{"id":44141,"date":"2022-06-06T11:05:04","date_gmt":"2022-06-06T05:35:04","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=44141"},"modified":"2022-06-06T11:05:47","modified_gmt":"2022-06-06T05:35:47","slug":"what-is-cdsco-sugam","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/what-is-cdsco-sugam\/","title":{"rendered":"What is CDSCO Sugam?"},"content":{"rendered":"\n<p>The CDSCO Sugam was introduced in November 2015 by the Central Drugs Standard Control Organisation. It is an online portal for filing applications for various services.<\/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\/what-is-cdsco-sugam\/#Brief_on_Central_Drugs_Standard_Control_Organisation\" >Brief on Central Drugs Standard\nControl Organisation<\/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\/what-is-cdsco-sugam\/#CDSCO_Sugam_Portal\" >CDSCO Sugam Portal<\/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\/what-is-cdsco-sugam\/#Sugam_for_Online_Licensing\" >Sugam for Online Licensing<\/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\/what-is-cdsco-sugam\/#CDSCO_Sugam_Login_and_Sub-Login_Guidelines\" >CDSCO Sugam Login and Sub-Login Guidelines<\/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\/what-is-cdsco-sugam\/#Objectives_of_CDSCO_Sugam_Portal\" >Objectives of CDSCO Sugam Portal<\/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\/what-is-cdsco-sugam\/#Benefits_of_CDSCO_Sugam\" >Benefits of CDSCO Sugam<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/corpbiz.io\/learning\/what-is-cdsco-sugam\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Brief_on_Central_Drugs_Standard_Control_Organisation\"><\/span>Brief on Central Drugs Standard\nControl Organisation<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Central Drugs Standard Control Organisation\n(CDSCO) works as per the directions of the Directorate General of Health\nServices, Ministry of Health and Family Welfare. CDSCO is a National Regulatory\nAuthority (NRA) in India. Its head office is in New Delhi. It has six Zonal\noffices, four sub-zonal offices, thirteen port offices and seven laboratories.\nThe Drugs &amp; Cosmetics Act and the Rules made thereunder have put\nresponsibilities on the CDSCO related to the following:<\/p>\n\n\n\n<ul><li>To approve New Drugs.<\/li><li>To conduct Clinical Trials.<\/li><li>To lay down the standards for drugs.<\/li><li>To control the quality of imported drugs in India.<\/li><li>To coordinate the activities of the State Drug Control Organisation      by providing expert advice to bring uniformity in the enforcement of the Act.<\/li><li>To grant license of certain categories of critical Drugs along with      the State regulators.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"CDSCO_Sugam_Portal\"><\/span>CDSCO Sugam Portal<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The <strong>Central Drug Standards Control Organisation (CDSCO<\/strong><sup><a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Home\/\"><strong>[1]<\/strong><\/a><\/sup><strong>)<\/strong> launched the module under the Sugam portal for updating and uploading the data on its website related to the licensed drug manufacturing facilities and approved or licensed drug formulations for having up to date information on drugs manufactured in India.<\/p>\n\n\n\n<p>The Sugam is building a comprehensive database of\nthe various licenses and permissions issued by the appropriate departments of a\nState. This includes details of manufacturers, manufacturing sites, and the\ndrug&#8217;s formulations.<\/p>\n\n\n\n<p>The implementation of Sugam has brought\ntransparency, accountability, timeliness, reliability and simplicity to the\nbusiness. It is a major reform in the Pharma Industry of India, and it directly\nrefers to the Government Digital India initiatives.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Sugam_for_Online_Licensing\"><\/span>Sugam for Online Licensing<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>CDSCO Sugam is an e-Governance system to discharge various\nfunctions of the CDSCO. It is a software system developed for an online web\nportal where an applicant applies for the followings:<\/p>\n\n\n\n<ul><li>NOCs<\/li><li>Licenses<\/li><li>Registration Certificates<\/li><li>Permissions<\/li><li>Approvals<\/li><\/ul>\n\n\n\n<p>The Sugam provides an online interface to track the\napplications, respond to queries and download the permissions issues by the\nCDSCO. It is also helping the CDSCO officials in processing the online\napplications and generating the online permissions and the MIS reports.