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The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world. The ICMR has always attempted to address itself to the growing demands of scientific advances in biomedical...

Dr Rajiv Bahl, Secretary to Government of India, Department of Health Research and Director General, Indian Council of Medical Research View Profile

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Indian Council of Medical Research (ICMR)

The indian council of medical research (icmr), new delhi, the apex body in india for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world.

The Indian Council of Medical Research (ICMR) is the apex and premier medical research organization in the country which spearheads planning, formulation, coordination, implementation and promotion of biomedical research. It is one of the oldest medical research bodies in the world. In 1911, Government of India made a historic decision to establish Indian Research Fund Association (IRFA) with the specific objectives of sponsoring and coordinating medical research in the country. After Independence, in 1949, the IRFA was re-designated as the Indian Council of Medical Research (ICMR) with considerably expansion in its functions and activities. The ICMR has a vision to translate research into action for improving the health of the population.

The Council's research priorities coincide with the National health priorities such as control and management of communicable diseases, fertility control, maternal and child health, control of nutritional disorders, developing alternative strategies for health care delivery, containment within safety limits of environmental and occupational health problems; research on major non-communicable diseases like cancer, cardiovascular diseases, blindness, diabetes and other metabolic and haematological disorders, mental health research and drug research (including traditional remedies). All the ICMR’s efforts are undertaken with a view to reduce the total burden of disease and to promote health and well-being of the population. The Council is involved in promotion of biomedical research in the country through intramural as well as extramural research.

The mandates of the Council are:

• Apex body in India for formulation, coordination and promotion of biomedical research
• Conduct, coordinate and implement medical research for the benefit of the society
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• Introducing products/processes in to the public health system
• Generate, manage and disseminate new knowledge.
• Increase focus on research on the health problems of the vulnerable, the disadvantaged and marginalized section of the society.
• Harness and encourage the use of modern biology tools in addressing health concerns of the country.
• Encourage innovations and translation related to diagnostics, treatment, methods/ vaccines for prevention.
• Inculcate a culture of research in academia especially medical colleges and other health research institutions by strengthening infra-structure and human resource.
• Integrate research in different systems of medicine.

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• India’s clinical research advancements: trends witnessed across technology and patient-centricity

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• Updated On Feb 24, 2022 at 10:51 AM IST

• Published On Feb 24, 2022 at 10:44 AM IST

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• Clinical research

Funding opportunities for health research in India - A technical scan

Affiliations.

• 1 Assistant Professor, Department of Physiology, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth, Puducherry, India.
• 2 Associate Professor, Department of Physiology, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth, Puducherry, India.
• PMID: 33318398
• DOI: 10.4103/ijph.IJPH_9_20

Health research plays an integral part in scientific and academic innovation in health care. India, a rapidly developing country, showed a tremendous increase in the number of health research projects and publications in recent years. Given the broad spectrum of health research areas and a vast number of funding agencies that fund specific areas, it is difficult to gain knowledge about them from a single source. Hence, we scanned the various funding opportunities which exist in India for healthcare research. Various agencies fund health-care research on their thrust areas of national importance. Choosing the funding agency depending on the area of interest and following the guidelines given by them ensures a successful proposal for funding. This article enlists various funding agencies and gives overall information about the nature of support and fund provided for health research in India.

Keywords: Funding; Research and Development; grant; health research.

• Delivery of Health Care*

• Health Condition of trial participants is now coded as per ICD-10 classification and must be chosen from the drop down list provided up to a maximum of 4 levels to the nearest disease category possible

Last Updated:

Clinical trials hold enormous potential for benefiting patients, improving therapeutic regimens and ensuring advancement in medical practice that is evidence based. Unfortunately, the data and reports of various trials are often difficult to find and in some cases do not even exist as many trials abandoned or are not published due to "negative" or equivocal results. However, this tendency for availability of only selective information from the myriad clinical trials conducted is not commensurate with the practice of "evidence-based medicine". Today, world over, a need has been felt on the imperative for transparency, accountability and accessibility in order to re-establish public trust in clinical trial data. And this would be feasible only if all clinical trials conducted are registered in a centralized clinical trials registry. Registration of trials will ensure transparency, accountability and accessibility of clinical trials. [Read more...]

The mission of the Clinical Trials Registry-India (CTRI) is to ensure that all clinical trials conducted in India are prospectively registered, i.e. before the enrolment of the first participant. Additionally, post-marketing surveillance studies, BA/BE studies as well as clinical studies as part of PG thesis are also expected to be registered in the CTRI.

The vision of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the trial data set items. While this register is meant primarily for trials conducted in India, the CTRI will also accept registration of trials conducted in other countries in the region, which do not have a Primary Registry of its own, provided ethics approval (in English) is available and the study has not begun enrolling.

The Clinical Trials Registry- India (CTRI), hosted at the ICMR's National Institute of Medical Statistics ( https://icmr-nims.nic.in ), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20 th July 2007 ( www.ctri.nic.in ). Initiated as a voluntary measure, since 15 th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) ( www.cdsco.gov.in ). Moreover , Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication 1, 2 .

Today, any researcher who plans to conduct a trial involving human participants, of any intervention such as drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the Department of AYUSH ( https://indianmedicine.nic.in/ ) is expected to register the trial in the CTRI before enrollment of the first participant. Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient . Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI. In the CTRI, details of Indian investigators, trial sites, Indian target sample size and date of enrollment are captured. After a trial is registered, trialists are expected to regularly update the trial status or other aspects as the case may be. After a trial is registered, all updates and changes will be recorded and available for public display.

Being a Primary Register of the International Clinical Trials Registry Platform (ICTRP) ( http://www.who.int/ictrp/search/en/ ), registered trials are freely searchable both from the WHO's search portal, the ICTRP as well as from the CTRI ( www.ctri.nic.in ). [Read more...]

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Country Selection

Regulatory Authority

Scope of assessment, regulatory fees, ethics committee, scope of review, ethics committee fees, oversight of ethics committees.

Clinical Trial Lifecycle

Submission Process

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Sponsorship

Definition of Sponsor

Site/investigator selection, insurance & compensation, risk & quality management, data & records management, personal data protection.

Informed Consent

Documentation Requirements

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Investigational Products

Definition of Investigational Product

Manufacturing & import, quality requirements, product management, definition of specimen, specimen import & export, consent for specimen, requirements, additional resources.

Quick Facts

Central Drugs Standard Control Organization

As set forth in the 2019-CTRules and 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 2019-CTRules , the Drugs Controller General of India (DCGI) heads CDSCO, and is responsible for granting permission for clinical trials to be conducted and for regulating the sale and importation of drugs for use in clinical trials. (Note: The DCGI is commonly referred to as the Central Licensing Authority in the Indian regulations.) 

According to 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.

In addition, 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 2019-CTRules further notes that the DCGI may, when required, constitute one (1) or more of these expert committees or group of experts with specialization in relevant fields to evaluate scientific and technical drug-related issues. In accordance with the 2019-CTRules and with the approval of the MOHFW, Order13Jan20 establishes the terms of reference that CDSCO will use to constitute the SECs from the groups/panels of approximately 550 medical experts with specialization in relevant fields, including the existing members of the SECs from various government medical colleges and institutions. Refer to Scope of Assessment section for additional information on the therapeutic areas to be reviewed by the SECs. (Note: the Hdbk-ClinTrial has not yet been updated to fully align with the 2019-CTRules .)

Please note: India is party to the Nagoya Protocol on Access and Benefit-sharing ( 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 , IND-70 , and IND-71 , 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: [email protected]

CDSCO Public Relations Office Helpline Phone: 011-23216367 ext. 102, 011-23502915, or 1 800 11 1454 (toll free) Email: [email protected]

In accordance with the 2019-CTRules and the Hdbk-ClinTrial , the Drugs Controller General of India (DCGI), who heads the Central Drugs Standard Control Organization (CDSCO) , is responsible for reviewing and approving clinical trial applications for all new drugs, investigational new drugs (INDs), and imported drugs to be registered in India. Additionally, per the 2019-CTRules , the G-ICMR , and IND-31 , the DCGI and a DCGI-registered ethics committee (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/research clinical trials that only require EC approval. Refer to the Scope of Review section for detailed information on non-regulatory academic/research clinical requirements. (Note: The DCGI is commonly referred to as the Central Licensing Authority in the Indian regulations.)

As per the 2019-CTRules and the Hdbk-ClinTrial , the scope of the DCGI assessment includes a review of applications for IND and new drug clinical trials, global clinical trials (GCTs), and post marketing studies (Phases I-IV). Per Notice18Feb20 , which clarifies information provided in IND-31 , the 2019-CTRules are only applicable to new drugs and investigational new drugs. (Note: the Hdbk-ClinTrial has not yet been updated to fully align with the 2019-CTRules .)

The 2019-CTRules defines a “new drug” as:

• A drug, including active pharmaceutical ingredients or phytopharmaceutical drugs, that has not been used in the country to any significant extent
• A drug that has already been approved by the DCGI and is now proposed to be marketed with modified or new claims
• A fixed dose combination of two (2) or more drugs, individually approved for earlier specific claims, and which are now proposed to be combined for the first time in a fixed ratio, or, if the ratio of ingredients in an already marketed combination is proposed to be changed
• A modified or sustained release form of a drug, or novel drug delivery system of any drug approved by the DCGI
• A vaccine, recombinant Deoxyribonucleic Acid (r-DNA)-derived product, living modified organism, monoclonal antibody, cell, or stem cell derived product, gene therapeutic product, or xenografts intended to be used as a drug

Per the 2019-CTRules and IND-31 , the above listed drugs, excluding the modified/sustained drug forms and biological drug products, will be deemed new for four (4) years from the date of first approval. The modified/sustained drug forms and biological products including vaccines should always be viewed as new drugs. See also IND-6 for additional information on the revised definition of “new drug” under the 2019-CTRules .

The 2019-CTRules defines an IND as a new chemical or biological entity or a product having therapeutic indication but that has never been tested on human beings, and as also noted in IND-31 , has not been approved as a drug for marketing in any country.

In addition, according to IND-31 , the DCGI review and approval process may be conducted in parallel with the institutional or independent EC review for each clinical trial site. However, per the 2019-CTRules and 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 2019-CTRules and 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 2019-CTRules ), a CDSCO official is responsible for conducting the initial administrative review. If the application is deemed complete, 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 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.

Per the Hdbk-ClinTrial , SECs are usually comprised of six (6) experts representing various therapeutic areas, including pharmacologists/clinical pharmacologists, and medical specialists. However, Order13Jan20 , issued in accordance with the 2019-CTRules , indicates that SECs will be comprised of eight (8) medical experts, specifically one (1) pharmacologist and seven (7) medical specialists. Per the 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 2019-CTRules further notes that the DCGI may, when required, constitute one (1) or more of these expert committees or group of experts with specialization in relevant fields to evaluate scientific and technical drug-related issues.

Additionally, per Order13Jan20 , SECs will evaluate and advise the DCGI on proposals in various categories for the approval of new drug and clinical trial applications. These include the following: new drug substances of chemical and biological origin including vaccines and r-DNA derived products; subsequent approval of new drug and biological products including vaccines and r-DNA derived products already approved in the country; global clinical trials; fixed dose combinations of two (2) or more drugs to be introduced for the first time in the country; causality analysis, drug safety, or any other technical matter requiring expert advice in the opinion of the Ministry of Health and Family Welfare (MOHFW) or the DCGI. See Order13Jan20 for the complete terms of reference required to constitute SECs.

Once an SEC has completed its review, the 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 2022-CTRules-3rdAmdt , which amends the 2019-CTRules , upon obtaining approval from the DCGI, the sponsor must notify CDSCO via Form CT-06A (see 2022-CTRules-3rdAmdt ) prior to initiating the clinical trial. The DCGI will then record the information provided on this form and it will become part of the official record known as the approval of the DCGI. The DCGI grants permission to initiate a clinical trial via either Form CT-06 (see 2019-CTRules ) or as an automatic approval via Form CT-4A (see 2019-CTRules ). 2022-CTRules-3rdAmdt further states that when the DCGI approves a clinical trial of a new drug already approved outside India per the 2019-CTRules , the sponsor must also notify CDSCO via Form CT-06A, and this record will become part of the official record known as the guaranteed approval of the DCGI.

Per the  2019-CTRules , the DCGI’s permission to initiate a clinical trial granted via either Form CT-06 or as an automatic approval via Form CT-4A will remain valid for two (2) years from the date of its issue, unless extended by the DCGI as noted in the 2019-CTRules and IND-31 .

In addition, per the 2019-CTRules , an investigator should not implement any deviations from or changes to the protocol without the sponsor’s agreement and after obtaining the EC’s prior review and documented approval or favorable opinion of the amendment. All protocol amendments should be submitted to the DCGI in writing along with the EC approval letter. Similarly, the G-ICMR indicates that the EC must review and approve any protocol amendments, major deviations, or violations prior to those changes being implemented.

The 2019-CTRules explains that the exception to this requirement is when it is necessary to eliminate an immediate hazard to the trial participant or when the changes involved are only logistical or administrative in nature. In this case, the EC as well as the DCGI must be notified immediately of all such exceptions. The DCGI should be notified of administrative or logistical changes or minor amendments in the protocol within 30 days.

The Hdbk-ClinTrial and the 2019-CTRules also note that application reviews should be based on the following evaluation parameters:

• Assessment of risk versus benefit to the patients
• Innovation vis-à-vis existing therapeutic option
• Unmet medical need in the country
• Safety/dosage/investigational tests (e.g., pharmacogenetic tests)
• Any additional information or study(ies) needed before marketing approval for inclusion in package insert/ summary product characteristic (SmPC) post marketing

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.)

Other Considerations

In addition, per the 2019-CTRules and IND-31 , the DCGI, with the approval of the Central Government, may waive the requirement to conduct a local trial for a new drug already approved outside India. The waiver will be considered for applications submitted to conduct a trial with a new drug already approved in certain countries if the following conditions are met:

• The new drug is approved and marketed in countries to be specified by the DCGI and no major unexpected serious adverse events have been reported, or
• The DCGI has already granted permission to conduct a GCT with the new drug that is currently ongoing in India and this new drug has also been approved for marketing in one (1) of the countries to be specified by the DCGI, and
• There is no probability or evidence, on the basis of existing knowledge, of any difference in the metabolism of the new drug by the Indian population, or any factor that may affect the pharmacokinetics, pharmacodynamics, and safety and efficacy of the new drug, and
• The applicant has committed in writing to conducting a Phase IV clinical trial to establish the new drug’s safety and efficacy per the DCGI-approved formulation

Per the 2019-CTRules , the DCGI plans to issue periodic orders to specify the countries that may be eligible for this waiver. For countries that do not meet the waiver eligibility requirements, the 2019-CTRules states that these applications must be approved by the DCGI within 90 working days from the date of application receipt. Although the 2019-CTRules does not delineate the countries that may be eligible for a waiver, according to IND-19 , the United States, the United Kingdom, the European Union, Canada, Australia, and Japan are the countries that will no longer be required to complete local clinical trials for already approved and marketed new drugs. 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 2019-CTRules .

As per the 2019-CTRules , 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 2019-CTRules and IND-43 specify that Form CT-04 should be accompanied by one (1) of the following officially mandated fees:

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

According to the 2019-CTRules , the sponsor must also submit a fee of 5,000 Rupees per product with an application for permission to manufacture or import the investigational product (IP) to be used in a clinical trial.

In addition, the 2019-CTRules states that 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 institute(s).

See also IND-31 for additional information on CDSCO fee requirements.

Payment Instructions

As described in the 2019-CTRules and 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 2019-CTRules , also known as the head of Fees & Fines, according to IND-42 .

According to IND-43 and IND-42 , once the user validates the payment information in 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 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.

(Note: Although the fees listed in IND-43 are correct, the SUGAM portal and associated documentation as well as CDSCO’s Pre-Screening Checklist ( IND-32 ) have not yet been aligned with the 2019-CTRules in terms of referencing the new application form (CT-04). However, the ClinRegs team is regularly monitoring the CDSCO website for new developments and will post the most current sources as they become available.)

As delineated in the 2019-CTRules and IND-31 , 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, and must meet the requirements set forth in the 2019-CTRules and 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 2019-CTRules , CDSCO requires institutions that intend to conduct biomedical and health research to have an EC that reviews and oversees this type of research study. In addition, CDSCO has also established a separate registration and monitoring system for ECs that review biomedical and health research. See the Scope of Review section for additional information on biomedical and research study requirements.

