CDSCO issues procedure for regulation of 19 FDCs out of 294

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Last Updated on August 31, 2021 by The Health Master

Download DCGI’s latest Notices: The Central Drugs Standard Control Organisation (CDSCO) has issued a procedure for regulation of 19 fixed dose combinations (FDCs) out of the 294 FDCs which require further generation of data and were licensed by State Licensing Authority (SLA) without prior approval from the Drugs Controller General (India).

Manufacturers who have the state license, but did not obtain a no-objection certificate from DCGI are required to submit their applications to CDSCO within six months.

The drug regulator, in another communication, said that another 31 FDCs have been considered as rational under the 294 FDCs category.

For the 19 FDCs, the CDSCO has requested the state drug regulators to direct all concerned stakeholders to follow the procedure for clearance of the cases and to ensure that product licenses in respect of these 19 FDCs are issued after approval of DCG(I) in favour of the applicant.

DCGI-dt-27-08-2021-Procedure-for-regulation-of-FDCs-declared-as-rational-in-respect-to-294-FDCs-by-DTAB-which-were-licensed-to-manufacture-and-market-by-SLA-without-approval-of-DCGI

DCGI-dt-27-08-2021-Procedure-for-regulation-of-19-FDCs-declared-as-rational-in-respect-to-294-FDCs-by-DTAB-which-were-licensed-to-manufacture-and-market-by-SLA-without-approval-of-DCGI

DCGI-dt-27-08-2021-Manufacturing-and-marketing-of-certain-FDCs-as-per-directions-of-Honble-High-Court-Maharashtra-Nagpur-Bench


The manufacturers were requested to follow the pathway for clearance of such applications by submitting Form CT21 duly filled, signed and stamped; requisite fees through Bharatkosh; name and composition of the FDC; copy of product permission issued by SLA to any firm prior to November 28, 2007 as available or the documents in supporting strength and dosage form of FDC; copy of manufacturing license of the applied product issued by SLA in Form 25/28; series number of FDC as per the Annexure-A and stability studies data as per earlier communication in this regard.

Further, the test specifications of the FDC along with method of analysis and phase IV trial protocol/commitment for conducting active post marketing surveillance study as the case may be, should be submitted for clearance.

In case of applicants who are not holding manufacturing licenses of the applied product from the SLA and what to apply for these FDCs, they can apply with data generated on Form 29 with the above pathway.

The CDSCO, in April 12, 2019, directed all SLCs to ask the concerned stakeholders to submit the requisite data. The data submitted by the stakeholders was evaluated by the expert committee.

As per the report of Drug Technical Advisory Board (DTAB) on April 13, 2021, and recommendations of the subcommittee of DTAB as approved, there are 19 FDCs which require further generation of data by way of conducting phase IV trial/active post marketing surveillance study.

The list of 19 FDCs requiring the Phase IV clinical trial data include aceclofenac+paracetamol+chlorzoxazone; aceclofenac+paracetamol+serratiopeptidase; aceclofenac+paracetamol+tizanidine; aplrazolam+melatonin; alprazolam+propranolol; calcium dobesilate+lignocaine; chlorzoxazone+paracetamol+diclofenac; diclofenac+paracetamol+serratiopeptidase; ibuprofen+paracetamol+serratiopeptidase; nimisulide+paracetamol+serratiopeptidase; propranolol+diazepam; tizanidine+nimisulide+paracetamol, among others.

The drug regulator has in February 27, 2019 and September 8, 2020, issued letters with detailed pathways for obtaining permission from the directorate for 83 FDCs and subsequently three FDCs were declared as rational.

As per the report of DTAB dated April 13, 2021 and recommendations of the subcommittee of DTAB as approved, 31 more FDCs have been considered as rational under 294 FDCs category.

The list of these 31 FDCs include amoxicillin+cloxacillin+lactic acid bacillus; amoxicillin+lactic acid bacillus; calcium dobesilate+lignocaine+hydrocortisone; cefadroxyl+lactic acid bacillus, cefdinir+lactic acid bacillus, cefixime+lactobacillus+dicloxacillin; cefprozil+lactobacillus, dicyclomine+ranitidine; doxycycline+lactobacillus; ofloxacin+lactic acid bacillus; aloe vera+vitamin-e acetate, among others

It has said that all the manufacturers who are already holding licenses from SLA for the 31 FDCs and did not obtain NOC from DCG(I) are required to submit their applications to this directorate at the earliest within six months.

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