Information Not Yet Incorporated Into Country Profile:
DCGI Order on Clinical Trial Waivers
On August 7, 2024, the Drugs Controller General of India (DCGI) of India issued an order specifying the countries for which the DCGI may waive the requirement to conduct a local clinical trial if the new drug is already approved in one of the named countries. See the order for more details.
Clinical trial application language Regulatory authority & ethics committee review may be conducted at the same time Clinical trial registration required In-country sponsor presence/representation required Age of minors Specimens export allowedClinical Trials Registries
Ethics Committees
Funding & Institutions
Jun 21, 2024 - The India profile in ClinRegs has been reviewed and updated with the following information:2024 Central Drugs Standard Control Organization (CDSCO) Notice on the National Single Window System (NSWS) online portal launch and related resources (See Regulatory Fees, Submission .
Feb 2, 2023 - The India profile in ClinRegs has been reviewed and updated with the following information: New amendment to the New Drugs and Clinical Trials Rules which provides the timelines for when ethics committee registration, clinical trials, investigational product manufacturing, and active .
Apr 28, 2022 - The India profile in ClinRegs has been updated to include an amendment to the definition of “new drug” in the New Drugs and Clinical Trials Rules. (See Scope of Assessment) Sources Added During this Update: (Regulation) New Drugs and Clinical Trials (Amendment) Rules, 2022 (2022-CTRules-Amdt .
Mar 24, 2022 - The India profile in ClinRegs has been reviewed and updated with the following information: Requirements for obtaining consent from participants with mental illness (See Mentally Impaired) A checklist for ethics committee re-registration (See Authorizing Body) A link to the Institutional .
Mar 26, 2021 - The India profile in ClinRegs has been reviewed and updated to reflect current requirements. Key updates include: Expanded information on the terms of reference the Central Drugs Standard Control Organization (CDSCO) uses to constitute Subject Expert Committees which .
May 11, 2020 - On May 6, 2020, the Indian Council of Medical Research (ICMR) posted National Guidelines for Ethics Committees Reviewing Biomedical & Health Research during COVID-19 Pandemic. The guidelines cover general ethical issues, review procedures for both COVID-19 related and non-COVID related .
Apr 1, 2020 - The India profile in ClinRegs has been reviewed and updated to reflect current regulatory requirements. Key updates include: Additional checklists and FAQs issued by the Central Drugs Standard Control Organization (CDSCO) to facilitate the clinical trial application .
Other Regulatory Databases
Other Regulatory Databases
Central Drugs Standard Control Organization
As set forth in the Hdbk-ClinTrial , the Central Drugs Standard Control Organization (CDSCO) is the regulatory authority responsible for clinical trial oversight, approval, and inspections in India. In accordance with the provisions of the IND-59 , CDSCO functions under the Directorate General of Health Services (DGHS) , which is part of the Ministry of Health and Family Welfare (MOHFW) . Per IND-59 and IND-47 , as the Central Drug Authority, CDSCO is responsible for approving new drugs, conducting clinical trials, establishing drug standards, overseeing the quality of imported drugs, providing expert advice, and coordinating the state licensing authorities who regulate the manufacture, sale, and distribution of drugs.
Per the DCA-DCR , the Drugs Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC) advise the DCGI. IND-16 states that the DTAB, a statutory board, is composed of technical experts who advise the central and state governments on technical drug matters and on making rules. The DCC, a statutory committee, consists of central and state drug control officials who advise the central and state governments and the DTAB to ensure drug control measures are enforced throughout India.
Further, as indicated in the Hdbk-ClinTrial , Subject Expert Committees (SECs) comprise experts representing the relevant therapeutic areas that are responsible for reviewing the submitted clinical trial applications, investigators’ brochures, and study protocols. The IND-29 ), which may have implications for studies of investigational products developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see IND-45 .