Ethics Committee Composition

Pursuant to the 2019-CTRules and 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 2019-CTRules and 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 2019-CTRules and the G-ICMR , preferably 50% of the members should also be non-affiliated or from outside the institution.

As per the 2019-CTRules and the G-ICMR , the composition should include the following:

• Chairperson from outside the institute (Vice Chairperson (optional))
• One (1) to two (2) basic medical scientists (preferably one (1) pharmacologist)
• One (1) to two (2) clinicians from various institutions
• Legal expert(s) or retired judge
• One (1) social scientist/representative of non-governmental voluntary agency
• One (1) philosopher/ethicist/theologian
• One (1) lay person from the community
• Member secretary (Alternative Member secretary optional)
• One (1) member whose primary area of interest/specialization is non-scientific
• At least one (1) member independent of the institution/trial site

Additionally, per the 2019-CTRules , EC members are required to:

• Be familiar with key clinical regulatory requirements as delineated in the 2019-CTRules and the G-ICMR that reference both the Declaration of Helsinki ( IND-63 ) and the most recently updated International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) ( IND-41 )
• Have post-graduate qualifications and experience in their fields if representing basic medical scientists/clinicians
• Represent the specific patient group as much as possible based on the research area requirement

Terms of Reference, Review Procedures, and Meeting Schedule

As delineated in the 2019-CTRules and 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 2019-CTRules and 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:

• Provide a recent signed Curriculum Vitae (CV) and training certificates on human research protection and good clinical practice (GCP) guidelines, if applicable
• Either be trained in human research protection and/or GCP at the time of induction into the EC, or undergo training and submit training certificates within six (6) months of appointment (or as per institutional policy)
• Be willing to undergo training or update their skills/knowledge during their tenure as an EC member

Further, if required, the 2019-CTRules and 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 his/her protocol falls in the exempted category without an EC review. Per the 2019-CTRules and 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 2019-CTRules , 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.

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 2019-CTRules , 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 2019-CTRules and 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.

Role in Clinical Trial Approval Process

As per the 2019-CTRules , the G-ICMR , and IND-31 , the Drugs Controller General of India (DCGI), head of the 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 IND-31 , the DCGI review and approval process may be conducted in parallel with the EC review for each clinical trial site. However, per the 2019-CTRules and the 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 2019-CTRules .)

The 2019-CTRules , the Hdbk-ClinTrial , and IND-31 specify that an EC must grant a separate approval for each trial site to be used, and the DCGI must be informed of each approval. A trial may only be initiated at each respective site after obtaining an EC approval for that site. The 2019-CTRules and IND-31 further state that if a site does not have an EC, it may obtain approval from another site’s EC provided that it is located within the same city or within a radius of 50 kilometers of the trial site. The DCGI should be notified of the EC’s approval within 15 working days of the approval being granted per the 2019-CTRules . Per the 2019-CTRules and IND-31 , the EC of each site should notify the DCGI of its approval and provide a copy within 15 working days of making this decision. Refer to IND-36 for the Indian Council of Medical Research (ICMR) ’s EC clinical trials application form.

During a clinical trial, per the 2019-CTRules , an investigator should not implement any deviations from or changes to the trial protocol without agreement by the sponsor and after obtaining the EC’s prior review and documented approval or favorable opinion of the amendment. All protocol amendments should be submitted to the DCGI in writing along with the EC’s approval letter.

The 2019-CTRules further states that the exception to this requirement is when it is necessary to eliminate an immediate hazard to the trial participant or when the changes involved are only logistical or administrative in nature. In this case, the EC as well as the DCGI must be notified immediately of all such exceptions. The DCGI should also be notified of administrative or logistical changes or minor amendments in the protocol within 30 days.

As delineated in the 2019-CTRules , ECs also have a continuing responsibility to monitor approved clinical trials and biomedical and health research studies to ensure ethical compliance throughout the study duration.

For all studies, 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 2019-CTRules or the G-ICMR . However, per the 2019-CTRules , in the event that an EC revokes its approval of a clinical protocol, it must record its reasons for doing so and immediately communicate this decision to the investigator as well as to the DCGI. For detailed EC review procedures and information on other administrative processes, see the 2019-CTRules , 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

As defined by the 2019-CTRules , an academic clinical trial is a clinical trial of a drug already approved for a certain claim and initiated by any investigator, academic or research institution for a new indication or new route of administration, or, new dose or new dosage form, where the results of such a trial are intended to be used only for academic or research purposes and not for seeking DCGI approval or regulatory authority approval in any country for marketing or commercial purpose.

The 2019-CTRules and IND-31 specify that an academic clinical trial does not require DCGI approval as long as the following conditions are met:

• The trial is approved by the EC, and
• The data generated is not intended for submission to the DCGI

In addition, per the 2019-CTRules and IND-31 , the EC should inform the DCGI about the academic trials it has approved and cases where there could be an overlap between the clinical trial for academic and regulatory purposes. If the DCGI does not comment to the EC within 30 days from receiving EC notification, it should be presumed that DCGI permission is not required. See also IND-6 for additional information on academic trial approval requirements.

IND-25 further explains that a drug import license is not required for EC-approved academic trials that will be using a permitted drug formulation with a new indication, a new route of administration, a new dose, or a new dosage form. See the Manufacturing & Import section for detailed information.

Biomedical and Health Research

According to the 2019-CTRules and the 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 2019-CTRules , any institution or organization that intends to conduct biomedical and health research involving human participants is required to have an EC to review and oversee the conduct of such research before the study is initiated and throughout its duration. See also 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 2019-CTRules .

The EC must also be registered with the designated authority within 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:

• The participating site ECs/Secretariats should establish communication with one another
• If any EC does not grant approval for a study at a site, the reasons must be shared with other ECs and should be considered
• The EC can suggest site-specific protocols and informed consent modifications as per local needs

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 located 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.

As 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.

In accordance with the 2019-CTRules and IND-31 , all ethics committees (ECs) that review drug clinical trials are required to register with the Drugs Controller General of India (DCGI), head of 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 2019-CTRules , all ECs that review biomedical and health research studies are required to register with the designated authority within 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 2019-CTRules and Notice1Aug18 , ECs that intend to review clinical trial research protocols must submit Form CT-01 via the SUGAM portal ( 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 2022-CTRules-3rdAmdt , provided that no communication has been received from the DCGI within the stated period of 45 working days, the EC registration will be deemed granted by the DCGI, and such registration will be regarded as legally valid for all purposes and the applicant will be authorized to initiate a clinical trial in accordance with these rules. 2022-CTRules-3rdAmdt further states that once the EC has obtained provisional approval from the DCGI per the 2019-CTRules , the committee must also notify CDSCO via Form CT-02A, which will become part of the official record known as the guaranteed registration of the DCGI.

Per the 2019-CTRules and 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 SUGAM portal 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 the SUGAM portal.

The 2019-CTRules also states that if the EC fails to comply with any of the registration conditions, the DCGI may, after giving the EC an opportunity to show cause as to why such an order should not be passed, prepare an order in writing to suspend or cancel the EC registration for such period as deemed necessary. The suspended or cancelled EC can appeal to the DCGI within the period specified in the show cause notice, and, after consideration, the DCGI may respond by taking one (1) or more of the following actions:

• Withdraw the notice
• Issue a warning to the EC describing the deficiency or defect observed during an inspection
• Reject the results of the clinical trial
• Suspend for a specified period or cancel the registration, or
• Debar its members to oversee any future trial for a specified period

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 2019-CTRules .

Registration Provisions for Biomedical and Health Research Ethics Committees

As explained in 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 submit an application electronically via the DHR’s NAITIK portal ( IND-54 ). See IND-66 for a checklist of NECRBHR registration requirements.

Per the 2019-CTRules , the EC must submit an application to the NECRBHR using Form CT-01 along with the required information and documentation specified in Table 1 of the Third Schedule of the 2019-CTRules . Upon receipt of the application, the DHR’s Office of Ethics Committee Registration (designated authority) must grant provisional registration to the EC for a period of two (2) years. Final registration will be granted to the EC on Form CT-03 when the DHR has completed its review of the application and the associated documentation. The final registration will remain valid for a period of five (5) years from the date of its issue, unless suspended or cancelled sooner.

The EC may also submit an application to request registration renewal using Form CT-01 along with the specified documentation at least 90 days prior to the final registration’s expiration date. The final registration will remain in force until the DHR completes its review of the renewal application provided that the following conditions are met:

• The DHR does not require the EC to provide a new set of documents
• There have been no changes in the submitted documents since the final registration was granted, and
• The EC submits a certificate to the DHR validating that the documents have not changed

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 2019-CTRules further states that if the EC fails to comply with any of the registration conditions, the DHR may, after giving the EC an opportunity to show cause as to why such an order should not be passed, prepare an order in writing to suspend or cancel the EC registration for such period as deemed appropriate. The suspended or cancelled EC can appeal to the DHR, and after consideration, the DHR may respond by taking one (1) or more of the following actions:

• Issue a warning to the EC describing the deficiency or defect observed, which may adversely affect the rights or well-being of the study participants
• Suspend the EC for a specified period or cancel the registration, or
• Debar its members from overseeing any future biomedical health research for a specified period

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 2019-CTRules in terms of explaining the application submission process. The 2019-CTRules does not specify that the application submission process is electronic as is stated in 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.

In accordance with the 2019-CTRules , the Hdbk-ClinTrial , the G-ICMR , and IND-31 , the sponsor (also known as the applicant) is required to submit a clinical trial application to the Drugs Controller General of India (DCGI), head of the 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 IND-31 , the DCGI review and approval process may be conducted in parallel with the EC review for each clinical trial site. However, per the 2019-CTRules and the 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 2019-CTRules .) Refer to IND-42 for instructions on uploading forms and related documentation to the SUGAM portal ( IND-59 ).

For specific guidelines regarding gene therapy and stem cell therapy clinical trial submissions, see G-GeneThrpy and G-StemCellRes .

Regulatory Submission

As indicated in the Notice15Jan18 , all clinical trial application submissions must be submitted electronically via CDSCO’s SUGAM portal ( IND-59 ) .

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.

Ethics Review Submission

As indicated in the 2019-CTRules , the Hdbk-ClinTrial , the G-ICMR , and IND-31 , India requires all clinical trials of drugs involving human participants to be reviewed by a DCGI-registered EC. Because the submission process at individual institutional ECs will vary, applicants should review and follow their institution’s specific requirements. The 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).

Regulatory Authority Requirements

As per the 2019-CTRules , the Hdbk-ClinTrial , IND-32 , and IND-35 , documentation must be submitted to the Drugs Controller General of India (DCGI), head of the Central Drugs Standard Control Organization (CDSCO) , as part of the approval process for investigational new drugs (INDs) will depend upon the type of application, phase of the study, stage in drug development process, and/or objective of the study. Information that may be required is included in the lists below (Note: The regulatory sources provide overlapping and unique elements so each of the items listed above will not necessarily be in each source):

• Form CT-04 (the clinical trial application form including sponsor (also known as applicant) name; sponsor nature/constitution and contact information; clinical trials site contact information and details; contact information for person responsible for 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 ethics committee (EC) and investigator names)
• Treasury Challan receipt demonstrating payment of corresponding fee or transaction ID
• Chemical and pharmaceutical information
• Animal pharmacology data
• Animal toxicology data
• Human clinical pharmacology data
• Active ingredient information (for INDs and global clinical trials (GCTs))
• Formulation data (for INDs and GCTs)
• Therapeutic class (for INDs and GCTs)
• Regulatory status in India and in other countries
• Proposed study status in other participating countries and any approvals, withdrawals, discontinuation of approval, etc. (for GCTs)
• Affidavit stating study has not been discontinued in any country (for GCTs)
• Prescribing information
• Testing protocol(s) for quality control testing
• Clinical study protocol
• Dosage form
• Justification and schematic diagram/flow chart proposed study and design (for INDs and GCTs)
• Number of patients globally (for GCTs) and number of patients to be enrolled from India (for INDs and GCTs)
• Details of all sites selected and assessment for suitability of sites and investigators (with contact details)
• EC registration status of the selected sites
• Relevance of study, investigational drug, or any specific study aspects to the health care needs of India
• Innovation vis-à-vis existing therapeutic options
• Unmet medical need in the country (as applicable)
• Any India-specific safety/dosage concerns/investigational tests to be done
• Clinical study reports should be submitted per the International Conference on Harmonisation (ICH) Common Technical Document (CTD) ( IND-68 )
• Protocol safety measures per toxicological studies; early clinical studies, approved product insert for marketed product, and published literature
• Investigator’s Brochure (IB)
• Investigational Medicinal Products Dossier (IMPD) (for (GCTs))
• Affidavit stating the IB information is correct and based on facts (for GCTs)
• Source of bulk drugs (for INDs)
• Treasury Challan with Form CT-16 (import license application) (for GCTs)
• Sponsor authorization letter (for GCTs)
• Details of biological specimens to be exported and the online application for export no objection certificate (NOC) for biological samples on the SUGAM portal ( IND-59 ) (for GCTs) (See IND-1 for the application form to request a NOC to export biological samples) (Refer to the Specimens topic for more information on specimen import/export)
• Case Report Form (CRF)
• Informed consent form (ICF) and patient information sheet (See Required Elements section for additional information)
• Investigator(s) undertaking
• EC approvals (if available)
• Clinical study report(s)
• Investigator list in India and site address

See the 2019-CTRules , the Hdbk-ClinTrial , IND-32 , and IND-35 for detailed DCGI application submission requirements. See also IND-22 for details on the SUGAM portal approval process for GCTs and IND-31 for clinical trial FAQs. (Note: The Hdbk-ClinTrial has not yet been updated to fully align with the 2019-CTRules .)

Refer to the 2019-CTRules and IND-31 to obtain detailed submission requirements for applications to conduct a clinical trial using an already approved new drug with a new indication, a new dosage form/new route of administration, a modified release dosage form, or a new drug with an additional strength.

Ethics Committee Requirements

Each institutional EC has its own application form and clearance requirements, which can differ significantly regarding the number of copies to be supplied and application format requirements. However, per the G-ICMR , the requirements listed below are basically consistent and shared by all of the Indian ECs:

• Cover letter to the Member Secretary
• Type of review requested
• Application form for initial review ( IND-39 )
• Informed consent document (in English and the local language(s)) including translation and back translation certificates, if applicable
• Case record form/questionnaire
• Recruitment procedures (e.g., advertisement, notices) if applicable
• Patient instruction card, diary, etc., if applicable
• IB (as applicable for drugs, biological, or device trials)
• Details of funding agency/sponsor and fund allocation, if applicable
• Investigators’ Curriculum Vitaes (CVs)
• Conflict of interest statement, if applicable
• Good Clinical Practice (GCP) training certificate for investigators (preferably within last five (5) years)
• Any other research ethics/other training evidence, if applicable as per EC standard operating procedures (SOPs)
• List of ongoing research studies undertaken by the principal investigator, if applicable
• Investigator’s undertaking statement with all participating investigator signatures
• Regulatory permissions (as applicable)
• Relevant administrative approvals (such as Health Ministry’s Screening Committee (HMSC) approval for international trials)
• Institutional Committee for Stem Cell Research (IC-SCR) Registration ( IND-72 ), if applicable
• Memorandum of Understanding (MoU) in case of studies involving collaboration with other institutions, if applicable
• Clinical trial agreement between the sponsors, investigator, and the head of the institution(s), if applicable
• Clinical trial registration documentation (preferable)
• Insurance policy (it is preferable to have the policy as well as the insurance certificate) for study participants indicating conditions of coverage, date of commencement and date of expiry of coverage of risk (if applicable)
• Indemnity policy, clearly indicating the conditions of coverage, commencement date, and expiry date of risk coverage (if applicable)
• Any additional document(s), as required by EC (such as other EC clearances for multicentric studies)

Furthermore, the ICMR has prepared a generic application for initial review ( IND-39 ) that may be used by the EC. The form is also included in the bulleted list above.

