IND and NDA Applications in India
IND and NDA Applications in India form part of the regulatory pathway for clinical development and new drug approval under the Central Drugs Standard Control Organisation (CDSCO). The regulatory framework for clinical trials, investigational new drugs and new drug approvals is primarily governed by the New Drugs and Clinical Trials Rules, 2019 (NDCTR 2019), as amended.
Although IND and NDA terminology is commonly used when discussing global drug development, IND and NDA Applications in India should be understood within the specific terminology, application forms and permission pathways established by Indian regulations rather than as direct equivalents of the U.S. IND and NDA system.
Investigational New Drugs in India
Under NDCTR 2019, an investigational new drug is generally a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country.
Before an investigational new drug is studied in human participants in India, the applicable permissions must be obtained from the Central Licencing Authority (CLA) in accordance with NDCTR 2019.
Application for Clinical Trial Permission
An applicant intending to conduct a clinical trial of a new drug or investigational new drug submits an application to the Central Licencing Authority in Form CT-04, together with the required information, documents and applicable fees.
The application includes information necessary to evaluate the proposed clinical development programme, including relevant quality, nonclinical and clinical information.
When the regulatory requirements are satisfied, permission to conduct the clinical trial may be granted in Form CT-06.
Clinical trials must also comply with applicable requirements concerning Ethics Committee oversight, informed consent, participant protection, safety reporting and Good Clinical Practice.
Clinical Development Phases
Clinical development may progress through Phase I, Phase II and Phase III studies before marketing approval, depending on the nature of the drug and its development programme.
These phases describe stages of clinical development. They should not be interpreted as phases through which an IND application itself progresses.
Phase I studies generally focus on initial safety, tolerability and pharmacological characteristics.
Phase II studies further evaluate therapeutic activity, dose-response and safety in patients with the relevant condition.
Phase III studies provide confirmatory evidence of safety and efficacy in a larger patient population and may support an application for marketing approval.
New Drug Approval in India
Following the generation of appropriate quality, nonclinical and clinical evidence, an applicant may seek permission from the Central Licencing Authority to import or manufacture a new drug for sale or distribution in India.
The regulatory submission provides the evidence necessary for CDSCO to evaluate the quality, safety and efficacy of the proposed product.
Depending on the application and regulatory pathway, the submission may include:
- Pharmaceutical and manufacturing information
- Nonclinical study data
- Clinical safety and efficacy data
- Proposed indications and conditions of use
- Product information and labelling
- Risk-benefit information
- Other documents required under the applicable regulatory framework
Regulatory Review and Permission
CDSCO evaluates the submitted information to determine whether the applicable regulatory requirements have been satisfied.
The review may include assessment of quality, nonclinical and clinical evidence and may involve evaluation by relevant Subject Expert Committees where applicable.
Regulatory requirements can vary according to factors such as the type of new drug, its approval status in other countries, available clinical evidence and the specific permission being requested.
For additional background on the evolution of India’s clinical-trial regulatory framework, see Indian Clinical Trial and Safety Regulations: From Schedule Y to NDCTR 2019.
SUGAM and Regulatory Applications
CDSCO uses the SUGAM online portal for various regulatory applications relating to clinical trials, investigational new drugs and new drugs.
Current regulatory information, notices and application requirements are available through the Central Drugs Standard Control Organisation (CDSCO).
Applicants should use the forms, supporting documents and procedures applicable to the particular regulatory activity being undertaken and verify the current CDSCO requirements before submission.
Post-Approval Safety Monitoring
Regulatory responsibilities continue after a new drug receives permission for marketing in India.
Post-marketing pharmacovigilance helps identify and evaluate safety information arising from wider use of the product. Applicable requirements may include adverse event reporting, periodic safety reporting and other regulatory measures intended to support continued assessment of the product’s benefit-risk profile.
IND and NDA Applications in India: Regulatory Terminology
The expressions IND and NDA are useful for understanding international drug-development concepts, particularly when comparing Indian requirements with the U.S. regulatory system.
However, regulatory submissions in India should be understood according to the terminology, application forms and permission pathways established under NDCTR 2019 and current CDSCO requirements.
Applicants should therefore refer to the latest CDSCO rules, guidance, forms and submission procedures when planning clinical development or seeking new drug approval in India.
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