DGHS evaluates Fixed Dose Combinations which were earlier considered as irrational in Kokate Committee report

Jun 05, 2019 | by Avantis RegTech Legal Research Team


The Directorate General of Health Services (DGHS) on May 29, 2019, has issued a Notice in order to evaluate 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.

The sub-committee has 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 should submit the information in the prescribed format as per Annexure ‘A’ (Page 2) along with the relevant documents in hard copy as well as soft copy to this office by June 30, 2019 till 5:00pm.

Click here to download the Notice.

 


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