Contact Information
According to IND-58 and IND-70 , CDSCO contact information is as follows:
Central Drugs Standard Control Organization
Directorate General of Health Services (DGHS)
Ministry of Health and Family Welfare
Government of India
FDA Bhavan, ITO, Kotla Road
New Delhi 110002
India
Phone: +91-11-23216367 (CDSCO)/23236975
Fax: +91-11-23236973
E-mail: dci@nic.in
Chapter I (2), Chapter II (3), Chapter V (19 and 21-22), Chapter XIII (100), Second Schedule (1), and Third Schedule (1)
Per the IND-6 for additional information on the revised definition of “new drug” under the Hdbk-ClinTrial , CDSCO must confirm that the EC approvals for each participating site have been obtained per the protocol prior to approving the initiation of the study. (See the Scope of Review section for more information.)
Clinical Trial Review Process
As set forth in the Hdbk-ClinTrial , the DCGI is responsible for reviewing and approving clinical drug applications. The evaluation timeline is dependent upon whether the investigational drugs under review are developed outside India, or discovered, researched, and manufactured in India. (Refer to the Timeline of Review section for detailed CDSCO timeline information.)
Per the Hdbk-ClinTrial , upon receipt of an application (via Form CT-04 which is found in the Hdbk-ClinTrial , SECs are usually comprised of six (6) experts representing various therapeutic areas, including pharmacologists/clinical pharmacologists, and medical specialists. However, Hdbk-ClinTrial , SECs are responsible for advising CDSCO with in-depth evaluations of non-clinical data (including pharmacological and toxicological data) and clinical trial data (Phases I-IV) provided by the sponsors for approval. The Ministry of Health and Family Welfare (MOHFW) or the DCGI. See Hdbk-ClinTrial indicates that the committee sends its comments via email to CDSCO. CDSCO will then compile any written SEC comments requiring sponsor clarification or modification and sends this feedback to the sponsor. The sponsor must submit a written reply to CDSCO, which is also sent to the SEC for review.
Following receipt of the sponsor’s response, the DCGI (CDSCO) will issue a final decision by official communication (permission, rejection, or resubmission) to the Technical or Apex Committee. In the case of a sponsor’s request for reconsideration, CDSCO will review the resubmitted application and send it to the SEC again, or, to the Technical Committee per the sponsor’s request. Following the SEC’s review, the DCGI (CDSCO) will send a final decision to the Technical or Apex Committee. If CDSCO rejects the reconsideration request, the agency will send a letter to the sponsor to communicate this decision. Refer to the Hdbk-ClinTrial for additional timeline information.
Per the G-ICMR indicates that the EC must review and approve any protocol amendments, major deviations, or violations prior to those changes being implemented.
See IND-46 for additional information on conducting clinical trials in India. For specific guidelines regarding gene therapy and stem cell therapy clinical trials, see the G-GeneThrpy and the G-StemCellRes .
(See the Submission Process and Submission Content sections for detailed submission requirements.)
Waiving Local Clinical Trials
Per the IND-19 , the United States, the United Kingdom, the European Union, Canada, Australia, and Japan are the countries for which the local clinical trials waiver will apply for new drugs already approved and marketed in those countries. Refer to the Manufacturing & Import section for detailed information on import requirements for new drugs already approved outside of India. See also IND-6 for additional information on local clinical trial waivers under the
7.11 and Annexures I, II, and III 4.8 (Table 4.2) and 7.0-7.1 4, 11.2, and Annexures I and II Preface, 4.0, 5.0-5.2, 5.22, 8.2, and Appendix 8.3Chapter I (2), Chapter II (3), Chapter III (11), Chapter V (19-26, and 28), Chapter XIII (100-101), First Schedule (3), Second Schedule (1 and Table 1), Third Schedule (1 and Table 4), Fourth Schedule (7), and Eighth Schedule (Forms CT-04, CT-4A, and CT-06)
Revising New Drug Definition and Waivers of Local Clinical Trial Data 2-3, 7, 10-11, 18, 22, 25, 31-33, 38, and 79Central Drugs Standard Control Organization
As per the IND-43 , and IND-42 , a sponsor (also known as applicant) is responsible for a paying a fee to the Drugs Controller General of India (DCGI), head of the Central Drugs Standard Control Organization (CDSCO) , to submit a clinical trial application. (Note: The DCGI is commonly referred to as the Central Licensing Authority in the Indian regulations.)
