BA/BE

<html> <head> <!DOCTYPE html> <html lang="en"> <title>BA/BE</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" type="text/css" 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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 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> 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Drugs Control <ul > <li> <a href="/opencms/opencms/en/State-Drugs-Control/" rel="tooltip" title="" data-original-title="state drug control">State Drugs Control</a></li> </ul> </li> </ul> </li></ul></div> </div> </div> <script> $( function() { $( "#comm_function" ).tabs(); } ); </script></div> </div><div class="row navbar-blue"> <div class="col-sm-12 col-lg-12 col-md-12"> <div id="cdsco_nav_content1" ></div></div> <div class="col-sm-0"> <div id="cdsco_nav_content2" ></div></div> </div> </header> <a class="scrollToTop" href="#" style="display: none;"> <i class="fa fa-chevron-circle-up fa-3x"></i> </a>  <div class="clearfix"></div> <style> .yellow1{ color:#fff700 !important; } </style> <div class="row" id="whats_new"> <span class="col-md-1 col-xs-3 padded1"> <label class="label css_blink" style="color: white">What's New</label> </span> <span class="col-md-11 col-xs-9 pad-t"> <marquee behavior="scroll" direction="left" id="nw_up" scrollamount="5"> <span><img class="image-responsive" 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onclick="printDiv('printableArea')" value="print a div!" /><i class="fa fa-print" aria-hidden="true"></i></div> </div> </div> </div> <script> function printDiv(printableArea) { var printContents = document.getElementById(printableArea).innerHTML; var originalContents = document.body.innerHTML; document.body.innerHTML = printContents; window.print(); document.body.innerHTML = originalContents; } </script></div> <section id="printableArea"> <div class="row pad-top text-center"> <div id="maintitle" ><div class="none"> <div > <div ><h2 class="blue bold" style="text-align: center; font-size: 25px;"><span class="maintitle">BA/BE</span></h2></div> </div> </div> </div></div>  <div class="row main_sec"> <div class="col-md-8 col-sm-12 zero"> <div id="cdsco_slider_imgs" ><div id="main-slider" class="form-group"> <div id="transition-timer-carousel" class="carousel slide transition-timer-carousel" data-bs-ride="carousel">  <div class="carousel-inner shadow"> <div class="carousel-item active"><a href="/opencms/opencms/system/modules/com.alkacon.bootstrap.formatters/formatters/slider_med_cdsco.jsp"> <img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/slider/bioequibalac22.png" alt="Hero Banner Images" /></a> </div>  <div class="carousel-item "><a href="/opencms/opencms/system/modules/com.alkacon.bootstrap.formatters/formatters/slider_med_cdsco.jsp"> <img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/slider/bioequibalac22.png" alt="Hero Banner Images" /></a> </div>  </div>  <a class="opacity-100 carousel-control-prev" data-bs-slide="prev" data-bs-target="#transition-timer-carousel"> <span class="carousel-control-prev-icon"></span> </a> <a class="opacity-100 right carousel-control-next" data-bs-slide="next" data-bs-target="#transition-timer-carousel"> <span class="carousel-control-next-icon"></span> </a> <hr class="transition-timer-carousel-progress-bar animate" /> </div>  </div>  </div></div> <div class="col-md-4 col-sm-12 col-xs-12"> <div class="inner-right-all"> <div id="cdsco_content_guidelines" ><div class="margin-bottom-30"> <div class="panel-group wrap" id="bs-collapse0832fe33-caf4-11e7-9106-0a0027000000"> <div class="panel panel-default bg-white"> <div class="panel-heading"> <h4 class="panel-title"> <a class="text-dark active" data-bs-toggle="collapse" data-bs-parent="#bs-collapse0832fe33-caf4-11e7-9106-0a0027000000" href="#collapse0832fe33-caf4-11e7-9106-0a0027000000-1"> About BA/BE<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse0832fe33-caf4-11e7-9106-0a0027000000-1" class="panel-collapse collapse " style="height: auto;" data-bs-parent="#bs-collapse0832fe33-caf4-11e7-9106-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="none"> <div > <div ><p style="text-align: justify;"><strong>Bioavailability (BA) :</strong> Bioavailability refers to the relative amount of drug from an administered dosage from which enters the systemic circulation and the rate at which the drug appears in the systemic circulation.</p> <p style="text-align: justify;"><strong>Bioequivalence (BE):</strong> Bioequivalence of a drug product is achieved if its extent and rate of absorption are not statistically significantly different from those of the reference product when administered at the same molar dose.