**Summary:**
This notice, issued by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), FDC Division, extends the deadline for manufacturers holding licenses from State Licensing Authorities prior to October 1, 2012, to submit applications for Category d Fixed Dose Combinations (FDCs) as per the Prof. Kokate Committee Report. The original deadline of November 22, 2019, has been extended to May 30, 2020, in response to requests from manufacturers/stakeholders. Manufacturers/stakeholders are requested to submit their applications along with the requisite fees as specified in the Sixth Schedule of the New Drugs and Clinical Trial Rules, 2019 by the new deadline. The notice is issued by Dr. V. G. Somani, Drugs Controller General India.
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 and Family Welfare, Government of India.
FDCs: Fixed Dose Combinations, referring to pharmaceutical products containing two or more active ingredients in a single dosage form.
Prof. Kokate Committee Report: A report by a committee headed by Prof. Kokate, likely concerning the regulation and evaluation of FDCs in India.
State Licensing Authorities: The regulatory bodies at the state level in India responsible for issuing licenses to manufacture drugs.
DCG I: Drugs Controller General of India, the head of the Central Drugs Standard Control Organization (CDSCO).
New Delhi: The location of Nirman Bhawan, where the Ministry of Health and Family Welfare is located.
Dr. V. G. Somani: The Drugs Controller General of India at the time of the notice.
Ministry of Health and Family Welfare: A governmental ministry responsible for public health in India.
F. No. 04-01/2013-DC (Misc. 13-PSC) (Pt. Il)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(FDC Division)
FDA Bhawan, Kotla Road,
New Delhi
Dated: 7/2/2<>0
NOTICE
Subject:- Pathway for subsequent manufacture of category ‘d’ FDCs as per
Prof. Kokate Committee Report-extension in time limit for
submission of application-reg.
This is in continuation to this Directorate notice of even number dated
22.05.2019. As per this said letter, manufacturers who are already holding licenses
from State Licensing Authorities for such FDCs before 01.10.2012 and did not apply
to DCG (I) were required to submit their applications to this Directorate. The date for
filing such applications expired on 22.11.2019.
Meanwhile, this Directorate received various representations requesting for
extension of time for submission of such applications. Accordingly, it has been
decided that manufacturers/stakeholders who were holding license prior to
01.10.2012 may submit their applications w.r.t category ‘d’ FDCs by 30.05.2020.
In view of above, without prejudice to legal validity of such product licenses, all
the concerned manufacturers/stakeholders are requested to submit their application
alongwith requisite fees as specified in the Sixth Schedule of the New Drugs and
Clinical Trial Rules, 2019 by 30.05.2020. \-
ae
(Dr. V. G. Somani)
Drugs Controller General (India)
Copy to:-
1. PS to JS(R), Ministry of Health and family Welfare, Nirman Bhawan, New
Delhi
2. All State/UT Drugs Controllers
3. CDSCO Zonal and Sub-Zonal offices
4. Indian Drug/Pharmaceuticals Association Forum
5. Web site of CDSCO