In 34th Apex Committee which was held on 02 June 2017, there were recommendation to remove three tier review of the studies in India. Here are the highlights
The Committee was apprised that the system of examination of proposals in CDSCO has since reached a maturity and, therefore, it will be appropriate that the approval processes should be streamlined. After discussion, it was decided that:
(i) the proposals relating to GCT (Global Clinical Trials) should be placed before the SEC and where these are accepted/rejected by the SEC, no further approval of the Technical Committee or Apex Committee will be required;
(ii) in cases, where DCGI is not in agreement with the recommendations of SECs in case of clinical trial application, the matter may be placed before the Technical Committee for a final decision within a month of the recommendations of the SEC;
(iii) the cases rejected by the SEC shall, in case the applicant feels aggrieved, be placed before the Technical Committee for its consideration. Where the Technical Committee decides, for reasons to be recoded in writing, to overrule the SEC, the decision of the Technical Committee shall be final;
Please find attached the full minutes of the meeting
Minutes of 34th Apex Committee 2 june 2017
Once the recommendations are implemented, the approval timelines shall significantly reduces to 3 months or less from present 6 months.
