**Summary:**
This public notice, issued by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), India, provides an update regarding the meeting of the Drugs Technical Advisory Board (DTAB) Sub-Committee. The meeting, conducted via WebEx Video Conference from April 19, 2021, to May 7, 2021, will examine Fixed Dose Combinations (FDCs) previously identified as irrational by the Prof. Kokate Committee.
This notice serves as a reminder to stakeholders who were initially requested on March 23, 2021, to submit details and confirm participation. Due to low response, stakeholders are urged to confirm their participation by emailing fccdsco.nic.in by April 16, 2021. The email should include a PowerPoint presentation, presenter details (name, mobile number, email), and the FDC identification number as per the March 23, 2021 public notice.
The notice clarifies that the Sub-Committee reserves the right to make decisions based on available information if an applicant fails to attend the hearing.
Dr. Nilima Kshirsagar, Emeritus Scientist and former Chair in Clinical Pharmacology at the Indian Council of Medical Research (ICMR), serves as the Chairperson. Sanjeev Kumar, DDCI, CDSCO HQ, serves as the Convener of the Sub-Committee of DTAB.
The Indian Drugs Manufacturing Associations (IDMA), FOPECI, and IIPA are requested to communicate this notice to their members and publicize it widely. The notice is also available on the CDSCO website.
Key Entities Referenced
Directorate General of Health Services: A department under the Govt. of India responsible for health services.
Central Drugs Standard Control Organization: National Regulatory Authority (NRA) of India responsible for regulation of pharmaceuticals and medical devices.
New Delhi, Delhi: Location of the FDA Bhawan and CDSCO HQ.
DTAB Sub Committee: A sub-committee of the Drugs Technical Advisory Board.
Fixed Dose Combinations: FDCs, the subject of examination by the DTAB Sub Committee.
Prof. Kokate Committee: A committee that identified FDCs considered as irrational.
Sanjeev Kumar: DDCI, CDSCO HQ Convener, SubCommittee of DTAB
Indian Council of Medical Research: ICMR, Chairperson Dr. Nilima Kshirsagar, Emeritus Scientist, former Chair in Clinical Pharmacology
File No. 4-01/2013-DC (Misc. 13-PSC-Part-lll)
Govt. of India
Directorate General of Health Services
Central Drugs Standard Control Organization (India)
(FDC Division)
FDA Bhawan, Kotla Road
New Delhi-110002
Dated: 9 -o\—202\
PUBLIC NOTICE
Subject: Meeting of DTAB Sub Committee through WebEx (Video Conference) w.e.f.
19.04.2021 to 07.05.2021 for examining the Fixed Dose Combinations (FDCs)
considered as irrational by Prof. Kokate Committee and to provide hearing to
the stakeholders-regarding.
This is in continuation to this Directorate Public Notice dated 23.03.2021 whereby, this
office requested to submit the details and confirm the participation details of stakeholders by
09.04.2021. However, it has been observed that only a few applicants have submitted the
requisite details.
You are therefore, once again requested to kindly confirm your participation through e-mail
at féc@cdsco.nic.in by 16.04.2021 and also submit PPT along with the presenter details, mobile
number, e-mail, FDC identification No as per this Directorate Public Notice dated 23.03.2021. It
may be noted that in the event that the applicant does not attend the hearing, the Sub-
Committee reserves the right to make its decision on the basis of information available before it.
This is for information of all the concerned.
ee
(Sanjeev Kumar)
DDC(I), CDSCO (HQ) &
Convener, Sub-Committee of DTAB
Copy for necessary action to:
1. Dr. Nilima Kshirsagar, Emeritus Scientist, former Chair in Clinical Pharmacology, Indian
Council of Medical Research (ICMR), (Chairperson)
2. Indian Drugs Manufacturing Associations (IDMA/FOPE/CIPI/IPA) - with the request to
communicate it to your members and publicize it widely so that all concerned can avail this
opportunity.
3. Website of CDSCO for information and necessary action to all stakeholders.