The IND-43 specify that Form CT-04 should be accompanied by one (1) of the following officially mandated fees:
According to the IND-24 indicates that for applications submitted to the National Single Window System (NSWS) portal ( IND-3 ), users should pay any required fees directly to CDSCO or any other ministry/department/state responsible for processing the application via the NSWS portal ( IND-3 ). At this time, however, per IND-14 , only a few CDSCO steps and processes (e.g., medical device related registration, manufacturing/import applications and drug manufacturing/import applications) have been moved to the NSWS portal ( IND-3 ).
Payment Instructions
As described in the IND-43 , 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 State Bank of India’s SBIePay payment gateway, which is accessed from the SUGAM portal ( IND-59 ). The payment should be credited to: Head of Account, 0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines per the IND-42 .
According to IND-43 and IND-42 , once the user validates the payment information in the SUGAM portal ( IND-59 ) , the payment request is redirected to the SBIePay payment gateway. When 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 in the SUGAM portal ( IND-59 ) to view the e-Challan (payment receipt).
IND-43 and IND-42 also specify that the online payment will take two (2) to three (3) days to be credited to the National Portal of India ’s Payment & Account Office. Therefore, users are requested to initiate online payments at least three (3) days prior to submitting an application to CDSCO. Refer to IND-43 and IND-42 for detailed fee requirements and online payment instructions via the SUGAM portal ( IND-59 ) .
(Note: Although the fees listed in IND-43 are correct, the SUGAM portal ( IND-59 ) and associated documentation as well as CDSCO’s Pre-Screening Checklist (
Chapter V (21), Chapter XIII (102), Sixth Schedule, and Eighth Schedule (Form CT-04) 1 (INDs) and 3 (Global Clinical Trials)As delineated in the G-ICMR . Prior to initiating and throughout the duration of a trial, every trial site must be overseen by an EC registered with the Drugs Controller General of India (DCGI), head of the Central Drugs Standard Control Organization (CDSCO) . (Note: The DCGI is commonly referred to as the Central Licensing Authority in the Indian regulations.)
Ethics Committees for Biomedical and Health Research
Per the G-ICMR , an institutional/independent EC should be multidisciplinary and multi-sectorial, representing a mixed gender and age composition. ECs that review clinical trial applications and those that review biomedical and health research share the same composition criteria including affiliations, qualifications, member specific roles and responsibilities, as well as terms of reference and review procedures.
The G-ICMR state that an EC should appoint from among its members a chairperson (from outside the institution) and a member secretary (generally from inside the institution). The other members should represent a balance of affiliated and non-affiliated medical/non-medical and scientific/non-scientific persons, including the lay public. Per the G-ICMR , preferably 50% of the members should not be affiliated with the institution.
As per the G-ICMR , the composition should include the following:
Terms of Reference, Review Procedures, and Meeting Schedule
As delineated in the G-ICMR , EC members should be made aware of their roles and responsibilities. The terms of reference should also include a statement on terms of appointment including duration and conditions; policy for removal/replacement; resignation procedure; meeting frequency; payment of processing fee to EC for review; honorariums to members and invited experts; maintenance of EC documentation and communication records, etc. Each committee should specify these terms in its own standard operating procedures (SOPs) that should be made available to each member.
In addition, per the G-ICMR , members should have no conflict of interest, and should voluntarily withdraw from the EC while making a decision on an application if a proposal evokes a conflict of interest. The G-ICMR indicates the term of membership is generally two (2) to three (3) years, and may be extended.
In terms of training, the G-ICMR also specifies each member must:
Further, if required, the G-ICMR , state subject experts could also be invited to offer their views, which must be recorded; however, the experts would not have any voting rights. Only members independent of the trial and the trial sponsor (also known as applicant) should vote/provide opinions in study related matters. In addition, all records must be safely maintained after the completion or termination of the study for at least five (5) years from the date of the trial’s completion or termination (both hard and soft copies).
The G-ICMR specifies that all EC members should review all proposals. Members should be given at least one (1) week to review the proposal and related documents, except in the case of expedited reviews. The Member Secretary should screen the proposals for their completeness and categorize them into three (3) types according to risk level: exemption from review, expedited review, or full committee review. An investigator cannot decide that a protocol falls in the exempted category without an EC review. Per the G-ICMR , a minimum of five (5) members is required for the quorum.
