Ethics Committee

<html> <head> <!DOCTYPE html> <html lang="en"> <title>Ethics Committee</title> <meta charset="UTF-8"> <meta name="description" content="{{description}}"> <meta name="keywords" content="CDSCO, National Regulatory Authority"> <link rel="author" href="https://cdsco.gov.in/opencms/opencms/en/Home/" /> <meta name="description" content="he Central Drugs Standard Control Organisation(CDSCO)under Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority (NRA) of India."> <meta name="viewport" content="width=device-width, initial-scale=1.0"> <script type="text/javascript" src="/opencms/export/system/modules/CDSCO.WEB/resources/js/jquery-3.7.1.min.js"></script> <link rel="stylesheet" type="text/css" href="/opencms/export/system/modules/CDSCO.WEB/resources/css/animate.min.css" /> <link rel="stylesheet" type="text/css" href="/opencms/export/system/modules/CDSCO.WEB/resources/css/owl.theme.css" /> <link rel="stylesheet" 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parseInt($('.main_div1 td').css('font-size')) + 1; curr_a = parseInt($('.main_div1 a').css('font-size')) + 1; curr_li = parseInt($('.main_div1 li').css('font-size')) + 1; if (curr_size <= 18) { $('.main_div1').css('font-size', curr_size); } if (curr_h3 <= 28) { $('.main_div1 h3').css('font-size', curr_h3); } if (curr_h5 <= 28) { $('.main_div1 h5').css('font-size', curr_h5); } if (curr_h2 <= 32) { $('.main_div1 h2').css('font-size', curr_h2); } if (curr_h4 <= 22) { $('.main_div1 h4').css('font-size', curr_h4); } if (curr_p <= 26) { $('.main_div1 p').css('font-size', curr_p); } if (curr_td <= 26) { $('.main_div1 td').css('font-size', curr_td); } if (curr_a <= 26) { $('.main_div1 a').css('font-size', curr_a); } if (curr_li <= 26) { $('.main_div1 li').css('font-size', curr_li); } }); $('.govt_link').click(function() { alert('The link leads you to an external website'); }); $('.ext').click(function() { alert('The link leads you to an external website'); }); }); </script> <script> function 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"><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Drugs-and-Cosmetics-Act/" ><p>Drugs and Cosmetics Act, 1940</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Drugs-Rules/" ><p>Drugs Rules, 1945</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Medical-Devices-Rules/" ><p>Medical Devices Rules, 2017</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/New-Drugs/" ><p>New Drugs and Clinical Trials Rules, 2019</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Cosmetics-Rules/" ><p>Cosmetics Rules, 2020</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Advisories_NO/" ><p>Advisories/Notices/O.Ms./Orders</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Final-Notifications/" ><p>Final Notifications</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Draft-Notifications/" ><p>Draft Notifications </p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Guidance-documents/" ><p>Guidance documents</p></a> </li></ul><li class="dropdown current-menu-item center"> <a class="text-decoration-none w-100" href="/opencms/opencms/en/bioequi_bioavail/" class="dropdown-toggle" data-toggle="dropdown" ><span class="fa-stacks fa-2s "> <i id="circle" class="fa fa-circle fa-2g "></i> <i class="fa fa-hourglass fa-1x fa-stack-1x bg-orange-head "></i> </span><p>BA/BE</p></a> <ul class="dropdown-menu "><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/bioequi_bioavail/index.html" ><p>BA/BE</p></a> </li></ul><li class="dropdown current-menu-item center current-menu-item center"> <a class="text-decoration-none w-100" href="/opencms/opencms/en/Clinical-Trial/" class="dropdown-toggle" data-toggle="dropdown" ><span class="fa-stacks fa-2s "> <i class="fa fa-circle fa-2g " id="circle"></i> <i class="fa fa-flask fa-1x fa-stack-1x bg-green-head "></i> </span><p>Clinical Trial</p></a> <ul class="dropdown-menu "><li class="active current-menu-item center"> <a class="text-decoration-none w-100" href="/opencms/opencms/en/Clinical-Trial/Ethics-Committee/" ><p>Ethics Committee</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Clinical-Trial/Global-Clinical-Trial/" ><p>Global Clinical Trial</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" 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</div> </div> </div></div> </div> </div> <div