Clinical Protocol

As delineated in the 2019-CTRules , the Hdbk-ClinTrial , and the G-ICMR , the clinical study protocol should include the following elements:

• Table of contents
• Brief summary ( G-ICMR )
• Study rationale
• Study objective
• Study design and methodology
• Study population
• Justification of inclusion/exclusion of vulnerable populations ( G-ICMR )
• Participant eligibility and recruitment procedures
• Study assessments
• Study conduct stating the types of activities that would be included (e.g., medical history, type of physical examination, etc.)
• Study treatment
• Ethical consideration
• Study monitoring and supervision
• Investigational product management (See Investigational Products topic for detailed coverage of this subject)
• Data analysis
• Undertaking by the Investigator statement

The G-ICMR also mentions the following requirements:

• Study duration
• Justification for placebo, benefit-risk assessment, plans to withdraw; if standard therapies are to be withheld, justification for the same
• Informed consent procedure and sample of the patient/participant information sheet and informed consent forms including audiovisual recording, if applicable, and informed consent for stored samples
• Plan to maintain the privacy and confidentiality of the study participants
• Adverse events/adverse drug reactions
• For research involving more than minimal risk, an account of management of risk or injury
• Proposed compensation, reimbursement of incidental expenses and management of research related injury/illness during and after research period
• Provision of ancillary care for unrelated illness during the duration of research
• Account of storage and maintenance of all data collected during the trial
• Plans for publication of results while maintaining confidentiality of participants’ personal information/identity

For detailed information on these elements, see the 2019-CTRules , the Hdbk-ClinTrial , and the G-ICMR .

Based on the 2019-CTRules , the Hdbk-ClinTrial , the G-ICMR , and IND-31 , the review and approval of a clinical trial application by the Drugs Controller General of India (DCGI), head of the Central Drugs Standard Control Organization (CDSCO) , is dependent upon obtaining ethics committee (EC) approval from a DCGI-registered EC prior to initiating a study. (Note: The DCGI is commonly referred to as the Central Licensing Authority in the Indian regulations.) According to IND-31 , the DCGI 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 clinical trials that only require EC approval. However, per the 2019-CTRules and the 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 2019-CTRules .)

Regulatory Authority Approval

As specified in the 2019-CTRules and IND-31 , upon receipt of a clinical trial application , the DCGI has 90 calendar days to evaluate the application for a new drug or an investigational new drug; 90 calendar days to evaluate a new drug already approved outside India; and 30 days to evaluate a drug discovered, researched, and manufactured in India. Per the  Hdbk-ClinTrial , upon receipt of an application, a CDSCO official conducts 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.

The 2019-CTRules further notes that the DCGI may, when required, constitute one (1) or more of these expert committees or group of experts with the specialization in relevant fields to evaluate scientific and technical drug-related issues. The committee/group may submit its recommendations within 60 days from the date of the request. See the Scope of Assessment section for more information on SEC composition and review processes.

Once the SEC has completed its review, the Hdbk-ClinTrial indicates that the committee sends its comments via email to CDSCO. CDSCO will then compile any written SEC comments requiring sponsor (also known as applicant) clarification or modification and send this feedback to the sponsor within one (1) week of receipt. The applicant must submit a written reply to CDSCO within four (4) weeks of receiving the comments, which will, in turn, be 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 within 15 days. 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 within 15 days. 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.

See also IND-22 for details on the SUGAM portal ( IND-59 ) approval process for global clinical trials, and IND-46 for additional information on conducting clinical trials in India.

Per the 2022-CTRules-3rdAmdt , which amends the 2019-CTRules , provided that no communication has been received from the DCGI within the stated period of 90 working days, permission to conduct all new drug or investigational new drug clinical trials as well as clinical trials for new drugs already approved outside India will be deemed granted by the DCGI. This permission will be regarded as legally valid for all purposes and the applicant will be authorized to initiate a clinical trial in accordance with these rules. Similarly, per the 2019-CTRules and IND-31 , if the DCGI does not respond within 30 days to applications for drugs developed in India, the sponsor may conclude that permission to conduct the trial has been granted. Refer to the Scope of Assessment section for information on obtaining a waiver for an already approved drug. See also the Manufacturing & Import section for detailed information on import requirements for new drugs already approved outside of India.

For specific guidelines regarding gene therapy and stem cell therapy clinical trials, see the G-GeneThrpy and the G-StemCellRes .

(See also the Submission Process and Submission Content sections for detailed submission requirements.)

Ethics Committee Approval

As per IND-9 , the EC review and approval process, which occurs at the same time as the DCGI review and approval, generally takes from four (4) to six (6) weeks. Many study sites also have scientific review committees (SRCs) review the scientific justification of the study. Once the SRC approves the study, it is submitted to the EC for its review and approval.

The G-ICMR indicates that EC members should be given enough time (at least one (1) week) to review the proposal and related documents, except in the case of expedited review. While all EC members should review all submitted proposals, each EC may adopt different procedures for protocol review per their standard operating procedures.

As set forth in the 2019-CTRules , the Hdbk-ClinTrial , the G-ICMR , and IND-31 , a clinical trial can only commence in India after the sponsor (also known as applicant) receives permission from the Drugs Controller General of India (DCGI) and approval from the respective ethics committees (ECs). The DCGI is head of the  Central Drugs Standard Control Organization (CDSCO) and is commonly referred to as the Central Licensing Authority in the Indian regulations. According to the 2019-CTRules and IND-31 , non-regulatory clinical trials intended for academic/research purposes only require institutional EC approval. (See the Scope of Review section for additional details). There is no waiting period required following the sponsor’s receipt of these approvals. (Note: the Hdbk-ClinTrial has not yet been updated to fully align with the 2019-CTRules .)

The 2022-CTRules-3rdAmdt , which amends the 2019-CTRules , further indicates that once the sponsor obtains approval from the DCGI for a new drug, an investigational new drug, or a new drug already approved outside India, the sponsor must notify CDSCO via Form CT-06A prior to initiating the clinical trial. The DCGI will then record the information provided on the form and it will become part of the official record known as the automatic approval of the DCGI.

In addition, per the 2019-CTRules and IND-31 , the sponsor is required to obtain approval from the 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. (See the Manufacturing & Import section for additional information.)

As explained in the 2019-CTRules and IND-31 , the EC should notify the DCGI about the academic trials it has approved and about cases where there could be an overlap between a clinical trial for academic and regulatory purposes. If the DCGI does not provide comments to the EC within 30 days from receiving EC notification, then it should be presumed that DCGI permission is not required.

Clinical Trial Agreement

According to the 2019-CTRules , the sponsor must have an agreement with the investigator, which is to be provided to the EC. Furthermore, the investigator must sign an undertaking to conduct the trial in accordance with the protocol, good clinical practice guidelines, and all applicable requirements, among other things. For more details, see Table 4 (Third Schedule) in the 2019-CTRules .

Clinical Trial Registration

Per the 2019-CTRules , the G-ICMR , and IND-31 , it is mandatory for all sponsors to register their clinical trials, including academic trials, with the Indian Council of Medical Research (ICMR) ’s Clinical Trials Registry - India (CTRI) ( IND-57 ) before initiating a study. Refer to the Scope of Review and Submission Process sections for further information on academic trials.

According to IND-56 , registrants are advised to factor in a minimum of 10-15 working days for trial review, verification, and validation and the submission must indicate “Not Yet Recruiting” for the trial’s status. A REF number is issued to those registrants who have successfully submitted a trial to CTRI.

In addition, per IND-10 , the ICMR has agreed to adopt the United Nation’s recommendations to register and publicly disclose results from all funded or supported clinical trials. The ICMR, along with other participating healthcare bodies, plans to develop and implement policies that require all trials they fund, co-fund, sponsor, or support to be registered in a publicly available registry. All study results will also be released within specified timeframes on the registry or through scientific journal publications. (Note: The CTRI ( IND-57 ) has not been updated as of September 30, 2022.)

See the 2019-CTRules , the Hdbk-ClinTrial , IND-32 , and IND-35 for detailed DCGI application submission requirements.

Safety Reporting Definitions

In accordance with the 2019-CTRules , the G-ICMR , and IND-42 , the following definitions provide a basis for a common understanding of India’s safety reporting requirements:

• Adverse Event (AE) – Any untoward medical occurrence (including a symptom/disease or an abnormal laboratory finding) during treatment with a pharmaceutical product in a patient or a human participant not necessarily related to the treatment
• Adverse Drug Reaction (ADR) – a noxious and unintended response at doses normally used or tested in humans (in cases of approved pharmaceutical products); a noxious and unintended response at any dose(s) (in cases of new unregistered pharmaceutical products); an untoward medical occurrence seemingly caused by overdosing, abuse/dependence and interactions with other medicinal products (in clinical trials)
• Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR) – an AE or ADR that is associated with death, in-patient hospitalization (in case the study was being conducted on outpatients), prolongation of hospitalization (in case the study was being conducted on in-patients), persistent or significant disability or incapacity, a congenital anomaly or birth defect, or is otherwise life threatening. Per IND-42 , Important Medical Events may be considered SAEs when they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one (1) of the outcomes listed in this definition
• Unexpected Adverse Drug Reaction – an ADR, the nature or severity of which is not described in the informed consent/information sheet or the applicable product information, such as an investigator’s brochure (IB) for the unapproved investigational product (IP) or package insert/summary of product characteristics for an approved product ( G-ICMR )

Safety Reporting Requirements

Per the 2019-CTRules , the sponsor (also known as applicant) and the investigator must forward any SAE/SADR report, after due analysis, within 14 days of the occurrence to the Drugs Controller General of India (DCGI), the ethics committee (EC) Chairman, and the head of the institution where the trial is being conducted. (Note: The DCGI is head of the Central Drugs Standard Control Organization (CDSCO) and is commonly referred to as the Central Licensing Authority in the Indian regulations.)

In the event of an SAE/SADR resulting in death, per the 2019-CTRules , the sponsor or the representative and the investigator must forward the 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 also required to forward its report along with its opinion on financial compensation, if any, to be paid by the sponsor or the representative, to the DCGI within 30 days of the incident.

See Table 5 of the 2019-CTRules for details on the data elements required for reporting SAEs/SADRs that occur during a clinical trial.

See the Insurance & Compensation section for additional information on sponsor compensation requirements.

Investigator Responsibilities

As indicated in the 2019-CTRules , the G-ICMR , and IND-42 , the investigator must report all SAEs/SADRs to the DCGI, the sponsor or the representative, and the EC, within 24 hours of occurrence. Per the 2019-CTRules , 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.

In addition, per the G-ICMR , the investigator must submit a report to the DCGI explaining how the SAE/SADR was related to the research within 14 days. According to the 2019-CTRules , 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.

Form Completion & Delivery Requirements

As per Notice25Feb21 , the investigator, the sponsor or the representative, and the EC must report all SAEs electronically via the SUGAM portal ( IND-59 ). However, follow-up reports pertaining to SAE reports submitted prior to March 14, 2021, will continue to be accepted in paper form. Refer to IND-59 for the SUGAM user manual and video tutorials. See also IND-42 for instructions on how to submit SAE reports (referred to as Due Analysis Reports) via the SUGAM portal ( IND-59 ).

The G-ICMR further states that the investigator may report SAEs/SADRs to the EC through email or fax communication (including on non-working days). Refer to IND-37 for the Indian Council of Medical Research (ICMR) 's EC Serious Adverse Event Reporting Format (Clinical Trials).

Interim and Annual Progress Reports

As described in the 2019-CTRules and IND-31 , the Drugs Controller General of India (DCGI), who heads the Central Drugs Standard Control Organization (CDSCO) , requires the sponsor (also known as applicant) to submit a six (6)-month status report for each clinical trial electronically via the CDSCO’s SUGAM portal ( IND-59 ). 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. In addition, per the 2019-CTRules , an ethics committee (EC) may periodically request study progress reports from the investigators.

As delineated in the 2019-CTRules , sponsors are also required to submit an annual status report for the clinical trial to the DCGI.

The 2019-CTRules further specifies that 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 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, 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.

See IND-35 for a Checklist of Notification for Annual Status Report documentation requirements to be included in a global clinical trial application.

Final Report

The final report should comply with the format and content guidelines listed in the 2019-CTRules as follows:

• Study synopsis (1 to 2 pages)
• List of abbreviations and definitions
• EC approval letter(s)
• Study team introduction
• Investigational plan
• Trial participants
• Efficacy evaluation
• Safety evaluation
• Discussion and overall conclusion
• List of references

See the 2019-CTRules for more detailed information on preparing the final report.

See also IND-35 for a checklist of documentation requirements to be included in a global clinical trial application pertaining to end of clinical trial notification.

As per the 2019-CTRules and the G-ICMR , a sponsor (also known as applicant) is defined as an individual, a company, or an institution that takes responsibility for the initiation, management, or financing of a clinical study. The G-ICMR further states that an investigator who independently initiates and takes full responsibility for a trial automatically assumes the role of a sponsor. The 2019-CTRules also indicates that the sponsor may appoint a contract research organization (CRO).

As stated in the 2019-CTRules , all investigators must possess appropriate qualifications, training, and experience, and should conduct the trials in compliance with Good Clinical Practices (GCPs) and Good Laboratory Practices. (See GCLP for the G-ICMR for Good Clinical Laboratory Practices, IND-31 for additional laboratory requirement information, and IND-40 and IND-30 for international Good Laboratory Practice guidelines.) Investigators should also have access to investigational and treatment facilities as relevant to the protocol.

Per the 2019-CTRules , prior to entering into an agreement with the investigator(s)/institution(s) to conduct a study, the sponsor (also known as applicant) should provide the involved parties with the protocol and an up-to-date investigator’s brochure and allow them sufficient time to review this documentation. The sponsor must also define and allocate all study-related duties and responsibilities to the respective identified person(s) and organization(s) prior to initiating the study.

In addition, per Notice2Dec19 , the Central Drugs Standard Control Organization (CDSCO) is preparing a comprehensive database of clinical trial sites and investigators involved in the conduct of global clinical trials in different therapeutic categories by collecting information from various sources. The first phase includes an Excel spreadsheet of sites and investigators involved in global clinical trials ( IND-26 ).

See also IND-28 for the Indian Council of Medical Research (ICMR) ’s research conduct policies.

Foreign Sponsor Responsibilities

No information is currently available on foreign sponsor responsibilities.

Data and Safety Monitoring Board

While there are no general requirements for establishing a Data Safety Monitoring Board (DSMB), the  G-Children recommends that a DSMB be strongly considered for research involving children in emergency situations.

Multicenter Studies

As delineated in the G-ICMR , in the case of multicenter research studies, all of the participating study sites are required to obtain approval from their respective ethics committees (ECs). The study sites also typically follow a common protocol to avoid duplication of effort, wastage of time, and communication issues. See the G-ICMR for additional participating site requirements when a primary EC is selected for common EC review. Also, see the Scope of Review section for additional details.

Further, per the G-ICMR , if a multicenter trial is going to be conducted, the sponsor may organize a coordinating committee or select coordinating investigators. The sponsor must also conduct training for investigators in ethics, GCPs, standard operating procedures (SOPs), and study protocols.

The G-ICMR specifies that the sponsor (also known as applicant) should provide insurance coverage or a provision in the budget for possible compensation for trial-related injuries. The G-ICMR also states that 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).

The 2019-CTRules states that the ethics committee (EC) also requires a copy of the insurance policy or details regarding compensation for participation and for serious adverse events (SAEs) occurring during the study as part of its submission review process. IND-60 provides a table of the different policy types available in India including no fault compensation, the claims-made policy, and the premium rating policy. Regarding coverage limits, IND-60 further indicates there is no set rule for establishing coverage limits or minimums in India; however, the consensus in the insurance community is that a clinical trials liability policy should carry a minimum limit of $1 million and can have upper limits of $10 million through $20 million or more. See IND-60 for additional information on policy types and coverage limits.

With regard to indemnity coverage, the G-ICMR states that an indemnity policy must be included in the documentation for EC review. The policy should clearly indicate the conditions of coverage, date of commencement, and coverage expiration date, if applicable.

Compensation

Injury or Death

In accordance with the 2019-CTRules and the G-ICMR , the sponsor is responsible for providing compensation to research participants and/or their legal heir(s) in the event of trial-related injuries, permanent disability, or death. Per the G-ICMR , in the event the investigator/institution becomes the sponsor in a clinical trial, it is the host institution’s responsibility to provide compensation for research-related injury or harm as determined by the ethics committee (EC).

Per the 2019-CTRules and the G-ICMR , the sponsor must also ensure that participants who suffer any trial-related injuries be provided with free medical treatment for such injuries as long as required per the opinion of the investigator (and the EC per the G-ICMR ), or until such time it is established that the injury is not related to the clinical trial, whichever is earlier. Per the 2019-CTRules , if the sponsor or the representative fails to provide medical management, the Drugs Controller General of India (DCGI), after a hearing, must issue a written order to suspend or cancel the study or restrict the sponsor, including the representative, from conducting any further clinical trials or taking any other action for such period deemed appropriate for this case. (Note: The DCGI is head of the Central Drugs Standard Control Organization (CDSCO) and is commonly referred to as the Central Licensing Authority in the Indian regulations.)