For detailed EC procedures and information on other administrative processes, see the G-ICMR , and IND-5 . See also IND-27 and IND-28 for the Indian Council of Medical Research (ICMR) ’s research conduct policies.
2.1, 2.8, 4.0-4.4, 4.10, Tables 4.1-4.3, Glossary, and Annex 1Chapters I, III-IV, and V (19-20 and 25); Third Schedule (1 and Table 1); and Eighth Schedule (Forms CT-01 and CT-02)
Sections 1-4 Sections 1-4Overview
The primary scope of information assessed by ethics committees (ECs) relates to maintaining and protecting the rights, safety, and well-being of all research participants, especially those in vulnerable populations, in accordance with the requirements set forth in the G-ICMR , the G-Children , the Declaration of Helsinki ( IND-63 ), and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) ( IND-41 ). (See the Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates ; and Mentally Impaired sections for additional information about these populations).
The G-ICMR also state that ECs must ensure an independent, timely, and competent review of all ethical aspects of the research protocols. They must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants, and they must verify the adequacy of confidentiality and privacy safeguards. Per the G-Children , ECs providing opinions on studies involving children should also include members with pediatric expertise. The expert(s) may be permanent EC members or invited as subject experts to provide advice and be consulted on an ad-hoc basis.
See also the G-AI-BiomedRes for EC review guidelines for biomedical and health research proposals involving artificial intelligence-based tools and technologies.
Role in Clinical Trial Approval Process
As per the G-ICMR , and Central Drugs Standard Control Organization (CDSCO) , and a DCGI-registered EC must approve a clinical trial application prior to the sponsor (also known as applicant) initiating the trial, except in the case of non-regulatory academic clinical trials that only require EC approval. (Note: The DCGI is commonly referred to as the Central Licensing Authority in the Indian regulations.) According to Hdbk-ClinTrial , CDSCO must confirm the EC approvals for each participating site have been obtained per the protocol prior to approving the initiation of the study. (Note: the Hdbk-ClinTrial has not yet been updated to fully align with the Hdbk-ClinTrial , and IND-36 for the Indian Council of Medical Research (ICMR) ’s EC clinical trials application form.
During a clinical trial, per the G-ICMR indicates that ECs must review and approve any protocol amendments, major deviations, or violations at regular intervals.
There is no stated expiration date for an EC approval in the G-ICMR . However, per the G-ICMR , IND-5 , and IND-27 . See also IND-36 for the EC clinical trial application form, and IND-52 for other commonly used EC review forms.
The G-ICMR further states that research during humanitarian emergencies and disasters can be reviewed by an EC through an expedited review and scheduled/unscheduled full committee meetings, and this may be decided by the member secretary on a case-by-case basis depending on the urgency and need. If an expedited review is done, full ethical review should follow as soon as possible. The EC should also closely monitor the conduct and outcome of research. See Section 12.5 of the G-ICMR for additional information on EC review requirements during humanitarian emergencies.
For specific guidelines regarding gene therapy and stem cell therapy clinical trials, see G-GeneThrpy and G-StemCellRes .
Academic Clinical Trials
In addition, per the IND-6 for additional information on academic trial approval requirements.
G-ICMR , biomedical and health research is defined as studies that include basic research, applied and operational research, or clinical research designed primarily to increase scientific knowledge about diseases and conditions (physical or socio-behavioral); their detection and cause; and evolving strategies for health promotion, prevention, or the amelioration of disease and rehabilitation.
As discussed in Notice15Sept19 and Chapter IV of the IND-28 for ICMR’s biomedical and health research conduct policies, and IND-6 for additional information on the regulation of biomedical and health research under the Ministry of Health and Family Welfare (MOHFW) ’s Department of Health Research (DHR) . Refer to the Oversight of Ethics Committees section for detailed registration requirements.