</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-collapse0832fe33-caf4-11e7-9106-0a0027000000" href="#collapse0832fe33-caf4-11e7-9106-0a0027000000-2"> Functionalities<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse0832fe33-caf4-11e7-9106-0a0027000000-2" class="panel-collapse collapse " style="height: 0px;" data-bs-parent="#bs-collapse0832fe33-caf4-11e7-9106-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="none"> <div > <div ><p style="text-align: justify;">The office of Drugs Controller General (India) at CDSCO (HQ) FDA Bhawan, New Delhi has been receiving applications from applicants requesting for the approval to carry out BA/BE studies with various pharmaceutical dosage formulations on Indian subjects. The office of DCG(I) would like to ensure the demonstration of the safety and tolerability of generics against corresponding innovator drugs; to ensure they are comparable and safe for consumption by human subjects. An Assessment of "interchangeability" between the investigational and the innovator product is carried out by a study of "in vivo equivalence" or "bioequivalence" (BE). In view of the above, the office of DCGI would like to ensure the uniformity of documents to be submitted to this Directorate for review and approval of BE-NOC for export to meet tenets of Schedule Y of Drugs and Cosmetics Act 1940 & Rules 1945 and also Indian Good Clinical Practices (GCP) guidelines.</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-collapse0832fe33-caf4-11e7-9106-0a0027000000" href="#collapse0832fe33-caf4-11e7-9106-0a0027000000-3"> Processes<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse0832fe33-caf4-11e7-9106-0a0027000000-3" class="panel-collapse collapse " style="height: 0px;" data-bs-parent="#bs-collapse0832fe33-caf4-11e7-9106-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="none"> <div > <div ><p style="text-align: justify;">The applicants submit the application for BE NOC & Test Licence through online Sugam Portal in applicable checklist. The application will be processed by the Assistant Drugs Inspector/Drugs Inspector (Reviewing Officer) and send to the ADC(I) (Nodal Officer) for further review. The Nodal Officer will send the application to DDC(I) (Deputy Decision Authority)/JDC(I) (Decision Authority) for recommendation for approval then DCG(I) (Licensing Authority) will grant the BE NOC & Test Licence to the applicant through Online Sugam Portal.</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-collapse0832fe33-caf4-11e7-9106-0a0027000000" href="#collapse0832fe33-caf4-11e7-9106-0a0027000000-4"> Organogram<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse0832fe33-caf4-11e7-9106-0a0027000000-4" class="panel-collapse collapse " style="height: 0px;" data-bs-parent="#bs-collapse0832fe33-caf4-11e7-9106-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="margin-bottom-20"> <div class=" "> <span > <div class="thumbnail-kenburn overflow-hidden"> <img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/babe_organo.jpg" class="img-responsive" alt="New image" title="New image " /> </div> </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-collapse0832fe33-caf4-11e7-9106-0a0027000000" href="#collapse0832fe33-caf4-11e7-9106-0a0027000000-5"> Guideline<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse0832fe33-caf4-11e7-9106-0a0027000000-5" class="panel-collapse collapse " style="height: 0px;" data-bs-parent="#bs-collapse0832fe33-caf4-11e7-9106-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="none"> <div > <div ><ul id="guide" class="guidelines"> <li style="text-align: justify;"><a style="color: black; text-decoration: none;" title="Guidelines Document" href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/BA_BE/guidance_doc_BABE_NOC1_1Jan2018.pdf" 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></li> <li style="text-align: justify;"><strong><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)" /> Sugam User Manual</a></strong></li> <li style="text-align: justify;"><strong><a style="color: black; text-decoration: none;" title="FAQ" href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/BA_BE/revidsefaqbabe.pdf" target="_blank" rel="noopener noreferrer"><img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/icons/faq_icon30x30.png" alt="faq_icon(30x30)" />    FAQ</a></strong></li> <li style="text-align: justify;"><strong><a style="color: black; text-decoration: none;" title="Tutorials" href="https://cdscoonline.gov.in/CDSCO/Help_Video" target="_blank" rel="noopener noreferrer"><img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/icons/icon-tut30x30.png" alt="icon-tut(30x30)" />       Tutorials</a></strong></li> <li style="text-align: justify;"><strong><a