Insight

NDAC/MDAC/SEC

  • 29th July, 2016

In order to strengthen the scientific review and approval of new drugs/devices, the ministry has appointed 12 New Drug Advisory Committee’s (NDAC), Subject Expert Committees (SEC) and 7 Medical Device Advisory Committee’s (MDAC) to advise the CDSCO in making their decisions on approval of new drugs and global clinical trials.The Committee members review the safety and efficacy data submitted with the application and subsequently the decision on the product is taken in the meeting, where industry representatives require to present the data pertaining to concerned projects.We have already attended numerous NDAC/SEC and MDAC meetings and this has enabled us to understand the approach of experts. We offer following invaluable services pertaining to NDAC/SEC/MDAC meeting.

  • Review and Scientific / Technical Consultation on 11 sets of experts dossier to be submitted for review by NDAC/SEC/MDAC members.
  • Advise and Assistance on presentation preparation for NDAC/SEC/MDAC meeting.
  • Advise and Assistance on how to deliver the presentation in front of experts.
  • Preparation of query response, if any.

The NDAC/MDAC meetings are held for following type of applications

New Drug Approval

  • New Formulations
  • Fixed Dosage Combination(s)
  • Modified Dosage Forms / Additional Indication /Additional Strength

New Device Approval

Import, registration and marketing authorization of New drug / Devices / Biological /Vaccines etc.

BE NOC for export of unapproved drugs