The 2019-CTRules further notes that the sponsor is responsible for compensating the research participant and/or the legal heir(s) if the trial-related injury, death, or permanent disability to a participant is specifically related to any of the following reasons:

• Adverse effects of an investigational product (IP)
• Any trial procedures involved in the study
• A violation of the approved protocol, scientific misconduct, or negligence by the sponsor, the representative, or the investigator
• Failure of the IP to provide the intended therapeutic effect where, the standard care, though available, was not provided to the participant per the protocol
• Not providing the required standard care, though available to the participant per the protocol in the placebo-controlled trial
• Adverse effects due to concomitant medication excluding standard care, necessitated as part of the approved protocol
• Adverse effect on the child in-utero due to a parent’s participation in a trial
• Any clinical trial procedures involved in the study leading to a serious adverse event (SAE/serious adverse drug reaction (SADR)

According to IND-31 , compensation and medical management requirements are also applicable in the case of injury or death occurring during an academic trial.

In the case of a trial-related injury, the 2019-CTRules and IND-31 state that the sponsor is required to provide complete medical management and compensation to the participant within 30 days of receiving an order from the DCGI. In the event of permanent injury or death, the sponsor is required to provide compensation to the participant or to the legal representative(s) or guardian(s) within 30 days of receiving the DCGI’s order.

The 2019-CTRules explains that in the case of an SAE resulting in death, the DCGI must constitute an independent expert committee to review the incident and make its recommendations to the DCGI for the cause of death and to provide a quantum of compensation. The sponsor or the representative and the investigator must forward their reports, after due analysis, to the DCGI and the head of the institution where the trial was conducted within 14 days of the occurrence. The EC must forward its report along with its opinion on financial compensation, if any, to be paid by the sponsor or the representative within 30 days of receiving the investigator’s report. The DCGI, in turn, must forward the sponsor, investigator, and EC reports to the expert committee chairperson. Following its review, the expert committee must make its recommendations to the DCGI as to the cause of the SAE resulting in death and the quantum of compensation within 60 days from receiving the DCGI’s submission. The DCGI must then consider the expert committee’s recommendations and issue an order within 90 days to the sponsor or the representative specifying the quantum of compensation he/she is required to pay within 30 days of receiving the order.

In the case of an SAE/SADR resulting in permanent disability or any injury other than death, the 2019-CTRules indicates that the sponsor or the representative and the investigator must forward their reports, after due analysis, to the DCGI, the EC chairperson, and the head of the institution where the trial has been conducted within 14 days of the occurrence. The EC, after due analysis, must forward its report along with its opinion on financial compensation, if any, to the DCGI within 30 days of the event occurrence. The DCGI, in turn, must determine the cause of the injury and issue an order, with the option to constitute an independent expert committee, within 60 days of receipt of the report. The DCGI must issue an order within 90 days of receiving the report indicating the quantum of compensation to be paid by the sponsor or the representative within 30 days of receipt of this order.

In the case of an injury not being permanent in nature, per the 2019-CTRules , compensation should be commensurate with the participant’s loss of wages.

Per the 2019-CTRules , in the event that a sponsor or the representative fails to provide compensation to a research participant for trial-related injuries, or to the legal heir(s) in case of death, the DCGI must, after giving an opportunity to show cause why such an order should not be passed by a written order, suspend or cancel the clinical trial, or restrict the sponsor or the representative from conducting any further clinical trials in India or taking any other action deemed fit given the circumstances.

See the 2019-CTRules and the G-ICMR for detailed information on terms of compensation payment.

Trial Participation

The G-ICMR explains that participants may also be compensated for their time and other expenses (e.g., loss of wages, food supplies, and travel). The EC should approve all payments, reimbursement, and medical services provided. Per the G-ICMR , participants should not be required to pay for any expenses incurred beyond routine clinical care and those that are research related including patient work-ups, or interventions associated with treatment, and if applicable, participants may receive additional medical services at no further cost.

Post-Trial Access

The 2019-CTRules and IND-31 explain that the investigator may recommend the sponsor provide post-trial access to the investigational product (IP) free of cost to the participant for such period as deemed necessary by the investigator and the EC. The sponsor must obtain DCGI approval to initiate this plan. The investigator’s recommendation will be based on the following conditions:

• If the trial is being conducted for an indication for which no alternative therapy is available, and the IP has been determined to be beneficial
• The participant and/or the legal representative(s) or guardian(s) has consented in writing to use the post-trial IP, and has certified and declared in writing, along with the investigator, that the sponsor must have no liability for post-trial use of the IP

See also IND-6 for additional information on post-trial access to IPs under the 2019-CTRules .

Quality Assurance/Quality Control

In accordance with the 2019-CTRules and the G-ICMR , the sponsor (also known as applicant) is responsible for implementing and maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data generated, recorded, and reported in compliance with the protocol, Good Clinical Practices (GCPs), and all applicable laws and regulations.

Monitoring Requirements

As per the 2019-CTRules , the sponsor must permit clinical trial site inspections by the Drugs Controller General of India (DCGI)-authorized officers. The officers may enter the premises and clinical trial site with or without prior notice to inspect, search, or seize any record, statistical result, document, investigational drug, and other related material. The sponsor must also reply to inquiries raised by the inspecting authority in relation to the conduct of the trial. (Note: The DCGI is head of the Central Drugs Standard Control Organization (CDSCO) and is commonly referred to as the Central Licensing Authority in the Indian regulations.)

In addition, as part of its QA system, the 2019-CTRules notes that investigator(s) may provide periodic study progress reports (PSUR), or regulatory officials or sponsor-designated authorized representatives may provide monitoring and internal audit reports to the ethics committee (EC) to support its recurring clinical trial reviews. An audit certificate may be issued, if available.

Furthermore, the 2019-CTRules requires the investigator to sign an undertaking indicating agreement to maintain adequate and accurate records and to make those records available for audit or inspection by the sponsor, the EC, the Central Licensing Authority, or their authorized representatives, in accordance with regulatory provisions and GCP guidelines. The investigator must agree to fully cooperate with any study-related audit conducted by regulatory officials or authorized representatives of the sponsor.

See IND-35 for a checklist of PSUR documentation requirements to be included in a global clinical trial application, and IND-34 for the DCGI’s GCP Inspection Checklist.

Premature Study Termination/Suspension

As delineated in the 2019-CTRules , when the sponsor fails to comply with any provisions of the DCA-DCR and the 2019-CTRules , the DCGI may, after giving an opportunity to show cause and after affording an opportunity of being heard, by an order in writing, implement one (1) or more of the following actions:

• Issue a warning in writing describing the deficiency or defect observed during inspection or otherwise which may affect adversely the right or well-being of a trial participant or the validity of clinical trial conducted
• Suspend for such period as considered appropriate or cancel the permission granted in Form CT-06 or in Form CT-4A
• Debar the investigator or the sponsor, including the representatives, from conducting any clinical trial in the future for such period as considered appropriate by the DCGI

The sponsor or the representative may appeal the DCGI’s decision within 60 working days of receipt of the order.

Further, per the 2019-CTRules , in case of studies prematurely discontinued for any reason, including lack of commercial interest in pursuing the new drug application, the sponsor should submit a summary report within three (3) months. The summary report should provide a brief description of the study, the number of patients exposed to the drug, dose and duration of exposure, details of adverse drug reactions, if any, and the reason for discontinuation of the study or non-pursuit of the new drug application.

See IND-35 for a checklist of premature study termination documentation requirements to be included in a global clinical trial application.

Electronic Data Processing System

No information is currently available on electronic data processing systems.

Records Management

Per the 2019-CTRules , the sponsor (known as applicant) must keep a record of new drugs manufactured and persons to whom the drugs have been supplied for clinical trial or bioavailability and bioequivalence study or for examination, testing, and analysis. In addition, the 2019-CTRules indicates that the licensed sponsor must maintain records of any imported new drug or substance that indicates the quantity of drug imported, used, and disposed of in any manner including related documentation.

Responsible Parties

For the purposes of data protection regulation in India, the ITAct , the ITActAmend , and the IT-SPDIRules delineate responsibilities of the “body corporate.” The body corporate as defined by the ITAct , the ITActAmend , and the IT-SPDIRules refers to any company including a firm, sole proprietorship, or other association of individuals engaged in commercial or professional activities. The IT-SPDIRules further explains that the body corporate or any person on its behalf is the entity responsible for collecting, receiving, possessing, storing, dealing with, or handling personal information, including sensitive personal data and information. (Note: In ClinRegs, the “body corporate” is referred to as “sponsor,” but the requirements may apply to other parties as well).

Data Protection

Data protection in India is currently regulated by the ITAct , the ITActAmend , and the IT-SPDIRules . Per the IT-SPDIRules , the sponsor (or the “body corporate”) must provide a privacy policy for the handling of or dealing with this personal information including sensitive personal data or information. The IT-SPDIRules defines sensitive personal data or information as information relating to password(s); financial information; physical, physiological, and mental health condition(s); sexual orientation; medical records and history; and biometric information. The sponsor must ensure that this policy is available for view by the information providers under a lawful contract. The policy must be published on the sponsor’s or its representative’s website and provide the following:

• Clear and easily accessible statements of its practices and policies
• The type of personal information including sensitive personal data or information collected
• The purpose of collection and usage of such information
• Disclosure of information including sensitive personal data or information
• Reasonable security practices and procedures

Please refer to the IT-SPDIRules for detailed requirements on implementing security practices and procedures and collecting, disclosing, and transferring sensitive personal data or information.

See also IND-65 for more detailed information on India’s data protection requirements.

Consent for Processing Personal Data

As set forth in the IT-SPDIRules , the body corporate or its representative must obtain consent in writing through letter, fax, or email from the provider of the sensitive personal data or information regarding the purpose of usage before collection of such information. The IT-SPDIRules further states that while collecting information directly from the information provider, reasonable steps must be taken to ensure that the information provider receives details regarding the following:

• The fact that the information is being collected
• The purpose for which the information is being collected
• The intended recipients of the information; and
• The name and address of the agency that is collecting the information, and the agency that will retain the information

Per the IT-SPDIRules , the body corporate or its representative, must provide an option to the information provider to withhold the requested data or information prior to the collection of information including sensitive personal data or information. The information provider must, at any time, also have the option to withdraw consent given earlier to the sponsor or the sponsor’s representative. This withdrawal of consent must be sent in writing.

Obtaining Consent

In all Indian clinical trials, a freely given, written informed consent is required to be obtained from each participant to comply with the requirements set forth in the 2019-CTRules , the G-ICMR , and the G-Children .

As per the 2019-CTRules and the G-ICMR , prior to beginning a clinical trial, the investigator is required to obtain ethics committee (EC) approval for the informed consent form (ICF) and the patient information sheet. This documentation must also be supplied to the Drugs Controller General of India (DCGI), prior to the trial’s initiation. The ICF and patient information sheet are ultimately integrated into one (1) document referred to as the ICF. (See the Required Elements section for details on what should be included in the form.) (Note: The DCGI is head of the Central Drugs Standard Control Organization (CDSCO) and is commonly referred to as the Central Licensing Authority in the Indian regulations.)

The 2019-CTRules , the G-ICMR , and the G-Children specify that investigator(s) should provide detailed study information to the research participant and/or the legal representative(s) or guardian(s). The ICF content should be briefly and clearly presented orally, and in writing, and in a manner that is easy to understand, commensurate with the comprehension level of the participants, and without coercion or unduly influencing a potential participant to enroll in the trial. Per the G-ICMR , the ICF language should not only be scientifically accurate and simple, but should also be sensitive to the participant’s social and cultural background. In addition, the participant and/or the legal representative(s) or guardian(s), should be given adequate time to consider whether to participate. The consent should also be given voluntarily and not be obtained under duress or coercion of any sort or by offering any inducements.

The G-ICMR also states that, in the case of differently abled participants, such as those with physical, neurological, or mental disabilities, appropriate methods should be used to enhance the participants’ understanding (e.g., Braille for the visually impaired).

As delineated in the 2019-CTRules , investigator(s) must obtain an audio-video (AV) recording of the informed consent process for vulnerable participants in clinical trials for a new chemical or molecular entity, including the procedure of providing information to the participant and his/her understanding of the consent. This AV recording should be retained in the investigator’s files. In cases where clinical trials are conducted on anti-human immunodeficiency virus (HIV) and anti-leprosy drugs, the investigator(s) must only obtain an audio recording of the informed consent process. The investigator(s) is also required to retain the audio recording for his/her records.

According to the G-ICMR and the G-Children , investigator(s) are required to renew the informed consent of each participant if there are any changes in the ICF related to the study conditions or research procedures, or if new information becomes available during the trial.

Per the G-ICMR and the G-Children , re-consent is applicable in cases in which a participant regains consciousness from an unconscious state and/or recovers mental capacity to understand the research study. If such an event is expected, then procedures to address this circumstance should be explained clearly in the ICF.

The G-ICMR and the G-Children explain that re-consent is required in the following situations:

• New information pertaining to the study becomes available that has implications for the participant(s) or that changes the benefit and risk ratio
• A research participant who is unconscious regains consciousness or suffered loss of mental competence and regains the ability to understand the research implications
• A child becomes an adult during the course of the study, or the legal representative(s) or guardian(s) have changed
• Research requires a long-term follow up or an extension
• There is a change in treatment modality, procedures, site visits, data collection methods, or tenure of participation which may impact a participant’s decision to continue in the research
• There is possibility of identity disclosure through data presentation or photographs (this should be camouflaged adequately) in an upcoming publication
• Future research may be carried out on stored biological samples if not anonymized

The partner/spouse may also be required to give additional re-consent in some of the above cases.

Language Requirements

As stated in the 2019-CTRules and the G-ICMR , the ICF should be written in English and/or in a vernacular language that the participant is able to understand.

Documenting Consent

The G-ICMR and the G-Children specify that the participant and/or the participant’s legal representative(s) or guardian(s) must sign and date the ICF. If the participant is incapable of giving an informed consent, the legal representative(s) or guardian(s) should sign and date the ICF. Where the participant and/or the legal representative(s) or guardian(s) is illiterate, verbal consent should be obtained in the presence of and countersigned by an impartial witness.

Per the G-ICMR , if the participant and/or the legal representative(s) or guardian(s) cannot sign, a thumb impression must be obtained. In addition, the investigator(s) who administers the consent should also sign and date the ICF. As stated in the G-ICMR and the G-Children , when written consent as a signature or thumb impression is not possible, verbal consent may be taken with the EC’s approval, in the presence of an impartial witness who should sign and date the consent document, or through an AV recording. Per the G-ICMR , the ICF may also be administered and documented electronically, as long as the EC approves the process first.

As described in the G-ICMR , the following special situations may also arise in administering consent:

• The gatekeeper’s (a group’s head/leader or the culturally appropriate authorities), may provide permission on the group’s behalf in writing or audio/video recording and be witnessed
• Community consent is required for certain populations in order for participants to be permitted to participate in the research

According to the G-ICMR and the G-Children , a copy of the signed ICF and the patient information sheet should be given to the participant or the legal representative(s) or guardian(s). Per the G-Children , the investigator should also keep a signed copy of the ICF.

Waiver of Consent

As specified in the G-ICMR and the G-Children , the investigator(s) can apply to the EC for a waiver of consent if the research involves less than minimal risk to participants and the waiver will not adversely affect the rights and welfare of the participants. In addition, per the G-ICMR , the EC may grant a waiver of consent in the following situations:

• Research cannot practically be carried out without the waiver and the waiver is scientifically justified
• Retrospective studies, where the participants are de-identified or cannot be contacted
• Research on anonymized biological samples/data
• Certain types of public health studies/surveillance programs/program evaluation studies
• Research on data available in the public domain, or
• Research during humanitarian emergencies and disasters, when the participant may not be in a position to give consent. An attempt should be made to obtain the participant’s consent as soon as possible

Refer to the Children/Minors section for information on waivers involving children.

See the G-ICMR , IND-5 , and IND-27 for additional information on informed consent requirements.

