{"id":7082,"date":"2026-02-19T10:02:44","date_gmt":"2026-02-19T10:02:44","guid":{"rendered":"https:\/\/advisou.com\/blog\/?p=7082"},"modified":"2026-02-19T10:02:46","modified_gmt":"2026-02-19T10:02:46","slug":"cdsco-license-registration-and-process","status":"publish","type":"post","link":"https:\/\/advisou.com\/blog\/cdsco-license-registration-and-process\/","title":{"rendered":"A CDSCO License: Complete Guide to Registration, Process, and Fees in India"},"content":{"rendered":"\n<p>The CDSCO License is considered one of the most important regulatory approvals for a business who is dealing in drugs, medical devices, or cosmetics in India. The product becomes a stamp of safety and quality as it is certified by the Central Drugs Standard Control Organisation (CDSCO) in India.<\/p>\n\n\n\n<p>Without this license, manufacturing or importing these items is illegal. In this guide, we simplify the entire CDSCO Licence registration process, breaking down the essential documents, government fees, and steps to help you stay compliant and market-ready.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_78 ez-toc-wrap-left 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\" style=\"cursor:inherit\">Table of 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 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/advisou.com\/blog\/cdsco-license-registration-and-process\/#Why_Does_Your_Business_Need_a_CDSCO_License\" >Why Does Your Business Need a CDSCO License?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/advisou.com\/blog\/cdsco-license-registration-and-process\/#Types_of_CDSCO_Licences\" >Types of CDSCO Licences<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/advisou.com\/blog\/cdsco-license-registration-and-process\/#Who_Must_Apply_for_CDSCO_Registration_in_India\" >Who Must Apply for CDSCO Registration in India?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/advisou.com\/blog\/cdsco-license-registration-and-process\/#Step-by-Step_Guide_to_the_CDSCO_Online_Registration_Process\" >Step-by-Step Guide to the CDSCO Online Registration Process<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/advisou.com\/blog\/cdsco-license-registration-and-process\/#Mandatory_Documents_Required_for_CDSCO_License\" >Mandatory Documents Required for CDSCO License<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/advisou.com\/blog\/cdsco-license-registration-and-process\/#Official_Fees_and_Approval_Timelines_for_CDSCO_Licenses\" >Official Fees and Approval Timelines for CDSCO Licenses<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/advisou.com\/blog\/cdsco-license-registration-and-process\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Why_Does_Your_Business_Need_a_CDSCO_License\"><\/span>Why Does Your Business Need a CDSCO License?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Central Drugs Standard Control Organisation is India&#8217;s main drug control body. It works under the Ministry of Health and Family Welfare. It ensures that organisations follow the provisions of the Drugs and Cosmetics Act for drugs, medical devices, and cosmetics.<\/p>\n\n\n\n<p>A <a href=\"https:\/\/advisou.com\/services\/cdsco-registration-2\"><strong>CDSCO License<\/strong><\/a> in India gives a company permission to make, import, or sell regulated products. It is illegal to sell these products without this license, you can face product seizure, heavy fines, and a market ban.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Types_of_CDSCO_Licences\"><\/span>Types of CDSCO Licences<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Different businesses need different types of licenses from CDSCO:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Drug and cosmetic related licenses<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Drug manufacturing license<\/strong> \u2013 You need this to make medicines for sale. It shows your factory follows good practices and quality rules.<\/li>\n\n\n\n<li><strong>Import license for drugs and cosmetics<\/strong> \u2013 You need this to bring in finished products, raw materials, or cosmetic items from other countries. It proves the foreign factory and products meet Indian safety standards.<\/li>\n\n\n\n<li><strong>Registration certificate<\/strong> \u2013 This lets you register and sell a specific product in India.<\/li>\n\n\n\n<li><strong>GMP certificate and COPP<\/strong> \u2013 You often need these when you export products from India or want to show you follow quality rules.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Medical device related approvals<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Medical device registration<\/strong> \u2013 All medical devices in Class A, B, C, and D need registration with CDSCO before you can sell them.<\/li>\n\n\n\n<li><strong>Manufacturing and import licenses<\/strong> \u2013 The fees change based on device risk class and whether you make it in India or bring it from abroad.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Who_Must_Apply_for_CDSCO_Registration_in_India\"><\/span>Who Must Apply for CDSCO Registration in India?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Indian companies that make drugs, medical devices, and cosmetics<\/li>\n\n\n\n<li>Companies that import regulated products into India<\/li>\n\n\n\n<li>Foreign companies that work with Indian agents<\/li>\n\n\n\n<li>Companies that do clinical trials or research with drugs or devices<\/li>\n\n\n\n<li>Testing labs that work on studies for exports<\/li>\n<\/ul>\n\n\n\n<p>You may require CDSCO Registration if your business imports, manufactures or sells any goods under the Drugs and Cosmetics Act. Contact Advisou experts if you experience difficulties.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Step-by-Step_Guide_to_the_CDSCO_Online_Registration_Process\"><\/span>Step-by-Step Guide to the CDSCO Online Registration Process<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The full CDSCO Registration process happens online through the SUGAM portal:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Account creation on the portal<\/strong><\/h3>\n\n\n\n<p>Go to the official <strong>CDSCO portal<\/strong><sup><a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Home\/\" target=\"_blank\" rel=\"noopener\"><strong>[1]<\/strong><\/a><\/sup> and click &#8220;Login\/Sign Up.