Multicenter Research
As delineated in the G-ICMR , in a multicenter research study, all of the participating study sites are required to obtain approval from their respective ECs. Each EC may conduct a separate review, or the ECs may decide to designate a main EC, with the others choosing to accept its decision. The study sites also typically follow a common protocol to avoid duplication of effort, wastage of time, and issues arising with communication between committees.
Per the G-ICMR , in the event that sites choose to have separate EC reviews, the following requirements must be met:
A separate review may be requested for studies with a higher degree of risk, clinical trials, or intervention studies where conduct may vary depending on the site, or, for any other reason that requires closer review and attention. See the G-ICMR for additional participating site requirements when a primary EC is selected for common EC review.
Per the G-ICMR , when the multicenter research study designates one (1) main EC, the nominated EC members that represent the participating sites may attend the meeting of the elected EC. The designated EC should also be in India and be registered with the relevant authority (either the DCGI or the DHR depending on the type of study). In addition, the decision to conduct a common review is only applicable for ECs in India. In the case of international collaboration for research and approval by a foreign institution, the local participating study sites would be required to obtain approval from a local EC. Refer to the G-ICMR for detailed information on multicenter studies that use the common review practice and involve international collaborations.
The G-ICMR further notes that the local site requirements (e.g., informed consent, research implementation and its monitoring) may be performed by the local EC, which would require good communication and coordination between the researchers and the EC secretariats representing the participating sites.
See the G-MultictrResRev for additional guidelines on streamlining the ethics review process for multicenter biomedical and health research studies conducted by the ICMR or its network of institutions.
7.11 and Annexures I, II, and III 1.0-1.1, 2.1, 2.3, 2.8-2.9, 4.0, 4.2, 4.7-4.8, 4.11, Tables 4.1-4.3, 12.5, Glossary, and Annex 1 4, 11.2, and Annexures I and II Preface, 4.0, 5.0-5.2, 8.2, and 8.3Chapter I, Chapter III (7, 11, and 13), Chapter IV (15-17), Chapter V (19-20, 25, and 28), and Third Schedule (1, 3, and Table 4)
Regulations on Biomedical and Health Research (BHR) and Academic Trials Introduction and Sections 1-4, and 6 2, 11, and 31-35 1.27 and 3.1As indicated in the G-ICMR , ethics committees (ECs) may charge a reasonable fee to cover the expenses related to optimal functioning to conduct reviews. EC members may also be given reasonable compensation for their time attending EC meetings, and every institution should allocate adequate funds to ensure the smooth functioning of the EC.
Overview
In accordance with the Central Drugs Standard Control Organization (CDSCO) , prior to reviewing and approving a clinical trial protocol. (Note: The DCGI is commonly referred to as the Central Licensing Authority in the Indian regulations.) As delineated in Notice15Sept19 and Chapter IV of the Ministry of Health and Family Welfare (MOHFW) ’s Department of Health Research (DHR) . According to IND-50 , the DHR’s Office for Ethics Committee Registration has been designated as the entity responsible for coordinating and monitoring registrations for ECs overseeing biomedical and health research in India. This office will receive applications for registration of ECs and will review and make decisions on EC registrations/re-registrations.
See also IND-69 for an application submission checklist to re-register ECs. Refer to IND-49 for a list of registered ECs, and IND-48 for a list of re-registered ECs.
Registration, Auditing, and Accreditation
Registration Provisions for Clinical Trial Ethics Committees
As specified in the IND-59 ) to register with the DCGI. The DCGI, in turn, will review the application within 45 working days from the date of receipt and, if satisfied with the information provided, grant the EC's registration request via Form CT-02. Per IND-53 , the EC registration will remain valid for a period of five (5) years from the date of issue, unless suspended or cancelled sooner. The EC may apply for registration renewal via the IND-59 using Form CT-01 and should include all additional required documentation 90 days prior to the registration’s expiration date. The registration will remain in force until the DCGI passes a new registration order as long as the application is received within the specified 90-day deadline. Following the DCGI’s review of the application and inspection report, if any, and provided that there are no changes to the documentation included in the original application, the EC’s request for registration renewal will be granted within 45 working days from the date of application receipt. See also IND-42 and IND-43 for detailed fee requirements and online payment instructions via IND-59 .