Per the 2019-CTRules , the G-ICMR , and the G-Children , the informed consent form (ICF) should include the following statements or descriptions, as applicable (Note: The regulatory sources provide overlapping and unique elements so each of the items listed below will not necessarily be in each source.):

• The study involves research and an explanation of its nature and purpose
• The expected duration of the participant's participation
• Any benefits reasonably expected from the research to the participant or others; if no benefit is expected, the participant should be made aware of this
• The disclosure of specific appropriate alternative procedures or therapies available to the participant
• The mechanism by which confidentiality of records identifying the participant will be maintained and who will have access to the participant’s medical records
• An explanation about whom to contact for trial-related queries, participant rights, and in the event of any injury
• The policy on compensation and/or medical treatment(s) available to the participant in the event of a trial-related injury, disability, or death
• Participation is voluntary, the participant can withdraw from the study at any time, and refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled
• Any reasonably foreseeable risks or discomforts to the participant resulting from participation
• Approximate number of participants enrolled in the study

Additional requirements listed in the G-ICMR and the G-Children include:

• Foreseeable extent of information on possible current and future uses of the biological material and of the data to be generated from the research (e.g., storage period of sample/data; probability of material being used for secondary purposes; whether material is to be shared with others; participant’s right to prevent use of his/her biological sample(s) at any time during or after the study; risk of discovery of biologically sensitive information and provisions to safeguard confidentiality)
• Publication, if any, including photographs and pedigree charts
• Payment/reimbursement for participation and incidental expenses depending on the type of study
• Insurance coverage, if any, for research-related or other adverse events
• If there is a possibility that the research could lead to any stigmatizing condition (e.g., HIV and genetic disorders, provision for pre-test and post-test counseling)
• Post-research plan/benefit sharing for biological material research and/or if data leads to commercialization

Additional requirements listed in the 2019-CTRules include:

• The procedures to be followed, including all invasive procedures
• The investigational product (IP) may fail to achieve the intended therapeutic effect
• In the case of a placebo-controlled trial, the placebo administered to the participant(s) must not have any therapeutic effect
• The anticipated prorated payment, if any, to the participant for participating in the trial
• The participant’s responsibilities in participating in the trial
• Foreseeable circumstances under which the investigator(s) may remove the participant without consent
• The consequences of a participant’s decision to withdraw from the research, and procedures for orderly withdrawal by the participant
• The participant and/or the legal representative(s) or guardian(s) will be notified in a timely manner if significant new findings develop during the course of the study which may affect the participant's willingness to continue
• The particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant), which are currently unforeseeable
• Additional costs to the participant that may result from participating in the study
• Any other pertinent information
• Clinical trial treatment schedule(s) and the probability for random assignment to each treatment

See the Vulnerable Populations and Consent for Specimen sections for further information.

In accordance with the 2019-CTRules and the G-ICMR , India’s ethical standards promote respect for all human beings and safeguard the rights of research participants. The G-ICMR upholds the Declaration of Helsinki ( IND-63 ). The 2019-CTRules , the G-ICMR , and the G-Children state that a participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process.

The Right to Participate, Abstain, or Withdraw

As stated in the 2019-CTRules , the G-ICMR , and the G-Children , the participant and/or the legal representative(s) or guardian(s) should be informed that participation is voluntary, the participant may withdraw from the research study at any time, and refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled.

The Right to Information

As per the 2019-CTRules , the G-ICMR , and the G-Children , a potential research participant and/or the legal representative(s) or guardian(s) has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation or treatment in the case of injury, and any significant new information regarding the research study.

The Right to Privacy and Confidentiality

As described in the 2019-CTRules , the G-ICMR , and the G-Children , all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right. The 2019-CTRules also states that it is the responsibility of the investigator(s) to safeguard the confidentiality of research data to protect the identity and records of research participants.

The Right of Inquiry/Appeal

The 2019-CTRules , the G-ICMR , and the G-Children state that the research participant and/or the legal representative(s) or guardian(s) should be provided with contact information for the investigator(s) and the ethics committee (EC) to address trial-related inquiries and/or to appeal against a violation of the participant’s rights.

The Right to Safety and Welfare

The G-ICMR clearly states that a research participant’s right to safety and protection of health and welfare must take precedence over the interests of science and society.

See the G-ICMR and IND-27 for additional information on informed consent requirements.

Refer to the Required Elements and Vulnerable Populations sections for additional information regarding requirements for participant rights.

Children in Emergency Situations

Per the G-Children , research involving children in emergency situations should only be carried out when it is scientifically justified and cannot be conducted outside this setting. The ethics committee(s) (EC) should review and approve these studies as well as the proposed timeframe in which formal consent will be obtained. If consent cannot be obtained in an emergency situation, deferred consent is suggested. Deferred consent involves giving minimum information verbally, followed by full details and formal consent later. If the legal representative(s) or guardian(s) are unavailable or unable to give consent, another individual, such as the participant’s doctor or a person nominated by the healthcare provider, can give consent. However, the doctor or a person nominated by the healthcare provider may not be involved in the research. It is recommended that a Data Safety Monitoring Board (DSMB) be strongly considered for these types of studies. See the Children/Minors section for additional pediatric informed consent requirements.

Moreover, per the G-Children , if a child’s legal representative(s) or guardian(s) refuses to give consent once their child is stabilized, he/she should not be included in the research, and no further research related procedures/data collection should be done. Additionally, the previously collected data obtained prior to the consent process should not be used without the legal representative(s)’s or guardian(s)’s permission.

Humanitarian Emergencies

As explained in the G-ICMR , during a humanitarian emergency or disaster, close attention should be paid to the effect of the emergency on perceptions of ethical questions, altered or increased vulnerabilities, provider-patient and researcher-participant relationships, and issues related to integrity of studies and ethical review processes. Obtaining valid informed consent in humanitarian emergencies is a challenge as the decisional capacity of the participants would be so low that they may not be able to differentiate between reliefs offered and research components. This should be very clearly distinguished during the informed consent process. Additional safeguards are required for participants due to their vulnerability, for example, counseling, psychological help, medical advice, and process of stakeholder consultation.

In addition, the G-ICMR indicates that the potential research participants might be under duress and traumatized. Researchers should be sensitive to this situation and are obligated to ensure that the informed consent process is conducted in a respectful manner. Researchers should strive to identify and address barriers to voluntary informed consent and not resort to inducements for research participation. The different roles of researchers, caregivers and volunteer workers must always be clarified, and potential conflict of interest declared. If research involves vulnerable individuals (such as minors), then the legal representative(s) or guardian(s) should give consent. Additional protections might be required in special cases, for example, children with untraceable or deceased relatives. In these situations, consent should be obtained from an individual who is not part of the research team who should be designated by the institution/agency conducting research.

For seeking a waiver of consent, the researchers should give the rationale justifying the waiver. The EC should approve such a waiver after careful discussion on the issue. Refer to the Documentation Requirements section for additional information on waivers of consent. When consent of the participant or the legal representative(s) or guardian(s) is not possible due to the situation, informed consent must be administered to the participant or the legal representative(s) or guardian(s) at a later stage, when the situation allows. However, this should be done only with the prior approval of the EC. See IND-5 for additional information on consent requirements during medical emergencies.

As set forth in the 2019-CTRules and the G-ICMR , in all clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. The G-ICMR further describes vulnerable groups and individuals as those who may have an increased likelihood of incurring additional harm, as they may be relatively (or absolutely) incapable of protecting their own interests. According to the G-ICMR , vulnerable populations are characterized as individuals/communities with hierarchical relationships (e.g., prisoners, armed forces personnel, or staff and students at medical, nursing, or pharmacy academic institutions); economically and socially disadvantaged individuals (e.g., persons who are unemployed, abandoned, orphans, have language barriers, or cultural differences); persons below the poverty line; ethnic, religious, or sexual minority groups; tribal and marginalized communities; terminally ill patients or those suffering from stigmatizing or rare diseases; patients in emergency situations; institutionalized persons; homeless persons, nomads, or refugees; minors; women in special situations (e.g., pregnant or lactating women, those with poor decision-making powers, or poor access to healthcare); those with mental illness and cognitively impaired, differently abled, or mentally or physically disabled; or others incapable of personally giving consent.

See the G-ICMR for detailed safeguards that must be complied with when trials involving vulnerable populations are conducted. The G-ICMR also describes research principles that must be upheld during these trials and upholds the Declaration of Helsinki ( IND-63 ).

See the Children/Minors; Pregnant Women, Fetuses & Neonates ; and Mentally Impaired sections for additional information about these vulnerable populations. See also IND-5 for additional information on consent requirements for vulnerable populations.

Terminally Ill Patients

Per the G-ICMR , terminally ill patients or patients seeking new treatments are vulnerable as they are ready to give consent for any intervention that could help them. The EC should carefully review protocols and recruitment procedures for these studies and comply with the following requirements:

• Additional monitoring should be done to detect any adverse event as soon as possible
• A benefit-risk assessment should be performed that considers the potential participant’s perception of benefits and risks
• Post-trial access to the medication

Indigenous Peoples

The G-ICMR states that research on tribal populations should only be conducted if it is of a specific therapeutic, diagnostic, and preventative nature with appropriate benefits to the tribal population. A competent administrative authority’s approval, such as the tribal welfare commissioner or the district collector, should be obtained prior to an investigator entering the area. Whenever possible, it is desirable to seek the help of government functionaries/local bodies or registered, non-governmental organizations who work closely with the tribal groups and have their confidence. The tribal leader, or other culturally appropriate authority may serve as the gatekeeper from whom permission to enter and interact should be obtained. A participant’s consent should be taken along as well as consulting with community elders and individuals who know the local language/dialect of the tribal population, and in the presence of appropriate witnesses. Additional precautions should be taken to avoid including children, pregnant women, and elderly people belonging to particularly vulnerable tribal groups. Benefit sharing with the tribal group should also be ensured for any research done using tribal knowledge that may have the potential for commercialization.

Elderly Persons

Permission to conduct clinical trials in geriatric patients must comply with the requirements listed in the Required Elements section . According to 2019-CTRules , geriatric patients should be included in Phase II and Phase III clinical trials at the sponsor’s (also known as the applicant’s) recommendation, in the following circumstances:

• The disease intended to be treated is typically a disease of aging
• The population to be treated is known to include substantial numbers of geriatric patients
• There is specific reason to expect that conditions common in the elderly are likely to be encountered
• The new drug is likely to alter the geriatric patient’s response (with regard to safety or efficacy) compared with that of the non-geriatric patient

Persons in Dependent Groups

As indicated in the G-ICMR , while reviewing protocols involving participants who are engaged in subordinate or dependent relationships, the ethics committee (EC) must ensure the following:

• Participant enrollment is specifically relevant to the research questions and is not merely a matter of convenience
• Extra efforts are required to ensure the autonomy of these individuals is respected, and that they are able to freely decide to participate or deny consent and/or later withdraw from the study without fear of any negative repercussions on their care
• Mechanisms to avoid coercion due to being part of an institution or hierarchy should be described in the protocol

Sexual Minorities and Sex Workers

Per the G-ICMR , sexual minorities and sex workers require additional protections as they are more vulnerable to privacy, confidentiality, stigma, discrimination, and exploitation issues during a research study. Research proposals should ensure the dignity of these participants is protected and that they have access to quality healthcare. Investigators should consult the community, if possible, prior to the proposal being finalized. It is also advised that a representative of the sexual minority group/lesbian/gay/bisexual and transgender (LGBT) community attend the EC meeting as a special invitee/member.

As per the G-ICMR , children are individuals who have not obtained the legal age of consent, which is 18.

As stated in the G-ICMR , the 2019-CTRules , and the G-Children , in the case of pediatric clinical trials, the participants are legally unable to provide written informed consent, and are dependent on their legal representative(s) or guardian(s) to assume responsibility for their participation in a research study.

However, as specified in the 2019-CTRules , all pediatric participants should be informed to the extent compatible with the child’s understanding, and if capable, the pediatric participant should sign and personally date the informed consent form (ICF). In these studies, the following requirements should be complied with:

• Written informed consent should be obtained from the legal representative(s) or guardian(s); however, all pediatric participants should be informed to the fullest extent possible about the study in a language and in terms that they are able to understand
• Where appropriate, pediatric participants should additionally provide their assent to enroll in the study, and mature minors and adolescents should personally sign and date a separately designed written assent form
• Although a participant’s wish to withdraw from a study must be respected, there may be circumstances in therapeutic studies for serious or life-threatening diseases in which, in the investigator’s and legal representative(s)’s or guardian(s)’s opinion, a pediatric patient’s welfare would be jeopardized by failing to participate in the study. In this situation, continued legal representative(s) or guardian(s) consent should be sufficient to allow participation in the study

The 2019-CTRules further specifies requirements for pediatric studies involving new drugs. These studies must take into account the following issues:

• The timing of new drug pediatric studies will depend on the medicinal product, the type of disease being treated, safety considerations, and the efficacy and safety of available treatments
• If the new drug is for diseases predominantly or exclusively affecting pediatric patients, clinical trial data should be generated in the pediatric population except for initial safety and tolerability data, which will usually be obtained in adults, unless such initial safety studies in adults would yield little useful information or expose them to inappropriate risk
• If the new drug is intended to treat serious or life-threatening diseases, occurring in both adults and pediatric patients, for which there are currently no or limited therapeutic options, the pediatric population should be included in the clinical trials early, following assessment of initial safety data and reasonable evidence of potential benefit; in circumstances where this is not possible, lack of data should be justified in detail
• If the new drug has a potential for use in pediatric patients, pediatric studies should be conducted
• Pediatric studies should include clinical trials, relative bioequivalence comparisons between pediatric and adult formulations, and pharmacokinetic studies for dose selection across the age ranges of pediatric patients in whom the drug is likely to be used
• If the new drug is a major therapeutic advance for the pediatric population, studies should begin early in the drug development, and this data should be submitted with the new drug application

The reviewing ethics committee (EC) should also include members who are knowledgeable about pediatric, ethical, clinical, and psychosocial issues.

Refer to the 2019-CTRules for detailed pediatric study requirements.

Per the G-ICMR , the EC should also perform a benefit-risk assessment to determine whether there is a need to implement additional safeguards/protections to conduct a study involving children. The EC should consider the circumstances of the children to be enrolled in the study including their age, health status, and other factors and potential benefits to other children with the same disease or condition, or to society as a whole. In addition, the G-Children should be consulted for detailed EC assessment criteria to be used to evaluate research studies involving children.

As per the G-Children , following EC approval of the protocol, the informed consent requirement for children may be waived in the following circumstances:

• When it is impractical to conduct research since confidentiality of personally identifiable information has to be maintained throughout the study (e.g., a study on the disease/burden of HIV/AIDS)
• Research is carried out on publicly available information, documents, records, works, performances, reviews, quality assurance studies, archival materials or third-party interviews, etc.
• Research on anonymized biological samples, leftover samples after clinical investigation/research, cell lines, or cell free derivatives (e.g., viral isolates, DNA or RNA from recognized institutions or qualified investigators, samples or data from repositories or registries, etc.) provided permission for future research on these samples has been taken in the previous ICF
• In emergency situations when no surrogate consent can be taken

Assent Requirements

As delineated in the G-ICMR , the 2019-CTRules , and the G-Children , if the pediatric participant has the capacity for assent, the participant’s affirmative assent is required to participate in a study according to their developmental level and decision-making capacity. Per the 2019-CTRules , mature minors and adolescents should personally sign and date a separately designed written assent form. According to the G-ICMR , mature minors are those from age seven (7) up to age 18.

The G-Children also explains that in addition to the children’s developmental level and capability of understanding, the assent process and form should also take into account their age, maturity, reading level, independence, autonomy as well as cultural and social factors. For children between ages seven (7) and 11, oral assent must be obtained in the presence of their legal representative(s) or guardian(s). For children between ages 12 and 18, written assent must be obtained.

A child’s dissent or refusal to participate must always be respected, and he/she must be informed in an understandable manner that the child may withdraw assent at any time during the study. The EC may also issue a waiver of assent in the following circumstances:

• If the research has the potential to directly benefit the child, and this benefit is only available through this study
• If the research involves children with intellectual and other developmental disabilities, they may not have the developmental level and intellectual capability to give assent

For details and guidance on preparing and using an assent form, see the G-Children .

As per the 2019-CTRules and the G-ICMR , clinical studies involving pregnant or nursing women and fetuses require additional safeguards to ensure that the research assesses the risks to the women and the fetuses. The following conditions are required for research to be conducted involving pregnant or nursing women or fetuses.

