RJPT - Regulatory requirements for conducting Clinical Trials in India

<!DOCTYPE html> <html> <head><meta charset="utf-8" /><meta http-equiv="X-UA-Compatible" content="IE=edge" />  <meta name="viewport" content="width=device-width, initial-scale=1" />  <title> RJPT - Regulatory requirements for conducting Clinical Trials in India </title><link href="css1/bootstrap.min.css" rel="stylesheet" />  <link href="fonts/css/font-awesome.min.css" rel="stylesheet" />  <link href="https://fonts.googleapis.com/css?family=Lato:400,300,400italic,700,900,700italic" rel="stylesheet" type="text/css" /><link href="https://fonts.googleapis.com/css?family=Roboto:500" rel="stylesheet" type="text/css" />  <link rel="stylesheet" href="css1/slicknav.css" />  <link href="rs-plugin/css/settings.css" rel="stylesheet" />  <link href="css1/owl.carousel.css" rel="stylesheet" />  <link href="style.css" rel="stylesheet" />  <link href="css1/responsive.css" rel="stylesheet" /><meta name="msapplication-TileColor" content="#ffffff" /><meta name="msapplication-TileImage" content="f_icon/ms-icon-144x144.png" /><meta name="theme-color" content="#ffffff" /> <script type="text/javascript" src="https://d3mkw6s8thqya7.cloudfront.net/integration-plugin.js" id="aisensy-wa-widget" widget-id="XFmHWJ" > </script> <meta name="Description" content="Clinical trial is mandatory for approval of drug to assure safety and efficacy of drug. To safeguard the safety of patient and ethical conduction of clinical trial, India has laid down CT regulations. Compliance with ICH-GCP guideline is mandatory which describes quality assurance and safety of subjects. Clinical trial is regulated under Drug and Cosmetic act 1940 and Rules 1945 which has given Rules to conduct the clinical trial. On March 19, 2019, the Union Ministry for Health and Family Welfare notified New drugs and Clinical Trials Rules, 2019 for promoting clinical research in the country. Central Government notified final rules in Gazette of India vide G.S.R.227(E). The objective of this study is to provide an overview on regulatory requirements to conduct the clinical trials in India and challenges involved in that." /><meta http-equiv="Content-Type" content="text/html; charset=utf-8" /><meta name="citation_title" content="Regulatory requirements for conducting Clinical Trials in India" /><meta name="citation_author" content="Kalpana Kamnoore" /><meta name="citation_author" content="M P Venkatesh" /><meta name="citation_author" content="Balamuralidhara V" /><meta name="citation_author" content="T M Pramod Kumar" /><meta name="citation_publication_date" content="2020/03/01" /><meta name="citation_date" content="2020/03/01" /><meta name="citation_journal_title" content="Research Journal of Pharmacy and Technology" /><meta name="citation_volume" content="13" /><meta name="citation_issue" content="3" /><meta name="citation_firstpage" content="1517" /><meta name="citation_lastpage" content="1522" /><meta name="citation_abstract_pdf_url" content="https://rjptonline.org/AbstractView.aspx?PID=2020-13-3-81" /><meta name="citation_html_url" content="https://rjptonline.org/HTMLPaper.aspx?Journal=Research Journal of Pharmacy and Technology;PID=2020-13-3-81" /><meta name="citation_abstract_html_url" content="https://rjptonline.org/AbstractView.aspx?PID=2020-13-3-81" /><meta name="citation_publisher" content="Research Journal of Pharmacy and Technology" /><meta name="citation_issn_print" content="0974-3618" /><meta name="citation_issn_online" content="0974-360X" /><meta name="citation_language" content="English" /><meta name="citation_keywords" content="Clinical trial; Regulations; Safety; Guidelines; Challenges " /><meta name="citation_doi" content="10.5958/0974-360X.2020.00276.0" /></head> <body> <form method="post" action="./AbstractView.aspx?PID=2020-13-3-81" id="form1"> <div class="aspNetHidden"> <input type="hidden" name="__EVENTTARGET" id="__EVENTTARGET" value="" /> <input type="hidden" name="__EVENTARGUMENT" 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" 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</div> </div> <div class="col-md-2 col-lg-2 col-sm-12 col-xs-12"> <div