style="color: black; text-decoration: none;" title="Checklist Document" href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/BA_BE/BE_NOC_Pre-Screening_Checklist_April_2014.pdf" target="_blank" rel="noopener noreferrer"><img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/icons/iStock30x30.jpg" alt="iStock(30x30)" />    Checklist Documents</a></strong></li> </ul></div> </div> </div> </div></div> </div> </div> </div> </div> </div></div> </div> </div>  <div class="row section2"> <div class="col-md-12 col-sm-12 col-xs-12 section2_medical pad-top double"> <div id="import_tab" ></div></div> </div> <div class="row section3 "> <div class="col-md-12 section3_medical"> <div class="col-md-12 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 class="fa fa-newspaper-o"></i> <div class="hidden-xs">News</div> </button> </li> <li class="nav-item" role="presentation"> <button type="button" id="notices" class="w-100 btn btn-default" data-bs-target="#tab3" data-bs-toggle="tab" aria-selected="false" aria-controls="#tab3"><i class="fa fa-file-text"></i> <div class="hidden-xs">Public Notices</div> </button> </li> <li class="nav-item" role="presentation"> <button type="button" id="gazette" class="w-100 btn btn-default" data-bs-target="#tab4" data-bs-toggle="tab" aria-selected="false" aria-controls="#tab4"><i class="fa fa-bell"></i> <div class="hidden-xs">Gazette Notifications</div> </button> </li> </ul> <div class="tab-content"> <div class="tab-pane fade show active" id="tab1"> <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 example" data-limit-navigation="5" data-page-size="10" data-filter="#filter" data-filter-text-only="false" id="example"> <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>BA-BE Study Centre Approval Under New Drugs and CT Rules 2019</td> <td>2021-Jun-11</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzMxMg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>354 KB</td> </tr> <tr> <td>2</td> <td>List of Approved BA/BE Centers</td> <td>2019-Jan-29</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzQyNQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>181 KB</td> </tr> <tr> <td>3</td> <td>Documents to be submitted for Bioequivalence Study for export applications</td> <td>2014-Jan-04</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzIzNQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>283 KB</td> </tr> <tr> <td>4</td> <td>Guidance document for approval of ba/be noc for export purpose as per schedule y & test licence in form 11 of drugs and cosmetics rules, 1945</td> <td>2014-Jan-04</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzIzOQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>934 KB</td> </tr> <tr> <td>5</td> <td>Guidance Document for BA/BE NOC Applications for Export Purpose (Draft 2014)</td> <td>2014-Jan-04</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzIzNw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>294 KB</td> </tr> <tr> <td>6</td> <td>Neutral Code - labelling</td> <td>2014-Jan-04</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzIzNA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1143 KB</td> </tr> <tr> <td>7</td> <td>Revised Checklist for Pre-screening of BA/BE Applications (Draft 2014) effective from 1st Feb 2014</td> <td>2014-Jan-04</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzIzNg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>327 KB</td> </tr> <tr> <td>8</td> <td>Document required for approval of BA-BE center</td> <td>2014-Jan-04</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzIzOA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>58 KB</td> </tr> </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>Name of approved Bio - Analytical Labs till DATE 28.02.2020</td> <td>2020-Feb-28</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTY3Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>12 KB</td> </tr> <tr> <td>2</td> <td>Updated BA-BE Study Centre List on 29.01.2019</td> <td>2019-Apr-02</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDI4OQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>154 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>Module for online processing of applications for registration of BA BE study centres (CT-08)</td> <td>2021-Oct-01</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzczOQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>303 KB</td> </tr> <tr> <td>2</td> <td>Submission of Post Approval Changes Applications through SUGAM Portal</td> <td>2021-Sep-29</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzczNQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>199 KB</td> </tr> <tr> <td>3</td> <td>Conduct of BA-BE