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Any clinical trails studies which is planned in India should be registered in SUGAM portal for getting approval, ethical clearance and etc. Find the detailed stepwise procedure for applying Clinical Trail ( CT) in SUGAM Portal- India.

What is SUGAM?

SUGAM is an e-governance solution from CDSCO for the stakeholders, applicant’s and also for the state licensing authority. SUGAM portal is also Known as Suraksha Gunvatta Avam Maanakta and its started from 2016 to improve the level of transparency in drug regulatory process and to reduce the timeline, paperwork’s and to track the status of application status.

The objective of SUGAM is to provide fast track approval and also to establish single window system for the multiple stakeholders. It also has streamlined the CDSCO process through this portal a member can apply for GCT, New Drug or SND.

Who can apply on the SUGAM Online?

- Importer (Application in Form 8)
- Indian Agent
- Foreign Enterprise holding Indian Subsidiary
- Corporate

Forms and Applicability:

CT-04 Application for grant of CT of New Drug or IND
CT-4A Information to initiate CT as a part of Discovery, research, manufacture of India
CT- 05 Application to conduct BA/BE Study
CT-06 Permission to conduct CT
CT-07 Permission to conduct BA/BE Study
CT-10 Application to manufacture new drug for CT/BA – BE or for examination, test or analysis
CT-11 Permission to manufacture new drug for CT/BA – BE or for examination, test or analysis

How to apply online in SUGAM Portal?

STEP-1 Register with SUGAM Portal and Get your USER CREDENTIALS
Enter in to the portal -

STEP -2 Selection of Role: Click on Indian Agent and now user will get option to submit the application.

STEP-3 Select concerned Department & Division (GCT in this case) and Form (Form CT 04/ Form CT 16) then click on PROCEED.

STEP-4 Fill all other necessary information and mandatory fields and click on SAVE and COTINUE

STEP- 5 Form can be previewed, which will enable you to verify the information which you entered – Only after all the necessary corrections download the PDF file – Sign & Upload it Back.

STEP-6 Finally SAVE and SUBMIT your application. (You Can generate the acknowledgement Number)

Note: When you apply for clinical trail in SUGAM ensure that you have filled all the requirement’s like, PART- 1 – Purpose of the applications and drug details, PART-2 Stability Data/Manufacture Details/ Regulatory Status/ Pre-Clinical Details, PART-3 CT Study Details, PART-4 Generation of the requisite Form, Finally the check list if applicable.

General Instructions:

- Fill Not Applicable is concerned section not applicable.

- Upload all the documents in PDF format. For those filed which are not applicable, please upload the page wherein it is written that this section is not applicable along with the detailed justification.

- Upload the proof of payment challan

Watch the below video to understand more

Last bumped by Admin on 16 Mar 2021, 19:31.
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