Investigational New Drug Application India: IND Requirements & Process

The Investigational New Drug application process in India is a structured regulatory framework that enables safe initiation of human clinical trials. It requires submission of preclinical and supporting scientific data for a detailed review by authorities. The evaluation focuses on safety, quality, and ethical compliance under the Second Schedule of New Drugs and Clinical Trial Rules. Approval ensures that only well-studied and justified investigational Drugs proceed to Clinical development stages.

What is Investigational New Drug application, and Why is it Important?

An Investigational New Drug (IND) application, India,is an important step in the Drug development process that allows a New Drug to be tested in humans for the first time. This stage plays a key role in assessing whether the Drug is appropriate for human use. Before any clinical study begins, approval must be obtained from the regulatory authority under the Investigational New Drug India framework.

The IND process includes different stages where the available data on the Drug is carefully reviewed. It focuses on assessing safety and expected effectiveness using submitted data. This step ensures that only properly studied Drugs move forward, helping to protect participants and maintain proper scientific and ethical standards during research.

To understand how IND applications are regulated in India, it is important to know the governing regulatory framework.

Regulatory Framework for IND in India

The regulatory framework for IND applications (India)

Checking regulatory history and safety information of the Drug
Ensuring compliance with Schedule Y, including informed consent from participants and compensation rules
Evaluating clinical trial sites, investigators, and ethics committee approvals
Reviewing patient recruitment plans and drug quality data

Based on this regulatory framework, specific preclinical requirements must be fulfilled before submitting an IND application.2

IND Requirements for New Drug Application in India

The requirements for IND application (India) depend on the stage of Drug development, the regulatory status of the Drug in India and other countries, and the purpose of the study. The submitted data should be appropriate to the phase of development and must support the safety and scientific basis for conducting clinical trials. The main requirements of an IND application include:

Introduction of the Drug: The application should clearly mention the investigational product name, its brief description, therapeutic category, and proposed indication for use.
Chemical and Pharmaceutical information: Complete details regarding composition, formulation, and quality of the Drug must be provided and are reviewed by Pharmaceutics experts for suitability.
Animal pharmacology data: Information should be presented as per Second Schedule and ICH CTD, including comparison with standard treatment, and proper conversion of animal or in-vitro data to human dose with justification.
Animal toxicology studies: Toxicity data must follow Second Schedulerequirements based on route of administration and duration of dosage. Justification must be given for any deviation, along with interpretation of findings in relation to human safety.
Clinical pharmacology (Phase I): Details should include calculation of first human dose, extrapolated safe dose, expected adverse reactions, and monitoring plans for safety and efficacy.
Clinical trial data: Information from Phase II and Phase III trials, along with special studies, should be submitted according to prescribed formats.
Regulatory status: The status of the Drug in other countries, including approval, withdrawal, or restrictions, must be clearly stated with supporting documents.
Prescribing and samples: Proposed prescribing information, labels, and required Drug samples with testing protocols must be submitted for evaluation.

Once these preclinical requirements are completed, the collected data is organized into a structured IND application dossier.2

Key Components of an IND Application Dossier

The IND application dossier must include all essential information required by regulatory authorities to evaluate a New Drug before clinical trials begin. The key components of an IND dossier include:

Regulatory status of the Drug, including approvals, withdrawals, and safety concerns in other countries
Compliance with Second Schedule, including informed consent, adverse event handling, and compensation
Details of clinical trial sites, investigators, and ethics committee approvals
Patient population details and relevance of the study to Indian healthcare needs
Risk-benefit evaluation, innovation over existing therapies, and safety measures based on available data

This forms a core part of the IND clinical trial process. Once the IND dossier is prepared with all required components, it is submitted along with supporting documents for regulatory review.

List of Documents Required for IND in India

The IND application (India) requires submission of a detailed set of documents to ensure a thorough evaluation before clinical trials begin. The documents cover administrative, scientific, and clinical aspects of the Drug to confirm its safety, quality, and suitability for human studies. The required documents generally include:

Application details such as CT-18/CT-21, applicant information, Drug name, composition, indication, and applicable fees
Manufacturing and Drug source information along with complete chemical and pharmaceutical data
Preclinical studies including animal pharmacology, toxicology, genotoxicity, and safety data
Clinical trial data such as Phase I, II, III study summaries, protocols, and special study reports
Regulatory status, prescribing information, sample submission, ethics approvals, and informed consent documents

Following document preparation, the IND application moves forward to the submission and review stage.

Figure 1

IND Application Submission and Review Process in India

As per New Drugs and Clinical Trial Rules, prior approval is required before initiating any clinical trial. The IND submission and review process in India includes the following aspects:

Definition and requirement: IND approval is mandatory before clinical trials and manufacturing permission. Preclinical requirements such as animal toxicology, reproductive studies, mutagenicity, teratogenicity, and carcinogenicity may be modified if sufficient published safety data is available from other countries.
Clinical trial planning: This includes preparation of the study protocol and detailed information on manufacturing, chemistry, and control of the investigational Drug. The application is submitted by a sponsor, which may be a company or organization. Pre-IND discussions may also be conducted to clarify requirements.
Regulatory permission: No clinical trial can be conducted without written approval from the Drugs Controller General of India (DCGI). Trials are categorized as domestic clinical trials (conducted in India from Phase I) and global clinical trials (based on data generated outside India with possible Phase II entry).
Submission and review: The sponsor submits Form 44 along with the prescribed fee and required documents, including Drug details, chemical and pharmaceutical data, animal studies, clinical data, and regulatory status. Both physical and electronic copies are submitted. CDSCO reviews the application to ensure compliance with Schedule Y, GCP guidelines, and regulatory standards before granting approval.

IND submission and review process plays a crucial role in the IND clinical trial process in India ensuring that all scientific, ethical, and regulatory requirements are adequately met before clinical trials are initiated.4

Conclusion

The IND application in India is an important regulatory requirement before starting human clinical trials. It ensures proper evaluation of drug safety, quality, and scientific data in accordance with Second Schedule guidelines. The process involves systematic documentation and review by regulatory authorities. This structured approach that only adequately tested and suitable Drugs are permitted to proceed to clinical development under regulatory supervision.

References

(Dr.) Mohd. Wasiullah (Dr.) Mohd. Wasiullah, Dr.) Piyush Yadav Dr) PY, Sushil Yadav SY, Nitesh Maurya NM. The IND Process: Innovation and challenges. IJPRA. 2025;10(2):2356-2362. doi:10.35629/4494-100223562362
Handbook for Applicants and Reviewers of Clinical Trials. Accessed April 11, 2026. https://www.icmr.gov.in/icmrobject/static/icmr/dist/images/pdf/reports/Handbook%20for%20Applicants%20and%20Reviewers%20of%20Clinical%20Trials.pdf
APPLICATIONS FOR INVESTIGATIONAL NEW DRUGS (INDs). Accessed April 11, 2026. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/New-Drugs/Checklist/Update_Checklist_10July2018.pdf
Jyoti Sambhaji D, B. Tidke P, .V. Phoke S. Review on “Regulatory Approval Process of INDA, NDA and Anda in India and Foreign Countries (Us, Europe, China, Australia, Canada).” International Journal of Innovative Science and Research Technology (IJISRT). Published online March 15, 2024:545-560. doi:10.38124/ijisrt/IJISRT24MAR495