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    This document outlines the rules and procedures for conducting clinical trials and importing or manufacturing new drugs in India. It discusses the necessary forms and data required for approval, including clinical trial protocols, non-clinical toxicity studies, informed consent documents, and procedures for reporting serious adverse events. The responsibilities of sponsors, investigators, and ethics committees are provided. An overview of the various phases of clinical trials is given along with requirements for special populations, post-marketing surveillance, and bioavailability/bioequivalence studies. Eleven appendices are referenced that provide more detailed guidelines.

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    Schedule Y

    Uploaded by

    Ramling Patrakar
    466 views11 pages
    This document outlines the rules and procedures for conducting clinical trials and importing or manufacturing new drugs in India. It discusses the necessary forms and data required for approval, including clinical trial protocols, non-clinical toxicity studies, informed consent documents, and procedures for reporting serious adverse events. The responsibilities of sponsors, investigators, and ethics committees are provided. An overview of the various phases of clinical trials is given along with requirements for special populations, post-marketing surveillance, and bioavailability/bioequivalence studies. Eleven appendices are referenced that provide more detailed guidelines.

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    This document outlines the rules and procedures for conducting clinical trials and importing or manufacturing new drugs in India. It discusses the necessary forms and data required for approval, including clinical trial protocols, non-clinical toxicity studies, informed consent documents, and procedures for reporting serious adverse events. The responsibilities of sponsors, investigators, and ethics committees are provided. An overview of the various phases of clinical trials is given along with requirements for special populations, post-marketing surveillance, and bioavailability/bioequivalence studies. Eleven appendices are referenced that provide more detailed guidelines.

    Copyright:

    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    466 views11 pages

    Schedule Y

    Uploaded by

    Ramling Patrakar
    This document outlines the rules and procedures for conducting clinical trials and importing or manufacturing new drugs in India. It discusses the necessary forms and data required for approval, including clinical trial protocols, non-clinical toxicity studies, informed consent documents, and procedures for reporting serious adverse events. The responsibilities of sponsors, investigators, and ethics committees are provided. An overview of the various phases of clinical trials is given along with requirements for special populations, post-marketing surveillance, and bioavailability/bioequivalence studies. Eleven appendices are referenced that provide more detailed guidelines.

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    © All Rights Reserved
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    of 11

    By D.

    Saidulu

    Rule

    Permission for

    122 A

    To import New drugs

    122 B

    To manufacture New drugs

    122 D

    To Import or Manufacture
    fixed dose combinations

    122DA

    To conduct clinical trials for


    New Drug/Investigational New
    drug

    122 DAA

    Definition of Clinical Trial

    It shall made in Form 44 accompanied with the


    following data in accordance with appendices,
    namely
    Clinical and pharmaceutical information
    Animal pharmacology data
    Animal Toxicology data
    Human Clinical pharmacology data
    Regulatory status in other countries
    Prescribing information

    FORM 12- To import Study drug for examination ,

    test or analysis

    1. Approval for Clinical trials


    CT on a New drug shall be initiated only after permission by

    licensing authority and approval from EC

    2. Responsibilities of Sponsor
    Implementing and maintaining QA
    Submit status report to the licensing authority periodically
    SAE should be reported to the licensing authority with in 14

    calendar days.

    3. Responsibilities of Investigator
    Ensure adequate medical care is provided to the subject
    SAE and unexpected AE should be reported to the sponsor within

    24 hrs and to the EC within 7 working days

    4.Informed consent
    Freely given informed written consent
    Provide information about the study verbally
    Non-Technically and understandable language

    5.Responsibilities of ethics committee

    Approval trial protocol to safe guard RSW of all trial subject and to

    protect RSW of all vulnerable subjects


    Conduct ongoing review of trials
    6. Human Pharmacology (Phase I)

    Safety and tolerability


    7. Therapeutic exploratory trials (phase II)

    To evaluate the effectiveness of a drug for a particular indication


    To determine the short term side effects and risk associated with

    the drug
    To determine the dosage regimen for phase III trials.
    8. Therapeutic confirmatory trials (phase III)

    Demonstration of therapeutic benefit


    Drug is safe and effective for use and provide and adequate basis

    for marketing approval

    9. Post marketing surveillance

    Performed after drug approval and related to the approved

    indication
    Includes drug-drug interaction, dosage response and safety
    studies , mortality/ morbidity studies

    3. studies in special population


    1. Geriatrics
    2. Pediatrics
    3. pregnant or Nursing Women

    4. Post marketing Surveillance


    closely monitored new drugs clinical safety
    PSUR- to report all relevant new information
    PSUR shall be submitted every 6months for the first 2
    years
    5. Special Studies- BA/BE studies
    conducted according to the guidance for BA and BE
    studies
    Evaluation of the effect of food on absorption following
    oral administration

    APPENDIX I- Data to be submitted along with the application to conduct clinical trial/import/ manufacture of new drugs for
    marketing in the country.

    APPENDIX I- Data required to be submitted by an applicant for grant of permission to import and/ or manufacture a new drug
    already approved in the country.

    APPENDIX II- Structure , contents and format for clinical Study Reports.

    APPENDIX III- Animal toxicology (Non- Clinical Toxicity studies)

    APPENDIX IV- Animal Pharmacology

    APPENDIX V- Informed Consent

    APPENDIX VI- Fixed Dose combinations (FDC)

    APPENDIX VII- Undertaking by Investigator

    APPENDIX VIII- Ethics Committee

    APPENDIX IX- Stability testing of New Drugs

    APPENDIX X- Contents of the proposed protocol for conducting clinical trials

    APPENDIX XI- Data elements for reporting serious adverse events occurring in a Clinical trial

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