Study for Export purpose in present situation due to outbreak of COVID-19</td> <td>2020-Jun-09</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTk4Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>599 KB</td> </tr> <tr> <td>4</td> <td>Notice regarding Permission to conduct BA/BE study and clinical trial</td> <td>2020-Feb-21</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc5Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>346 KB</td> </tr> <tr> <td>5</td> <td>Notice regarding sub-acute toxicity study report for injectable products for BA/BE study in human for export</td> <td>2020-Feb-21</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc5Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>350 KB</td> </tr> <tr> <td>6</td> <td>Notice regarding Stability data for BA/BE study in Human for export</td> <td>2020-Feb-21</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc5MQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>384 KB</td> </tr> <tr> <td>7</td> <td>Notice regarding Processing of application for BA/BE permission issued in Form CT-07 and Import Licence issued in Form CT-17 for Export</td> <td>2020-Feb-21</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTYxOQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>228 KB</td> </tr> <tr> <td>8</td> <td>Processing of Post Approval Changes to BA/BE permission issued in CT-07 and Import Licence issued in Form CT-17 for Export</td> <td>2020-Jan-27</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTQ5OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>261 KB</td> </tr> <tr> <td>9</td> <td>Notice dated 18-10-2019</td> <td>2019-Oct-18</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTE3Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>470 KB</td> </tr> <tr> <td>10</td> <td>Name Of Approved Clinical Centres</td> <td>2018-Apr-08</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTgz'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>262kb</td> </tr> <tr> <td>11</td> <td>Guidance document for approval of ba/be noc for export purpose as per schedule y & test licence in form 11 of drugs and cosmetics rules, 1945</td> <td>2018-Jan-01</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTg0'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>934kb</td> </tr> <tr> <td>12</td> <td>Documents to be submitted for Bioequivalence Study for export applications</td> <td>2018-Jan-01</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTg2'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>92kb</td> </tr> <tr> <td>13</td> <td>Document required for approval of BA-BE center</td> <td>2017-Jan-01</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTg3'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>58kb</td> </tr> <tr> <td>14</td> <td>Notice regarding SUGAM Online </td> <td>2016-Sep-21</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTIw'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1,820KB</td> </tr> <tr> <td>15</td> <td>Extension of validity of approval of BA/BE Centre from 01 (one) year to 03 (three) years. </td> <td>2016-Sep-05</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTIy'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>45KB</td> </tr> <tr> <td>16</td> <td>Notice regarding for online BA/BE for Export</td> <td>2016-Aug-22</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTI3'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1,290KB</td> </tr> <tr> <td>17</td> <td>Notice regarding meeting 12 july 2016 CDSCO</td> <td>2016-Jul-05</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTMz'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>302KB</td> </tr> <tr> <td>18</td> <td>Notice </td> <td>2015-Aug-11</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjQx'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>312KB</td> </tr> <tr> <td>19</td> <td>Revised Checklist for Pre-screening of BA/BE Applications (Draft 2014) effectiv</td> <td>2014-Feb-01</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTg5'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>327kb</td> </tr> <tr> <td>20</td> <td>Guidance Document for BA/BE NOC Applications for Export Purpose (Draft 2014)</td> <td>2014-Jan-25</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTkw'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>294kb</td> </tr> <tr> <td>21</td> <td>Requirement of Obtaining Approval from the Office of Drugs Controller General of India (DCGI) Prior to Initiation of activity of Bio Analytical Laboratory for the Purpose of Analysis of Samples Obtained from Bio Availablity and Bio Equivalence Studies</td> <td>2014-Jan-04</td> <td><a 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