4. Regulatory Authority (RA)/Competent Authority (CA)

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant. 

The data required will depend upon the type of application, phase of the study, stage in the drug development process, and/or objective of the study. Information that may be required is included in the list below:

1. Form CT-04 (the clinical trial application form including applicant name; sponsor nature/constitution and contact information; clinical trials site contact information and details; contact information for the person responsible for the compensation payment, if any; correspondence address; new drug/investigational new drug name(s) and details (i.e., therapeutic class, dosage form, composition, and indications); clinical trial phase; protocol number with date; and EC and investigator names) (See Form CT-04 in the 2019-CTRules for additional details).
2. Treasury Challan receipt demonstrating payment of a corresponding fee or transaction ID
3. Chemical and pharmaceutical information
4. Animal pharmacology data
5. Animal toxicology data
6. Human clinical pharmacology data
7. Active ingredient information (for INDs and global clinical trials (GCTs))
8. Formulation data (for INDs and GCTs)
9. Therapeutic class (for INDs and GCTs)
10. Regulatory status in India and in other countries
11. Proposed study status in other participating countries and any approvals, withdrawals, discontinuation of approval, etc. (for GCTs)
12. Affidavit stating study has not been discontinued in any country (for GCTs)
13. Prescribing information
14. Testing protocol(s) for quality control testing
15. Clinical study protocol
16. Dosage form
17. Justification and schematic diagram/flow chart proposed study and design (for INDs and GCTs)
18. Number of patients globally (for GCTs) and number of patients to be enrolled from India (for INDs and GCTs)
19. Details of all sites selected and assessment for suitability of sites and investigators (with contact details)
20. EC registration status of the selected sites
21. Relevance of study, investigational drug, or any specific study aspects to the health care needs of India
22. Innovation vis-à-vis existing therapeutic options
23. Unmet medical needs in the country (as applicable)
24. Any India-specific safety/dosage concerns/investigational tests to be done
25. Clinical study reports should be submitted per the International Conference on Harmonisation (ICH) Common Technical Document (CTD) (IND-68)
26. Protocol safety measures per toxicological studies; early clinical studies, approved product insert for the marketed product, and published literature
27. Investigator’s Brochure (IB)
28. Investigational Medicinal Products Dossier (IMPD) (for (GCTs))
29. Affidavit stating the IB information is correct and based on facts (for GCTs)
30. Source of bulk drugs (for INDs)
31. Treasury Challan with Form CT-16 (import license application) (for GCTs)
32. Sponsor authorization letter (for GCTs)
33. Details of biological specimens to be exported and the online application for export - no objection certificate (NOC) for biological samples on the SUGAM portal (for GCTs)
34. Case Report Form (CRF)
35. Informed consent form (ICF) and patient information sheet
36. Investigator(s) undertaking
37. EC approvals (if available)
38. Clinical study report(s)
39. Investigator list in India and site address

See form CT-04 and documentation requirements on page 197 of The New Drugs and Clinical Trials Rules 2019.

The nature and extent of information to be included in the application may vary based on the application type, study phase, drug development process stage, and study objective.

https://clinregs.niaid.nih.gov/country/india#submission_content

4.2 Time required for RA/CA review and approval process and turnaround time if any query is raised during the review process. 

Upon receipt of a clinical trial application, The DCGI has 90 calendar days to evaluate the application for drugs developed outside India and 30 days for drugs discovered, researched, and manufactured in India. If the DCGI does not respond within 30 days to applications for drugs developed in India, the sponsor (applicant) may conclude that permission to conduct the trial has been granted.

CDSCO coordinates the clinical trial application process. Upon receipt of an application, a CDSCO official is responsible for conducting the initial administrative review. If the application is deemed complete, within four (4) weeks following receipt, the official forwards the application along with a summary of his/her evaluation and a statement referring the proposal to a Subject Expert Committee (SEC) for further technical review. If the proposal is not accepted by the SEC, the sponsor (applicant) may request additional consideration of the proposal by the Technical Committee. Otherwise, only the SEC’s recommendations are required for the DCGI (CDSCO) to issue a final decision to the Technical or Apex Committee.

4.3 Does the regulation support electronic submission?

Yes, the application takes place electronically through the National Single Window System Portal (NSWS). As of 10 February 2024, this replaced the SUGAM portal process.

https://www.nsws.gov.in/

https://clinregs.niaid.nih.gov/country/india#submission_process

4.4 Does the regulation require the applicant to be a Principal Investigator (PI)/Chief Investigator (CI)?

No. The Sponsor/Applicant can be two different people.

4.5 Please describe the process of RA/CA submission for clinical trial approval. 

4.6 Does the RA/CA provide written acknowledgment of the submitted application? If not, describe how the application is tracked.

Yes. The acknowledgment of submission is provided by the NSWS portal. 

https://clinregs.niaid.nih.gov/country/india#submission_content

https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/GCT_PDFs/Approval_process_flowchart_GCT_Online.pdf

4.7 What is the relevant RA/CA fee in local currency/USD? Please provide as much information as possible (e.g. if the fee is different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, etc.)

Fees for submission to the DCGI are currently as follows (all USD amounts are as at the time of publishing):

• 3,00,000 Rupees (USD3600) for Phase I (human) clinical trials
• 2,00,000 Rupees (USD2400) for Phase II (exploratory) clinical trials
• 2,00,000 Rupees (USD 2400) for Phase III (confirmatory) clinical trials
• 2,00,000 Rupees (USD2400) for Phase IV clinical trials
• 50,000 Rupees (USD600) for reconsideration of the application for permission to conduct a clinical trial

In addition, no fee is required to be paid along with the clinical trial application if a trial is being conducted by an institution or an organization wholly or partially funded or owned by the Central Government of India or one of India’s state government institutes.

https://clinregs.niaid.nih.gov/country/india#regulatory_fees

4.8 Does RA/CA accept checks or can payment be made electronically? Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent?

Payment must be made electronically via the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001, any other Bank of Baroda branch, or any other bank approved by the Ministry of Health and Family Welfare (MOHFW) via the SBI ePay payment gateway. 

The payment should be credited to: the Head of Account, 0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines, also known as the head of Fees & Fines. In addition, payment is made via the SUGAM portal. 

Once the payment is submitted, the bank payment gateway will confirm that the payment was successful, and the user will be redirected to the online payment status page on the SUGAM portal to view the e-Challan (payment receipt).

https://clinregs.niaid.nih.gov/country/india#regulatory_fees

4.9 Is there any guidance tool available for making electronic applications? If yes, provide the link and/or step-by-step instructions.

Yes. Guidance is provided for the use of the NSWS portal.

4.10 Does RA/CA require any screenshots/mock screens for participant-facing materials?

Yes. Where electronic patient-facing materials are used, screenshots should be provided.