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Pre- Clinical Study Approval (Approval from RCGM) in India


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    CliniExpert-usp test license

    Do you wish to conduct preclinical and/or safety studies for your biologicals, with the approval from RCGM? If yes, CliniExperts is your one-stop shop for successfully and efficiently navigating the critical licensing process of Form C3a . Our decade-old team of experienced regulatory specialists understands the subtleties of roadblocks and provides solutions for quick preclinical study approval from RCGM.

    Pre- Clinical Study Approval (Approval from RCGM) – Overview

    Manufacturers can submit Form C3a to the Indian Biosafety Knowledge Portal, Department of Biotechnology via the onsite site https://ibkp.dbtindia.gov.in/). Once all the documents are uploaded, the regulatory authority, the Review Committee on Genetic Manipulation (RCGM) will review all the documents and issue the license.

    Who Can Apply?

    Any manufacturer who intends to conduct preclinical and/or safety studies of similar biologic developed using genetically modified organisms (GMOs) or living modified organisms (LMOs) for healthcare and industrial use can apply for Form C3a.

    How To Apply?

    The Applicant must follow the following process:

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      Log in to https://ibkp.dbtindia.gov.in/
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      Create a ‘New application’.
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      Choose the option, Form C3a
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      Add the relevant documents
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      Submit application form.
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    Validity

    No Validity
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    Fee Involved

    No Fees

    Important Documents

    Important Documents
    The following documents need to be furnished:
    1. Key objectives and scientific background of the projects
    2. Basic clinical information and preclinical study procedures
    3. Chronology of approval(s) accorded so far by the IBSC and RCGM for the Similar Biologic under investigation
    4. Details about the reference biological
    5. Details of molecular characterization

    Timeline to get from

    60 to 90

    Days

    Essential Tips

    Key factors to keep in mind while making this application include:-
    • The application should be accompanied by approval of Institutional Biosafety Committee (IBSC) of the developer (copy of the minutes should be submitted)
    • Approval of the Institutional Animal Ethics Committee (IAEC) should be added, if available.
    • Details of the proposed site for conduct of toxicity testing and personnel to be involved e.g. study director, principal investigator, pathologist, other investigators and quality assurance officer at the site should be provided
    Expert Advise

    According to our experts, ensure the following to avoid any delays or cancellation of your license

    • Inclusion of the approval of Institutional Bio Safety Committee (IBSC Guidelines)
    • In detail reference of the similar and reference biologicals used

    Frequently Asked Questions

    What is a similar biologic?

    A "similar biologic" is a biological product that is comparable in quality, safety, and efficacy to a reference product licensed or approved in India or an innovator product approved in International Council of Harmonization (ICH) member nations.

    What is RCGM?

    The Review Committee on Genetic Manipulation (RCGM) is the concerned authority for approval of Form C3a. RCGM is managed by the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India. In the field of similar biologics, RCGM authorizes research and development, exchanges genetically altered cell banks, and reviews data till preclinical evaluation.