The aggrieved EC may file an appeal to the Government of India (Central Government) within 60 working days. The Central Government may subsequently pass an order in response to the appeal within 60 working days from the date of the appeal filing.
The EC must also allow CDSCO officials to enter the committee premises to inspect any records, data, documents, or other materials related to a clinical trial. The EC must provide adequate replies to any queries raised by the inspecting authority in relation to the conduct of the trial as noted in the Notice15Sept19 and IND-51 , ECs planning to review biomedical and health research studies are initially required to register on the DHR’s National Ethics Committee Registry for Biomedical and Health Research (NECRBHR) website ( IND-51 ). The NECRBHR facilitates the receipt and processing of application submissions and assists the DHR’s Office of Ethics Committee Registration. An authorized signatory/responsible person must complete the EC Applicant Registration Form ( IND-38 ) and submit it online on the NECRBHR website ( IND-51 ). Once the NECRBHR verifies the application and approves the account registration, the applicant will receive an email with login instructions to apply electronically via the DHR’s NAITIK portal ( IND-54 ). See IND-66 for a checklist of NECRBHR registration requirements.
Following a review of the registration renewal application and further inquiry to confirm there have been no documentation changes, the DHR will renew the EC’s registration on Form CT-03 within 45 working days from the date of application receipt. The renewed registration will remain valid for five (5) years from the date of its issue, unless suspended or cancelled sooner.
The aggrieved EC may file an appeal to the Government of India (Central Government) within 45 working days. In response to the appeal, as deemed necessary, and after giving the EC an opportunity to be heard, the Central Government may subsequently pass an order considered appropriate to the case.
(Note: The registration provisions for biomedical and health research ECs in Notice15Sept19 and IND-51 have not yet been aligned with the Notice15Sept19 and IND-51 . Further, only Notice15Sept19 and IND-51 specify that the DHR’s Office of Ethics Committee Registration is the designated authority. However, the ClinRegs team is regularly monitoring the CDSCO website for new developments and will post the most current sources as they become available.)
Additional Provisions for Clinical Trial and Biomedical and Health Research Ethics Committees
In addition to requiring all ECs to register with the relevant regulatory authority (the DCGI or the DHR), the G-ICMR specifies that ECs should be encouraged to seek recognition, certification, and accreditation from established national and international bodies (e.g., the SIDCER-FERCAP Foundation , the Association for the Accreditation of Human Research Protection Programs (AAHRPP) , CDSCO, and the Quality Council of India through National Accreditation Board for Hospitals and Healthcare Providers (NABH) , etc.). Although voluntary, the G-ICMR states that these certifications and accreditations should be continually updated to help with quality assurance and quality improvement and ensure that ECs comply with best practices to protect research participants.
4.1 and 4.15Chapter III (6, 8-11, and 14), Chapter IV, and Chapter V (19-20 and 25), Third Schedule (Table 1), and Eighth Schedule (Forms CT-01, CT-02, and CT-03)
2-3, 12, and Form CT-02A Registration of Ethics Committees reviewing Biomedical & Health ResearchIn accordance with the Hdbk-ClinTrial , the G-ICMR , and Central Drugs Standard Control Organization (CDSCO) , to obtain authorization to conduct a clinical trial in India. (Note: The DCGI is commonly referred to as the Central Licensing Authority in the Indian regulations.) The investigator must also obtain ethics committee (EC) approval from a DCGI-registered EC prior to initiating a study. According to Hdbk-ClinTrial , CDSCO must confirm the EC approvals for each participating site have been obtained per the protocol prior to approving the initiation of the study. (Note: the Hdbk-ClinTrial has not yet been updated to fully align with the G-GeneThrpy and G-StemCellRes .
Regulatory Submission
SUGAM Pre-Submission Registration
As explained in IND-42 , CDSCO created the SUGAM portal ( IND-59 IND-59 ) to be used by applicants to apply for no objection certificates (NOCs), licenses, registration certificates, permissions, and approvals. Once submitted, applicants can track their applications, respond to queries, and download CDSCO issued permissions. According to IND-20 , importers, Indian agents, foreign enterprises that hold an Indian subsidiary, and corporate users can register on the SUGAM portal ( IND-59 ).
