{"id":4526,"date":"2019-04-29T16:54:44","date_gmt":"2019-04-29T11:24:44","guid":{"rendered":"https:\/\/swaritadvisors.com\/learning\/?p=4526"},"modified":"2019-08-05T17:23:05","modified_gmt":"2019-08-05T11:53:05","slug":"how-to-apply-for-drug-license-online-in-india","status":"publish","type":"post","link":"https:\/\/swaritadvisors.com\/learning\/how-to-apply-for-drug-license-online-in-india\/","title":{"rendered":"Procedure for obtaining Drug License online in India"},"content":{"rendered":"\n<p class=\"has-drop-cap\">I f you wish to sell medicines or open a pharmacy in India, firstly, you need to obtain a drug license. The reason why drug license is mandatory is to ensuring public health. Further, it is to ensure that medicines and related items are not abused by any entity within the Nation. Therefore, keeping all such things into consideration, the Government of India came up with strict laws for manufacturing and distributing medicines and drugs in India.<\/p>\n\n\n\n<p>Drugs and Cosmetics Act, 1940 is the concerned law for regulating the manufacturing and sale of medicines or drugs and rules made thereunder. For the rest of the details regarding the drug license, we recommend you continue reading the blog. We will help you with every significant aspect of acquiring the license.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_65 counter-hierarchy ez-toc-counter ez-toc-light-blue ez-toc-container-direction\">\n<p class=\"ez-toc-title\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a3482bb7c737\" class=\"ez-toc-cssicon-toggle-label\"><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><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a3482bb7c737\"  aria-label=\"Toggle\" \/><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:\/\/swaritadvisors.com\/learning\/how-to-apply-for-drug-license-online-in-india\/#Market_Overview_of_Drug_Industry_or_Pharmaceutical_Industry\" title=\"Market Overview of Drug Industry or Pharmaceutical Industry\">Market Overview of Drug Industry or Pharmaceutical Industry<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/swaritadvisors.com\/learning\/how-to-apply-for-drug-license-online-in-india\/#1_The_international_market_scenario_of_the_drug_industry\" title=\"1.&nbsp; &nbsp; &nbsp;The international market scenario of the drug industry\">1.&nbsp; &nbsp; &nbsp;The international market scenario of the drug industry<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/swaritadvisors.com\/learning\/how-to-apply-for-drug-license-online-in-india\/#2_The_domestic_market_scenario_of_the_Indian_Pharmaceutical_Industry\" title=\"2.&nbsp; &nbsp; &nbsp;The domestic market scenario of the Indian Pharmaceutical Industry\">2.&nbsp; &nbsp; &nbsp;The domestic market scenario of the Indian Pharmaceutical Industry<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/swaritadvisors.com\/learning\/how-to-apply-for-drug-license-online-in-india\/#What_is_Drug_License\" title=\"What is Drug License?\">What is 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:\/\/swaritadvisors.com\/learning\/how-to-apply-for-drug-license-online-in-india\/#Types_of_Drug_License_in_India\" title=\"Types of Drug License in India\">Types 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-6\" href=\"https:\/\/swaritadvisors.com\/learning\/how-to-apply-for-drug-license-online-in-india\/#Checklist_for_obtaining_the_drug_license_in_India\" title=\"Checklist for obtaining the drug license in India\">Checklist for obtaining the drug license in India<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/swaritadvisors.com\/learning\/how-to-apply-for-drug-license-online-in-india\/#For_competent_personpharmacist\" title=\"For competent person\/pharmacist\">For competent person\/pharmacist<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/swaritadvisors.com\/learning\/how-to-apply-for-drug-license-online-in-india\/#Area_of_the_pharmacy_set-up\" title=\"Area of the pharmacy set-up\">Area of the pharmacy set-up<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/swaritadvisors.com\/learning\/how-to-apply-for-drug-license-online-in-india\/#The_storage_facility_of_drugs\" title=\"The storage facility of drugs\">The storage facility of drugs<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/swaritadvisors.com\/learning\/how-to-apply-for-drug-license-online-in-india\/#Documents_required_for_obtaining_a_license_for_selling_drugs_in_India\" title=\"Documents required for obtaining a license for selling drugs in India\">Documents required for obtaining a license for selling drugs in India<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/swaritadvisors.com\/learning\/how-to-apply-for-drug-license-online-in-india\/#Procedure_for_obtaining_drug_license_online_in_India\" title=\"Procedure for obtaining drug license online in India\">Procedure for obtaining drug license online in India<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/swaritadvisors.com\/learning\/how-to-apply-for-drug-license-online-in-india\/#Step_1_Sign_in_on_the_official_website_of_FSDAUP\" title=\"Step 1: Sign in on the official website of FSDAUP\">Step 1: Sign in on the official website of FSDAUP<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/swaritadvisors.com\/learning\/how-to-apply-for-drug-license-online-in-india\/#Step_2_Upload_the_required_documents\" title=\"Step 2: Upload the required documents\">Step 2: Upload the required documents<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/swaritadvisors.com\/learning\/how-to-apply-for-drug-license-online-in-india\/#Step_3_Send_the_hard_copy_of_application_and_documents_to_the_concerned_authority\" title=\"Step 3: Send the hard copy of application and documents to the concerned authority\">Step 3: Send the hard copy of application and documents to the concerned authority<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/swaritadvisors.com\/learning\/how-to-apply-for-drug-license-online-in-india\/#Step_4_Inspection_of_documents\" title=\"Step 4: Inspection of documents\">Step 4: Inspection of