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Dated: 27.03.2025

CDSCO Launches Online CRO Registration via SUGAM Portal

The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health & Family Welfare, Government of India, has introduced an online registration and renewal process for Clinical Research Organisations (CROs) through its SUGAM portal using Form CT-07B.

Implementation Date:

• This digital submission process is currently active, and all CROs registration and renewal process will be mandated from 1^st April 2025.

Registration Procedure:

For New Users:

• Access the SUGAM portal and select ‘Clinical Research Organisation’ under the registration purpose.
• Complete email verification for account activation.
• Obtain approval from the CDSCO authority post-review.

For Existing Users:

• Request the addition of the ‘Clinical Research Organisation’ role from the user profile.

Submitting Application Form CT-07B:

• Log in and select ‘GCT Division’ followed by ‘Form CT-07B’.
• Specify the purpose of your application (Registration or Renewal).
• Add or select your correspondence address.
• Provide accreditation details (if applicable).

Document Upload and Checklist:

• Upload all necessary documents as per the portal-provided checklist during the submission.

Documents List-

• Proof of Accreditation (if applicable):
• Accreditation certificates from recognized bodies.
• Legal Entity Documents:
• Certificate of Incorporation or Registration.
• PAN card and GST details.
• Details of Key Personnel:
• CVs and qualifications of scientific and administrative personnel.
• Infrastructure Details:
• Facility details (address, layout, equipment list).
• Supporting photographs or video recordings of the facility.
• Standard Operating Procedures (SOPs):
• Copies of standard operating procedures covering essential activities.
• Financial Details:
• Evidence of financial viability, including audited financial statements.
• Undertakings:
• Duly signed undertakings and declarations about adherence to ethical and legal compliance.
• Previous Experience:
• Documented proof of previous experience in conducting clinical research or trials (if renewal or experienced CRO).
• Signed Application Form:
• System-generated application form downloaded from the portal, duly signed.

Payment Process:

• The registration fee is ₹500,000.
• Payments are made online through the Bharat Kosh portal, clearly marking the payment purpose as ‘CRO Registration’ or ‘CRO Renewal’.

Final Submission:

• Verify and confirm all information entered.
• Download, sign, and upload the system-generated form.
• Receive a confirmation email and application reference number for tracking purposes.

Communication and Technical Support:

• Use the ‘e-vartalap’ communication feature for smooth interaction with CDSCO during the application review.
• Technical support is available through the ‘Raise Ticket for Help-Desk’ option.

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Source: CDSCO

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