Date: 2024-03-22Category: Not ApplicableState: Union GovernmentCountry: India
Meeting through WebEx Video-conference of the DTAB-sub Committee on 05.04.2024 at 11.00 a.m. to 6:00 p.m. to Evaluation of 16 FDCs which were earlier considered as irrational in the Expert Committee report of the Prof. Kokate Committee
**Summary:**
A meeting of the Drugs Technical Advisory Board (DTAB) sub-committee is scheduled for April 5, 2024, from 11:00 AM to 6:00 PM via WebEx videoconference. The purpose of the meeting is to evaluate 16 Fixed Dose Combinations (FDCs) previously identified as irrational in the Prof. Kokate Committee report. This meeting follows the notice issued on March 31, 2023. Applicants/stakeholders who have submitted information in the prescribed format (Annexure A) will present their proposals to the committee for further recommendations.
Stakeholders are requested to attend the meeting via WebEx. Failure to attend may result in the committee making a decision based on available information. The WebEx link will be shared on the meeting date. Presenter details (name, email ID, contact number) and PPT presentations should be forwarded to fdccdsco.nic.in by April 2, 2024.
The notice is for the information of all concerned, including Dr. Nilima Kshirsagar (Chairperson of the sub-committee), expert committee members, and relevant pharmaceutical associations (IDMA, FOPECI, IIPA, OPPI, etc.). These associations are requested to disseminate the information to their members. The notice is also available on the CDSCO website.
For further information, contact Deepak Kumar, Assistant Drugs Controller of India, at 01123236965 (telephone) or 01123236973 (fax).
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
DTABsub Committee: A sub-committee of the Drugs Technical Advisory Board (DTAB). It evaluates proposals related to Fixed Dose Combinations (FDCs).
Prof. Kokate Committee: An expert committee that submitted a report regarding irrational Fixed Dose Combinations (FDCs).
Fixed Dose Combinations: Combinations of two or more active pharmaceutical ingredients (APIs) in a single dosage form.
Deepak Kumar: Assistant Drugs Controller of India
Dr. Nilima Kshirsagar: Former Chair in Clinical Pharmacology, ICMR, Mumbai, chairperson, subcommitte of DTAB.
ICMR, Mumbai: Indian Council of Medical Research located in Mumbai, Maharashtra.
New Delhi, Delhi: Location of FDA Bhawan and Central Drugs Standard Control Organization
F.NO. 4-01/2013-DC (Misc. 13 PSC -Part-lll) Tele. No. : 011-23236965
Government of India Fax No. : 011-23236973
Directorate General of Health Services
Central Drugs Standard Control Organization
(FDC Division)
FDA Bhawan, Kotla Road
New Delhi-110002
Dated: 22 MAR 2024
NOTICE
Subject:-Meeting through WebEx (Video-conference) of the DTAB-sub Committee on
05.04.2024 at 11.00 a.m. to 6:00 p.m. to Evaluation of 16 FDCs which were
earlier considered as irrational in the Expert Committee report of the Prof.
Kokate Committee -regarding.
This is in reference to the Notice vide F.No. 04-01/2013-DC(Misc. 13-PSC Part-lll)
dated 31.03.2023 from this office on the subject cited above. Accordingly, some of the
applicants/stakeholders have submitted the information in prescribed format as per Annexure-
A which needs to be deliberated with the DTAB-sub Committee.
In order to evaluate these proposals, a meeting has been scheduled on 05.04.2024 at
11:00 am through WebEx Video conference. During the meeting, applicants/stakeholders will
be asked to make a presentation before the committee for further recommendation on such
FDCs.
It is requested to kindly make it convenient to attend the meeting on the said date
through WebEx (Video-conference) before the DTAB-sub Committee. In the event that the
Stakeholders does not attend the hearing, the Committee reserves the right to make its
decision on the basis of information available before it. The weblink will be shared on the date
of the meeting. Applicants/stakeholders are also requested to forward details of presenter, e-
mail ID, contact number along with PPT presentation at fdc@cdsco.nic.in by 02.04.2024.
This is for information of all concerned.
Yours fait!
(Deepak Kumar)
Assistant Drugs Controller (Indi
Copy to:
1.Dr. Nilima Kshirsagar, Former Chair in Clinical Pharmacology, ICMR, Mumbai,
chairperson, sub-committe of DTAB.
2.To all the experts committee members.
3.Indian Drug/Pharmaceuticals Association (IDMA/FOPE/CIPI/IPA/OPPI, etc.,) with the
request to communicate it to your members and publicize it widely so that all concerned
can avail this opportunity.
4. Website of CDSCO for information and necessary by concerned stakeholders.