Date: 2022-04-28Category: Not ApplicableState: Union GovernmentCountry: India
Procedure to be followed for regularization of FDCs with respect to 294 FDCs examined' by the DTAB which were licensed to manufacture and market by State Licensing Authority without prior approval from DCG(I)
**Summary:**
This policy document, issued by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), FDC Division, addresses the regularization of Fixed Dose Combinations (FDCs) that fall within the 294 FDC category. These FDCs were licensed for manufacture and marketing by State Licensing Authorities without prior approval from the Drugs Controller General (DCG).
The document serves as a notification to all State/UT Drugs Controllers, informing them of a decision to grant a final extension for manufacturers holding licenses from State Licensing Authorities to submit applications to the CDSCO for FDCs falling under the 294 category. The deadline for submission of applications, along with requisite fees, is **October 31, 2022.**
This decision was made in response to representations received by the Directorate requesting an extension of time for submission of applications, due to the Covid-19 pandemic. The policy references earlier directives on the same subject, specifically letters F. No. 041462007DC PartI dated February 27, 2019, August 19, 2019, September 8, 2020 and August 27, 2021.
State/UT Drugs Controllers are requested to direct all concerned manufacturers/stakeholders who are already holding manufacturing permissions for these FDCs to submit their applications to the Directorate by the specified deadline.
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; refers to pharmaceutical products containing two or more active ingredients in a fixed ratio.
DTAB: Drugs Technical Advisory Board; a statutory body advising the Central Government and State Governments on technical matters related to drugs.
State Licensing Authority: The authority in each state of India responsible for granting licenses to manufacture and market drugs.
DCG: Drugs Controller General; the head of the Central Drugs Standard Control Organization (CDSCO).
Directorate General of Health Services: A government organization responsible for public health programs and initiatives in India.
Dr. V. G. Somani: The Drugs Controller General of India at the time of the notification.
Ministry of Health and Family Welfare, New Delhi: A ministry of the Government of India responsible for health policy.
F. No. 04-146/2007-DC (Part-I)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(FDC Division)
FDA Bhawan, Kotla Road,
New Delhi
Dated: ? 8 APR 2627
To
All State/UT Drugs Controllers,
Subject:- Procedure to be followed for regularization of FDCs with respect to 294
FDCs examined: by the DTAB which were licensed to manufacture and
market by State Licensing Authority without prior approval from DCG(|)-
regarding.
Reference: 1. This Directorate letter no 04-146/2007-DC (Part-l) dated 27.02.2019.
2. This Directorate letter no 04-146/2007-DC (Part-l) dated 19.08.2019.
3. This Directorate letter no 04-146/2007-DC (Part-I) dated 08.09.2020.
4. This Directorate 02 letters no 04-146/2007-DC (Part-l) dated
27.08.2021.
Sir,
This is with reference to this Directorate’s various above letters w.r.t. FDCs falling
under 294 category. As per the said letters, manufacturers who are already holding
licenses from State Licensing Authorities for such FDCs and did not apply to DCG(!) were
required to submit their applications to this Directorate as per the defined pathways. The
date for filing such applications of various categories has already expired.
Meanwhile in the wake of Covid 19 pandemic, this Directorate has received various
representations requesting for extension of time for submission of such applications.
Accordingly, it has been decided that manufacturers/stakeholders who are holding licenses
from State Licensing Authorities and have not yet applied to this Directorate may submit
their applications w.r.t these FDCs by 31.10.2022.
In view of above, you are requested to direct all the concerned
manufacturers/stakeholders who are already holding manufacturing permissions for
manufacturing these FDCs to submit their application to this Directorate alongwith requisite
fees by 31.10.2022 positively.
Yours faithfully
\ae
V—
(Dr. V. G. Somani)
Drugs Controller General (India)
Copy to:-
ON PS to JS(R), Ministry of Health and family Welfare, Nirman Bhawan, New Delhi
CDSCO Zonal and Sub-Zonal offices
Indian Drug/Pharmaceuticals Association Forum
Web site of CDSCO
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