Procedure for approval of FDC drugs: CDSCO releases notification; Details

New Delhi: Through a recent notification, the Central Drugs Standard Control Organization (CDSCO) has directed drug manufacturers and all the concerned stakeholders to follow a procedure for clearance of the Fixed-dose Combinations (FDCs) which require a generation of data.

This comes in response to CDSCO's letter whereby all the State/UT Drugs Controllers were instructed to ask the concerned manufacturers in their State to prove the safety and efficacy of FDCs within 18 months which were permitted by State Licensing Authorities without due approval from the office of DCG(I).

After examination of such applications in consultation with Prof. Kokate Committee constituted by the Ministry of Health and Family Welfare, concerned manufacturers were earlier asked to conduct Phase IV study in the postmarket scenario for the generation of data to decide further on such FDCs falling under the category 'd' as per the report of the Committee.

Subsequently, the directorate received representations from various stakeholders requesting for waiver of Phase IV clinical trial. The matter was examined by the directorate, in consultation with Prof. Kokate Committee and after due deliberation, the Committee recommended for categorization of these FDCs into following sub-groups namely-

• FDCs which require Phase IV trial (Post Marketing Trial/Bioequivalence Study) as per Drugs & Cosmetics Rules, 1945.

• FDCs for which Active Post Marketing Surveillance shall be conducted under intimation to DCG(I) and report shall be submitted for further evaluation.

Further, the directorate also received representations from the subsequent applicants for obtaining NOC for manufacturing and marketing FDCs falling under category 'd' to have a level playing field. The list of FDCs falling under category 'd' is enclosed as Annexure A'.

With the approval of the Ministry, it has been now decided to follow the pathway for clearance of such subsequent applications as under:-

1. Documents required in case of manufacturers already holding licenses from State Licensing Authority (SLA) before 01.10.2012 for the proposed FDCs shall at least contain:-

• Form CT 21(duly filled, signed and stamped)


• Fees as specified in the sixth schedule of New Drugs and Clinical Trials Rule 2019 through Bharatkosh.


• Name and composition of the FDC


• Product Permission issued by SLA


• Copy of Manufacturing license in Form 25/28


• SI. no. and name of FDC as per the "Annexure A" and


• Phase IV trial protocol/commitment for conducting Active Post Marketing Surveillance study/Bio-equivalence study protocol, as the case may be.

2. Documents required in case of new manufacturers for the proposed FDCs shall at least contain:-

• Form CT 21(duly filled, signed and stamped)


• Fees as specified in the sixth schedule of New Drugs and Clinical Trials Rules 2019 through Bharat Kosh.


• Name and composition of the FDC


• Product Permission issued by SLA in Form 29


• Copy of Manufacturing license in Form 25/28


• SI. no. and name of FDC as per the "Annexure A"


• Stability studies data (06 months accelerated)


• Test Specifications of the FDC along with Method of Analysis


• Phase IV trial protocol/commitment for conducting Active Post Marketing Surveillance study/Bio-equivalence the study protocol, as the case may be.

3. All the manufacturers who are already holding licenses from State Licensing Authorities for such FDCs before01.10.2012 and did not apply to DCG (I) are required to submit their applications to the directorate at the earliest but not later than 6 months, failing which their applications will not be considered and their licenses will be considered as without legal validity.

In view of the above, all concerned stakeholders are required to follow the above procedure for clearance of such cases.

List of FDCs falling under category "d" as per Prof. Kokate Committee Report reads;

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDQ2MA==

Also Read: FDC Rationality: Now 6 months accelerated stability study data to be submitted, directs DCGI