Date: 2021-03-05Category: Not ApplicableState: Union GovernmentCountry: India
Meeting of DTAB Sub Committee for examining the Fixed Dose Combinations (FDCs) considered as irrational by Prof. Kokate Committee and to provide hearing to the stakeholders-regarding.
**Summary:**
This public notice, issued by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India, on March 5, 2021, announces a hearing for stakeholders regarding Fixed Dose Combinations (FDCs) considered irrational by the Prof. Kokate Committee. A sub-committee of the Drugs Technical Advisory Board (DTAB), chaired by Dr. Nilima Kshirsagar, has been constituted to examine these FDCs. Stakeholders who were requested to submit information via the public notice dated May 29, 2019, are now invited to a hearing via WebEx video conference, commencing April 19, 2021. The schedule for hearings concerning specific FDCs will be published periodically on the CDSCO website (www.cdsco.nic.in). Stakeholders are advised to regularly check the website for updates and hearing dates. Dr. Sanjeev Kumar, DDCI, CDSCO HQ, serves as the Convener of the DTAB Sub-Committee. Copies of this notice have been sent to Dr. Nilima Kshirsagar, IDMA/FOPECI/IIPA, and the CDSCO website for dissemination.
Key Entities Referenced
Directorate General of Health Services: An agency of the Government of India responsible for public health.
Central Drugs Standard Control Organization: National Regulatory Authority (NRA) in India responsible for regulating pharmaceuticals and medical devices.
New Delhi, Delhi: The location of the FDA Bhawan office of the CDSCO, where the public notice originates.
DTAB Sub Committee: A sub-committee of the Drugs Technical Advisory Board (DTAB) responsible for examining Fixed Dose Combinations (FDCs).
Fixed Dose Combinations: Combinations of two or more active pharmaceutical ingredients in a single dosage form.
Prof. Kokate Committee: A committee that assessed the rationality of certain Fixed Dose Combinations (FDCs).
Dr. Nilima Kshirsagar: Chairperson of the DTAB Sub-Committee examining FDCs.
Indian Council of Medical Research: The apex body in India for the formulation, coordination and promotion of biomedical research.
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: {} 5 MAR 2021
PUBLIC NOTICE
Subject: Meeting of DTAB Sub Committee for examining the Fixed Dose
Combinations (FDCs) considered as irrational by Prof. Kokate Committee
and to provide hearing to the stakeholders-regarding.
As you are aware that the Sub-Committee of DTAB has been constituted under the
chairpersonship of Dr. Nilima Kshirsagar, Emeritus Scientist, former Chair in Clinical
Pharmacology, Indian Council of Medical Research (ICMR), to examine the Fixed Dose
Combinations (FDCs) considered as irrational by Prof. Kokate Committee.
Accordingly, it was requested vide this office public notice dated 29.05.2019 to
submit the information in the prescribed format in hard as well as in soft copy.
Now, it has been proposed to give hearing to all the stakeholders for deliberation by
the Sub-committee. The meetings will be conducted through WebEx (Video Conference).
Accordingly, Sub-Committee invites the concerned stakeholders for hearing w.e.f.
19.04.2021. As regard to hearing for the particular FDC, the schedule of hearing will be
published from time to time on CDSCO website i.e. www.cdsco.nic.in. Accordingly, you may
regularly visit the CDSCO website and avail the opportunity of hearing on the given date.
This is for information of all the concerned.
A
{
(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.