CDSCO extends the date of evaluation of Fixed Dose Combinations

Jul 09, 2019 | by Avantis RegTech Legal Research Team


The Central Drugs Standard Control Organization (CDSCO) on July 01, 2019, has further extended the date of submission of information is extended from June 30, 2019 to August 16, 2019 till 5:00 pm.

CDSCO had evaluated the Fixed Dose Combinations (FDCs) by the Drug Technology Advisory Board (DTAB) sub-committee which were earlier considered as irrational in the assessment report of the Prof. Kokate committee. It was desired that the manufacturers and concerned stakeholders should be given an opportunity for presenting the precise data with respect to these FDCs. The manufacturers and concerned stakeholders were asked to submit the information by June 30, 2019 till 5:00pm.

Now, all the manufacturers or stakeholders may note that the date for submission of information in the prescribed format is extended upto August 16, 2019 till 5:00 p.m.


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