class="opening_time s_header"> <p class="uppercase" style="color: #1a00cc; font-size: 14px; font-weight: bold">ISSN</p> <p style="color: #1a00cc; line-height: 21px"> 0974-360X (Online) <br /> 0974-3618 (Print) </p> </div> </div> </div> </div> <br /> </div> </div>   <section class="slider_area"> <div class="mainmenu_area"> <div class="container"> <div class="row"> <div class="col-md-10 col-lg-10"> <div class="mainmenu nav"> <nav> <ul id="nav"> <li class="current"><a href="Home.aspx">Home <i class="fa fa-angle-down"></i></a> <ul> <li><a href="AboutJournal.aspx">About Journal</a></li> <li><a href="Indexed_In.aspx">Indexing Information</a></li> <li><a href="ContactUs.aspx">Raise Query</a></li> </ul> </li> <li><a href="PastIssues.aspx">Past Issues</a></li> <li><a href="EditorialBoard.aspx">Editorial Board</a></li> <li><a href="#">For Authors <i class="fa fa-angle-down"></i></a> <ul> <li><a 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class="request_code"> <a href="SubmitArticle.aspx">Submit Article</a> </div> </div> </div> </div> </div> </section>  <div class="container"> <div class="col-md-9 col-lg-9 col-sm-12 col-xs-12"> <section class="blog_area section_padding"> <div class="row"> <div class="Abstract_page_title text-center"> <h1> <span id="ContentPlaceHolder1_PaperTitle" style="font-weight:bold;"><a href='AbstractView.aspx?PID=2020-13-3-81' class='myLink'>Regulatory requirements for conducting Clinical Trials in India</a><a href='https://scholar.google.co.in/scholar?q=Regulatory requirements for conducting Clinical Trials in India' target='_blank' style='color:blue'> <img src='Images/GoogleScholar.png' style='height:23px'></a></span> </h1> </div> <div class="single_blog"> <div style="background: #f6f6f6 none repeat scroll 0 0; padding: 8px; border-left: 4px solid #11c3f1"> <p style="text-align: left; font-size: 14px"> <span style="color: rgba(193, 4, 4, 0.76)">Author(s):</span> <span id="ContentPlaceHolder1_AuthorName"><a href='search.aspx?key=Kalpana Kamnoore' >Kalpana Kamnoore</a>, <a href='search.aspx?key=M P Venkatesh' >M P Venkatesh</a>, <a href='search.aspx?key=Balamuralidhara V' >Balamuralidhara V</a>, <a href='search.aspx?key=T M Pramod Kumar' >T M Pramod Kumar</a></span> </p> <p style="text-align: left; font-size: 14px"> <span style="color: rgba(193, 4, 4, 0.76)">Email(s):</span> <span id="ContentPlaceHolder1_AuthorEmail"><a href='mailto:venkateshmpv@jssuni.edu.in' target='_blank' >venkateshmpv@jssuni.edu.in</a> </span> </p> <p style="text-align: left; font-size: 14px;"> <span style="color: rgba(193, 4, 4, 0.76)">DOI:</span> <span id="ContentPlaceHolder1_DOI_No" style="font-weight:normal;"><a href='https://doi.org/10.5958/0974-360X.2020.00276.0' target='_blank' style='color:blue'>10.5958/0974-360X.2020.00276.0</a>    <a href='https://scholar.google.co.in/scholar?q=10.5958/0974-360X.2020.00276.0' target='_blank' style='color:blue'> <img src='Images/GoogleScholar.png' style='height:25px'></a></span> </p> <p style="text-align: left; font-size: 14px"> <span style="color: rgba(193, 4, 4, 0.76)">Address:</span> <span id="ContentPlaceHolder1_AuthorAddress">Kalpana Kamnoore, M P Venkatesh*, Balamuralidhara V, T M Pramod Kumar<br> Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru-570015, Karnataka, India.<br> *Corresponding Author</span> </p> <p style="text-align: left; font-size: 13px; margin-top: 5px"> <span style="color: rgba(193, 4, 4, 0.76)">Published In:</span>   <a href="Issues.aspx?VID=13&IID=3" id="ContentPlaceHolder1_Vol_Issue_link" style="font-weight:bold">Volume - <span id="ContentPlaceHolder1_VOL_no" style="font-weight:normal;">13</span>,      Issue - <span id="ContentPlaceHolder1_ISSUE_no" style="font-weight:normal;">3</span>,     Year - <span id="ContentPlaceHolder1_Pub_Year" style="font-weight:normal;">2020</span> </a> </p> <div class="clearfix"></div> <div style="float:right;"> <span id="ContentPlaceHolder1_Cite_icon_lbl" style="font-weight:normal;"><script async src='https://badge.dimensions.ai/badge.js' charset='utf-8'></script> <span class='__dimensions_badge_embed__' data-doi='10.5958/0974-360X.2020.00276.0' data-style='small_circle'></span> <div