{"id":21945,"date":"2020-12-15T12:24:04","date_gmt":"2020-12-15T06:54:04","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=21945"},"modified":"2020-12-15T12:24:06","modified_gmt":"2020-12-15T06:54:06","slug":"registration-process-to-obtain-drug-license-in-india","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/registration-process-to-obtain-drug-license-in-india\/","title":{"rendered":"A Detailed Outlook on the Registration Process to Obtain Drug License in India"},"content":{"rendered":"\n<p class=\"has-drop-cap\">Ensuring everyone having fair access to medicine &amp; drug is\nthe fundamental concern of the Indian government. However, the right to sell\n&amp; manufacture the drugs has to be given with extreme caution. Producing\ndrugs in India is not an easy task since it is subjected to stringent rules and\nregulations. The Act that governs the manufacturing and selling of the drug in\nIndia is the Drugs and Cosmetics Act, 1940. In this write-up, we will unveil\nthe Registration Process to Obtain Drug License.&nbsp;<\/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\/registration-process-to-obtain-drug-license-in-india\/#Categories_of_Drug_license_in_India\" >Categories of Drug license in India<\/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\/registration-process-to-obtain-drug-license-in-india\/#Prerequisites_to_be_Considered_for_Availing_Drug_License\" >Prerequisites to be Considered for Availing Drug 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\/registration-process-to-obtain-drug-license-in-india\/#Application_Related_to_Registration_Process_to_Obtain_Drug_License\" >Application Related to Registration Process to Obtain Drug 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\/registration-process-to-obtain-drug-license-in-india\/#Type_of_Documents_to_be_Arranged_for_Obtaining_Drug_License\" >Type of Documents to be Arranged for Obtaining Drug 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\/registration-process-to-obtain-drug-license-in-india\/#Type_of_Application_Forms_for_Drug_license_that_Serve_Different_Purposes\" >Type of Application Forms for Drug license that Serve Different Purposes<\/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\/registration-process-to-obtain-drug-license-in-india\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Categories_of_Drug_license_in_India\"><\/span>Categories of Drug license in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In the view of the definition of \u201cDrug\u201d given under the act, the pharmaceutical companies in the country would require to avail of the following licenses:-\u00a0<\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter\"><img decoding=\"async\" width=\"1000\" height=\"448\" src=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/12\/Categories-of-Drug-license-in-India.png\" alt=\"Categories of Drug license in India\" class=\"wp-image-21955\" srcset=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/12\/Categories-of-Drug-license-in-India.png 1000w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/12\/Categories-of-Drug-license-in-India-300x134.png 300w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/12\/Categories-of-Drug-license-in-India-768x344.png 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Manufacturing License<\/h3>\n\n\n\n<p>Such Licenses are essentially issued to the entities involved\nwith the manufacturing of drugs, including allopathic\/ homeopathy medicines.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Sale License&nbsp;<\/h3>\n\n\n\n<p>License is issued to those entities who wish to engage with the\nbusiness of drug selling. The sale license is further classified into the 3\ncategories&nbsp;<\/p>\n\n\n\n<ul><li><a href=\"https:\/\/corpbiz.io\/wholesale-drug-license\"><strong>Wholesale Drug License<\/strong><\/a><\/li><li>Retail Drug License<\/li><li>Restricted Drugs<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Loan License<\/h3>\n\n\n\n<p>A loan license is issued to those entities which outsource the\ndrug manufacturing services to another entity.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Import License&nbsp;<\/h3>\n\n\n\n<p>Import licenses serve those firms that intend to import certain\ncategories of drugs and medicine from the overseas location.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Multi-Drug License<\/h3>\n\n\n\n<p>A multi-drug license is mandated for those business establishments that own pharmacies in several states with the same name.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Prerequisites_to_be_Considered_for_Availing_Drug_License\"><\/span>Prerequisites to be Considered for Availing Drug License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Applicant seeking <a href=\"https:\/\/corpbiz.io\/drug-license\"><strong>Drug license<\/strong><\/a> must take the following parameter into the account before engaging with the Registration Process to Obtain Drug License. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Pharmacist\/ Competent Individual<\/h3>\n\n\n\n<p>The pharmacist must carry sufficient qualifications in the case\nof a retail business. Meanwhile, in the case of a wholesale business, the\napplicant must be at least a graduate individual with in-hand experience of not\nless than one year. In case if the applicant is an undergraduate then he\/she\nmust have 4 years of experience in the same field.&nbsp;&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Space Requirement<\/h3>\n\n\n\n<p>Space is another crucial prerequisite that has to be taken into\nthe account before applying for a drug license.<\/p>\n\n\n\n<ul><li>For both retail &amp; wholesale license- 15 meter square. <\/li><li>In remaining cases- 10 meter square. <\/li><\/ul>\n\n\n\n<p>The height of the premises where the activities of drug selling is proposed to be conducted should be as per the <strong>National Building Code of India, 2005<\/strong><sup><a href=\"https:\/\/bis.gov.in\/index.php\/standards\/technical-department\/national-building-code\/\"><strong>[1]<\/strong><\/a><\/sup><strong>.<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Storage Facility<\/h3>\n\n\n\n<p>The storage facilities is another key parameter that ought to be\nconsidered since the majority of the drug is sensitive to a higher temperature\nand even get expired in case of prolonged exposure.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Application_Related_to_Registration_Process_to_Obtain_Drug_License\"><\/span>Application Related to Registration Process to Obtain Drug License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Below we have outlined a detailed guide to avail the drug\nlicense from the relevant authority:-<\/p>\n\n\n\n<ul><li>The applicants must make an online application for the license given their line of business, for which they have a legitimate contact number and valid email ID.\u00a0<\/li><li>The next step is to determine whether the document related to the Drug license is updated or not.\u00a0<\/li><li>Next, upload the scan copy of the document and the form along with the requested fees.\u00a0<\/li><li>After completing the online process, an official will visit the premises (where the business is proposed to be conducted) for the verification of the documents.<\/li><li>The authority would either accept or reject your candidature for drug license based on the verification of submitted documents and application.\u00a0<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Type_of_Documents_to_be_Arranged_for_Obtaining_Drug_License\"><\/span>Type of Documents to be Arranged for Obtaining Drug License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Documentation is a vital part of the Registration Process to\nObtain Drug License. The applicant seeking a drug license must arrange the\nfollowing documentation without exception:-<\/p>\n\n\n\n<ul><li>Constitution of the establishment: &#8211; Articles of Association (AOA) and Memorandum of Association (MOA) in case if the entity is registered as a private limited or public limited entity. In case, if the establishment is a partnership-oriented firm or an LLP, then a partnership deed would be required.<\/li><li>Identification proof of the Director\/Partner\/Proprietor.\u00a0<\/li><li>Documentation related to the establishments- Copy of      the document representing the ownership of the property or rental      agreement depending<\/li><li>Documents related to premises \u2013 Copy of ownership documents of property or rental agreement depending on the circumstances.<\/li><li>Detailed Floor plan of the establishments.<\/li><li>Copy related to the board resolution for availing the drug license.<\/li><li>A document highlighting the availability of storage space acting as cold storage, refrigerator for preserving the drugs in the controlled environment.\u00a0<\/li><li>Copy of challan acting as a proof of depositing fee.<\/li><li>An affidavit showing the non-indulgence of the partner or director with the criminal activities.\u00a0<\/li><li>The affidavit from the competent individual\/pharmacist for authenticating the candidature of the applicant.\u00a0<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">For a Pharmacist Engaged in the Retail Sale<\/h3>\n\n\n\n<ul><li>Qualification proof&nbsp;<\/li><li>Registration availed from the local pharmacy council<\/li><li>Letter of appointment&nbsp;<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">For a pharmacist engaged in the Wholesale Sale<\/h3>\n\n\n\n<ul><li>Proof of qualification<\/li><li>Experience certificate<\/li><li>Appointment letter<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Type_of_Application_Forms_for_Drug_license_that_Serve_Different_Purposes\"><\/span>Type of Application Forms for Drug license that Serve Different Purposes <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>S.No<\/strong>\n  <\/td><td>\n  <strong>Form no.<\/strong>\n  <\/td><td>\n  <strong>Purpose<\/strong>\n  <\/td><\/tr><tr><td>\n  1.