Investigational New Drug (IND)

Investigational new drug is defined as a new substance, chemical or biological entity that has not been approved by any regulatory authorities for marketing as a drug in any country. Investigational drug is often known as “study drug” or “experimental drug”.


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Investigational New Drug (IND)

According to, ICH GCP, Investigational Product is:

“A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.”

In India, the approval of manufacture/import of new drugs for marketing in the country is given by Central Licensing Authority (CLA). A permission to conduct clinical trials of new drugs including Investigational New Drugs is also given by CLA.

During early development phase of the drug, the safety and efficacy of the new product for use in human being should be established - this step is an essential aspect for getting approval for import or manufacturing and marketing of a drug in the country.

Rules and Regulation

In India, New Drugs & Clinical Trials Rules-2019 is applicable for submission of the information/ data required for approval of clinical trial and/or to import or manufacture of new drug/investigational.

The information is submitted online through CDSCO’s SUGAM online portal. The information submitted by the applicant is reviewed by the authorities at CDSCO and response is usually given within 90 working days.


Content of IND Application

Information required to be submitted for IND can be divided into three br/oad categories:

  • Animal Pharmacology and Toxicology Studies – The information in this section is generated through pre-clinical studies on animal and contains information to ensure that the drug is safe for human testing. Information related to history of use of the drug on humans is also required to be submitted.

  • Manufacturing Information – This contains information related to manufacturing unit to ensure that the manufacturer is capable for producing adequate batches of the drug of same property and quality.

  • Clinical Protocols and Investigator Information – Includes information related to investigational product form different resources to anticipate risk associated with initial testing in humans and the clinical protocol in accordance of which the clinical trials are conducted.

Phases of clinical trial for IND Application


A. For Phase I Clinical Trials the following are required:

1. Systemic Toxicity studies

  • Single dose toxicity studies

  • Dose Ranging Studies

  • Repeat-dose systemic toxicity studies of appropriate duration. This is required to support the duration of proposed human exposure.

2. Male fertility study

  • In-vitro genotoxicity tests

  • Local toxicity studies with proposed route of clinical application (in this case duration is dependent on the proposed exposure)

  • Hypersensitivity or test for allergy (for IND proposed to be used parenterally or local application)

  • Test for Photo-allergy or dermal photo-toxicity (if the IND or its metabolite is have an potential to cause photo-sensitivity)


B. For Phase II Clinical Trials the following are required:

  • Summary of non-clinical safety data (as listed above) submitted for Phase I trial permission and references for the same.

  • An application for directly starting a Phase II trial – complete safety data for Phase I trial must be submitted.

  • Repeat-dose systemic toxicity studies of appropriate duration. Required to provide evidence to support the duration of proposed human exposure.

  • In-vivo geno-toxicity tests.

  • Segment II reproductive or developmental toxicity study

C. For Phase III Clinical Trials the following are required:

  • Summary of non-clinical safety data submitted for Phase I and II trials, with references.

  • For an application for directly initiating a Phase III trial – complete non-clinical safety data needed for obtaining the permissions for Phase I and II trials

  • Repeat-dose systemic toxicity studies of appropriate duration to support the duration of proposed human exposure.

  • Reproductive or developmental toxicity studies

  • Segment I (if the study involves female of child bearing age), and Segment III (for drugs to be given to pregnant or nursing mothers or where the adverse effect on foetal development is aniticipated).

  • Carcinogenicity studies (if the drug is supposed to be carcinogenic or when the proposed treatment duration of the drug is more than 6 months).


D. For Phase IV Clinical Trials the following are required:


  • Summary of non-clinical safety data submitted for obtaining the permissions for Phase I, II and III trials, and references.