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Pre-Application: Registration<\/h3>\n\n\n\n<p>Sugam portal is a single-window interface for the\nstakeholders to access online services under the CDSCO. Before applying to any\nform, the applicant needs to register on the portal. The applicant fills in all\nthe details in the registration form and submits it. The CDSCO administrator\napproves or rejects such submitted registration forms. After approval of the\nregistration form, the applicant logins to the portal or if the form is\nrejected, then an email is sent to the applicant stating the reason for the\nrejection.<\/p>\n\n\n\n<p>The registration form is filed by the authorised\nsignatory or responsible person only. The hard copy of ID proof, undertaking,\nand address proof is submitted to the CDSCO office. The registration is\napproved by the CDSCO only after the evaluation of the documents submitted.\nAfter successful registration, the applicant can log in to the portal.<\/p>\n\n\n\n<p>The applicant who can register on the CDSCO Sugam\nportal are:<\/p>\n\n\n\n<ul><li>Corporate<\/li><li>Indian Agent<\/li><li>Importer<\/li><li>Foreign Enterprises holding Indian Subsidiary<\/li><li>Cosmetics<\/li><li>Ethics Committee<\/li><li>Formulation R&amp;D Organisation<\/li><li>BA\/BE Approved Sites<\/li><li>Sponsor (BA\/BE &amp; CT)<\/li><\/ul>\n\n\n\n<p>If the applicant has more than one manufacturing\nunit, then the applicant first registers its corporate on the Sugam Portal and\nthen registers its sub-units on the portal. The Manufacturing units do not\nregister directly; the corporate initiates the registration process for the\nmanufacturing units.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Purpose of Registration<\/h3>\n\n\n\n<p>The applicant registers on Sugam Portal with\ndifferent purposes with assigned roles and the Forms as given below:<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Purpose of Registration<\/strong>\n  <\/td><td>\n  <strong>Roles on Sugam<\/strong>\n  <\/td><td>\n  <strong>Forms Available<\/strong>\n  <\/td><\/tr><tr><td>\n  Cosmetics Registration \n  <\/td><td>\n  Applicant for Cosmetics\n  <\/td><td>\n  Form 42\n  <\/td><\/tr><tr><td>\n  Ethics Committee Registration \n  <\/td><td>\n  Ethics Committee \n  <\/td><td>\n  Ethics Committee Registration\n  <\/td><\/tr><tr><td>\n  Formulation R&amp;D Organisation \n  <\/td><td>\n  Formulation R&amp;D Organisation\n  <\/td><td>\n  Form 44 \n  Form 12\n  <\/td><\/tr><tr><td>\n  Import of Drugs\/Medical Devices\/Test\n  License\n  <\/td><td>\n  Corporate Importer (Form 8) \n  Foreign Enterprise holding Indian\n  Subsidiary Indian Agent\n  <\/td><td>\n  Form 40\n  Form 8\n  <\/td><\/tr><tr><td>\n  BA\/BE Approved Sites\n  <\/td><td>\n  BA\/BE Approved Sites\n  <\/td><td>\n  Form 44\n  <\/td><\/tr><tr><td>\n  Sponsors (BA\/BE &amp; CT)\n  <\/td><td>\n  Sponsors (BA\/BE &amp; CT)\n  <\/td><td>\n  Form 44\n  Form 12\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h3 class=\"wp-block-heading\">Documents<\/h3>\n\n\n\n<p>The followings are the documents required\nas per the purpose of registration:<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Purpose of Registration<\/strong>\n  <\/td><td>\n  <strong>Documents Required<\/strong>\n  <\/td><\/tr><tr><td>\n  Cosmetics Registration \n  <\/td><td>\n  Details of ID Proof, Power of Attorney,\n  Corporate Address Proof\n  <\/td><\/tr><tr><td>\n  Ethics Committee Registration \n  <\/td><td>\n  Details of ID Proof, Power of Attorney,\n  Corporate Address Proof\n  <\/td><\/tr><tr><td>\n  Formulation R&amp;D Organisation \n  <\/td><td>\n  Details of ID Proof, Power of Attorney\n  <\/td><\/tr><tr><td>\n  Import of Drugs\/Medical Devices\/Test\n  License\n  <\/td><td>\n  Details of ID Proof, Power of Attorney,\n  Corporate Address Proof and Manufacturing or Wholesale License (Form 20B\n  &amp; Form 21B)\n  <\/td><\/tr><tr><td>\n  BA\/BE Approved Sites\n  <\/td><td>\n  Details of ID Proof, Power of Attorney,\n  Corporate Address Proof\n  <\/td><\/tr><tr><td>\n  Sponsors (BA\/BE &amp; CT)\n  <\/td><td>\n  Details of ID Proof, Power of Attorney,\n  Corporate Address Proof\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h3 class=\"wp-block-heading\">Application Form Submission<\/h3>\n\n\n\n<p>The applicant fills the application form with all\nrequired details and submits it to the portal. Then the applicant submits the\ndocuments accordingly. After uploading the documents, the applicant makes\npayment either online or challan.