182 Circular regarding Requirement of NOC from DCGI for addition of new Clinical trial site or investigator 2016-Aug-03 493kb

File No. 12-01/14-DC (Pt-47)

Central Drug Standard Control Organization Directorate General of Health Services Ministry of Health and Family Welfare FDA Bhawan, Kotla Road, New Delhi 110002

Circular

Subject: Requirement of NOC from DCGI for addition of new clinical trial site or investigatorregarding.

To deliberate stake holders concerns and the way forward relating to some issues on conduct of clinical trial in India, two meetings were held on 20.08.2015 and 06.10.2015 under the Chairmanship of Secretary, Ministry of Health and Family Welfare in which experts including secretary, D/o Health Research and Director General, ICMR and Director General of Health Services were present.

As regards requirement of NOC from DCGI for addition of new clinical trial site or Investigator in clinical trial, it was decided in the meeting that the respective Ethics Committee after due diligence can approve proposals for addition of site(s) and investigator(s) and no NOC from DCGI in the normal course, should be necessary. However, the applicant would inform DCGI about any such addition /deletion and thereafter, if no objection was received from DCGI, it would be deemed to have concurrence of CDSCO.

This is communicated for information and necessary compliance by all concerned.

Drugs ControllerleGeneral (India)

To:-

I. All stakeholders through website of DCG(I).

II]. Zonal and Sub-zonal offices of CDSCO/ all officers of CDSCO (HQ)

Copy to:-

I. PPS to secretary

II. PPS to DGHS III. PPS to AS (Food and drugs) IV. PS to JS (R)