Per IND-42 , users are required to complete a registration form requesting access to the SUGAM portal ( IND-59 ) along with uploading the required identification (ID) documentation. IND-42 specifies that the authorized signatory/responsible person in an organization should complete the registration form. After registration is approved, the user is required to submit hard copies of identification (ID), proof of undertaking, and address to the CDSCO office. Registration will be approved by CDSCO only after evaluation of the submitted documents. IND-20 further notes that the email ID provided in the registration form should be an official email ID as all correspondence with CDSCO via the SUGAM portal ( IND-59 ) will be completed using this registered email ID. Additionally, IND-20 , the user will receive login credentials on the registered email ID after completion of the verification process from the CDSCO office. For detailed registration instructions, see IND-42 and IND-20 .
NSWS Portal Pre-Submission Registration
Per National Single Window System (NSWS) portal ( IND-3 ) that will eventually serve as a one-stop shop for all approvals, licenses, registrations, and clearances. IND-24 further explains NSWS portal ( IND-3 ) is a digital platform that is designed to integrate the services provided by various ministries, departments, and states thereby enabling users to identify and apply for regulatory approvals and registrations per their business requirements in a single location. According to IND-14 , once the implementation process is completed, various regulatory documents including approvals, applications, and records will be accessible via the NSWS portal ( IND-3 ). At this time, however, per IND-3 ). Per IND-24 , while the NSWS portal ( IND-3 ) does not charge a fee for registration, users are required to pay any fees required by CDSCO or any other ministry/department/state to process applications submitted for approval via the NSWS portal ( IND-3 ).
IND-24 indicates that to access the NSWS portal ( IND-3 ) services, users are required to sign up by registering with an email address and mobile phone, and then creating a business profile. As explained in IND-61 , to complete the business profile, users are required to have a tax identification number known as a Permanent Account Number (PAN)). According to IND-33 , a PAN is issued by the Income Tax Department within the Indian Ministry of Finance . Both domestic and foreign users can apply for a PAN using the appropriate application form.
Per IND-62 and IND-64 , the user’s PAN will need to be verified using Digital Signature Certificate (DSC) for the created business profile. The steps involved in this process include adding authorized signatory information, registering the DSC, and verifying the PAN details against the registered DSC. IND-62 and IND-64 also note that users will need to have emBridge software installed on their computers to serve as a connecting link between the NSWS portal ( IND-3 ) and DSC. Please refer to IND-62 and IND-64 for detailed instructions on completing this registration process which is required to apply for approval and registrations. See also IND-4 for a complete list of NSWS portal ( IND-3 ) user guides.
Submissions
As indicated in the Notice15Jan18 , all clinical trial application submissions must be submitted electronically via CDSCO’s SUGAM portal ( IND-59 ). Refer to IND-42 for instructions on uploading forms and related documentation via the SUGAM portal ( IND-59 ).
Per IND-7 , CDSCO has introduced a new protocol for the submission of regulatory affairs related documents to facilitate the transition from hard copy to soft copy document submission. As explained in IND-7 , effective immediately, CDSCO’s Clinical Research Unit (CRU) Division is requesting that stakeholders submit bulky dossiers, documents, query replies, and similar materials in soft copy format. The soft copies should be submitted in PDF format and ideally less 20 MB on a CD or pen drive to the CRU Division or submitted via email to cru.division@cdsco.nic.in . The files will then be forwarded to the appropriate Division along with the stakeholder’s cover letter.
The DCA-DCR delineates that English should be used for specific documents included in the clinical trial application submission. For the informed consent form and patient information sheet, English and/or the vernacular language of the participant(s) should be used. English should also be used for the package inserts.
In addition, per IND-59 ) after receiving an invitation letter from CDSCO, and well in advance of the scheduled meeting.
Ethics Review Submission
As indicated in the Hdbk-ClinTrial , the G-ICMR , and G-ICMR also specifies that investigators should submit research proposals as soft or hard copies to the EC Secretariat for review in the prescribed format and required documents as per EC standard operating procedures (SOPs).