documents<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/swaritadvisors.com\/learning\/how-to-apply-for-drug-license-online-in-india\/#Step_5_Rectification_of_information_in_the_document\" title=\"Step 5: Rectification of information in the document\">Step 5: Rectification of information in the document<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/swaritadvisors.com\/learning\/how-to-apply-for-drug-license-online-in-india\/#Step_6_Issuance_of_a_Drug_license\" title=\"Step 6: Issuance of a Drug license\">Step 6: Issuance of a Drug license<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Market_Overview_of_Drug_Industry_or_Pharmaceutical_Industry\"><\/span>Market Overview of Drug Industry or Pharmaceutical Industry<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>As per the <a href=\"https:\/\/www.ibef.org\/industry\/pharmaceutical-india.aspx\" target=\"_blank\" rel=\"noopener noreferrer\">latest report of IBEF<\/a>, India is the world\u2019s largest contributor to generic drugs. Moreover, the pharmaceutical industry of India supplies over 50% of global demands, for the number of vaccines. Besides, the Indian pharmaceutical sector provides over 80% of the antiretroviral drugs used for combating Acquired Immune Deficiency Syndrome (AIDS).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"1_The_international_market_scenario_of_the_drug_industry\"><\/span>1.&nbsp; &nbsp; &nbsp;The international market scenario of the drug industry<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Here\u2019s the past, current, and future market scenario of Indian Drug Industry to the international market:<\/p>\n\n\n\n<ul><li>In the year 2017, the value of the pharmaceutical industry was expected at US$ 33 billion.<\/li><li>However, over 2015-20, the nation\u2019s drug industry is estimated to increase at a CAGR (Compound Annual Growth Rate) of 22.4% to reach US$ 55 billion.<\/li><li>Although pharmaceutical exports remained at US$ 15.52 billion in the Financial Year 2019 (up to January 2019).<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"2_The_domestic_market_scenario_of_the_Indian_Pharmaceutical_Industry\"><\/span>2.&nbsp; &nbsp; &nbsp;The domestic market scenario of the Indian Pharmaceutical Industry<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Not only in the international market but the Indian Drug Industry has achieved a hike in the domestic market as well. Here\u2019s the actual market overview:<\/p>\n\n\n\n<ul><li>In 2018, the turnover of India\u2019s domestic pharmaceutical market reached to Rs. 129, 015 crore .i.e., US$ 18.12 billion. It has a growth of 9.4% as compared to the year 2017.<\/li><li>In 2017, the pharmaceutical sector was calculated to be Rs. 116, 389 crores (US$ 17.87 billion).<\/li><\/ul>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter is-resized\"><img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/swaritadvisors.com\/learning\/wp-content\/uploads\/2019\/04\/drug-Turnover-in-US-Billion.png\" alt=\"drug Turnover in US$ Billion\" width=\"449\" height=\"360\"\/><\/figure><\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_Drug_License\"><\/span>What is Drug License?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The drug license is a mandatory permit granted by the governing authority under the Drugs and Cosmetic Act, 1940 to carry on the business of medicines or drugs or cosmetics. The concerned authority for issuing the license is the Central\/State Drugs Standard Control Organization.<\/p>\n\n\n\n<div class=\"shadow1\">The amount of drugs in the medicine should be in a medically prescribed ratio so that it can cure public health. Further, it ensures that it doesn\u2019t harm the human body anyway. Therefore, the Government of India has imposed some strict laws and regulations for the process of manufacturing and distributing drugs\/medicines.<\/div>\n\n\n\n<div>&nbsp;<\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Types_of_Drug_License_in_India\"><\/span>Types of Drug License in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Mainly, there are three <a href=\"https:\/\/swaritadvisors.com\/drug-license\">types of drug licenses issued<\/a> in India. They are as follows:<\/p>\n\n\n\n<ul><li>Manufacturing License<\/li><li>Loan License<\/li><li>Sales License<\/li><\/ul>\n\n\n\n<p>In this write-up, we will primarily focus on the sales license. The sales license is further classified as:<\/p>\n\n\n\n<ul><li>Retail license<\/li><li>Wholesale license<\/li><li>Restricted license for general stores (which depends on the type of sales done)<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Checklist_for_obtaining_the_drug_license_in_India\"><\/span>Checklist for obtaining the drug license in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In order to obtain a drug license in India, you need to satisfy the following conditions:<\/p>\n\n\n\n<ul><li>\n<h3><span class=\"ez-toc-section\" id=\"For_competent_personpharmacist\"><\/span>For competent person\/pharmacist<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<\/li><\/ul>\n\n\n\n<p>There must be a specialist in medicines who can take care of all the drugs. Additionally, if you are applying for a retail license, then you should be a qualified pharmacist. However, if you need a wholesaler license, you should be a graduate with at least one year of experience or an undergraduate with four years of experience.<\/p>\n\n\n\n<ul><li>\n<h3><span class=\"ez-toc-section\" id=\"Area_of_the_pharmacy_set-up\"><\/span>Area of the pharmacy set-up<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<\/li><\/ul>\n\n\n\n<p>The required area of the pharmacy shop should be at least 10 square meters. Besides, if you are applying for both wholesale and retail pharmacy, the minimum area of the carpet must be 15 square meters. Furthermore, the premises must contain ventilation.