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width:50px; height:50px;"></a></span></div></div><div id="pathway"><div class="pathone"><a href="https://www.businesstoday.in/">Home</a></div><div class="pathtwo"><a href="/current">BIZ WRAP</a></div><div class="paththree"><a href="/current/economy-politics">Economy and Politics</a></div><div class="pathsix"><span class="selected">Story</span></div></div><div class="headline"><h1>Race for Remdesivir: Five firms await nod from DCGI to manufacture coronavirus drug</h1></div><div class="story_kicker"><h2>Coronavirus treatment: DCGI has asked the five companies concerned to furnish various sets of data including animal toxicity, stability study etc</h2></div><div class="story-details"><a target="_blank" rel="noopener" href="https://twitter.com/@bt_india" data-show-count="false" data-lang="en"><img src="https://akm-img-a-in.tosshub.com/sites/btmt/businesstoday/resources/images/Twitter-image.png" alt="twitter-logo"></a> <a href="/search.jsp?searchword=BusinessToday.In&searchtype=text&searchphrase=exact&search_type=author">BusinessToday.In</a> New Delhi Last Updated: June 8, 2020 | 09:39 IST </div><div style="clear:both"></div><div id="box"><div class="video-poster"><div class="poster-height"></div><img src="https://akm-img-a-in.tosshub.com/sites/btmt/images/stories/vaccine_corona_660_080620093143.jpg" alt="Race for Remdesivir: Five firms await nod from DCGI to manufacture coronavirus drug" title="Race for Remdesivir: Five firms await nod from DCGI to manufacture coronavirus drug" width="448"/></div><div class="storyKickerImageCaption">Coronavirus vaccine: Five companies await regulator's nod for Remdesivir</div></div><div id="story-maincontent" class="ad-blocker-ajax"><div class="story-left"><script> storyRelatedAjaxInclude("/chunk_story_releted.jsp?countCount=3&idForRelated=406236&storyByline=BusinessToday.In&reletedSection=100"); </script></div><div class="story-right relatedstory paywall" itemprop="articleBody"><p><p>As the number of cases increases in the country, companies await marketing approval from Drugs Controller General of India (DCGI) to roll out the experimental coronavirus drug Remdesivir in the country. However, it might be a while as the regulator has sought various sets of data from the companies. Five companies have applied for permission to manufacture Remdesivir in India after signing a licencing deal with original developer and drug maker Gilead. </p><p>According to a report in Times of India, an official said that it might take some time before Remdesivir is available in the Indian market. DCGI has asked the companies concerned to furnish various sets of data including animal toxicity, stability study etc. "Even if these trials are conducted on a fast-track basis, they will take at least a month's time," an official told the daily.</p><p>The five companies have signed licencing agreement with Gilead Sciences to manufacture and distribute Remdesivir in 127 countries. The regulator has however granted approval to Gilead to import and sell Remdesivir in India. </p><p>A Central Drugs Standard Control Organisation (CDSCO) official told the daily that they have asked for this data to ensure quality of the drug. The data furnished by Gilead can only waive off clinical trials, the official told the daily. </p><p>India had recently approved the use of drug Remdesivir for emergency use, as mentioned by Health Ministry Joint Secretary Lav Agarwal at a press conference. This approval was given after the emergency use authorisation by the US Food and Drug Administration. "Remdesivir approved on June 1 under emergency use with condition for five dose administration," the regulator had said.