Approval procedure of 2,131 FDCs: DCGI

DCGI Directs State DCs To Ask Cos To Get Product Licenses Of 2,131 FDCs Approved By Kokate Committee and the DCGI

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DCGI Directs State SDCs To Ask Cos To Get Product Licenses Of 2,131 FDCs Approved By Kokate Committee

Mumbai: The Drugs Controller General of India (DCGI) has directed state drug controllers (SDCs) to ask manufacturers to get manufacturing licenses of 2,131 new fixed dose combinations (FDCs) approved by Prof. Kokate Committee and the DCGI.

VG Somani DCGI
Dr. VG Somani, DCGI

This is in continuation to the DCGI letter to state SDCs dated December 12, 2018 whereby all the state SDCs were requested to ask the concerned manufactures to follow the procedure for getting manufacturing licenses as stipulated by the Central Drugs Standard Control Organization (CDSCO) (FDC Division).

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As per the DCGI letter dt 08-01-2020 to the state SDCs, in continuation to the said letter, it may be noted that apart from these 1,681 FDCs, further there are 450 more FDCs which have been declared as rational by the committee and report of the committee has been accepted by the union health ministry.

Accordingly with approval of the Union health ministry, it has been now decided to follow a specific pathway for grant of product licenses by the State DCs for these FDCs.

Manufacturers shall submit the requisite fees preferably through Bharatkosh for each FDC to CDSCO as specified under Drugs and Cosmetic (D&C) Act, 1940 and existing Rules thereunder.

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The manufacturer / applicant shall submit application to the concerned SDC for grant of product manufacturing license giving the following details of FDC

  • Serial number of the FDC in the list
  • Stability studies data (6 months accelerated),
  • Test specification of the FDC alongwith method of analysis
  • As well as label and other documents as required for grant of product license under D&C rules.

The state SDC shall grant the product license of such FDCs without seeking NOC from DCGI, if other conditions of license under the D&C Rules, which need to be verified by state licensing authority (SLA) are found to have been fulfilled.

The SLAs shall verify the quality of such FDCs of each applicant or manufacturer before grant of license.

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DCGI further stated that every manufacturer permitted to manufacture these FDCs shall submit the periodic safety update reports (PSURs) as per new drugs and clinical trial rules – 2019 to the central licensing authority as defined in Rule 3 i.e. DCGI.

Failure to submit the PSURs shall be considered as contravention of these rules.

Union health ministry had on September 16, 2014 constituted a committee under the chairmanship of Prof C K Kokate, former vice-chancellor, KLE University, Belgaum, Karnataka for examining the safety and efficacy of unapproved FDCs which were licensed by the SLAs without due approval of DCGI.

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After holding a series of meetings the Kokate Committee had submitted its second assessment report to the Union health ministry on May 27, 2016 categorizing FDCs into following:

  • “Irrational (category ‘a’)”,
  • “Requiring further deliberation (category ‘b’)”,
  • “Rational (category ‘c’)” and
  • “FDCs requiring generation of data (category ‘d’)”.