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    This document outlines the rules and permissions required for conducting clinical trials and importing or manufacturing new drugs in India. It discusses the application process and required data, including clinical and pharmaceutical information, animal studies, human clinical pharmacology data, and prescribing information. It describes the responsibilities of sponsors, investigators, and ethics committees. It also summarizes the different phases of clinical trials - including human pharmacology, therapeutic exploratory trials, therapeutic confirmatory trials, and post-marketing surveillance. Special studies like those in geriatrics, pediatrics, or pregnant women are also mentioned. Appendices provide more details on specific requirements and guidelines.

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    Siva Prasad
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    This document outlines the rules and permissions required for conducting clinical trials and importing or manufacturing new drugs in India. It discusses the application process and required data, including clinical and pharmaceutical information, animal studies, human clinical pharmacology data, and prescribing information. It describes the responsibilities of sponsors, investigators, and ethics committees. It also summarizes the different phases of clinical trials - including human pharmacology, therapeutic exploratory trials, therapeutic confirmatory trials, and post-marketing surveillance. Special studies like those in geriatrics, pediatrics, or pregnant women are also mentioned. Appendices provide more details on specific requirements and guidelines.

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    This document outlines the rules and permissions required for conducting clinical trials and importing or manufacturing new drugs in India. It discusses the application process and required data, including clinical and pharmaceutical information, animal studies, human clinical pharmacology data, and prescribing information. It describes the responsibilities of sponsors, investigators, and ethics committees. It also summarizes the different phases of clinical trials - including human pharmacology, therapeutic exploratory trials, therapeutic confirmatory trials, and post-marketing surveillance. Special studies like those in geriatrics, pediatrics, or pregnant women are also mentioned. Appendices provide more details on specific requirements and guidelines.

    Copyright:

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

    Schedule y

    Uploaded by

    Siva Prasad
    This document outlines the rules and permissions required for conducting clinical trials and importing or manufacturing new drugs in India. It discusses the application process and required data, including clinical and pharmaceutical information, animal studies, human clinical pharmacology data, and prescribing information. It describes the responsibilities of sponsors, investigators, and ethics committees. It also summarizes the different phases of clinical trials - including human pharmacology, therapeutic exploratory trials, therapeutic confirmatory trials, and post-marketing surveillance. Special studies like those in geriatrics, pediatrics, or pregnant women are also mentioned. Appendices provide more details on specific requirements and guidelines.

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    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


    Application for permission

    Clinical Trial

    Studies in Specific Population

    Post Marketing Surveillance

    Special Studies : BA/BE studies


    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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