</p><script>googletag.cmd.push(function(){googletag.defineSlot('/1007232/Businesstoday_ROS_Desktop_300x250_MTF', [300, 250], 'div-gpt-ad-1559567251990-0').setTargeting('category',['BT_WEB_728x90_MTF_Loop0','current', 'Economy Politics', 'story', '406236']).addService(googletag.pubads());googletag.pubads().enableSingleRequest();googletag.pubads().collapseEmptyDivs();googletag.enableServices();});</script><div id='div-gpt-ad-1559567251990-0' style='height:250px; width:300px;margin:0 auto;'><script>googletag.cmd.push(function(){googletag.display('div-gpt-ad-1559567251990-0'); });</script></div><p><i><b>Also read: <a mce_href="https://www.businesstoday.in/latest/trends/coronavirus-treatment-rs-35000-42000-for-five-day-dosage-of-remdesivir/story/405898.html" target="_blank" href="https://www.businesstoday.in/latest/trends/coronavirus-treatment-rs-35000-42000-for-five-day-dosage-of-remdesivir/story/405898.html">Gilead says Indian licensees free to decide Remdesivir price</a></b></i></p><p><i><b>Also read: <a mce_href="https://www.businesstoday.in/latest/trends/coronavirus-outbreak-maharashtra-to-procure-10000-vials-of-remdesivir-for-treatment/story/406170.html" target="_blank" href="https://www.businesstoday.in/latest/trends/coronavirus-outbreak-maharashtra-to-procure-10000-vials-of-remdesivir-for-treatment/story/406170.html">Coronavirus outbreak: Maharashtra to procure 10,000 vials of Remdesivir for treatment</a></b></i></p></p></p></div></div><script>storyRelatedAjaxInclude("/like-dislike.jsp?contentId=406236&contentType=text&ScfUrl=race-for-remdesivir-five-firms-await-nod-dcgi-manufacture-coronavirus-drug.html")</script><style>.twittershare{display: block;float: left;}.googleshare{display: block;float: left;}.wiged-left > .IN-widget {width: 80px !important;float: left;}#planntocontainer ul{padding-left:0;}</style><div style="clear:both"></div><div id="topsharetool"><div class="wiged-left"><span class="facebookshare" id="btfblike"></span><span class="facebookshare" id="btfbshare"></span><span class="twittershare"><a href="https://twitter.com/share" class="twitter-share-button" data-via="bt_india" data-vuukle-share="Twitter">Tweet</a><script>!function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0];if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src="//platform.twitter.com/widgets.js";fjs.parentNode.insertBefore(js,fjs);}}(document,"script","twitter-wjs");</script></span><span class="youtube"><a class="youtube_t" href="https://www.youtube.com/channel/UC2ozzcjJsD0Q1DglEytSZrQ?sub_confirmation=1" title="You Tube" target="_blank" rel="noopener">Youtube</a></span><script> (function() { var po = document.createElement('script'); 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$("#scc_all ol").empty(); $("#scc_resultStats").empty(); activeTab = $(this).attr('tab'); if (activeTab == "photos" || activeTab == "videos") { $("#scc_webPagi").hide(); } currentPage = 1; startPageNum = 1; nextPage = 1; filter = "m1"; H = 0; Rati = 0; var q = $("#scc_search_txt").val(); }); //Spaeach Recogonization option function call $(".scc_tlkNw").click(function() { $(".scc_tlkNw").hide(); $(".scc_spk_stat_txt").html("Listening"); speech_recognition(); }); $(".scc_tlkHsbNw").click(function() { $(".scc_tlkHsbNw").hide(); $(".scc_spk_stat_txt_hsb").html("Listening"); speech_recognition_hsb(); }); $(".scc_search_btn").click(function() { $('#right_search_txt').val($('#scc_search_txt').val()); search_btn(); }); $(".scc_search_mic_btn").click(function() { $('#right_search_txt').val($('#scc_search_txt').val()); search_btn(); }); function inGssHomeSearchBox() { var ighsb = "<div class='scc_searchBox'><label for='mod_search_searchword' style='display:none;'></label><input id='mod_search_searchword' type='text' onkeypress='return blockSpecialChar(event)' onkeyup='removeClass()' data-trn-holder='Enter search keyword' placeholder='Enter search keyword' autocomplete='on' name='searchword' class='scc_search scc_advancedSearchTextbox trn input-box' style='height:28px;'><a href='#' title='scc_micLink' name='scc_micLink' class='scc_micLink scc_tlkHsbNw'><svg version='1.1' id='Layer_1' xmlns='http://www.w3.org/2000/svg' xmlns:xlink='http://www.w3.org/1999/xlink' x='0px' y='0px' width='30px' height='30px' viewBox='0 0 288 287.5' enable-background='new 0 0 288 287.5' xml:space='preserve'> <path fill='none' stroke='#929497' stroke-width='10' stroke-miterlimit='10' d='M170.448,153.013 c0,13.821-11.206,25.022-25.022,25.022l0,0c-13.817,0-25.023-11.201-25.023-25.022V67.22c0-13.821,11.206-25.023,25.023-25.023l0,0 c13.816,0,25.022,11.202,25.022,25.023V153.013z'/> <g><defs><rect id='SVGID_1_' x='75.171' y='159.195' width='139.908' height='126.305'/></defs> <clipPath id='SVGID_2_'><use xlink:href='#SVGID_1_' overflow='visible'/></clipPath> <path