CDSCO pulls manufacturers for failing to submit application for category d FDCs; Details
New Delhi: Through a recent notification, the Central Drugs Standard Control Organization (CDSCO) has pulled up the Fixed-Dose Combination (FDCs) manufacturers and directed them to submit an application for category 'd' Fixed-Dose Combinations (FDCs) as per Kokate Committee Report by May 30, 2020.
The Kokate Committee, headed by Prof. C. K. Kokate, Former Vice-Chancellor, KLE University, Karnataka, examined the Safety and Efficacy of unapproved FDCs which were licensed by State Licensing Authorities without due approval of DCGI.
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 require more data for 2 FDCs and 4 FDCs require 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.
The last date for filing such application was decided as November 22, 2019. However, with the expiry of the last date, CDSCO has provided another chance to the FDC manufacturers by giving them more time for submission of the application. In this regard, the apex drug regulator has extended the last date till May 30, 2020.
The extension came following various representations received by the Drugs Controller General of India (DCGI), requesting for an extension of time for submission of such applications. Accordingly, it has been decided that manufacturers or stakeholders who were holding license prior to October 1, 2012, may submit their applications with respect to category 'd' FDCs by May 30, 2020.
A letter on the same has also been sent to all the state drugs controllers and India drug/pharmaceuticals associations.
As per the said letter, manufacturers who are already holding licenses from State Licensing Authorities for such FDCs before 01.10.2012 and did not apply to DCGI were required to submit their applications. The date for filing such applications expired on 22.11.2019.
"In view of above, 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 30.05.2020, " the notice added.
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