatives / Guidelines]

Dear Experts,

We have some queries in notice order published on CDSCO site dated on 22 July 2015 (File No.DCG(I)/Misc./2015(132), could you please help us on same.

Is this notice effective from 22 July 2015 or whether we need to done for all BENOCS had received in the past also.
If we had not initiated studies in six month after receipt of BENOCs, What will be the next step, after intimation of such BENOCs, whether such BENOCs get extra validity after intimation??
The statement mentioned on notice order "without further communication would be initiated as per merit under Drugs and cosmetics Rules". Kindly explain??

Thanks in Advance.

Your comments are highly appreciated.

Regards
Bharat N.

drgunasakaran1
★★

2015-08-02 17:04
(3978 d 23:02 ago)

@ accutest
Posting: # 15179
Views: 3,446

BENOC-DCGI

Post reply

Dear Mr Accutest,

❝ 1. Is this notice effective from 22 July 2015 or whether we need to done for all BENOCS had received in the past also.

Yes. It will be applicable for past BENOCs too.

❝ 2. If we had not initiated studies in six month after receipt of BENOCs, What will be the next step, after intimation of such BENOCs, whether such BENOCs get extra validity after intimation??

Its up to the DCGI office to decide :-D

. I hope that DCGI will extend the BENOC after seeing the reasons for not conducting the study within the period of 6 months.

❝ 3. The statement mentioned on notice order "without further communication would be initiated as per merit under Drugs and cosmetics Rules". Kindly explain?? :confused:

I am too confused :confused:

. What DCGI meant by that? Lets wait for next circular from DCGI for better clarity.

—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn