{"id":48479,"date":"2022-09-09T14:04:22","date_gmt":"2022-09-09T08:34:22","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=48479"},"modified":"2022-09-13T16:02:16","modified_gmt":"2022-09-13T10:32:16","slug":"who-can-apply-for-cdsco-license","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/who-can-apply-for-cdsco-license\/","title":{"rendered":"Who can apply for CDSCO License?"},"content":{"rendered":"\n<p>CDSCO or Central Drugs Standard Control Organisation, it is the National Regulatory Authority for Indian pharmaceutical &amp; medical devices under the Directorate General of Health Services and Ministry of Health &amp; Family Welfare in India. It is the responsibility of CDSCO to approve new drugs &amp; conduct clinical trials in India under the Drugs &amp; Cosmetics Act, 1940 and <strong>Drugs &amp; Cosmetics Rules, 1945<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Rules,_1945\"><strong>[1]<\/strong><\/a><\/sup>. It also lays down standards for drugs &amp; control the quality of imported cosmetics &amp; drugs in the country to bring about uniformity in enforcing the Act &amp; Rules. The Act &amp; Rules entrust several responsibilities to the Central &amp; State Regulators for regulating Cosmetics &amp; Drugs in India. CDSCO is the Central Drug Authority that discharges the functions assigned to the Central Government under this Act. It is also provides expert advice to State Drug Control Organisations and coordinates their activities. CDSCO and State regulators are jointly responsible for issuing CDSCO licenses for specific specialised categories of critical drugs like vaccines, IV fluids, sera, blood, and blood products. In this article, we will discuss who can apply for CDSCO License in India.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title ez-toc-toggle\" style=\"cursor:pointer\">Page Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/corpbiz.io\/learning\/who-can-apply-for-cdsco-license\/#A_Brief_on_CDSCO_SUGAM_Portal\" >A Brief on CDSCO SUGAM Portal<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/corpbiz.io\/learning\/who-can-apply-for-cdsco-license\/#Purpose_to_apply_for_CDSCO_License\" >Purpose to apply for CDSCO License<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/corpbiz.io\/learning\/who-can-apply-for-cdsco-license\/#Who_are_Eligible_to_Apply_for_CDSCO_License\" >Who are Eligible to Apply for\nCDSCO License?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/corpbiz.io\/learning\/who-can-apply-for-cdsco-license\/#Documents_required_to_apply_for_CDSCO_License\" >Documents required to apply for\nCDSCO License<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/corpbiz.io\/learning\/who-can-apply-for-cdsco-license\/#Procedure_to_Obtain_CDSCO_License\" >Procedure to Obtain CDSCO\nLicense<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/corpbiz.io\/learning\/who-can-apply-for-cdsco-license\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"A_Brief_on_CDSCO_SUGAM_Portal\"><\/span>A Brief on CDSCO SUGAM Portal<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The CDSCO (Central\nDrugs Standard Control Organisation) introduced this portal in November 2015.\nTo have up-to-date information on medications made in India, CDSCO created the\nmodule under the SUGAM portal for updating &amp; uploading data on its website\npertaining to the licenced Drug Manufacturing facilities &amp; approved or\nlicenced drug formulations. SUGAM&#8217;s deployment has improved the company&#8217;s\naccountability, dependability, transparency, and ease of use. It&#8217;s a\nsignificant overhaul for India&#8217;s pharmaceutical sector and specifically\nmentions the Government Digital India plan. An electronic governance system\ncalled CDSCO SUGAM is used to carry out various CDSCO tasks. It is software\ncreated for an online application portal used to request NOCs, permissions,\nlicences, registration certificates, and approvals. This portal offers a web\ninterface for following applications, answering questions, and downloading\npermissions granted by the CDSCO. Additionally, it assists CDSCO staff members\nwith processing online applications, creating online permissions, and producing\nMIS reports.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Purpose_to_apply_for_CDSCO_License\"><\/span>Purpose to apply for CDSCO License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>An applicant applies for <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO License<\/strong><\/a> for different objectives. The different objectives for which an applicant can register under the CDSCO portal are the following:<\/p>\n\n\n\n<ul><li>Cosmetics Registration<\/li><li>Export NOC (Zone);<\/li><li>Ethics Committee Registration;<\/li><li>Blood Bank Registration;<\/li><li>Dual Use NOC (Trader);<\/li><li>Blood Product Registration;<\/li><li>Sponsors (BA\/BE &amp; CT)<\/li><li>Manufacture or Import of Drugs;<\/li><li>Test License;<\/li><li>Formulation R&amp;D Organisation;<\/li><li>BA\/BE Approved Sites.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Who_are_Eligible_to_Apply_for_CDSCO_License\"><\/span>Who are Eligible to Apply for\nCDSCO License?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following is the list of applicants who can apply for CDSCO License:<\/p>\n\n\n\n<ul><li>Importers<\/li><li>Authorised Indian Representatives (AIR);<\/li><li>Corporates;<\/li><li>Foreign Enterprises were holding Indian\nSubsidiary.