clip-path='url(#SVGID_2_)' fill='none' stroke='#929497' stroke-width='10' stroke-miterlimit='10' d='M209.435,152.046 c0,35.538-28.808,64.345-64.345,64.345l0,0c-35.537,0-64.344-28.807-64.344-64.345V73.402c0-35.537,28.807-64.344,64.344-64.344 l0,0c35.537,0,64.345,28.807,64.345,64.344V152.046z'/> </g> <line fill='#808184' stroke='#929497' stroke-width='10' stroke-miterlimit='10' x1='145.125' y1='246.188' x2='145.125' y2='215.088'/> <line fill='#808184' stroke='#929497' stroke-width='10' stroke-miterlimit='10' x1='129.576' y1='246.961' x2='160.674' y2='246.961'/> </svg></a><button type='submit' class='scc_btn scc_btn-success scc_search_home_btn'></button></div><div class='scc_overlay'><div class='scc_overlayWrapper'><div class='scc_overlayTitle trn'><p>Speak Now</p></div><div class='scc_overlayContent'><svg style='margin:0px auto;' version='1.1' id='Layer_1' xmlns='http://www.w3.org/2000/svg' xmlns:xlink='http://www.w3.org/1999/xlink' x='0px' y='0px' width='25%' height='25%' viewBox='0 0 216 216' enable-background='new 0 0 216 216' xml:space='preserve'><circle fill='#DBDBDA' cx='108' cy='108' r='107'/><circle fill='#EE3A4D' cx='108' cy='108' r='83'/><g><defs><rect id='SVGID_1_' x='67.753' y='109.387' width='75.333' height='64'/></defs><clipPath id='SVGID_2_'><use xlink:href='#SVGID_1_' overflow='visible'/></clipPath><path clip-path='url(#SVGID_2_)' fill='none' stroke='#FFFFFF' stroke-width='8' stroke-miterlimit='10' d='M131.066,108.65c0,13.08-10.604,23.684-23.684,23.684l0,0c-13.079,0-23.682-10.604-23.682-23.684V71.349c0-13.08,10.603-23.683,23.682-23.683l0,0c13.08,0,23.684,10.603,23.684,23.683V108.65z'/></g><path fill='#FFFFFF' d='M119.42,110c0,6.259-5.373,11.333-11.999,11.333l0,0c-6.628,0-12.001-5.074-12.001-11.333V86c0-6.259,5.373-11.333,12.001-11.333l0,0c6.626,0,11.999,5.074,11.999,11.333V110z'/><rect x='102.42' y='134.721' fill='#FFFFFF' width='10' height='14'/></svg><br/> <span class='scc_spk_stat_txt_hsb trn' style='display:none;'>Listening</span> <br/><div class='scc_ppButtonWrap'><a name='re_speak' type='submit' href='#' class='scc_btn scc_btn-success scc_ppBtnReSpeak scc_tlkHsbNw trn' style='display:none;'>Re Speak</a><a name='submit' type='submit' href='JavaScript:Void(0);' class='scc_btn scc_btn-success scc_ppBtnSubmit scc_search_home_mic_btn trn' style='display:none;'>Submit</a></div></div><div class='scc_closeOlay speech_recognitionEnd'>x</div></div></div>"; return ighsb; } //Fuction for browser detection function browser_detector() { var isOpera = (!!window.opr && !!opr.addons) || !!window.opera || navigator.userAgent.indexOf(' OPR/') >= 0; if (isOpera) { var browser = "opera"; } // Firefox 1.0+ var isFirefox = typeof InstallTrigger !== 'undefined'; if (isFirefox) { var browser = "firefox"; } // At least Safari 3+: "[object HTMLElementConstructor]" var isSafari = Object.prototype.toString.call(window.HTMLElement).indexOf('Constructor') > 0; if (isSafari) { var browser = "safari"; } // Internet Explorer 6-11 var isIE = /*@cc_on!@*/ false || !!document.documentMode; if (isIE) { var browser = "IE"; } // Edge 20+ var isEdge = !isIE && !!window.StyleMedia; if (isEdge) { var browser = "edge"; } // Chrome 1+ var isChrome = !!window.chrome && !!window.chrome.webstore || navigator.userAgent.indexOf(' OPR/') >= 0 || navigator.userAgent.indexOf('Chrome') >= 0; if (isChrome) { var browser = "chrome"; } // Blink engine detection var isBlink = (isChrome || isOpera) && !!window.CSS; if (isBlink) { var engine = "blink"; } return browser; } $('.speech_recognitionEnd').click(function() { speech_recognitionEnd(); }); function speech_recognitionEnd() { $(".scc_overlay").hide(); $(".scc_tlkNw").show(); recognition.stop(); recognition.onstop = function() { recognizing = false; inputEl.placeholder = oldPlaceholder; }; } function speech_recognition_hsb() { $(".scc_overlay").show(); var inputEl = document.querySelector('input[name=searchword]'); recognition.continuous = true; recognition.lang = lang; event.preventDefault(); if (recognizing) { recognition.stop(); return; } inputEl.value = finalTranscript = ''; recognition.start(); recognition.onstart = function() { oldPlaceholder = inputEl.placeholder; //document.getElementById("mod_search_searchword").focus(); inputEl.placeholder = "Start Talking"; $(".scc_spk_stat_txt_hsb").show(); $(".scc_search_home_mic_btn").hide(); recognizing = true; restartTimer(); }; recognition.onend = function() { recognizing = false; $(".scc_tlkHsbNw").show(); clearTimeout(timeout); if (oldPlaceholder !