Per the 2019-CTRules :

• Pregnant or nursing women should be included in clinical trials only when the drug is intended for use by pregnant or nursing women, fetuses, or nursing infants, and where the data generated from women who are not pregnant or nursing is unsuitable

Per the G-ICMR :

• For studies related to pregnancy termination, only pregnant women who undergo Medical Termination of Pregnancy as per the Medical Termination of Pregnancy Act, 1971 can be included
• The research should carry no more than minimal risk to the fetus or nursing infant and the research objective is to obtain new knowledge about the fetus, pregnancy, and lactation
• Clinical trials involving pregnant or nursing women would be justified to ensure that these women are not deprived arbitrarily of the opportunity to benefit from investigations, drugs, vaccines, or other agents that promise therapeutic or preventive benefits
• Research related to prenatal diagnostic techniques in pregnant women should be limited to detecting fetal abnormalities or genetic disorders as per the Pre-Conception and Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 , amended in 2003, and not used to determine the sex of the fetus
• Researchers must provide the ethics committee (EC) with proper justification for including pregnant and nursing women in trials designed to address the health needs of such women or their fetuses or nursing infants
• If women of reproductive age are to be recruited, they should be informed of the potential risk to the fetus if they become pregnant, be asked to use an effective contraceptive method, and be told about the options available in case of failure of contraception
• A woman who becomes pregnant must not automatically be removed from the study when there is no evidence showing potential harm to the fetus. The matter should be carefully reviewed, and she must be offered the option to withdraw or continue
• If the female sexual partner of a male participant gets pregnant during his research participation, the EC should review the protocol and informed consent form (ICF) to determine if a plan exists to document this event, and both the pregnant partner and fetus must also be followed for the outcome and reported in the study results
• Pregnant women have the right to participate in clinical research relevant to their healthcare needs (e.g., gestational diabetes, pregnancy-induced hypertension, and HIV)
• Benefit-risk assessment must be done at all stages for both the mother and the fetus
• Research involving pregnant women and fetuses must only take place when the objective is to obtain new knowledge directly relevant to the fetus, the pregnancy, or lactation
• Women should not be encouraged to discontinue nursing for the sake of participation in research except in those studies where breastfeeding is harmful to the infant
• Appropriate studies on animals and non-pregnant individuals should have been completed, if applicable
• Researchers should not participate in decision-making regarding any termination of a pregnancy
• No procedural changes, which will cause greater than minimal risk to the woman or fetus, will be introduced into the procedure for terminating the pregnancy solely in the interest of the trial
• When research is planned on sensitive topics (e.g., domestic violence, genetic disorders, and/or rape) confidentiality should be strictly maintained and privacy protected

Fetuses and Neonates

As described in the G-Children , study protocols involving neonates should take into consideration that this group is the most vulnerable within the pediatric population in terms of the risk of long-term effects of interventions, including developmental effects. ECs reviewing such proposed protocols should have an advisory member with expertise in neonatal research/care. ECs should scrutinize all proposed research for potential risks and weigh them against the possible benefits and ensure a competent person(s) conducts a proper scientific review of the protocol. In addition, when possible, older children should be studied before conducting studies in younger children and infants.

The consent of one (1) parent is also required for neonate studies where research exposes them to no or minimal risk, or in studies that offer the prospect of direct benefit to the participant. However, for studies that do not offer the prospect of direct benefit or are high-risk, consent from both parents is required. Exceptions to this requirement include the following:

• Only one (1) parent has legal responsibility for the care and custody of the child
• One (1) parent is deceased, unknown, incompetent, or not available. In such cases, it is the duty of the investigators to provide adequate justification.

If one (1) of the parents is a minor, then he/she should not provide consent. If both parents are minors, then enrollment of such a baby should be avoided as much as possible. Investigator(s) should provide adequate justification to the EC to enroll such neonates for research. A legally acceptable representative should provide an informed consent in such situations.

As noted in the G-ICMR , prisoners are included in the description of vulnerable populations due to their diminished autonomy caused by dependency or being under a hierarchical system.

The G-ICMR specifies that during the review process, the ethics committee (EC) must ensure compliance with the following:

• Enrolling participants is specifically pertinent to the research questions and is not merely a matter of convenience
• Extra efforts are made to respect the autonomy of these individuals because they are in a hierarchical position and may not be in a position to disagree to participate for fear of authority
• It is possible for the participant to deny consent and/or later withdraw from the study without any negative repercussions on her/his care

The G-ICMR states that, in the case of differently abled participants, such as those with physical, neurological, or mental disabilities, appropriate methods should be used to enhance the participants’ understanding. The G-ICMR also states that the presence of a mental disorder is not synonymous with incapacity of understanding or inability to provide informed consent. However, ethics committees (ECs) have special responsibilities when research is conducted on participants who are suffering from mental illness and/or cognitive impairment. ECs should exercise caution and require researchers to justify exceptions and their need to depart from the guidelines governing research. ECs should ensure that these exceptions are as minimal as possible and are clearly spelled out in the informed consent form. The G-ICMR also upholds the Declaration of Helsinki ( IND-63 ).

As set forth in the MHA2017 , every person, including a person with mental illness, must be deemed to have the capacity to make decisions regarding mental healthcare or treatment providing the person has the ability to engage in the following:

• Understand the information that is relevant to make a decision on treatment, admission, or personal assistance
• Appreciate any reasonably foreseeable consequence of a decision or lack of decision on the treatment, admission, or personal assistance, or
• Communicate the decision by means of speech, expression, gesture, or any other means

Per MHA2017 , information must be provided to a person with mental illness using simple and understandable language, sign language, visual aids, or any other means to enable the person to understand the information. In the case in which a person makes a decision regarding one’s mental healthcare or treatment that is perceived by others as inappropriate or wrong, that by itself, must not be interpreted as the person not having the capacity to make such a decision, as long as the person has the capacity to meet the above stated requirements.

MHA2017 further delineates that every person with mental illness who is not a minor must have the right to appoint a nominated representative. The nomination must be made in writing on plain paper with the person’s signature or thumb impression. The person appointed as nominated representative must not be a minor, be competent to discharge the duties or perform the assigned functions under the MHA2017 , and give consent in writing to the mental health professional to discharge the person’s duties and perform the assigned functions. A person who has appointed an individual as the nominated representative may revoke or alter the appointment at any time. The appointment of a nominated representative, or the inability of a person with mental illness to appoint a nominated representative, must not be construed as the lack of capacity of the person to make decisions about mental healthcare or treatment. All persons with mental illness must have the capacity to make mental healthcare or treatment decisions but may require varying levels of support from their nominated representative to make decisions. When fulfilling responsibilities, the nominated representative must have the right to give or withhold consent for research under circumstances.

Pursuant to MHA2017 , professionals conducting research must obtain free and informed consent from all persons with mental illness for participation in any research that involves interviewing the person, or any research that involves psychological, physical, chemical, or medicinal interventions. In the case of research involving psychological, physical, chemical, or medicinal interventions to be conducted on a person who is unable to give free and informed consent, but does not resist participation in such research, permission to conduct such research must be obtained from the concerned State Authority. The State Authority may allow the research to proceed based on informed consent being obtained from the person’s nominated representative if the State Authority is satisfied that the following criteria are met:

• The proposed research cannot be performed on persons who are capable of giving free and informed consent
• The proposed research is necessary to promote the mental health of the population represented by the person
• The purpose of the proposed research is to obtain knowledge relevant to the particular mental health needs of persons with mental illness
• A full disclosure of the interests of the persons and organisations conducting the proposed research is made and there is no conflict of interest involved, and,
• The proposed research follows all the national and international guidelines and regulations concerning the conduct of such research, and ethical approval has been obtained from the institutional EC where such research is to be conducted

A research-based study of the case notes of a person who is unable to give informed consent will be permitted so long as the anonymity of the person is secured. In addition, the person with mental illness or the nominated representative who gives informed consent for participation in any research under MHA2017 may withdraw consent at any time during the research period.

As delineated in the 2019-CTRules , an investigational product (IP) is defined as the pharmaceutical formulation of an active ingredient or a placebo (including the comparator product) being tested or used as a reference in a clinical trial.

The 2019-CTRules further defines an investigational new drug as a new chemical or biological entity or a product having a therapeutic indication, but which has never been tested before on human participants.

Manufacturing

As specified in the 2019-CTRules and IND-31 , the Drugs Controller General of India (DCGI) is responsible for authorizing the manufacture of investigational products (IPs) in India. The DCGI approves the manufacture of IPs as part of the clinical trial application review and approval process. The DCGI is head of the Central Drugs Standard Control Organization (CDSCO) and is commonly referred to as the Central Licensing Authority in the Indian regulations.

The 2019-CTRules explains that applicants must apply to the DCGI using Form CT-10 to obtain permission to manufacture an IP for clinical trial purposes. After reviewing Form CT-10 and any supplemental information, the DCGI will either grant permission to manufacture the IP via Form CT-11 or reject the application, for reasons to be recorded in writing, within 90 working days from the date of application receipt. If applicable, the DCGI must inform the applicant of deficiencies in the application within 90 working days. If the applicant chooses to rectify the deficiencies within the specified period and provide the required information and documents, the DCGI must review the application again. Based on the review, the DCGI will either grant manufacturing permission to the applicant or reject the application within a period of 90 working days from the date the required information and documents were provided. In the case of rejection, the applicant may request the DCGI reconsider the application within a period of 60 working days from the rejection date along with payment of the specified fees in the 2019-CTRules and submission of the required information and documents. Refer to the 2019-CTRules for additional timeline information and the applicable forms.

Applicants who intend to manufacture an unapproved active pharmaceutical ingredient (API) to develop a pharmaceutical formulation for clinical trial purposes should submit to the DCGI either Form CT-12, if applying as a pharmaceutical formulation manufacturer, or Form CT-13, if applying as an API manufacturer, and any supplemental information. After reviewing the submission and conducting further inquiry, if needed, the DCGI will grant permission to the applicant to manufacture the unapproved API in Form CT-15 and permission to the manufacturer of the pharmaceutical formulation in Form CT-14 within 90 working days. If dissatisfied, the DCGI will reject the application, for reasons to be recorded in writing, within a period of 90 working days from the application submission date. Refer to the 2019-CTRules for additional timeline information and the applicable forms.

In addition, Notice18Feb20 clarifies information provided in IND-31 concerning where applications should be sent to obtain permission to manufacture trial batches of new drugs or IPs for testing and analysis, clinical trials, or bioavailability and bioequivalence (BA/BE) studies. For biological drugs, applications should be sent to CDSCO Headquarters (HQ) at FDA Bhavan, New Delhi; for drugs other than biologicals, applications should be sent to the appropriate zonal office/sub-zonal office for pure chemical testing, and the zonal office/sub-zonal office or CDSCO HQ for clinical trials or BA/BE studies. Furthermore, if the applicant obtains permission to manufacture new drugs/IPs for a clinical trial or BA/BE study, he/she should automatically consider the approval as permission to conduct other chemical/physical testing and analysis on these new drugs/IPs. Refer to IND-58 for detailed CDSCO HQ, zonal office/sub-zonal office contact information. Notice20Feb20 further specifies that applications sent to either CDSCO HQ or the appropriate zonal office/sub-zonal office will be processed within seven (7) working days of receipt.

Notice18Feb20 states that applicants must clearly mention the site where the product will be manufactured in their applications using the following statement: M/s. [name and address of the firm] having manufacturing premises for test and analysis at [name and address of the manufacturing site for test and analysis]. Refer to Notice18Feb20 for additional information.

Per Notice13Mar20 , when the application is solely to conduct a clinical trial, the DCGI also requires the sponsor (also known as applicant) to submit the international non-proprietary name (INN) or generic name, drug category, dosage form, and data supporting IP stability in the intended container-closure system for the duration of the clinical trial. See the 2019-CTRules (Second Schedule, Table 1) for detailed data requirements. Additionally, for Phase III clinical trial batches, process validation data requirements may not be required; however, this requirement will vary depending on the IP’s complexity (biological, high tech, etc.).

If approved, the DCGI will grant permission for a period of three (3) years to both manufacturers of new drugs or investigational new drugs and manufacturers of unapproved APIs. In exceptional circumstances, the DCGI may extend the period of permission for an additional year. See the 2019-CTRules and IND-31 for more detailed information on manufacturing application submission requirements.

As delineated in the 2019-CTRules and IND-31 , the DCGI is responsible for authorizing the import of IPs in India. The DCGI approves the import of IPs as part of the clinical trial application review and approval process.

Per the 2019-CTRules and IND-31 , the sponsor is required to obtain a license from the DCGI using Form CT-16 to import an IP (new drug or investigational new drug) for clinical trial purposes. Per the 2019-CTRules , the sponsor must also ensure that the imported IPs are manufactured in accordance with Good Manufacturing Practices (GMPs) as laid down in the DCA-DCR . Refer to Schedule M of the DCA-DCR to review the GMP requirements. See also the Second Schedule in the 2019-CTRules for the data requirements to be included in the DCGI’s import application.

The 2019-CTRules and IND-31 further state that the DCGI will grant an import license within 90 working days of receipt of the application. Once approved, the import license must remain valid for three (3) years from the date of issue, unless suspended or cancelled. In exceptional circumstances, the DCGI may extend the license for an additional year. (See the Submission Process, Submission Content, and Regulatory Fees sections for detailed clinical trial application requirements). See also IND-35 for a checklist of manufacturing and import related forms to be included in a global clinical trial application submission. According to the 2019-CTRules , the sponsor must submit a fee of 5,000 Indian National Rupees (INRs) per product with an application for permission to manufacture or import the IP to be used in a clinical trial. Refer to IND-43 and IND-42 for detailed fee requirements and online payment instructions via the SUGAM portal ( IND-59 ).

As explained in IND-25 , the DCGI does not require a drug import license to be obtained when an ethics committee (EC) has granted approval for the conduct of an academic clinical trial that will be using a permitted drug formulation with a new indication, a new route of administration, a new dose, or a new dosage form. A copy of the EC approval for the trial must be provided to the Port office at the time of import along with a letter of undertaking that specifies the quantity of the drug being imported and states that it will be used exclusively for the academic clinical trial.

In addition, per the 2019-CTRules and IND-31 , the DCGI will relax, abbreviate, omit, or defer clinical and non-clinical data requirements to import or manufacture new drugs already approved in other countries on a case-by-case basis for life threatening or serious/rare diseases and drugs intended to treat diseases of special relevance to the Indian population, unmet medical needs in India, and in disaster or special defense use (e.g., hemostatic and quick wound healing, enhancing oxygen carrying capacity, radiation safety, or drugs to combat chemical, nuclear, or biological conditions). This decision will vary depending on the specific clinical trial phase proposed and the clinical parameters related to the study drug.

Investigator's Brochure

The 2019-CTRules requires the Investigator’s Brochure (IB) to contain the version number, release date, and the following sections:

• Introduction
• Physical, Chemical, and Pharmaceutical Properties and Formulation
• Non-clinical studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
• Effects in humans (Pharmacokinetics and Product Metabolism in Humans, Safety and Efficacy, and Marketing Experience)
• Summary of Data and Guidance for the Investigator

Refer to the 2019-CTRules for detailed content guidelines.

Per the 2019-CTRules , the licensee is responsible for ensuring the products are manufactured in accordance with the principles of Good Manufacturing Practice (GMP). (See the Product Management section for additional information on investigational product (IP) supply, storage, and handling requirements).

Additionally, per Notice13Mar20 , when the application is solely to conduct a clinical trial, the DCGI also requires the sponsor (also known as applicant) to submit the international non-proprietary name (INN) or generic name, drug category, dosage form and data supporting IP stability in the intended container-closure system for the duration of the clinical trial (see the Second Schedule, Table 1 in the 2019-CTRules for detailed data requirements). Additionally, for Phase III clinical trial batches, process validation data requirements may not be required; however, this requirement will vary depending on the IP’s complexity (biological, high tech, etc.).

Quality Documentation

As noted in the 2019-CTRules the applicant is required to provide the following:

• A free sale certificate from country of origin
• Certificate(s) of analysis of IP shipped

Per IND-75 , the Central Drugs Standard Control Organization (CDSCO) determined that the Certificate of Pharmaceutical Product (COPP) should be issued under the World Health Organization (WHO) GMP Certification Scheme and extended the validation period from two (2) to three (3) years subject to the condition that the manufacturing facility GMP status be monitored per WHO guidelines through periodic inspections.

Further, per the 2019-CTRules , the submission of requirements related to pre-clinical/toxicological animal studies may be modified or relaxed in the case of new drugs approved or marketed for several years in other countries if the DCGI determines there is adequate published evidence regarding a drug’s safety.

See IND-35 for a checklist of global clinical trial (GCT) documentation requirements.