<\/li><\/ul>\n\n\n\n<p><strong><em>Note:\nA manufacturing unit cannot register directly on the CDSCO portal. A corporate\nmust create login credentials for the manufacturing unit by which they can log\nin on the CDSCO portal.<\/em><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_required_to_apply_for_CDSCO_License\"><\/span>Documents required to apply for\nCDSCO License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are some essential documents to apply for CDSCO License:<\/p>\n\n\n\n<ul><li>ID Proof Documents;<\/li><li>Address Proof Documents;<\/li><li>Undertaking granted by a Government Authority;<\/li><li>Manufacturing License or Wholesale Licenses in\ncase of manufacture or import of Drugs, blood product registration, test\nlicense registration.<\/li><li>Copy of BA\/BE Site Registration and approval\nfrom CDSCO in case of BA\/BE Approved sites Registration.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_to_Obtain_CDSCO_License\"><\/span>Procedure to Obtain CDSCO\nLicense<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are some essential steps to obtain CDSCO License in India:<\/p>\n\n\n\n<p><strong>Step 1:<\/strong>\nThere are different kinds of drugs &amp; cosmetic licenses, and the type of\nlicense required depends on products, services, activities and the nature of\nthe business. The applicant has to apply in the requisite form according to the\ncategory mentioned on the site with fees and required documents.<\/p>\n\n\n\n<p><strong>Step 2:<\/strong>\nDocumentation for obtaining a drug &amp; cosmetic license is crucial in India&#8217;s\nlicensing procedure.<\/p>\n\n\n\n<p><strong>Step 3:<\/strong>\nThe applicant has to apply separate applications for all types of prescribed\nlicenses via different forms.<\/p>\n\n\n\n<p><strong>Step 4:<\/strong>\nScrutiny of application &amp; inspection of factory location take place. The\ndrug inspector visits the location and verifies the particulars of the\napplication. A query is raised if there is any discrepancy\/ shortcoming.<\/p>\n\n\n\n<p><strong>Step 5:<\/strong>\nProduct Scrutiny also takes place. The Drug inspector verifies information of\nthe product applied on the application, and in case they are found to comply\nwith the norms and conditions, the application will be considered for grant of\nlicense. Inspector may raise any clarification in the application.<\/p>\n\n\n\n<p><strong>Step 6:<\/strong>\nAfter satisfactory verification, Drug Controller Department issues the license.<\/p>\n\n\n\n<p><strong>Step 7:<\/strong>\nThe drugs control administration also provides the approval for technical staff\naccording to Drugs &amp; Cosmetics Rules, 1945, framed under the legislation\nabiding through the WHO &amp; GMP inspection norms.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Under the Drugs &amp; Cosmetics Act, CDSCO is responsible for approval of New Drugs,&nbsp; laying down the standards for Drugs, Conduct of Clinical Trials, control over the quality of imported Drugs, cosmetics, and medical devices in the country and coordinating the activities of State Drug Control Organizations by providing expert advice and a view of bringing about the consistency in the enforcement of the Drugs &amp; Cosmetics Act. <\/p>\n\n\n\n<p class=\"text-left\"><b>Read our Article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/importance-of-cdsco-certificate-in-public-health-domain\/\">Importance of CDSCO Certificate in Public Health Domain <\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>CDSCO or Central Drugs Standard Control Organisation, it is the National Regulatory Authority for Indian pharmaceutical &amp; medical devices under the Directorate General of Health Services and Ministry of Health &amp; Family Welfare in India. It is the responsibility of CDSCO to approve new drugs &amp; conduct clinical trials in India under the Drugs &amp; [&hellip;]<\/p>\n","protected":false},"author":42,"featured_media":48502,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2707],"acf":{"service_id":"508"},"authorName":"Krishna Kumar","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/07\/MicrosoftTeams-image-62.jpg","authorDescription":"Krishna Kumar has completed BA-LLB with a specialization in constitutional Laws from ICFAI University. As a recent graduate, He has both legal research and content writing experience in various law firms. He secures good drafting skills for various legal documents in multiple fields of law.","postViews":2893,"readingTime":3,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48479"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/42"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=48479"}],"version-history":[{"count":21,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48479\/revisions"}],"predecessor-version":[{"id":48680,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48479\/revisions\/48680"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/48502"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=48479"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=48479"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=48479"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}