2. General Questions
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2. General Questions
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2.1 Name of Regulatory Authority
Medicines are regulated in India by the Central Drugs Standard Control Organization (CDSCO).
https://cdsco.gov.in/opencms/opencms/en/Home/
2.2 Name of Ethics Committee
India has a decentralized process for the ethical review of clinical trial applications and requires ethics committee (EC) approval for each trial site. Because there is no national EC in the country, ECs are based at either institutions/organizations or function independently.
https://clinregs.niaid.nih.gov/country/india#ethics_committee
2.3 Clinical Trial Application Language
English
https://clinregs.niaid.nih.gov/country/india#submission_process
2.4 Is regulatory approval required from both regulatory authorities and/or EC?
Yes. CDSCO approval is required in addition to EC approval, except for academic/research clinical trials where only EC approval is needed.
2.5 Can regulatory authority and EC submission be done in parallel?
Yes. The CDSCO review and approval process may be conducted at the same time as the EC review for each clinical trial site, except in the case of non-regulatory academic/research clinical trials that only require EC approval. (Section 31)
https://clinregs.niaid.nih.gov/country/india#timeline_of_review
2.6 Requirement of any import permit/license before investigational product/study product is shipped from point of origin
Yes. The sponsor (applicant) is required to obtain approval from the Drug Controller General of India (DCGI) to manufacture or import investigational products (IPs) and to obtain an import license for the shipment of IPs to be used in the trial.
The application for Import Licence Form is on page 7 of the CDSCO guidance.
2.7 Biological Specimen Export Requirements
Research proposals requiring biological material transfer may be considered by the EC on a case-by-case basis. Collaborators should obtain applicable regulatory clearances as mandated by laws such as the Environmental Protection Act, 198620, the Biological Diversity Act, 200221, of the Ministry of Environment and Forests, Drugs and Cosmetics Act, 1940, and Rules, 1945, and the relevant amendments.
See page 24 of the ICMR Ethical Guidelines for further information.
2.8 Are studies of GMOs permitted (e.g., GMOs used in vaccines/vaccine manufacture and other modified products)?
In India, genetically modified organisms (GMOs) and the products thereof are regulated under the “Rules for the Manufacture, Use, Import, Export & Storage of Hazardous Microorganisms, Genetically Engineered Organisms or Cells, 1989” (referred to as Rules, 1989) notified under the Environment (Protection) Act, 1986.”
Rules, 1989, are implemented by the Ministry of Environment, Forest and Climate Change (MoEFCC) jointly with the Department of Biotechnology (DBT), the Ministry of Science & Technology, and state governments. Six Competent Authorities have been established to regulate products as follows:
- rDNA Advisory Committee (RDAC)
- Institutional Biosafety Committee (IBSC)
- Review Committee on Genetic Manipulation (RCGM)
- Genetic Engineering Appraisal Committee (GEAC)
- State Biotechnology Coordination Committee (SBCC)
- District Level Committee (DLC)
Approval from the relevant authority is required prior to the commencement of any study involving a GMO.
http://geacindia.gov.in/acts-and-rules.aspx
2.9 Is in-country sponsor presence/representation required?
Yes. Sponsors must have a locally based representative as defined in the 2019 Clinical Trial Rules.
https://cdsco.gov.in/opencms/opencms/en/Acts-and-rules/New-Drugs/
2.10 Is there any mandatory requirement to identify a local PI or can a PI be based in a foreign country?
There is no specific requirement for the PI to be located in India.
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadImmunization/Clinical.pdf
2.11 Is there any mandatory requirement to identify a local chief or coordinating investigator?
Yes. Where a trial is conducted over multiple sites, a qualified lead investigator needs to be assigned to make all trial-related medical decisions.
2.12 If the applicant is CRO or a third party, does regulatory authority need any authorization or transfer of obligations from the sponsor? Does the authorization letter need to be notarized and/or apostilled?
There are no specific requirements around the delegation of responsibilities to a CRO.
2.13 Is there a requirement to register clinical trials on a local registry or database?
Yes. Sponsors must register their trial on the Clinical Trial Registry India (CTRI) before enrolment of the first patient.
https://ctri.nic.in/Clinicaltrials/login.php
2.14 What is the local requirement for clinical study documents archival; minimum of years for the archival, specific format followed (electronic/paper and/or both)?