Per the 2019-CTRules and IND-31 , the labeling of any new drug or investigational new drug product manufactured or imported for the purpose of conducting a clinical trial or for testing and analysis should include the following items:

• The drug name or code number
• Batch number or lot number
• Manufacture date
• Use before date
• Storage conditions
• Name of institution/organization/center where the clinical trial or testing and analysis is proposed to be conducted
• Manufacturer name and address
• Purpose for which the investigational product is being imported

Supply, Storage, and Handling Requirements

According to the 2019-CTRules and IND-31 , in the event that a new drug or investigational new drug manufactured for clinical trial or testing and analysis purposes is left over, remains unused, incurs damage, has an expired shelf life date, or has been found to be of sub-standard quality, the drug must be destroyed and the action taken should be recorded.

Per the 2019-CTRules , the investigational product (IP) section of the protocol submitted as part of the clinical trial application must include the following:

• IP description and packaging (i.e., IP ingredients and formulation, and placebos used, if applicable)
• Dosing required during study
• Packaging, labeling, and blinding method
• Method of assigning treatments to participants and identification code numbering system to be used
• Accountability (e.g., instructions for receipt, storage, dispensation, and return of IPs)
• Policy and procedure for handling unused IPs

Record Requirements

No information is currently available on IP record requirements.

In India, per the G-XBiolMat , the G-ICMR , and the G-StemCellRes , a specimen is referred to as “human biological material,” “human biological sample,” “biological material,” or “biospecimen.” The G-XBiolMat defines a specimen as human material with the potential for use in biomedical research. According to the G-XBiolMat , the G-ICMR , and the G-StemCellRes , this material specifically includes (Note: The regulatory sources provide overlapping and unique elements so each of the items listed below will not necessarily be in each source.):

• Organs and parts of organs
• Cells and tissue
• Blood (e.g., cord blood and dried blood spots)
• Gametes (e.g., sperm, ova, and oocytes)
• Embryos and fetal tissue
• Blastocysts
• Somatic cells

The G-XBiolMat definition also includes the following:

• Sub-cellular structures and cell products
• Wastes (e.g., urine, feces, sweat, hair, epithelial scales, nail clippings, placenta, etc.)
• Cell lines from human tissues

As per the G-XBiolMat , these biological specimens or human material samples may be obtained from the following sources:

• Patients following diagnostic or therapeutic procedures (e.g., dental, labor, etc.)
• Autopsy specimens
• Organ or tissue donation from living or dead persons
• Fetal tissue
• Abandoned tissue
• Tissue banks

Import/Export

As specified in the G-XBiolMat , the HumBiol-ImprtExprt , and IND-55 , the applicable import/export guidelines for human biological materials/specimens in India are determined by whether the materials are to be used for biomedical research or for commercial purposes. According to IND-55 , the G-XBiolMat should be followed to import/export human biological material for biomedical research purposes, and the HumBiol-ImprtExprt is to be used to import/export human biological samples for commercial purposes.

Biomedical Research

According to the G-XBiolMat , the following guidelines should be considered for requests to transfer biological material abroad for research/diagnostic purposes, and for requests to transfer biological material from abroad to Indian institutions for research purposes:

• Exchange of material for diagnostic or therapeutic purposes for individual cases may be done without restriction, if this exchange is considered necessary by the doctor(s) in charge of the patient
• Exchange of material from and to recognized laboratories such as the World Health Organization (WHO)’s Collaborating Centres may be allowed as part of routine activities relating to quality control, quality assurance, comparison with reference material, etc., without having to seek permission from any authority
• Where exchange of material is envisioned as part of a collaborative research project, the project proposal as a whole must be routed through the appropriate authorities for evaluation and clearance (see International Research Collaboration section below for additional information)
• The availability of facilities within India for carrying out certain investigations need not prevent collaboration with scientists in other countries from conducting the same investigations, including transfer of human material, if required
• For the technology transfer/training of Indian scientists abroad/training of foreign scientists and students in India, and visits by foreign collaborators to their Indian partners’ laboratories to work with Indian material, there should be no restrictions on the visits of scientists to the laboratories concerned. However, any fieldwork to be undertaken in the community and other sensitive issues would have to be regulated according to the National Portal of India ’s rules

International Research Collaboration

In the case of international research collaboration involving human biological material transfer, the G-XBiolMat and the G-ICMR indicate that the export of all biological materials is to be covered under existing Government of India and ethics guidelines. The G-ICMR further specifies that all biomedical and health research proposals relating to foreign assistance and/or collaboration should be submitted to the Indian Council of Medical Research (ICMR) for a technical review. Next, the ICMR submits the project to the Health Ministry’s Screening Committee (HMSC) for review and approval through its International Health Division that serves as the HMSC’s secretariat. Refer to IND-15 for detailed information on the HMSC.

Per the G-ICMR , the ethics committee (EC) may review research proposals requiring biological material transfer on a case-by-case basis. The exchange of human biological material from and to WHO Collaborating Centres for specific purposes, as well as for individual cases of diagnosis or therapeutic purposes, may not require permission. However, Indian participating center(s) must have appropriate regulatory approval and registration to receive foreign funds for research.

See IND-1 for the application form to request a no objection certificate (NOC) to export biological samples. Refer to the G-XBiolMat , the G-ICMR , IND-74 , and IND-27 for additional information.

Commercial Purposes

According to the HumBiol-ImprtExprt , per the Directorate General of Foreign Trade (DGFT) within India’s Ministry of Commerce and Industry , the import of human biological samples by Indian diagnostic laboratories/Indian clinical research centers for laboratory analysis/research and development testing, or, for exporting these materials to foreign laboratories, should be permitted by customs authorities at the port of entry/exit without prior approvals (import license/export permit) from any other government agency. In these cases, the concerned Indian company/agency should submit a statement that it is following all the applicable rules, regulations, and procedures for the safe transfer and disposal of biological samples being imported/exported. For more information, see the HumBiol-ImprtExprt .

Material Transfer Agreement

Per the G-ICMR and IND-74 , any research involving the exchange of biological materials with collaborative institutions outside India must sign a Material Transfer Agreement (MTA). The MTA must justify the purpose and quantity of the sample being collected; the type of investigation(s) to be conducted using the material; the names/addresses of institution(s)/scientist(s) to whom the material is to be sent; and address confidentiality issues, data sharing, post-analysis handling of remaining biological materials, safety norms, etc. The G-ICMR also indicates that an appropriate memoranda of understanding (MoU) should be in place to safeguard mutual country interests and ensure compliance.

Per the G-XBiolMat , the collaborating partners (India and foreign) should enter into an MoU and/or MTA for requests to transfer biological material abroad for research/diagnostic purposes, and for requests to transfer biological material from abroad to Indian institutions for research purposes.

In accordance with the G-ICMR , prior to collecting, storing, or using a research participant’s human biological material, consent must be obtained from the participant and/or the legal representative(s) in writing. In addition, per the G-ICMR , it is necessary for all health research involving human participants and their biological material and data to be reviewed and approved by an appropriately constituted ethics committee (EC).

In addition to the informed consent form (ICF) required elements listed in the Informed Consent topic , the G-ICMR requires investigator(s) to communicate the following information to participants in the ICF regarding the use of their biological samples:

• The participant’s right to prevent the use of his/her biological sample (e.g., DNA, cell-line, etc.) and related data at any time during the conduct of the research
• The risk of discovery of biologically sensitive information and provisions to safeguard confidentiality

The GCLP further indicates that prior to specimen collection, appropriate counseling should be completed and written consent obtained. Attention should also be paid to the participant’s sensibilities during the entire process.

The G-ICMR also require the following information:

• The storage period of the sample/data and probability of the material being used for secondary purposes
• A statement clearly indicating whether material is to be shared with others
• If research on biological material and/or data leads to commercialization, a statement describing post-research plan/benefit sharing
• The publication plan, if any, including photographs and pedigree charts
• A provision for pre-test and post-test counseling, if there is the possibility that the research could lead to any stigmatizing condition (e.g., HIV and genetic disorders)

Human Genetic Research Consent Requirements

As stated in the G-ICMR , investigator(s) must comply with stringent norms and exercise caution in conducting the consent process with participants for genetic research purposes. The following considerations must be taken into account during this process:

• For routine genetic diagnostic testing, written consent may or may not be needed as per institutional policies; however, it is required for any research
• Written informed consent is essential for procedures such as pre-symptomatic testing, next generation sequencing (NGS), prenatal testing, genomic studies, and carrier status, etc.
• The investigator(s) should emphasize that consent for screening or a subsequent confirmatory test does not imply consent to any specific treatment, or termination of a pregnancy, or for research
• If the research or testing involves a child, appropriate age-specific assent (verbal/oral/written) should be obtained along with parental consent

The G-ICMR further specifies that the ICF for genetic research testing should address the following additional points:

• The nature and complexity of information that would be generated
• The nature and consequences of returning results and the choice offered to the participant as to whether to receive that information and incidental findings, if any
• Direct/indirect benefits and their implications, including if there are no direct benefits to the participants
• How the data/samples will be stored, for how long, and procedures involved in anonymization, sharing, etc.
• Choice to opt out of testing/withdraw from research at any time
• Whether the affected individual or the participant at the starting point of the study (proband) would like to share her/his genetic information with family members who may benefit from it
• Issues related to ownership rights, intellectual property right concerns, commercialization aspects, and benefit sharing

Per the G-ICMR , in the case of population or community-based studies, group consent must also be taken from the community head and/or the culturally appropriate authority due to the potential of the genetic research to generate information applicable to the community/populations from which the participants are drawn. However, even if group consent is taken, it will not be a replacement for individual consent.

In addition, as indicated in the G-ICMR , the transfer of human biological material to be stored at a biorepository or a biobank, or another institution, must be communicated to the participant. The participant owns the biological sample and data collected from her/him and could therefore withdraw both the biological material donated to the biobank and the related data unless the latter is required for outcome measurement and is mentioned accordingly in the initial informed consent document. Please refer to Section 11 of the G-ICMR for detailed consent requirements associated with storing human biological materials in a biorepository or a biobank. (See the Required Elements and Participant Rights sections for additional information on informed consent).

For specific guidelines regarding gene therapy and stem cell therapy clinical trials, see the G-GeneThrpy and G-StemCellRes . See the G-ICMR , IND-5 , and IND-27 for additional information on genetic research informed consent requirements.

Country Announcement

See the India updates page for details on recent revisions to the profile.

COUNTRY NEWS (Information Not Yet Incorporated Into Country Profile):

New National Single Window Portal On January 1, 2024, the Central Government of India announced the launch of the National Single Window System (NSWS) Portal as a one-stop shop for government approvals, licenses, registrations, and clearances. Per this notice , effective February 10, 2024, the SUGAM online portal will be disabled and the NSWS should be used for submitting the applications listed below, which can be found on the Central Approvals web page .

• Application for grant of permission to manufacture new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis (CT-10)
• Application for grant of permission to manufacture formulation of unapproved active pharmaceutical ingredient for test or analysis or clinical trial or bioavailability or bioequivalence study (CT-12)
• Application for grant of permission to manufacture unapproved active pharmaceutical ingredient for development of formulation for test or analysis or clinical trial or bioavailability or bioequivalence study (CT-13)
• Application for grant of license to import new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis (CT-16)
• Application to import drugs for the purposes of examination, test or analysis (Form 12)

CDSCO Updates

• On January 31, 2024, the Central Drugs Standard Control Organization (CDSCO) issued a notice stating that effective immediately, investigational new drugs (IND) proposal evaluation meetings will be conducted by the SEC division. Applicants must submit a copy of their presentations through e-vartalap (Sugam Portal) only to the concerned division well in advance, after receipt of the invitation letter from CDSCO.
• On October 12, 2023, CDSCO issued a notice stating that effective immediately, all stakeholders are encouraged to submit bulky dossiers, documents, query replies, and other documents to CDSCO’s Clinical Research Unit (CRU) in soft copy format. Soft copies should be submitted in PDF format less than 20 MB on a CD or pen drive, or via email to [email protected].

Digital Personal Data Protection Legislation Update

On August 11, 2023, the President of India assented to the Digital Personal Data Protection Bill, 2023, thus enacting the Digital Personal Data Protection Act, 2023 (Act). The effective date of the Act will be announced by the Indian Government via an Official Gazette notification and will amend certain provisions of the Information Technology Act, 2000 .

Indian Council of Medical Research (ICMR) Update

On March 17, 2023, the ICMR published the Joint Ethics Review of Multicentre Research , which provides step-by-step guidance to streamline the ethics review process of multicenter research being undertaken by ICMR institutions. These guidelines do not extend to clinical trials that require approval from the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act and Rules.

Building a successful medical career: 5 essential tips for aspiring medical students

B ecoming a medical professional is a noble and rewarding journey that demands dedication, perseverance, and a commitment to lifelong learning. In India, where the healthcare system plays a crucial role in the lives of millions, medical students hold a significant responsibility.

Aspiring doctors must not only excel academically but also embrace a set of values and practices that align with the country's healthcare ethos.

Here are a few essential guidelines that all medical students in India should follow to ensure a successful and fulfilling career in the medical field.

1. RESPECT FOR DIVERSITY AND CULTURAL SENSITIVITY

India is a melting pot of various cultures, traditions, and languages. Medical students have the privilege of interacting with patients from various backgrounds, each with unique beliefs and practices. It is crucial to approach patient care with cultural sensitivity and an open mind.

Understanding and respecting patients' cultural preferences can lead to better communication, trust, and ultimately, more effective medical care. Taking the time to learn about the customs and beliefs of different communities can significantly improve patient-doctor relationships and outcomes.

2. ETHICAL PRACTICE AND PROFESSIONALISM

Medical ethics and professionalism are the cornerstones of a successful medical career. Indian medical students must adhere to the ethical principles outlined in the Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002.

These guidelines emphasize the importance of patient confidentiality, informed consent, and maintaining the highest standards of integrity. Upholding ethical values not only ensures the well-being of patients but also contributes to building a trustworthy reputation within the medical community.

3. DEVELOP EFFECTIVE STUDY HABITS

As a medical student, you will be bombarded with a vast amount of information. To succeed, it is crucial to develop effective study habits. Create a study schedule that allows for regular breaks and incorporates active learning techniques such as summarising, flashcards, and teaching others.

Additionally, prioritize understanding concepts rather than memorising facts. This will not only help you retain information better but also prepare you for clinical practice.

4. HOLISTIC PATIENT CARE

In a country where access to healthcare can be a challenge for many, medical professionals often find themselves treating not just physical ailments, but also addressing socio-economic factors.

Indian medical students should be prepared to deliver holistic patient care by considering the patient's economic, social, and psychological background. This approach may require a more comprehensive diagnosis and treatment plan that considers all aspects of the patient's well-being.

5. EMBRACE TECHNOLOGICAL ADVANCEMENTS

The healthcare landscape in India is rapidly evolving with technological advancement. From electronic health records to telemedicine, embracing these innovations can streamline patient care and enhance medical practice.

Medical students should stay updated on the latest technologies, as they have the potential to revolutionise healthcare delivery, especially in remote and underserved areas. Integrating technology into medical practice can lead to increased efficiency, accuracy, and accessibility of healthcare services.

6. LIFELONG LEARNING AND ADAPTABILITY

The field of medicine is characterised by constant advancements in research, treatments, and medical knowledge. Indian medical students should cultivate a mindset of lifelong learning to stay up to date with the latest medical developments.

Pursuing continuing medical education, attending conferences, and engaging in research activities can help doctors-in-training refine their skills and expand their knowledge base. Adaptability to new medical techniques and practices is essential for providing the best possible care for patients.

Becoming a successful medical professional in India goes beyond academic achievements. It requires a deep-rooted commitment to cultural sensitivity, ethical practice, holistic care, technological integration, and continuous learning. As the healthcare system in India continues to evolve, medical students have a pivotal role in shaping its future. By following these few essential guidelines, aspiring doctors can not only excel in their careers but also contribute positively to the well-being of the nation's population. Remember, the journey may be tough, but the impact you will have on the lives of patients makes it all worthwhile.

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Why a New Study Dubbed India the ‘Cancer Capital of the World’

A new study has unveiled an alarming picture of declining overall health in India. The report, released by the Indian multinational healthcare group, Apollo Hospitals, found that skyrocketing cases of cancer and other non-communicable diseases across the country have now made it “the cancer capital of the world.”

The report is an "attempt to highlight the growing 'silent epidemic' that needs prioritized action by every Indian," the authors write.

Despite reporting more than a million new cases every year, India’s cancer rate has not yet surpassed countries like Denmark, Ireland, and Belgium, which record some of the highest cancer rates in the world. It is also currently lower than the U.S., reporting 100 cases for every 100,000 people compared with 300 in the U.S. 