class='clearfix'></div></span> </div> <div class="blog_page" style="padding: 10px; margin-bottom: 28px"> <a href="HTMLPaper.aspx?Journal=Research Journal of Pharmacy and Technology;PID=2020-13-3-81" id="ContentPlaceHolder1_HTML_View_lnk" class="top_quate_action2 float_Right"> <img src="Images/html.png" />  View HTML</a>      <a id="ContentPlaceHolder1_PDF_View_lnk" class="top_quate_action2 float_Right" href="javascript:__doPostBack('ctl00$ContentPlaceHolder1$PDF_View_lnk','')"><img src="Images/pdf.png" style="height:28px" />   View PDF</a> </div> <div class="clearfix"></div> </div> <div class="blog_content blog_page"> <br /> <p style="text-align: justify"> <span style="color: black; font-weight: bold">ABSTRACT:</span> <br /> <span id="ContentPlaceHolder1_Abstract" style="color:Black;">Clinical trial is mandatory for approval of drug to assure safety and efficacy of drug. To safeguard the safety of patient and ethical conduction of clinical trial, India has laid down CT regulations. Compliance with ICH-GCP guideline is mandatory which describes quality assurance and safety of subjects. Clinical trial is regulated under Drug and Cosmetic act 1940 and Rules 1945 which has given Rules to conduct the clinical trial. On March 19, 2019, the Union Ministry for Health and Family Welfare notified New drugs and Clinical Trials Rules, 2019 for promoting clinical research in the country. Central Government notified final rules in Gazette of India vide G.S.R.227(E). The objective of this study is to provide an overview on regulatory requirements to conduct the clinical trials in India and challenges involved in that.</span> </p> <br /> <div class="tags"> <i class="text-left" style="color:black; font-size: 13px; font-weight: normal">Keywords:</i> <span id="ContentPlaceHolder1_Key_words" style="font-size:Smaller;"><ul class='text-left'><li><a href=''Clinical trial' target='_blank' >Clinical trial</a></li><li><a href=''Regulations' target='_blank' >Regulations</a></li><li><a href=''Safety' target='_blank' >Safety</a></li><li><a href=''Guidelines' target='_blank' >Guidelines</a></li><li><a href=''Challenges.' target='_blank' >Challenges.</a></li></ul></span> </div> </div> <div class="highlight_text"> <img src="img/hilight.png" alt=""> <p> <span style="color: rgba(193, 4, 4, 0.76)">Cite this article:</span> <br /> <span id="ContentPlaceHolder1_Cite">Kalpana Kamnoore, M P Venkatesh, Balamuralidhara V, T M Pramod Kumar. Regulatory requirements for conducting Clinical Trials in India. Research J. Pharm. and Tech 2020; 13(3):1517-1522. doi: 10.5958/0974-360X.2020.00276.0</span> <br /><br /> <span style="color: rgba(193, 4, 4, 0.76)">Cite(Electronic):</span> <br> <span id="ContentPlaceHolder1_Cite1">Kalpana Kamnoore, M P Venkatesh, Balamuralidhara V, T M Pramod Kumar. Regulatory requirements for conducting Clinical Trials in India. Research J. Pharm. and Tech 2020; 13(3):1517-1522. doi: 10.5958/0974-360X.2020.00276.0   Available on: https://rjptonline.org/AbstractView.aspx?PID=2020-13-3-81</span> </p> </div> <div class="clearfix"></div> <br /> <span id="ContentPlaceHolder1_Additional_Information_lbl">REFERENCES:<br>1.    Pikee Saxena, Rohit Saxena. Clinical Trials: Changing Regulations in India. Indian J Community Med. 2014 Oct-Dec; 39(4): 197–202. <br>2.    Drug and Cosmetic Act 1940 and Rules 1945. 2016 Available from: URL: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdfdocuments/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf<br>3.    Rajashree Devarakonda. Current Clinical Trial Scenario of India: Challenges and Solutions. Pharma Bio World. July 2013; Page 16-20.<br>4.    Schedule Y- CDSCO. 2019. Available from: URL: https://rgcb.res.in/documents/Schedule-Y.pdf<br>5.    Aggregating clinical research regulations from around the world. National institute of allergy and infectitious disease. 2019. Available from: URL: https://clinregs.niaid.nih.gov/country/india#labeling_and_packaging<br>6.    Lovely Joylen Castelino, Anoop Narayanan V, Swapnil Dylan Fernandes, Pankaj Kumar, Sandeep D S. Good Clinical Practices: An Indian Perspective. Research J. 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