CDSCO Introduces Online CRO Registration Mandate from April 1, 2025, sets fee at Rs 5 lakh
New Delhi: With the mandated registration of clinical research organizations (CROs) effective from April 1, 2025, the Central Drug Regulator has set up the Sugam portal for online registration, allowing organizations to complete the process by making an online payment of Rs. 5 lakh.
The Ministry of Health and Family Welfare has published G.S.R. 581(E) dated 19th September 2024, wherein registration of Clinical Research Organization (CRO) has been made mandatory, effective from 1st day of April, 2025.
In keeping with the aforementioned, the Central Drug Standard Control Organisation (CDSCO), Directorate General of Health Service, Government of India, has declared in a notice that the Sugam Portal will be used to register Clinical Research Organisation (CRO) applications. A payment of Rs. 500000 can be made online to complete the registration process.
The notice stated, “The online registration of Clinical Research Organization (CRO) is now functional on SUGAM portal (www.cdscoonline.gov.in).”
“Applications for registration shall be submitted through SUGAM portal only along with the prescribed checklist of documents for the registration.” the notice added.
In accordance with the application for registration of Clinical Research Organization, the notice stated that the application for the Form CT07B is now available on the SUGAM Portal.
Furthermore, the notice added a user manual for the SUGAM-Ane-Governance solution, Online Forms Submission, CRO (Clinical Research Organization) by the Central Drugs Standard Control Organisation (CDSCO).
In line with the user manual, explaining the registration process for new users, the notice mentioned,
“New users can visit the SUGAM Portal and click on Login/Sign-Up. Navigate to sign-up here and select the registration purpose as “Clinical Research Organisation”.Applicants may the fill the registration form as per the below screenshot.Please note that the email address mentioned in the username will be used in future for further communication and for the verification of email address upon successful form submission.Once the email address is verified, competent authority at CDSCO will further review the account request and grant approval accordingly. Once the account is approved by CDSCO, applicants may login into the SUGAM portal.”
In addition, regarding the Registration process for existing users, the notice stated,
‘Existing users on SUGAM Portal may submit are quest for additional role from user profile. Applicants may select role as “Clinical Research Organisation”.It is important to complete the user profile to enable form submission.’
In continuation, the user manual added the process of filling out FORMCT-07B:
- Applicants may login into the SUGAM Portal and click on the submit application page. Select “GCT Division” as the department and “Form CT07B” as the form. Click on the checkbox for the undertaking and click on “Proceed” button to proceed further.
- After clicking on “Proceed” button form for CRO registration or renewal will open. Below mentioned details are to be submitted:
Purpose of Application
Application in Form CT-07B can be filled either with the registration purpose or renewal purpose.
Correspondence Address
Kindly select correspondence address from the drop down menu. In case the address details are not available then the same can be added from “Add Address Details” page from “User Profile” available in top left menu.
Details of Accreditation
Select option as “Yes” incase details of accreditation are available. Upon selecting “Yes” additional field will be visible where details of accreditation can be added. In case details of accreditation are not available, kindly select “No”.
- Next, Click on the “Save” button to view the preview of the application form. Kindly ensure that the details mentioned in the preview page are in line with the details entered on the application page.
- Next, Click on “Proceed to Checklist” button in order to view the checklist. Submit necessary documents on all checklist items and proceed further with the payment for the application.
- On the payment page select “Online” as the mode of payment and the purpose.
Fees for registration application is Rs.500000
- Kindly ensure that the payment purpose is selected either as “CRO Registration” or “CRO Renewal” on payment page before generating deposit slip for bharat kosh.
- Select desired challan from the drop down menu “Payment Reference Number” and click on “Submit” button to proceed further.
- Final preview of the application will be displayed, kindly ensure that all details are correct, and payment related details are also captured correctly on preview page. Download system generated legal form by clicking on “Download PDF” button. System generated form needs to be duly signed by the applicant.
- Click on “Next” button to proceed further with form submission.
- Kindly upload duly signed copy of legal form on the final submission page and click on “Submit To CDSCO” button. Please note application number for future reference. Acknowledgement email for file submission will be sent on registered email address.
- Application will be visible under “Submitted Applications” on applicant dashboard. Applicant may utilize e-vartalap functionality to communicate with concerned division during the course of file processing.
- In case of any query applicant may raise ticket for IT-Helpdesk using “Raise Ticket for Help-Desk” option in top left menu
To review the full notice, click the below link: