In India, the regulatory framework for investigational new drug (IND) is governed by the CDSCO under the DCGI. INDs are regulated by the New Drugs and Clinical Trials Rules, 2019 (with amendments in 2026). It ensures that investigational drugs undergo rigorous safety, quality, and ethical review before human clinical trials can begin.
What is investigational new drug?
An Investigational New Drug (IND) is a pharmaceutical substance or biologic that has shown promise in laboratory and animal studies but has not yet been approved for general use in humans. It is submitted to regulatory authorities to seek permission for clinical trials.
Regulatory framework for IND in India
In India, the regulatory framework for investigational new drug (IND) is overseen by the Central Drugs Standard Control Organization (CDSCO) under the Drug Controller General of India (DCGI). The regulatory guidelines for IND are primarily detailed in the Drugs and Cosmetics Act, 1940, Schedule Y, and the New Drugs and Clinical Trials Rules, 2019 (amended in 2026). These rules mandate that sponsors submit comprehensive preclinical data, manufacturing details, and clinical trial protocols via the SUGAM online portal. Moreover, the CDSCO and registered Ethics Committees conduct parallel review. All trials must be registered with the Clinical Trial Registry of India (CTRI).
Additionally, strict provisions exist for informed consent, compensation for injury, and reporting of serious adverse events. The 2026 amendments introduced faster approval timelines (reduced from 90 to 45 days), a prior intimation system for certain low-risk studies, and simplified bioavailability/bioequivalence study approvals. This aligns India’s regulatory framework for investigational new drug more closely with global standards, such as ICH-GCP. Thus, the framework emphasizes risk-based evaluation, patient safety, ethical oversight, and transparency, while also supporting innovation and global collaboration in drug development.
What is the investigational new drug (IND) application?
The investigational new drug (IND) application is a formal regulatory dossier submitted by a sponsor (pharmaceutical company, academic institution, or clinical researcher) to seek official government permission to test an unapproved chemical or biological substance on humans. The IND application serves as a comprehensive dossier containing preclinical safety and efficacy data, manufacturing and quality details, and proposed clinical trial protocols. It aims to ensure that the investigational product can be ethically and safely tested in humans.
Therefore, an IND is defined as a novel substance that has not yet been approved for marketing as a drug in any country. The IND application serves as the legal bridge between preclinical laboratory research and human clinical trials. The IND application is heavily evaluated to ensure that a compound is safe enough to be exposed to human volunteers for the first time. The purpose of the IND application is to ensure:
- Participant safety: Verifying that animal safety and toxicology data justify human exposure.
- Scientific validity: Confirming that the human clinical trial design is strictly structured, ethical, and statistically sound.
- Manufacturing control: Ensuring that the experimental batch is pure, stable, and consistently manufactured.
Why is an IND application needed?
An investigational new drug (IND) application is needed because it acts as the formal request to regulatory authorities for permission to begin human clinical trials of a new drug that has only been tested in laboratory and animal studies.
- Regulatory permission: An IND application is the formal request to the regulator (CDSCO/DCGI in India) for approval to begin human clinical trials.
- Protect human subjects: Ensure the safety and rights of participants during all phases of the clinical trial.
- Validate the science: Ensure the clinical study design is adequate to evaluate the drug’s safety and effectiveness.
- Safety assurance: The application provides preclinical toxicology and pharmacology data to prove the drug is reasonably safe for human use. It ensures trials are conducted in line with CDSCO GCP and Schedule Y standards.
- Ethical oversight: IND submission requires Ethics Committee approval and trial registration with CTRI. This protects participants’ rights through informed consent and compensation mechanisms.
What is included in an IND application?
- Preclinical data: The application must include results from laboratory and animal studies covering toxicology, pharmacology, and pharmacokinetics. These data demonstrate that the drug is reasonably safe to move into human trials.
- Drug information: Sponsors provide the drug’s name, description, therapeutic category, and intended indication. Details of formulation, dosage form, and route of administration are also required.
- Manufacturing: Details on how the drug is made, its composition, and quality control. Chemistry, Manufacturing, and Controls (CMC) information must be submitted, including GMP compliance.
- Quality data: Stability studies and batch records ensure consistent quality and safety of the investigational product.
- Clinical trial protocols: The IND contains detailed trial designs, objectives, inclusion/exclusion criteria, and dosing regimens. Investigator credentials, trial site details, and monitoring plans are also reviewed.
- Ethics and regulatory compliance: Ethics Committee approvals, informed consent forms, and compensation policies must be included. Trials must be registered with the Clinical Trial Registry of India (CTRI) to ensure transparency.
- Safety oversight: The application outlines procedures for reporting Serious Adverse Events (SAEs). Risk mitigation strategies and pharmacovigilance plans are required to protect participants during the study.
Investigation new drug application categories
In India, IND applications are categorized based on their purpose: commercial use, research purposes, and emergency/compassionate use. These categories help regulators distinguish between drugs intended for eventual marketing, those meant purely for scientific investigation, and those required for urgent patient needs. The IND application categories are as follows:
- Commercial INDs
- Research (Non‑Commercial) INDs
- Compassionate Use / Emergency INDs
- Investigator INDs
- Treatment INDs
CDSCO license for investigational new drug application in India
To conduct a clinical trial or bioavailability/bioequivalence (BA/BE) study for an investigational new drug (IND) in India, you must obtain Form CT-06 license from the CDSCO. Approval for INDs is managed under the New Drugs and Clinical Trials (ND&CT) Rules, 2019. Apply using Form CT-04 for clinical trial of INDs. Once approved, the Central Licensing Authority (CLA) grants permission on Form CT-06.
IND application approval process
- Submission via SUGAM portal: Sponsors file the IND application online through CDSCO’s SUGAM portal. The dossier must include preclinical data, manufacturing details, and clinical trial protocols.
- Parallel review: The CDSCO/DCGI and registered Ethics Committees (ECs) review the application simultaneously. This ensures regulatory and ethical compliance are assessed in parallel, reducing delays.
- Mandatory trial registration: All clinical trials must be registered with the Clinical Trial Registry of India (CTRI). This step ensures transparency and public accountability of ongoing studies.
- Risk‑based evaluation: Regulators assess safety, efficacy, and ethical standards using a risk‑based approach. Special focus is placed on informed consent, compensation for injury, and SAE reporting.
- Timelines for approval: Standard IND approvals are typically granted within 90 days. Under the 2026 amendments, low‑risk studies and BA/BE trials may be approved in 45 days.
- Outcome and oversight: Approval allows initiation of human clinical trials under strict monitoring. Ongoing pharmacovigilance, periodic reporting, and compliance with ICH‑GCP are mandatory.
Special Indian context provisions
- Accelerated timeline for local innovation: If an IND is discovered, researched, and manufactured entirely within India, the NDCTR 2019 mandates an accelerated review. The CDSCO must decide on the application within 30 days. If no response or objection is provided by the CLA within this timeframe, the application is legally treated as a deemed approval.
- Global Clinical Trials (GCT): If the IND is part of a global clinical trial where India is one of multiple international testing sites, the mandatory regulatory review window is extended to 90 days.
- Phased clinical trial waiver: For experimental drugs intended to treat life-threatening or rare diseases, or diseases of localized public health relevance to India, the CDSCO can grant a waiver for specific trial phases (such as bypassing large-scale local Phase III trials if robust global data is present).
Hence, the Indian investigational new drug regulatory framework acts as a safeguard balancing innovation with patient safety. For any CDSCO regulatory support for securing drug licenses, email at [email protected] or call/Whatsapp on 9996859227.
