Rationalisation of 294 FDC drugs: CDSCO issues Fresh directions to manufacturers

New Delhi: In a move to regularise Fixed Dose Combinations (FDCs), the Central Drugs Standard Control Organization (CDSCO) has notified the process to be followed by all the manufacturers and stakeholders of the 294 FDC drugs that were declared rational by the organisation earlier this year.

The manufacturers and stakeholders of the 294 FDC drugs have been directed to submit their application along with the requisite fees as specified in the Sixth Schedule of the New Drugs and Clinical Trial Rules, 2019 by 2nd December 2019.

These 294 FDCs were declared rational by the country's top advisory on drugs and medical devices Drug Technical Advisory Board (DTAB) which were licensed to manufacture and market by State Licensing Authority without prior approval from DCGI.

The CDSCO notice in this regard reads;

"In continuation to this Directorate letter 04-146/2007-DC (Part-I) dated 27.02.2019 and various representations received in the matter, it has been decided that manufacturers/stakeholders who are holding a license for these FDCs from State Licensing Authority (SLA) may submit their applications by 02.12.2019. Further, all the applicants are requested to submit their applications along with requisite fees as specified in the Sixth Schedule of the New Drugs and Clinical Trial Rules, 2019."

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The details of the 294 FDCs released by CDSCO read;