class="panel panel-default bg-white"> <div class="panel-heading"> <h4 class="panel-title"> <a class="text-dark " data-bs-toggle="collapse" data-bs-parent="#bs-collapse5a3d7c5f-f441-11e7-bfac-0a0027000000" href="#collapse5a3d7c5f-f441-11e7-bfac-0a0027000000-2"> Functionalities<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse5a3d7c5f-f441-11e7-bfac-0a0027000000-2" class="panel-collapse collapse " style="height: 0px;" data-bs-parent="#bs-collapse5a3d7c5f-f441-11e7-bfac-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="none"> <div > <div ><p style="text-align: justify;">Ethics Committee division deals with the applications seeking registration, re-registration and post approval changes of Institutional Ethics Committee. No Ethics Committee shall review and accord its approval to a clinical trial protocol without prior registration with the Licensing Authority as defined in clause (b) of Rule 21.</p> <p style="text-align: justify;">An application for registration of Ethics Committee shall be made to the Licensing Authority in accordance with the requirements as specified in the Appendix VIII of Schedule Y.</p> <p style="text-align: justify;">The Licensing Authority after being satisfied that the requirements have been complied with, may grant registration to the Ethics Committee subject to such conditions as may be stated therein.</p> <p style="text-align: justify;">The registration of Ethics Committees is valid for a period of three years. The re-registration applications need to be made within 3 months before the expiry of registration. Registration remains deemed continued unless otherwise orders are passed or until the registration is Suspended or Cancelled. Accordingly applicant shall apply to CDSCO for re-registration as per checklist.</p> <p style="text-align: justify;"> </p> <p style="text-align: justify;">Checklist of Documents for Registration of Ethics Committee can be downloaded from:-</p> <p><a href="http://cdsco.nic.in/writereaddata/CHECKLIST%20FOR%20SUBMISSION%20192013.pdf" target="_blank" rel="noopener noreferrer">Click here to Download the Document</a></p> <p style="text-align: justify;"> </p> <p style="text-align: justify;">Checklist of Documents for Re-registration of Ethics Committee can be downloaded from:-</p> <p><a href="http://cdsco.nic.in/writereaddata/23_5_2016ecchecklist.pdf" target="_blank" rel="noopener noreferrer">Click here to Download the Document</a></p> <p style="text-align: justify;"> </p> <p style="text-align: justify;">Note: CDSCO is also encouraging the online applications for registration and re-registration of Ethics Committees through <strong>SUGAM - An e-Governance solution for CDSCO. Details of SUGAM registration and subsequent Ethics Committee registration procedure are available on </strong><a href="https://cdscoonline.gov.in/CDSCO/homepage"><strong>https://cdscoonline.gov.in/CDSCO/homepage</strong></a></p></div> </div> </div> </div></div> </div> </div> <div class="panel panel-default bg-white"> <div class="panel-heading"> <h4 class="panel-title"> <a class="text-dark " data-bs-toggle="collapse" data-bs-parent="#bs-collapse5a3d7c5f-f441-11e7-bfac-0a0027000000" href="#collapse5a3d7c5f-f441-11e7-bfac-0a0027000000-3"> Processes<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse5a3d7c5f-f441-11e7-bfac-0a0027000000-3" class="panel-collapse collapse " style="height: 0px;" data-bs-parent="#bs-collapse5a3d7c5f-f441-11e7-bfac-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="none"> <div > <div ><p>Content not Available.</p></div> </div> </div> </div></div> </div> </div> <div class="panel panel-default bg-white"> <div class="panel-heading"> <h4 class="panel-title"> <a class="text-dark " data-bs-toggle="collapse" data-bs-parent="#bs-collapse5a3d7c5f-f441-11e7-bfac-0a0027000000" href="#collapse5a3d7c5f-f441-11e7-bfac-0a0027000000-4"> Organogram<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse5a3d7c5f-f441-11e7-bfac-0a0027000000-4" class="panel-collapse collapse " style="height: 0px;" data-bs-parent="#bs-collapse5a3d7c5f-f441-11e7-bfac-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="margin-bottom-20"> <div class=""> <span > <img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/organo_ethics.png" class=" img-responsive " alt="New image" title="New image " /> </span> </div> </div> </div></div> </div> </div> <div class="panel panel-default bg-white"> <div class="panel-heading"> <h4 class="panel-title"> <a class="text-dark " data-bs-toggle="collapse" data-bs-parent="#bs-collapse5a3d7c5f-f441-11e7-bfac-0a0027000000" href="#collapse5a3d7c5f-f441-11e7-bfac-0a0027000000-5"> Guideline<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse5a3d7c5f-f441-11e7-bfac-0a0027000000-5" class="panel-collapse collapse " style="height: 0px;" data-bs-parent="#bs-collapse5a3d7c5f-f441-11e7-bfac-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="none"> <div > <div ><ul id="guide"> <li style="text-align: justify;"><a style="color: black; text-decoration: none;" title="Guidelines Document" href="#" target="_blank" rel="noopener noreferrer"><img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/icons/faculty30x30.png" alt="image" />    <strong>Guidelines Document</strong></a><br /> <ol> <li style="text-align: left;"><a href="http://www.cdsco.nic.in/html/GCP1.html" target="_blank" rel="noopener noreferrer">CDSCO GCP Guidelines<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> </ol> </li> <li style="text-align: justify;"><a style="color: black; text-decoration: none;" title="Sugam User Manual" href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/SUGAM_user_manual.pdf" target="_blank" rel="noopener noreferrer"><img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/icons/UserguidePNG30x30.png" alt="UserguidePNG(30x30)" />    <strong>Sugam User Manual</strong></a></li> <li style="text-align: justify;"><a style="color: black; text-decoration: none;" title="FAQ" href="http://cdsco.nic.in/forms/list.aspx?lid=1586&Id=1" target="_blank" rel="noopener noreferrer"><img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/icons/faq_icon30x30.png" alt="faq_icon(30x30)" />    <strong>FAQ</strong></a></li> <li style="text-align: justify;"><a style="color: black; text-decoration: none;" title="Chechlist Document" href="#" target="_blank" rel="noopener noreferrer"><img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/icons/iStock30x30.jpg" alt="iStock(30x30)" />    <strong>Checklist Documents</strong></a> <ol> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/Ethics-Committee/Checklist-Document/New-undertaking.pdf" target="_blank" rel="noopener noreferrer">Undertaking Format </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/Ethics-Committee/Checklist-Document/Check-List_Regsitration.pdf">Check-List_Regsitration</a></li> <li><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/Ethics-Committee/Checklist-Document/Check-List-_Re-Reg-.pdf">Check-List_Re-Regsitration</a></li> </ol> </li> </ul></div> </div> </div> </div></div> </div> </div> </div> </div> </div></div> </div> </div>  <div class="row section3 "> <div class="col-md-12 section3_medical">    <div class="row"> <div class="col-md-9 col-sm-12 col-xs-12 pad-top double" id="med_nav"> <!DOCTYPE html> <html lang="en"> <head> <style> ul { list-style-type: none; } li{ list-style-type: none; padding-top:3px; } </style> <script> $(document).ready(function() { $(".btn-pref .btn").click(function () { $(".btn-pref .btn").removeClass("btn-primary").addClass("btn-default"); // $(".tab").addClass("active"); // instead of this do the below $(this).removeClass("btn-default").addClass("btn-primary"); }); }); </script> <div class="col-lg-12 col-sm-12"> <ul class="btn-pref nav nav-tabs" id="myTab" role="tablist"> <li class="nav-item" role="presentation"> <button type="button" id="alerts" class="w-100 active btn btn-primary" data-bs-target="#tab1" data-bs-toggle="tab" aria-selected="true" aria-controls="#tab1"><i class="fa fa-exclamation-triangle"></i> <div class="hidden-xs">Alerts</div> </button> </li> <li class="nav-item" role="presentation"> <button type="button" id="news" class="w-100 btn btn-default" data-bs-target="#tab2" data-bs-toggle="tab" aria-selected="false" aria-controls="#tab2"><i 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<thead > <tr > <th>S.no</th> <th>Title</th> <th>Release Date</th> <th>Download Pdf</th> <th>Pdf Size</th> </tr> </thead> <tbody> </tbody> </table> </div> </div> </div> <div class="tab-pane fade " id="tab2"> <div class="wrap-appr"> <div class="col-md-12 col-sm-12 table-responsive"> <table class="w-100 table table-bordered bg-head table-striped example1" data-limit-navigation="5" data-page-size="10" data-filter="#filter" data-filter-text-only="false" id="example1"> <thead > <tr > <th>S.no</th> <th>Title</th> <th>Release Date</th> <th>Download Pdf</th> <th>Pdf Size</th> </tr> </thead> <tbody> <tr> <td>1</td> <td>List of Registered / Re Registration Ethics Committee as on 15.12.2022</td> <td>2023-Jan-04</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTgwOQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>503 KB</td> </tr> <tr> <td>2</td> <td>Ethics Committee Registration Data</td> <td>2019-Aug-30</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDg5NQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>836 KB</td> </tr> </tbody> </table> </div> </div> </div> <div class="tab-pane fade" id="tab3"> <div class="wrap-appr"> <div class="col-md-12 col-sm-12 table-responsive"> <table class="w-100 table table-bordered bg-head table-striped example2" data-limit-navigation="5" data-page-size="10" data-filter="#filter" data-filter-text-only="false" id="example2"> <thead > <tr > <th>S.no</th> <th>Title</th> <th>Release Date</th> <th>Download Pdf</th> <th>Pdf Size</th> </tr> </thead> <tbody> <tr> <td>1</td> <td>Notice regarding Ethics committee registration through SUGAM portal</td> <td>2018-Aug-01</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTg3MA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>2,170KB</td> </tr> <tr> <td>2</td> <td>Notice Ethic Committee Clinical trial</td> <td>2013-Jul-30</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzYy'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>317KB</td> </tr> </tbody> </table> </div> </div> </div> <div class="tab-pane fade " id="tab4"> <div class="wrap-appr"> <div class="col-md-12 col-sm-12 table-responsive"> <table class="w-100 table table-bordered bg-head table-striped example3" data-limit-navigation="5" data-page-size="10" data-filter="#filter" data-filter-text-only="false" id="example3"> <thead > <tr > <th>S.no</th> <th>Title</th> <th>Release Date</th> <th>Download Pdf</th> <th>Pdf Size</th> </tr> </thead> <tbody> <tr> <td>1</td> <td>G.S.R 778 (E) dated 14 Oct 2022 regarding the New Drugs and Clinical Trials (Third Amendment) Rules 2022</td> <td>2022-Oct-14</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTEzOQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1209 KB</td> </tr> <tr> <td>2</td> <td>Extract of the New Drugs and Clinical Trials Rules 2019 relevant to Ethics Committee for Clinical Trial, Bioavailability and Bioequivalence study</td> <td>2022-Aug-08</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODk1MQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>354 KB</td> </tr> <tr> <td>3</td> <td>The New Drugs Clinical Trials Rules, 2019</td> <td>2019-Mar-19</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODk1MA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>2458 KB</td> </tr> </tbody> </table> </div> </div> </div> </div> </div> </div>  <div class="col-md-3 col-sm-12 col-xs-12 pad-top double"> <div class="col-md-12 col-sm-12 col-xs-12"> <div id="approval_clearance" ><div class="ap-linksequence ethics_reg"> <div class="ap-plain"><h3 >Ethics Commitee Registration & Re-registration</h3> </div> <ul > <li > <a href="/opencms/opencms/en/Clinical-Trial/Ethics-Committee/Ethics-Committee-Re-Registration/" ><span class="ap-icon-label"><i class="fa fa-link" title=""></i></span>List Of Re-Registered Ethics Committees</a> </li> <li > <a href="/opencms/opencms/en/Clinical-Trial/Ethics-Committee/Ethics-Committee-Registration/" ><span class="ap-icon-label"><i class="fa fa-link" title=""></i></span>List Of Registered Ethics Committees</a> </li> <li > <a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/ecddec22.pdf" ><span class="ap-icon-label"><i class="fa fa-link" title=""></i></span>List of Registered / Re Registration Ethics Committee as on 15.12.2022</a> </li> </ul> </div></div></div> </div> </div> </div>  </div> </section>  </div>  <div class="push"></div> </div> <div class="wrap-f"> <footer> <div id="footer1" ><div> <div class="container"> <div class="row"> <div class="col-md-4"> <div class="wrap-footer navigfooter"> <h5>QUICK LINKS</h5> <ul> <li><span 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Ethics Committee