On February 07, 2020, the Central Drugs Standard Control Organization (CDSCO) directed the manufacturers of Fixed-Dose Combination (FDCs) who are already holding the licenses from state drug licensing authority for such FDCs from before October 01, 2012, and did not submit an application to Drug Controller General of India (DCGI), are required to submit their application on or before May 30, 2020. The notification is applicable only to the manufacturers for category 'd' Fixed-Dose Combinations (FDCs) as per Kokate Committee Report.

The Prof. C. K. Kokate Committee, after holding a series of meetings had submitted its second assessment report to the Ministry of Health and Family Welfare (MoHFW) on May 27, 2016, categorizing FDCs into:

  • irrational (category 'a')
  • requiring further deliberation (category 'b')
  • rational (category 'c'), and
  • y FDCs requiring generation of data (category'd').

The committee had examined 418 applications of FDCs and found 324 FDCs as irrational while only 28 FDCs as rational. The panel had further stated that they required more data for 2 FDCs and 4 FDCs required further deliberation. It was also observed that out of the remaining 60 FDCs, 48 FDCs have already been prohibited, 11 have been declared rational and one FDC is sub-judice category (1 FDC) by the Kokate Committee which were placed in the list of these 418 applications of FDCs inadvertently.

Accordingly, the committee examined the safety and efficacy of unapproved FDCs which were licensed by state licensing authorities without due approval of DCGI. The committee requested such manufactures who are already holding the licenses from state drug Licensing authorities for such FDCs from before October 01, 2012, and did not submit an application to DCGI, to file application to DCGI well before November 22, 2019. However, with the expiry of the last date, and various representations received requesting for an extension of time, the CDSCO has decided to provide another chance to these manufacturers for category 'd' FDCs to submit their application with the date extended till May 30, 2020.

In furtherance to this, the CDSCO requested that without prejudice to the legal validity of such product licenses, all the concerned manufacturers/stakeholders are requested to submit their application along with requisite fees as specified in the Sixth Schedule of the New Drugs and Clinical Trial Rules, 2019, by May 30, 20201.


1 https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTU0Ng==

Originally published 28 April, 2020

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