== null) { inputEl.placeholder = oldPlaceholder; } }; recognition.onresult = function(event) { $(".scc_search_home_mic_btn").show(); $(".scc_tlkHsbNw").show(); clearTimeout(timeout); for (var i = event.resultIndex; i < event.results.length; ++i) { if (event.results[i].isFinal) { finalTranscript += event.results[i][0].transcript; } } finalTranscript = capitalize(finalTranscript); inputEl.value = finalTranscript; $(".scc_spk_stat_txt_hsb").html(finalTranscript); restartTimer(); //$( ".overlay" ).hide(); $("#gsc-i-id1").trigger(jQuery.Event('keydown', { which: 13 })); }; } function speech_recognition() { $(".scc_overlay").show(); var inputEl = document.querySelector('input[name=searchword]'); recognition.continuous = true; recognition.lang = lang; event.preventDefault(); if (recognizing) { recognition.stop(); return; } inputEl.value = finalTranscript = ''; recognition.start(); recognition.onstart = function() { oldPlaceholder = inputEl.placeholder; document.getElementById("scc_search_txt").focus(); //inputEl.placeholder = "Start Talking"; $(".scc_spk_stat_txt").show(); $(".scc_search_mic_btn").hide(); recognizing = true; restartTimer(); }; recognition.onend = function() { recognizing = false; $(".scc_tlkNw").show(); clearTimeout(timeout); if (oldPlaceholder !== null) { inputEl.placeholder = oldPlaceholder; } }; recognition.onresult = function(event) { $(".scc_search_mic_btn").show(); $(".scc_tlkNw").show(); clearTimeout(timeout); for (var i = event.resultIndex; i < event.results.length; ++i) { if (event.results[i].isFinal) { finalTranscript += event.results[i][0].transcript; } } finalTranscript = capitalize(finalTranscript); inputEl.value = finalTranscript; $(".scc_spk_stat_txt").html(finalTranscript); finalTranscript = ''; restartTimer(); //$( ".overlay" ).hide(); $("#gsc-i-id1").trigger(jQuery.Event('keydown', { which: 13 })); }; } // Capitalize a string function capitalize(str) { return str.length ? str[0].toUpperCase() + str.slice(1) : str; } function restartTimer() { timeout = setTimeout(function() { recognition.stop(); }, patience * 2000); } function getNumber(number) { number = parseInt(number, 10); return isNaN(number) || number === null || typeof(number) === 'undefined' ? 0 : number; } function search_home_btn() { currentPage = 1; var x = getRndInteger(); var y = getRndInteger(); $("#scc_resultStats").empty(); var res = $("#scc_inGssHomeSbOnly").attr("resultUrl"); var qVal = $("#scc_inGssHomeSbOnly #mod_search_searchword").val(); if (qVal != '' && qVal.length > 0 ) { window.location.href = "https://www.businesstoday.in/search.jsp?option=com_search&searchword=" + qVal.toLowerCase().split(' ').join('_')+"&x="+x+"&y="+y; } } $("#scc_inGssHomeSbOnly .scc_search_home_mic_btn").on('click', function() { search_home_btn(); }); $('.scc_overlay').click(function() { //$('.scc_overlay').hide(); }); $(document).mouseup(function(e) { //$('.scc_overlay').hide(); }); $(document).ready(function() { $("#scc_inGssHomeSbOnly").ready(function() { var homeSccLang = $("#scc_inGssHomeSbOnly").attr('scc_lang'); }); $("#scc_inGssSearchResBlk").ready(function() { if (naviPlatfrm()) { $("#scc_inGssSearchResBlk").addClass('web'); $("#scc_inGssHomeSbOnly").addClass('web'); } }); if (naviPlatfrm()) { $("#scc_settingFilters").hide(); $(".scc_fltrWrpWeb").css("display", "inline-block"); $(".scc_settingFilterShow").css("display", "none"); $("#scc_cng_vw").removeClass('scc_mob_blk'); $("#scc_cng_vw").addClass('scc_desk_blk'); } }); })(jQuery); function getRndInteger() { return Math.floor(Math.random() * 100);; } </script><script> function validatesearch(modsearch) {var srchtextvalue = document.getElementById(modsearch); var re = new RegExp("^(?=.*[a-zA-Z0-9 ]).*$"); if(re.test(srchtextvalue.value)) { }else{srchtextvalue.value = ''} if(srchtextvalue.value=='') {alert('Please enter text to search.');return false;} if(srchtextvalue.value!='') { if(srchtextvalue.value!='') {var x=srchtextvalue.value;var y = '';var iChars = "abcdefghijklmnopqrstuvwxyzABCDEFGHIJKLMNOPQRSTUVWXYZ0123456789_.-';?:%,! 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