<\/p>\n\n\n\n<p>The details of departments and their forms are as\nfollow:<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>CDSCO Departments\/ Stakeholders<\/strong>\n  <\/td><td>\n  <strong>Processes<\/strong>\n  <\/td><td>\n  <strong>Forms<\/strong>\n  <\/td><\/tr><tr><td>\n  Import &amp; Registration \n  <\/td><td>\n  Fresh Registration Certificate,\n  Endorsement &amp; re-registration, Post submission &amp; Post Approval\n  changes (PAC)\n  <\/td><td>\n  Form 40\/41\n  Form 8\/10\n  Form 12AA\n  17 cases of PAC\n  <\/td><\/tr><tr><td>\n  Medical Devices &amp; Diagnostics\n  <\/td><td>\n  Fresh Registration Certificate,\n  Endorsement &amp; re-registration, Post submission &amp; Post Approval\n  changes (PAC)\n  <\/td><td>\n  Form 40\/41\n  Form 8\/10\n  17 cases of PAC\n  <\/td><\/tr><tr><td>\n  Cosmetics Registration\n  <\/td><td>\n  Fresh Registration Certificate,\n  Endorsement, Re-registration\n  <\/td><td>\n  Form 42\/43\n  4 cases of PAC\n  <\/td><\/tr><tr><td>\n  Ethnic Committee Registration\n  <\/td><td>\n  Ethnic Committee Registration and\n  Re-registration \n  <\/td><td>\n  &nbsp;\n  <\/td><\/tr><tr><td>\n  Global Clinical Trials\n  <\/td><td>\n  NOC to conduct clinical trials \n  Import license for test and analysis\n  <\/td><td>\n  Form 44\/NOC \n  Form 12\/11\n  11 Cases of PAC\n  <\/td><\/tr><tr><td>\n  BA\/BE\n  <\/td><td>\n  NOC to BA\/BE studies\n  Import license for test and analysis\n  <\/td><td>\n  Form 44\/45\/46\n  NOC \n  &nbsp;\n  <\/td><\/tr><tr><td>\n  Biological- New Dug- Vaccines\n  <\/td><td>\n  Permission to Market\/Import\/Conduct Clinical\n  Trials\n  <\/td><td>\n  Form 44\/45\/46\n  NOC \n  <\/td><\/tr><tr><td>\n  New Drugs\/SND\/FDC\n  <\/td><td>\n  Permission to Market\/Import\/Conduct\n  Clinical Trials\n  <\/td><td>\n  Form 44\/45\/46\n  NOC\n  <\/td><\/tr><tr><td>\n  CLAA Processes\n  <\/td><td>\n  Grant &amp; Renewal of Licenses for:\n  Blood BankAnti-Sera Stem Celles\n  \n  \n  &nbsp;\n  <\/td><td>\n  Form 27C\/28C\n  Form 26G\n  Form 27F\/Form 28F\n  <\/td><\/tr><tr><td>\n  Port Offices\n  (7 locations)\n  <\/td><td>\n  Permission to import drugs in small\n  quantity for personal use\n  <\/td><td>\n  Form 12A\/12B\n  <\/td><\/tr><tr><td>\n  Zonal\/Sub Zonal Offices\n  <\/td><td>\n  Import License for Test &amp; Analysis\n  for Drugs more than 4 years (old drugs)\n  <\/td><td>\n  Form 12\/11\n  <\/td><\/tr><tr><td>\n  Zonal\/Sub Zonal Offices\n  <\/td><td>\n  Export NOC for manufacturing (5 cases):\n  Export purpose- BD, FF, material transfer, Exhibit Batches- BD, FF\n  <\/td><td>\n  Application Form\/NOC\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"CDSCO_Sugam_Login_and_Sub-Login_Guidelines\"><\/span>CDSCO Sugam Login and Sub-Login Guidelines<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>After the CDSCO approves registration, the\napplicant can log in to the Sugam portal. The applicant files the application\nwith all mandatory details. The application is further approved, rejected,\nsuspended or withdrawn by the authority.<\/p>\n\n\n\n<p>An applicant from the pharmaceutical industry can\npossess roles of the corporate, Indian agent, sponsors, etc. This function of\nthe Sugam portal is known as&nbsp;<strong>Switch Role<\/strong>. An applicant can also\nhave an additional role, and at the Sugam portal, he can&nbsp;<strong>request\nadditional roles<\/strong>. The applicant provided the required documents to the\nCDSCO Sugam portal for this additional role.<\/p>\n\n\n\n<p>The Sugam portal allows corporate applicants to\ncreate a sub-login account for filing independent applications by manufacturing\nunit, R&amp;D unit or any other unit. The sub-login can be created for the\nfollowing:<\/p>\n\n\n\n<ul><li>Branch Office<\/li><li>CRO<\/li><li>Manufacturing Site<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Objectives_of_CDSCO_Sugam_Portal\"><\/span>Objectives of CDSCO Sugam Portal<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The prime objectives of the Sugam portal are:<\/p>\n\n\n\n<ul><li>Establishes a single window for a number of stakeholders related to      the process of CDSCO.