&#8221; Pick the right &#8220;Registration Purpose&#8221; from the list. Fill in details like your type, username, and email. Upload your ID proof, a signed statement, and address proof. You will get a link in your email. After CDSCO officials approve your account, you can log in and apply for licenses.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Product and license planning<\/strong><\/h3>\n\n\n\n<p>Before you apply, find out your correct product type always verify the classification as a drug, cosmetic, or device. Determine whether you are required to obtain a license to manufacture, import or register the product. It\u2019s important to get this right because it affects the papers you need and how much you pay.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Document preparation and application filing<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Device Master File or Plant Master File:<\/strong> Details about how you make the product.<\/li>\n\n\n\n<li><strong>Technical Data:<\/strong> Documents about product use and risk.<\/li>\n\n\n\n<li><strong>Quality Certification:<\/strong> Certificates like ISO 13485.<\/li>\n\n\n\n<li><strong>Regulatory Status:<\/strong> Permission from the home country for imports.<\/li>\n\n\n\n<li><strong>Clinical Evidence:<\/strong> Test data for new or risky products.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Review and Final Approval<\/strong><\/h3>\n\n\n\n<p>CDSCO officials will check your application and may ask for more details or extra papers. Once they are satisfied with everything, they issue your license or certificate through the portal.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Mandatory_Documents_Required_for_CDSCO_License\"><\/span>Mandatory Documents Required for CDSCO License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Compulsory documents you may need include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Government ID proof and address proof<\/li>\n\n\n\n<li>Making or selling license from your State Licensing Authority<\/li>\n\n\n\n<li>Company papers like incorporation certificate<\/li>\n\n\n\n<li>Technical file with product details and use<\/li>\n\n\n\n<li>Quality certificates<\/li>\n\n\n\n<li>Free Sale Certificate or permission for imported products<\/li>\n\n\n\n<li>Test data for new or risky products<\/li>\n\n\n\n<li>Sample labels with all required information<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Official_Fees_and_Approval_Timelines_for_CDSCO_Licenses\"><\/span>Official Fees and Approval Timelines for CDSCO Licenses<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>For Medical Devices<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Class A and B Making:<\/strong> \u20b95,000 per factory and \u20b9500 per device<\/li>\n\n\n\n<li><strong>Class C and D Making:<\/strong> \u20b950,000 per factory and \u20b91,000 per device<\/li>\n\n\n\n<li><strong>Class A Import:<\/strong> $1,000 per factory and $50 per device<\/li>\n\n\n\n<li><strong>Class B Import:<\/strong> $2,000 per factory and $1,000 per device<\/li>\n\n\n\n<li><strong>Class C and D Import:<\/strong> $3,000 per factory and $1,500 per device<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>For Cosmetics<\/strong><\/h3>\n\n\n\n<p>Registration costs \u20b910,000 (or $250) for up to 10 items in one category. Additional items will cost \u20b9500 each.<\/p>\n\n\n\n<p>Low-risk devices can get approval in a few months if all papers are correct. High-risk products take longer because officials do deeper checks. Missing or wrong papers can add weeks or months to the wait time.<\/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>A CDSCO license is required for healthcare and cosmetics business under Central Drug Standard Control Organisation. Understanding the necessary approvals for your projects, the required documents and their costs results in better planning.<\/p>\n\n\n\n<p>With proper preparation and expert guidance, your business can get the right permits and comply. If you have any queries related to business compliance, you can trust <strong><a href=\"https:\/\/advisou.com\/\">Advisou<\/a><\/strong> for reliable guidance.<\/p>\n\n\n\n<p><strong>Also Read:<\/strong>&nbsp;<a href=\"https:\/\/advisou.com\/blog\/nbfc-license-registration-process-in-india\/\">Complete NBFC License Registration Process in India as per RBI<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The CDSCO License is considered one of the most important regulatory approvals for a business who is dealing in drugs, medical devices, or cosmetics in India. The product becomes a stamp of safety and quality as it is certified by the Central Drugs Standard Control Organisation (CDSCO) in India. Without this license, manufacturing or importing [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":7087,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1065],"tags":[1078,1079,1080],"class_list":["post-7082","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cdsco-registration","tag-cdsco-license","tag-cdsco-registration","tag-what-is-cdsco"],"blocksy_meta":[],"_links":{"self":[{"href":"https:\/\/advisou.com\/blog\/wp-json\/wp\/v2\/posts\/7082","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/advisou.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/advisou.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/advisou.com\/blog\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/advisou.com\/blog\/wp-json\/wp\/v2\/comments?post=7082"}],"version-history":[{"count":4,"href":"https:\/\/advisou.com\/blog\/wp-json\/wp\/v2\/posts\/7082\/revisions"}],"predecessor-version":[{"id":7086,"href":"https:\/\/advisou.com\/blog\/wp-json\/wp\/v2\/posts\/7082\/revisions\/7086"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/advisou.com\/blog\/wp-json\/wp\/v2\/media\/7087"}],"wp:attachment":[{"href":"https:\/\/advisou.com\/blog\/wp-json\/wp\/v2\/media?parent=7082"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/advisou.com\/blog\/wp-json\/wp\/v2\/categories?post=7082"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/advisou.com\/blog\/wp-json\/wp\/v2\/tags?post=7082"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}