Clinical trial documents (either as electronic or paper copies) 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).
See section 13 (1) of the Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt of India.
https://clinregs.niaid.nih.gov/country/india#ethics_committee
2.15 Requirements around periodic safety reporting and timelines on SAEs/AEs/ADRs/SUSARs/DSURs.
- The investigator must report all SAEs/SADRs to the Drugs Controller General of India (DCGI), the sponsor or their representative, and the ethics committee (EC), within 24 hours of occurrence. In the event that the investigator fails to report any SAE/SADR within the stipulated period, he/she is required to provide reasons for the delay to the DCGI along with the SAE/SADR report for the DCGI’s approval. Note: The DCGI is head of the Central Drugs Standard Control Organization (CDSCO) and is commonly referred to as the Central Licensing Authority in Indian regulations.
- The sponsor (applicant) and the investigator must forward any SAE/SADR report, after due analysis, within 14 days of the occurrence to the DCGI, the EC Chairman, and the head of the institution where the trial is being conducted.
- In addition, the investigator must submit a report to the DCGI on how the SAE/SADR was related to the research within 14 days.
- The investigator must also promptly report to the EC all changes in the clinical trial activities and all unanticipated problems involving risks to human research participants or others.
- In the event of an SAE/SADR resulting in death, the sponsor or his/her representative and the investigator must forward his/her SAE/SADR reports to the DCGI within 14 days of knowledge of this occurrence. The 2019-CTRules and IND-42 also indicate that the EC is required to forward its report along with its opinion on financial compensation, if any, to be paid by the sponsor or his/her representative, to the DCGI within 30 days of the incident.
Forms for reporting SAEs - Table 5, pg 218
https://clinregs.niaid.nih.gov/country/india#safety_reporting
2.16 Requirement on any periodic clinical study update, specific template, and its frequency (e.g., interim or annual progress report and final report, etc.)?
The Drugs Controller General of India (DCGI) requires the sponsor (applicant) to submit a six (6)-month status report for each clinical trial electronically via the Central Drugs Standard Control Organization (CDSCO)’s SUGAM portal. The report should clarify whether the trial is ongoing, completed, or terminated. In the case of termination, detailed reasons for such termination must be communicated to the DCGI within 30 working days of the termination. Sponsors are required to submit an annual status report for the clinical trial to the DCGI.
In cases where trials have been prematurely discontinued for any reason, including a lack of commercial interest in pursuing the new drug application (NDA), the sponsor (applicant) should submit a summary report within three (3) months. The summary report should provide a brief description of the study, the number of participants exposed to the drug, the dose/duration of exposure, details of adverse drug reactions, if any, and the reason for the study’s discontinuation or non-pursuit of the NDA.
A final report is required to include the following information:
- Title page
- Study synopsis (1-2 pages)
- List of abbreviations and definitions
- Table of contents
- EC approval letter(s)
- Study team introduction
- Study objective
- Investigational plan
- Trial participants
- Efficacy evaluation
- Safety evaluation
- Discussion and overall conclusion
- List of references
- Appendices
https://clinregs.niaid.nih.gov/country/india#progress_reporting
2.17 Does the local regulation require notification of “serious breaches” of GCP or the trial protocol?
Yes, the sponsor (applicant) and the investigator must forward any SAE/SADR report, after due analysis, within 14 days of the occurrence to the DCGI, the EC Chairman, and the head of the institution where the trial is being conducted.
2.18 Does RA/CA require insurance and indemnity to cover the sponsor and investigator’s potential liability?
The sponsor should provide insurance coverage or a provision in the budget for possible compensation for trial-related injuries. It is preferable to have the insurance certificate and the policy for study participants. Further, the policy should explain the conditions of coverage, date of commencement, and expiration date for risk coverage (if applicable). In addition, institutional mechanisms must be established to allow for insurance coverage of trial-related or unrelated illnesses (ancillary care).
https://main.icmr.nic.in/sites/default/files/guidelines/ICMR_Ethical_Guidelines_2017.pdf
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