Date: 2019-08-19Category: Not ApplicableState: Union GovernmentCountry: India
Procedure to be followed for regularisation of FDCs declared as rational in respect to 294 FDCs by the DTAB which were licensed to manufacture and market by State Licensing Authority without prior approval from DCG(I)-regarding
**Summary:**
This notice, issued by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), FDC Division, addresses the procedure for regularizing Fixed Dose Combinations (FDCs) declared rational by the Drugs Technical Advisory Board (DTAB). These FDCs were previously licensed for manufacture and marketing by State Licensing Authorities (SLAs) without prior approval from the Drugs Controller General.
This notice is a continuation of the Directorate's letter No. 041462007DC PartI dated 27.02.2019 and clarifies the process further based on representations received. Manufacturers holding licenses for these FDCs from SLAs were required to submit their applications by December 2, 2019, along with the requisite fees as specified in the Sixth Schedule of the New Drugs and Clinical Trial Rules, 2019.
Furthermore, for FDCs included in the list of 83 rational FDCs already approved by the Directorate in a specific strength and dosage form, applicants/stakeholders can directly approach the State Licensing Authority for manufacturing licenses, adhering to established procedures. This excludes strengths and dosage forms approved after the Directorate's letter dated 27.02.2019.
The notice is issued by Dr. V. G. Somani, Drugs Controller General of India. Copies have been distributed to the PS to JSR, Ministry of Health and Family Welfare, all State/UT Drugs Controllers, CDSCO Zonal and Sub-Zonal offices, the Indian Drug Pharmaceuticals Association Forum, and the CDSCO website. The file reference is F. No. 041462007DC PartI.
Key Entities Referenced
Directorate General of Health Services: A department under the Government of India responsible for health services.
Central Drugs Standard Control Organization: National Regulatory Authority, responsible for regulation of drugs and cosmetics in India.
FDCs: Fixed Dose Combinations, referring to drugs containing two or more active pharmaceutical ingredients in a single dosage form.
DTAB: Drugs Technical Advisory Board, a statutory body advising the government on technical matters related to drugs and cosmetics.
State Licensing Authority: The authority in each state responsible for licensing the manufacture and sale of drugs.
DCG: Drugs Controller General, head of the CDSCO.
New Drugs and Clinical Trial Rules, 2019: Rules that govern the approval of new drugs and clinical trials in India.
Ministry of Health and Family Welfare: A ministry of the Government of India.
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: \a} Slog
NOTICE
Subject:- Procedure to be followed for regularisation of FDCs declared as
rational in respect to 294 FDCs by the DTAB which were licensed to
manufacture and market by State Licensing Authority without prior
approval from DCG(|)-regarding.
In continuation to this Directorate letter 04-146/2007-DC (Part-!) dated 27.02.2019
and various representation received in the matter, it has been decided that
manufacturers/stakeholders who are holding license for these FDCs from State
Licensing Authority (SLA) may submit their applications by 02.12.2019. Further, all
the applicants are requested to submit their applications alongwith requisite fees as
specified in the Sixth Schedule of the New Drugs and Clinical Trial Rules, 2019.
We
(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
APRON All State/UT Drugs Controllers
CDSCO Zonal and Sub-Zonal offices
Indian Drug/Pharmaceuticals Association Forum
Web site of CDSCOF. No. 04-146/2007-DC (Part-l)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(FDC Division)
FDA Bhawan, Kotla Road,
New Delhi
Dated: Al el eet
NOTICE
Subject:- Procedure to be followed for regularisation of FDCs declared as
rational in respect to 294 FDCs by the DTAB which were licensed to
manufacture and market by State Licensing Authority without prior
approval from DCG(|)-regarding.
This is in continuation to this Directorate letter of even no. 04-146/2007-DC (Part-I)
dated 27.02.2019 and 12.04.2019. In this regard, it is to further clarify that for the
FDCs mentioned in the list of 83 rational FDCs which are already approved by this
Directorate in a particular strength and dosage form, the concerned
applicants/Stakeholders may directly approach State Licensing Authority for obtaining
the manufacturing license as per the defined procedures except for those strengths
and dosage form which are approved after the issuance of this Directorate letter
dated 27.02.2019
ye
is
(Dr. VG. 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