But that could soon change due to what some experts have called an “epidemiological transition.” The new report finds that currently, one in three Indians is pre-diabetic, two in three are pre-hypertensive, and one in 10 struggles with depression. Moreover, chronic conditions like cancer, diabetes, hypertension , cardiovascular diseases, and mental health disorders are now so prevalent that they have reached “critical levels,” according to the report. 

In particular, the number of cancer cases is expected to rise at a rate that will surpass global averages—from 1.39 million in 2020 to 1.57 million by 2025. Among women, the most common forms of cancer are breast cancer, cervix cancer, and ovarian cancer. Among men, they are lung cancer, mouth cancer, and prostate cancer. While men generally report a 25% higher incidence of cancer than women globally, India bucks this trend with more women getting diagnosed with cancer, according to a study published in the Lancet Oncology . Certain cancers are also affecting younger people sooner than in the U.S., U.K., and China. The median age for lung cancer, for example, is 59 in India, but 70 in the U.S., 68 in China, and 75 in the U.K., according to the new report.

The high incidence of cancer stems from a mix of environmental and socioeconomic factors, like high levels of pollution, as well as lifestyle and dietary preferences. Almost 40% of cancer cases in India are due to rampant tobacco use, which significantly elevates the risk of lung, oral, and throat cancers, while factors like poor diet and lack of physical activity cause 10% of cases.

The report also warns of an eventual healthcare crisis across the country because of a surge in obesity rates (9% in 2016 to 20% in 2023) and hypertension (9% in 2016 to 13% in 2023). Moreover, pre-diabetes, prehypertension, and mental health disorders are manifesting at increasingly younger ages, while the risk of obstructive sleep apnea among Indians has reached higher proportions.

“The importance of health in our nation’s development cannot be overstated,” said Dr Preetha Reddy, the Vice Chairperson of Apollo Hospitals Group. “We strongly believe that the entire healthcare ecosystem and the nation needs to come together and have a unified outlook so that we can combat non-communicable diseases in the truest sense.” 

The experts highlighted the importance of regular health screenings , including monitoring blood pressure and body mass index levels, in reducing the risk of cardiac-related ailments. Currently, India has a screening program in place for oral, breast, and cervical cancer, but screening rates are less than 1%, according to national data. However, the latest report also noted that “people are increasingly choosing more comprehensive health checks today than before,” highlighting a “positive step” towards safeguarding health and wellness.

Still, the experts warn that health checks need to expand their reach across India. In the long term, that can only be done “by prioritizing investments in health infrastructure, promoting preventive healthcare measures, and addressing health inequities,” the report stated.

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Opportunities and challenges for Indian students pursuing medical education in the US

Indian students pursuing medical education in the us face both opportunities and challenges. all you need to know..

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As the appeal of global education continues to grow, more and more Indian students are choosing to pursue medical education in the United States. With its renowned institutions, cutting-edge research opportunities, and diverse clinical experiences, the US offers a promising landscape for aspiring medical professionals.

However, embarking on this journey presents its unique opportunities and challenges. Here's everything you need to know from expert Mamta Purbey, Associate Vice President of Student Acquisition at the American University of Antigua College of Medicine.

1. Duration

The duration of medical education in the United States presents a significant consideration for Indian students. Unlike some countries where medical programs are shorter in duration, the US typically requires a longer commitment, with undergraduate pre-medical studies followed by four years of medical school and additional 3-7 years of residency training depending upon the speciality. This extended timeline not only requires careful planning and dedication but also adds to the overall cost and time investment for aspiring physicians.

2. Application Process

The application process for Indian students seeking medical education in the United States is extremely intricate and multifaceted. From navigating the intricacies of various medical school requirements to ensuring compliance with visa regulations, each step requires careful preparation. Prospective students must meticulously research and select suitable institutions, taking into account factors such as program curriculum, faculty expertise, and research opportunities. Additionally, they must devote substantial time and effort to prepare for standardized tests such as the MCAT, ensuring competitive scores that meet the rigorous standards of US medical schools. Crafting compelling personal statements and securing strong letters of recommendation further add to the complexity of the application process. Moreover, the application timeline is often protracted, with deadlines spanning several months and multiple stages of review.

3. Acceptance Rate

A significant hurdle for international students applying to medical school is the limitation of options, as they can only apply to a restricted number of schools. Fewer than one-third of medical schools in the United States admit international students, with only a small number being matriculated into programs. Policies regarding international applicants vary among schools, so it's crucial to verify each institution's policy before applying. Competition for seats in medical schools is fierce, with acceptance rates hovering around 3% to 4% for international applicants.

4. Financial constraints

The greatest challenge for international students attending medical school often revolves around financial constraints. Regrettably, international students are ineligible for US federal loans. As per the AAMC (Association of American Medical Colleges), certain medical schools may demand applicants to demonstrate adequate financial means to cover the entirety of their four-year medical education or require them to have the entire amount deposited in an escrow account.

Hence, financial considerations pose a significant challenge for many Indian students. The cost of tuition, living expenses, and healthcare in the US can be prohibitively high, making it difficult for students from middle-class backgrounds to afford a medical education abroad. While scholarships and financial aid options are available, they are often limited for international students and highly competitive.

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• v.10(3); Jul-Sep 2019

Does India need more medical scientists?

Suhasini sharma.

Director, Medical Affairs, Sciformix Technologies, Mumbai, Maharashtra, India

Research in any field builds new knowledge, brings about improvements in existing practices and new advances. Biomedical research is critical for advancing the health of a nation. Sadly, in India, medical research is woefully neglected. A study analyzing research output from 579 Indian medical institutions and hospitals between 2005 and 2014 reported that only 25 (4.3%) of the institutions produced more than 100 papers a year compared to the annual research output of 4600 papers from the Massachusetts General Hospital and 3700 from the Mayo Clinic.[ 1 ]

Medicine is an applied science that is constantly evolving. Without the research done over the last century, medicine and healthcare would have remained primitive, and the improvements in therapeutics and life-expectancy that we see today would not have been possible! The importance of medical research and scientists to healthcare is evident by the list of Nobel Laureates which features many physician-scientists whose contributions have benefitted millions of patients the world over. Who hasn’t heard of Sir Alexander Fleming, Edward Jenner, Robert Koch, and Frederick Banting!

India today is well known the world over for its excellent medical facilities and depth of clinical expertise. Every clinical specialty is well represented in most Indian hospitals. But can we say the same about the extent of biomedical research in the country? While Indian medical graduates excel in various research fields overseas, do we see a similar picture here at home? How many healthcare innovations or therapeutic advances have been based on research done in India? Even though every medical postgraduate in India is required to conduct “original research” for his/her thesis, and every position in public and private health-care setup requires publication of original research papers, the state of biomedical research in India, both basic and applied, is miserable.

Basic medical sciences such as physiology, pathology, biochemistry, and genetics enhance knowledge of the human body from the molecular level to the whole organism-its structure, functions, and alterations that happen in disease states. Medical scientists study diseases, their underlying causes, and how they can be prevented and treated. Pharmacologists and microbiologists try to find more specific therapy targets, develop newer drugs and improve existing treatments. Basic medical research provides knowledge to understand disease mechanisms and find appropriate targets and pathways for new drugs, diagnostic tools, or therapies to work. Considering our limited resources, it is understandable that we cannot spend our scarce resources on basic research in medicine. However, looking at our vast population, huge health-care needs and clinical expertise available in the country, we can certainly carry out outstanding clinical and public health research.

Take the case of public health research. Every nation must undertake research in public health to keep advances in healthcare locally relevant to benefit their own population. Certain diseases are specific to certain geographical regions or populations. It is well known that genetic, environmental, sociocultural, and dietary factors greatly influence manifestations and management of diseases; hence, health research done locally would have the greatest impact on the health of local populations. Multidrug-resistant tuberculosis, HIV/AIDS, malaria, and noncommunicable diseases (NCD) such as diabetes, heart diseases, chronic pulmonary obstructive diseases, and cancers are the biggest health-related challenges facing India today.[ 2 ] Our research effort in these areas is not commensurate with our needs. Even though the quantum of public health research in India has gone up in the last few years, the proportion related to NCD which contribute significantly to the disease burden is still very small.[ 3 ]

The reasons for such a sorry state of affairs are many. The often cited ones are lack of sophisticated research infrastructure, paucity of funds, and physicians “overburdened” with patient care. These certainly are there, but at a more basic level, the reasons may be hidden in our education system that promotes rote learning over a spirit of scientific inquiry and lateral thinking. We revel in our past glories in having given the world many sciences including Ayurveda, yet are unwilling to test ancient therapies using modern scientific methods or participate in modern medical research on local populations. We tend to view any form of medical research as “using Indian patients as guinea pigs,” or done “for the benefit of pharmaceutical industry.”

More importantly, our medical education and institutions lack training curriculum in conducting systematic research; neither is there any emphasis on recording and documenting observations systematically in medical practice. In addition, most medical graduates have a tendency to look on nonclinical branches of medicine such as physiology, biochemistry, and pathology as noncritical. This prejudice against basic medical sciences, and the glamour and pecuniary rewards of clinical practice lure many more budding physicians to take up clinical specialties over medical research as a professional career.

If we want more medical research to happen in India, we need to address these shortcomings systematically. We need to encourage scientific inquiry and rational thinking in our young population; our medical education needs overhaul to include training programs in systematic research methodologies, and our medical institutions must nurture and mentor budding scientists treating them on par with clinical specialists. We should invest in building proper research infrastructure, and make resources available for supporting medical research at the institutional level.[ 4 ] In addition, perceptions of the stakeholders including the general public need to be addressed to create a more open environment for medical research.

Equally, we must remember that research need not happen only in advanced institutions under sophisticated settings, it can be done at patient bedside in clinical practice. An astute, observant, and reasoning clinician can seek answers to many clinical questions through simple yet well-designed clinical experiments in his day-to-day practice, as beautifully illustrated through many well-known examples by Nanivadekar in his thoughtful essay.[ 5 ] To this effect, we must inculcate in our medical students and clinicians an attitude of scientific curiosity and reasoning, and a habit of systematically recording and documenting their observations.

We must firmly believe that while clinicians are the patient interface working to perfect the existing practice of medicine, medical scientists are needed to generate new knowledge and test new theories and therapies to bring about betterment and innovations in healthcare. Contributions by both are equally essential to medical science and patient care. A combination of both in a single professional is an ideal blend. We need both clinicians and medical scientists to make this world a better place!

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Opinion Guest Essay

Teaching Patients How to Heal

Madiwalappa Saranappa Hosamani recovers at home with his wife in Bengaluru after open-heart surgery. Credit...

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By Vidya Krishnan

Photographs by Gayatri Ganju

Ms. Krishnan, a journalist based in Goa, India, and Ms. Ganju, a photographer based in Bengaluru, India, reported from Bengaluru.

• April 12, 2024

By around 2 p.m., just after lunch, activity at the critical care unit of the Jayadeva hospital in Bengaluru, India, is at an ebb. No one is running down the halls with X-rays, bills or samples of body fluids to be tested. The morning rounds are over. The doctors are gone, and the nursing shift has just changed.

That’s when Girish Balakrishnappa walks in. He is a staff nurse but has the demeanor of a teacher. He starts off by asking everyone to put their phones on silent and gather around. Patients who can walk drag chairs toward him. Those who can’t walk sit up in their beds. Others are asleep, their family members taking notes for them.

Over the next hour, the nurses, physicians and technicians fall back, ceding the floor to Mr. Balakrishnappa as the ward morphs into an intensive care unit classroom. The students are anxious cardiac care patients, some of whom have only just awakened from open-heart surgery, and their even more anxious families. Mr. Balakrishnappa will tell them how to cough without stressing their hearts, how to scratch without ripping open their wounds and how a pacemaker works.

He will explain that having open-heart surgery does not mean the doctors will remove the heart. In India, where health care walks hand in hand with superstition, myths and luck, Mr. Balakrishnappa helps patients sift through good and bad information — a matter of life and death both inside a critical care ward and after patients are discharged.

This ad hoc classroom is part of a decade-long experiment unfolding in Asia that has been testing a simple yet radical idea: If patients are most comforted by their loved ones, why not involve them in the medical process and see how that affects recovery?

This approach also emerged as part of a solution to the enduring problems faced by health systems across the world that were battered by the Covid-19 pandemic. The World Health Organization estimates that between 80,000 and 180,000 health care workers may have died of Covid-19 between January 2020 to May 2021, which created a dangerous shortage in the work force.

Today, India has one doctor for every 834 people, compared with a rate of around 2.4 doctors for every 1,000 people in the United States. But only 80 percent of Indian doctors are allopathic, or practicing Western medicine. The rest practice traditional healing such as Ayurveda, naturopathy, homeopathy or Unani medicine. Similar shortages plague India’s nursing industry, where there are just 1.7 nurses per 1,000 people, compared with 12.7 in the United States.

Those numbers are important, but the lesson behind them is equally so: how a lack of communication between doctors and patients affects patient health. According to Noora Health, which has introduced its “care companion” program in hundreds of hospitals and thousands of clinics in India, Bangladesh and Indonesia, when medical information is properly communicated to patients and their families, not only are common post-surgery complications reduced, but so are acts of violence by frustrated family members against health care workers.

“We realized that caregivers get little to no guidance within the health care system,” said Shahed Alam, a co-founder of Noora Health, a Bengaluru-based nonprofit. “Many patients do not know why they are in the hospital, what’s going to be done to them. Doctors and nurses go from patient to patient, repeating the same information.”

By training hospital staff to train patients and their family members, he added, “It reduces the palpable anxiety in the ward.”

During the pandemic, Noora Health’s work became even more relevant: The lockdown turned family members into primary care givers for Covid-19 patients and for those with complex illnesses like tuberculosis and cardiac problems. The organization responded by expanding virtual training programs and developing new guidelines for respiratory hygiene, mental health and health care worker safety.

Many patients and their family members come to see Mr. Balakrishnappa as a therapist, coach, friend and philosopher all rolled into one. He teaches patients about everything from managing their side effects to the importance of hand washing. He wraps up each class with breathing exercises.

At the end of each class, Mr. Balakrishnappa takes questions, most of which are about diet and the side-effects of medicines. Some patients wonder how much longer they will be in the I.C.U. He patiently answers every question. By the end of their stay, patients and families have fortified their bonds by sharing the sacred space of life and death.

“There is strength in this. They form human connections that are needed to survive their medical conditions,” Mr. Balakrishnappa explained to me. After a full day of teaching patients how to navigate the hospital, he catches a quick lunch in the canteen when I sit down with him. I ask him if he gets bored repeating the same things over and over.

“Never. If I get bored, people lose lives,” he replied. “Most of my patients are not educated, don’t speak English, and it is important that they have all the information they need, or else they will not make a full recovery.”

Patients, too, tell me that the time they spend with Mr. Balakrishnappa is the high point of their day — and having high points inside a hospital is no small thing. I asked Dilip Kumar, a 9-year-old boy who spent a month in the I.C.U. after being treated for a hole in his heart, what was the most helpful advice he received. He thinks for a bit before explaining that Mr. Balakrishnappa had warned him he’d be scared when he woke up after surgery in the recovery ward.

“He told me to not to panic or pull at the wire attached to me and told me that my mom will not be allowed inside the ward,” Dilip replied, “and that I have to be twice as brave inside the operating theater and in the recovery ward, where I’ll be alone. But only for a bit.”

Three days after his discharge, I visited Dilip at home in the gold-mining district of Kolar, outside Bengaluru. His favorite thing about being home was that he was not “cold all the time due to the air-conditioner.” He was still wearing his face mask, as Mr. Balakrishnappa had instructed. It covered most of his tiny face but it was easy to tell when he smiled — the kind of smile many children have that goes from their mouth to their eyes.

His mother, Manjula, was making sure everyone in the family was following hand hygiene as taught at the hospital. She told me that Dilip missed the nursing staff and, “of course, Girish.” She missed him too, she added. “He was a friend, and it was unexpected to make friends at such a big hospital,” she said, adding that they talk about Mr. Balakrishnappa at home all the time.

“Without him, I would not have been able to go through this,” she said. “He taught me how to take care of my child.”

Vidya Krishnan (@ VidyaKrishnan ) is a journalist based in Goa, India, who specializes in health issues. She is the author of “The Phantom Plague: How Tuberculosis Shaped History.”

Gayatri Ganju is a photographer based in Bengaluru, India. Her editorial and personal works address gender and the environment. She received the Photography Award from the Musée du Quai Branly in 2022 and is currently a Magnum fellow.

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