<\/li><li>Consolidates the Indian Drug Regulatory Framework by streamlining      the CDSCO process<\/li><li>Enables the paperless grant of various <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO licenses<\/strong><\/a>, or NOC<\/li><li>Enables transparency in the Drug Regulatory Process<\/li><li>Enables the ease in the pharmaceutical business and regulatory      agency.<\/li><li>Enables greater outreach of citizen-centric information related to      India&#8217;s quality and standard of drugs.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Benefits_of_CDSCO_Sugam\"><\/span>Benefits of CDSCO Sugam<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The following are the benefits of the Sugam Portal:<\/p>\n\n\n\n<ul><li>The Sugam provides a single-window for all stakeholders to access      services provided by implementing role-based access control and actions.<\/li><li>It has consolidated the whole Drug Regulatory framework.<\/li><li>It provides a centralised dashboard to monitor all the regulatory      clearances in India.<\/li><li>It provides high-level transparency as the status of the applications can be tracked on the portal.<\/li><li>It provides the project with all the information to reduce delays      in the regulatory process.<\/li><li>It provides an integrated workflow from making applications to      obtaining permission.<\/li><li>It also answers all the queries.<\/li><\/ul>\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>CDSCO Sugam is an online portal for CDSCO licensing. It was launched by the Ministry of Health and Family Welfare. It is an e-governance system which is launched to perform different functions of the CDSCO. These functions are provided under the Drugs and Cosmetics Act as approval of new drugs, Clinical Trials, etc. Implementation of Sugam has brought simplicity, transparency, reliability, accountability, etc. Sugam has multiple benefits, such as providing a single window for all stakeholders to access services.<\/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\/cdsco-medical-devices-manufacturing-registration-requirement\/\">CDSCO Medical Devices Manufacturing Registration Requirement\n<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The CDSCO Sugam was introduced in November 2015 by the Central Drugs Standard Control Organisation. It is an online portal for filing applications for various services. Brief on Central Drugs Standard Control Organisation The Central Drugs Standard Control Organisation (CDSCO) works as per the directions of the Directorate General of Health Services, Ministry of Health [&hellip;]<\/p>\n","protected":false},"author":36,"featured_media":44149,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2403],"acf":{"service_id":"508"},"authorName":"Shambhavi Suyesha","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/03\/IMG-20220324-WA0005.jpg","authorDescription":"Shambhavi holds a strong legal background, having completed her BA LLB and LLM. She is particularly interested in legal research and writing, and wishes to utilise her knowledge to create informative legal content. She is an analytical researcher and keeps herself updated about the current legal affairs. She also holds prior experience in publishing articles on assorted legal areas.","postViews":6412,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/44141"}],"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\/36"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=44141"}],"version-history":[{"count":16,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/44141\/revisions"}],"predecessor-version":[{"id":44158,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/44141\/revisions\/44158"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/44149"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=44141"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=44141"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=44141"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}