<\/p>\n\n\n\n<ul><li> <h3><span class=\"ez-toc-section\" id=\"The_storage_facility_of_drugs\"><\/span>The storage facility of drugs<span class=\"ez-toc-section-end\"><\/span><\/h3> <\/li><\/ul>\n\n\n\n<p>One must store the medicines in a clean, hygienic, cool, and ventilated area. However, certain drugs and vaccines require a low-temperate freezing zone for storage. While an air conditioner and a refrigerator are mandatory for everybody willing to acquire a drug license in India. Therefore, every medicine and drug should be stored as prescribed or the authority will reject the application for the license.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_required_for_obtaining_a_license_for_selling_drugs_in_India\"><\/span>Documents required for obtaining a license for selling drugs in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>You require providing the following documents for acquiring sales license for selling the drug in India:<\/p>\n\n\n\n<ul><li>Memorandum of Association (MOA) and Articles of Association (AOA) of the firm;<\/li><li>Identity proof such as PAN card of the sole proprietor, directors and their partners;<\/li><li>Address proof of the owned office premises;<\/li><li>In the case of rented property, rent agreement is mandatory;<\/li><li>Details of drug storage such as invoices of the refrigerator and air conditioner;<\/li><li>Qualification proof such as certificates or form of degrees or mark sheets;<\/li><li>Any other additional wholesale documents for obtaining a wholesale license for selling drugs;<\/li><li>Required experience certificate depending upon the kind of sales license;<\/li><li>Other licenses as required.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_obtaining_drug_license_online_in_India\"><\/span>Procedure for obtaining drug license online in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>For acquiring a drug license, you need to file an application with the concerned authority of your state. However, before that, you need to find out the form suitable for you. Below, we have described a few significant steps to help you with online registration. Here we go:<\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter is-resized\"><img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/swaritadvisors.com\/learning\/wp-content\/uploads\/2019\/04\/drug-license-steps-in-india.png\" alt=\"drug license steps in india\" width=\"493\" height=\"597\"\/><\/figure><\/div>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Step_1_Sign_in_on_the_official_website_of_FSDAUP\"><\/span><strong>Step 1: Sign in on the official website of FSDAUP<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Firstly, go to the <a rel=\"noopener noreferrer\" href=\"http:\/\/fsdaup.gov.in\/online-licensing.htm\" target=\"_blank\">official website of FSDAUP<\/a>, and sign in as a new user. Fsduap is an online platform for the Food Safety and Drug Administration. There, you need to select the option of online registration for Drugs\/Cosmetics sales.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Step_2_Upload_the_required_documents\"><\/span><strong>Step 2: Upload the required documents<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Secondly, upload the essential documents required for drug license for sales and click on submit.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Step_3_Send_the_hard_copy_of_application_and_documents_to_the_concerned_authority\"><\/span><strong>Step 3: Send the hard copy of application and documents to the concerned authority<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Next, you require sending one hard copy of the application along with all the other obligatory documents to the office of Food Safety and Drug Administration.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Step_4_Inspection_of_documents\"><\/span>Step 4: Inspection of documents<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Once you have sent the documents to the concerned authority, they will scrutinize them as intimated to the applicant.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Step_5_Rectification_of_information_in_the_document\"><\/span><strong>Step 5: Rectification of information in the document<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>In the case, the Drugs Control Authorities find any error; they will give the applicant a prescribed time for rectification.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Step_6_Issuance_of_a_Drug_license\"><\/span><strong>Step 6: Issuance of a Drug license<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Once the applicant has addressed the objection, he\/she will receive the license from the Licensing Authority.<\/p>\n\n\n\n<p>Hence, this is all the registration process of the drug license required. However, if you still have some doubts, you can leave a comment below. Or if you want a drug license, you can contact Swarit Advisors. We will aid you with the fastest issuance of the license.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>I f you wish to sell medicines or open a pharmacy in India, firstly, you need to obtain a drug license. The reason why drug license is mandatory is to ensuring public health. Further, it is to ensure that medicines and related items are not abused by any entity within the Nation. Therefore, keeping all [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":4610,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[494],"tags":[495,34,32],"_links":{"self":[{"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/posts\/4526"}],"collection":[{"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/comments?post=4526"}],"version-history":[{"count":23,"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/posts\/4526\/revisions"}],"predecessor-version":[{"id":5857,"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/posts\/4526\/revisions\/5857"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/media\/4610"}],"wp:attachment":[{"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/media?parent=4526"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/categories?post=4526"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/tags?post=4526"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}