  • For an application for initiating the Phase IV trial, complete non-clinical safety data needed for obtaining the permissions for Phase I, II and III trials

  • Application of Good Laboratory Practices (GLP) –An accredited laboratory should be used for conducting all the animal studies , pharmacology studies, toxicology studies

Cliniexperts provide full-service regulatory support and assistance in navigating the various regulation steps for Investigational New Drug (IND). CliniExperts provide full spectrum services for the following types of Drug Clinical Trials:

  • Local Clinical Trial -

    Phase I Trial
    Phase II Trial
    Phase III Trial
    and Phase IV Trial or Post Marketing Studies (PMS) (exclusively in India)

  • Global Clinical Trial -

    Phase I Trial
    Phase II Trial
    and Phase III Trial

Reference

New Drugs and Clinical Trials Rules, 2019, Ministry of Health & Fam. Welfare, Notification, G.S.R. 227(E), (March 19, 2019).


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Frequently Asked Questions

What is an “orphan drug” as per the New Drugs and Clinical Trial Rules, 2019?

“Orphan drug” means a drug intended to treat a condition which affects not more than five lakh persons in India.

“New drug” means, (i) a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labelling thereof and has not been approved as safe and efficacious by the Central Licencing Authority with respect to its claims; or (ii) a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or (iii) a fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or (iv) a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licencing Authority; or (v) a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug; Explanation: The drugs, other than drugs referred to in sub-clauses (iv) and (v), shall continue to be new drugs for a period of four years from the date of their permission granted by the Central Licencing Authority and the drugs referred to in sub-clauses (iv) and (v) shall always be deemed to be new drugs;

Yes. As per clause (w) of rule 2 of the New Drugs and Clinical Trials Rules, 2019 modified/sustained/prolonged/controlled release and NDDS of an approved drug are always considered as new drug and hence, require prior permission from CLA before obtaining the manufacturing license from the SLA for such products.

Any new drugs or investigational new drugs imported for the purpose of clinical trial shall be kept in containers bearing labels, indicating the name of the drug or code number, batch or lot number, wherever applicable, date of manufacture, use before date, storage conditions, name of the institution or organisation or the centre where the clinical trial is proposed to be conducted, name and address of the manufacturer, and the purpose for which it has been imported. Where a new drug or an investigational new drug is imported by the licencee on behalf of another person, the licencee shall indicate on the label of the container of the such drug, the name and address of the importer and the person to whom it is being supplied along with the scientific name of such drug, if known, or the reference which shall enable such drug to be identified and the purpose for which it is manufactured. No person or importer shall alter, obliterate or deface any inscription or mark made on the container, label or wrapper of any new drug imported without permission of the Central Licencing Authority.

A subsequent new drug means a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form. A subsequent new drug also includes a new drug already approved in the country.

Any person or institution or organisation having permanent establishment in India who intends to conduct clinical trial study of a new drug or an investigational new drug can submit application for clinical trial study

Yes. Any sponsor or investigator intended to initiate a clinical trial for new drug or investigational new drug shall obtain permission from CLA in Form CT-06. The applicant shall submit application in Form CT-04 along with all other necessary documents specified under Second Schedule and fees as specified under Sixth Schedule of CT Rules 2019.

In general, the timeline for disposal of an application for conduct of clinical trial study is 90 working days from the date of receipt of application. However, if the drug is discovered in India or research and development of the drug are being done in India and also the drug is proposed to be manufactured and marketed in India then the timeline for disposal of an application for conduct of such clinical study is 30 working days from the date of receipt of application. In such case, if no response is issued by the CDSCO within 30 working days, the clinical trial will be considered to be deemed approved.

Minimum of seven members from medical, non-medical, scientific and non-scientific areas with at least, one lay person; one woman member; one legal expert; one independent member from any other related field such as social scientist or representative of non-governmental voluntary agency or philosopher or ethicist or theologian At least 50% of members not affiliated with the institute or organization in which EC is constituted Every member of the EC shall be required to undergo such training and development programs

An application for grant of permission to conduct clinical trial of new drug or investigational new drug shall be made in Form CT-04. The application should be accompanied by the necessary documents as specified under Second Schedule along with the fees as specified under Sixth Schedule of the NDs & CTs Rules, 2019. Order issued by CDSCO on 10th Apr 2019, Form CT-04 (and other Forms) can be manually completed and uploaded in SUGAM, till all the new Forms are integrated into the online submission portal.


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