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Evaluation of 16 Fixed Dose Combinations (FDCs) by DTAB Sub-Committee


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Manufacturer   |   CDSCO
31 March, 2023
Enforcement Date: 31 March, 2023
Evaluation of 16 Fixed Dose Combinations (FDCs) by DTAB Sub-Committee

Official notification was released by the Central Drugs Standard Control Organization on 31st March 2023 notifying all manufacturers to submit precise data for 16 irrational fixed dose combinations (FDCs) with all supporting documents in the office by 30th April 2023 by 5:00 pm.


The notification notifies the following information to all the manufacturers and concerned stakeholders: a. In the 86th meeting of the Drug Technical Advisory Board (DTAB), the request of Prof. Kokate Committee is accepted regarding the irrational fixed dose combinations (FDCs). b. A sub-committee under Dr Nilima Kshirsagar, Emeritus Scientist, Former Chairperson in Clinical Pharmacology, ICMR, Mumbai, shall examine the 16 irrational FDCs in detail as per the procedure. c. All manufacturers are requested to present the precise data with respect to these FDCs in detail as per the prescribed format in Annexure A, along with all supporting documents in soft and hard copy in the office by 30th April 2023 by 5:00 pm.

Applicable For: Manufacturer
Reference Number: 04-01/2013-DC(Misc.13-PSC Part-III) Notification Link

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