\n  <\/td><td>\n  Form 19\n  <\/td><td>\n  Application for the renewal or\n  issuance of a license to sell out, procure, exhibit, or distribute drugs\n  other than listed under Schedule X.\n  <\/td><\/tr><tr><td>\n  2.\n  <\/td><td>\n  Form 19A\n  <\/td><td>\n  Application for issuing or renewing a limited license to sell,\n  procure, sale, or distribute drugs through a&nbsp;\n  retail channel that doesn\u2019t involve the service of a qualified\n  individual.\n  <\/td><\/tr><tr><td>\n  3.\n  <\/td><td>\n  Form 19B\n  <\/td><td>\n  Application for license to sell,\n  procure or sale, or distribute Homoeopathic-based Medicines.\n  <\/td><\/tr><tr><td>\n  4.\n  <\/td><td>\n  Form 19C\n  <\/td><td>\n  Application related to issuance or renewal of a [license to\n  sell, procure, <em>exhibit or offer for sale<\/em>, or distribute] drugs\n  mentioned in Schedule X.\n  &nbsp;\n  <\/td><\/tr><tr><td>\n  5.\n  <\/td><td>\n  Form 24\n  <\/td><td>\n  Application for either the issuance\n  or renewal of a license or to manufacture or for distribution of drugs\n  excluding those which are mentioned in [Schedule C, C (1) and X].\n  <\/td><\/tr><tr><td>\n  6.\n  <\/td><td>\n  Form 24A\n  <\/td><td>\n  Application for either the issuance or renewal of a loan\n  license for manufacturing or distribution of drugs expects those mentioned in\n  Schedule C, C (1), and X.\n  <\/td><\/tr><tr><td>\n  7.\n  <\/td><td>\n  Form 24B\n  <\/td><td>\n  Application related for issuance or\n  renewal of a license serving the purpose of drug repacking for sale or\n  distribution. It doesn&#8217;t cover the drug mentioned Schedule C and C (1)\n  <\/td><\/tr><tr><td>\n  8.\n  <\/td><td>\n  Form 24C\n  <\/td><td>\n  Application related to the issuance or renewal of a license\n  serving the purpose of manufacturing or distribution of Homoeopathic\n  medicines or a license to produce potentized preparations from the back\n  potencies by licensees having a license in Form 20-C\n  <\/td><\/tr><tr><td>\n  9.\n  <\/td><td>\n  Form 24F\n  <\/td><td>\n  Application related to the issuance\n  or renewal of a license which is required for manufacturing or distribution\n  of drugs other than specified in Schedule C and C(1).\n  <\/td><\/tr><tr><td>\n  10.\n  <\/td><td>\n  Form 27\n  <\/td><td>\n  Application for issuance or renewal of a license to\n  manufacture for sale or distribution of drugs specified in Schedule C and C\n  (1) except those mentioned in part XB and Schedule X\n  <\/td><\/tr><\/tbody><\/table>\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>Drug License is imperative for establishments involved with the\nmanufacturing, distribution, and procurement of the drug. The Registration\nProcess to Obtain Drug License may seem plain and simple on the surface, but it\nis a lot more complicated in the real-world scenario. <\/p>\n\n\n\n<p>The rejection rate of the drug license is relatively higher than any other license since it is associated with human life in one way or another. The issuance authority might cancel your request for a license even if it got a negligible disparity. Therefore, the individual must be spot on with the documentation work and meet the remaining prerequisite against the prescribed norms.<\/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\/purchase-of-drug-patents-by-the-pharmaceutical-companies-in-india\/\">\nPurchase of Drug Patents by the Pharmaceutical Companies in India\n<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ensuring everyone having fair access to medicine &amp; drug is the fundamental concern of the Indian government. However, the right to sell &amp; manufacture the drugs has to be given with extreme caution. Producing drugs in India is not an easy task since it is subjected to stringent rules and regulations. The Act that governs [&hellip;]<\/p>\n","protected":false},"author":22,"featured_media":21950,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[223],"tags":[1322],"acf":{"service_id":"98"},"authorName":"Pankaj Tyagi","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/01\/MicrosoftTeams-image-42.jpg","authorDescription":"Pankaj has a diverse experience of writing research papers, blog, and articles during his college time. Earlier, he was working as a tax consultant in a financial firm, but his interest in writing drives him to pursue a career in the writing field.","postViews":3939,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/21945"}],"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\/22"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=21945"}],"version-history":[{"count":11,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/21945\/revisions"}],"predecessor-version":[{"id":21959,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/21945\/revisions\/21959"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/21950"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=21945"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=21945"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=21945"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}