{"id":9502,"date":"2020-03-16T08:30:06","date_gmt":"2020-03-16T03:00:06","guid":{"rendered":"https:\/\/swaritadvisors.com\/learning\/?p=9502"},"modified":"2020-07-03T12:52:18","modified_gmt":"2020-07-03T07:22:18","slug":"how-to-obtain-a-drug-license-certificate-in-india","status":"publish","type":"post","link":"https:\/\/swaritadvisors.com\/learning\/how-to-obtain-a-drug-license-certificate-in-india\/","title":{"rendered":"How to obtain a Drug License Certificate in India?"},"content":{"rendered":"\n<p class=\"has-drop-cap\">Stepping into Pharmaceutical industry is quite challenging, specifically in a country like India that already accommodates about <strong>5, 50,000 Drug stores<\/strong>. The market of Indian Retail Pharmacy has tremendously grown over the recent years on an average of 18% per annum. The increasing health deterioration cases have prompted the need for multiple <strong>Drug stores &amp; Pharmacists<\/strong> in every nook and corner of our nation. If you also want to open a Drugstore, then you have to acquire permission from Government in the <strong>form of Drug License<\/strong>. This document will provide you comprehensive knowledge related to <strong><a href=\"https:\/\/swaritadvisors.com\/drug-license\">Drug License Certificate<\/a> in India<\/strong>.    <\/p>\n\n\n\n<div class=\"wp-block-button aligncenter\"><a class=\"wp-block-button__link has-background\" href=\"https:\/\/swaritadvisors.com\/drug-license\" style=\"background-color:#01669c\">Apply for Online Drug License Today<\/a><\/div>\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-6a3a6183e46af\" 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-6a3a6183e46af\"  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-obtain-a-drug-license-certificate-in-india\/#Importance_of_Drug_License_in_India\" title=\"Importance of Drug License in India  \n\">Importance of Drug License in India  \n<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/swaritadvisors.com\/learning\/how-to-obtain-a-drug-license-certificate-in-india\/#Provisions_to_get_a_Drug_License_Certificate\" title=\"Provisions to get a Drug License Certificate \n\">Provisions to get a Drug License Certificate \n<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/swaritadvisors.com\/learning\/how-to-obtain-a-drug-license-certificate-in-india\/#Who_can_apply_for_Drug_License\" title=\"Who can apply for Drug License?\">Who can apply for 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:\/\/swaritadvisors.com\/learning\/how-to-obtain-a-drug-license-certificate-in-india\/#Checklist_of_documents\" title=\"Checklist of documents \n\">Checklist of documents \n<\/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-obtain-a-drug-license-certificate-in-india\/#Online_process_for_Drug_License_Registration\" title=\"Online process for Drug License Registration \n\">Online process for Drug License Registration \n<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/swaritadvisors.com\/learning\/how-to-obtain-a-drug-license-certificate-in-india\/#Conclusion\" title=\"Conclusion \n\">Conclusion \n<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Importance_of_Drug_License_in_India\"><\/span>Importance of Drug License in India  \n<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Anyone who wishes to carry out the activities of trade, sale, manufacture, import or resale of Drugs in Pharmaceutical market must procure Drug License. It is mandatory to have a <strong>Drug License Certificate<\/strong> under Drugs &amp; Cosmetics Act, 1940. \u00a0It is issued by Central Drug Standard Control Organization (CDSCO).<\/p>\n\n\n\n<p>CDSCO regulates and approves new <strong>clinical trials and Drugs in India<\/strong>. The Authority also lays a set of standards for Drugs and ensures the quality of imported Drugs by coordinating with State Drugs Standard Control Organizations. Further, it aims to bring steadiness in the enforcement of Drugs and Cosmetics Act, 1940.<\/p>\n\n\n\n<p>The Act safeguards the public health and any negligence of Drug retailer or manufacturer shall be considered as an offence.  Drug License is indispensable to have for every type of cosmetics and Drugs business ranging from Homeopathic to Ayurvedic, Allopathic and even Unani Drugs.   <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Provisions_to_get_a_Drug_License_Certificate\"><\/span>Provisions to get a Drug License Certificate \n<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Drugs and Cosmetic Act 1940<\/strong> has laid the guidelines and rules which are required to be met by a Pharmaceutical applicant. Here are the conditions to comply with before and after attaining a <strong><a href=\"https:\/\/swaritadvisors.com\/drug-license\">Drug License<\/a><\/strong>:  <\/p>\n\n\n\n<ul><li>Any person with the intent of <strong>running a Drug business<\/strong> must have at least four years of knowledge and practical experience in Drug distribution. <\/li><li>A Drug retailer needs to make an entry in the register each time of Drug supply. <\/li><li>The <strong>Drug Licensee must not sell any Drug subsequent<\/strong> to its expiry.  <\/li><li>The Drugs can only be manufactured under the supervision of a Registered Pharmacist. <\/li><li>Every <strong>Drug Licensee<\/strong> must keep a record of the Drugs sold through retailing or intended for sale. <\/li><li>Drugs are prohibited from being sold by a minor (below 18 years). <\/li><li>The Drug Licensee must not store any Drug at his\/her premise that was meant for free sample distribution to a Medical Practitioner. <\/li><li>A medicine to cure animals must be labeled with \u201cNot for human use, for the treatment of animals only.\u201d <\/li><li>Schedule X and Schedule H Drugs categorized under the\u00a0Drugs\u00a0and Cosmetics Rules 1945 should only be supplied to the registered hospitals, dispensaries, nursing homes on a signed written order. <\/li><li>A Registered Pharmacist must undertake a thorough inspection of medicines prescribed by a Registered Medical Practitioner before retail supply. <\/li><li>In case, a <strong>Drug License<\/strong> has\u00a0stored an expired Drug to claim a rebate from the Income Tax Department; then it shall not be regarded as an offence under the\u00a0Drug and Cosmetic Act, 1940\u00a0until it was not intended for sale. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Who_can_apply_for_Drug_License\"><\/span>Who can apply for Drug License?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Nowadays everyone relies upon local Drugstores for trivial diseases, it is crucial to have certified professionals operating the entity. Therefore, Central Drug Standard Control Organization has listed stringent <strong>criteria to get Drug License Certificate<\/strong>:<\/p>\n\n\n\n<ul><li><strong>Drug Storage Facility<\/strong>&#8211; A Pharmacy or Drugstore must have a sound ventilation system, refrigerator and an air conditioner. <\/li><li><strong>Area of Pharmacy\/Drugstore<\/strong>&#8211; The minimum carpet area of a Drugstore\/pharmacy shop has to be 10 Sq. meters for retail or wholesale outlets. Moreover, in the case of a combined wholesale and retail Drugstore or Pharmacy, the prescribed area is 15 Sq. meters. <\/li><li><strong>Requirement of a competent person<\/strong>&#8211; An individual can only conduct a Drug business under the guidance of these persons: <ul><li>A Registered Pharmacist\/Chemist under State Pharmacy Council; <\/li><li>A graduate with at least one year of experience in Drug marketing &amp; sales in a reputed Pharmacy; <\/li><li>A person who has passed S.S.L.C. and has four years of experience in Pharmacy marketing; <\/li><li>Any certified person from the department of Drug control is also eligible. <\/li><\/ul><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Checklist_of_documents\"><\/span>Checklist of documents \n<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Affix the documents given below along with your Drug License Application Form:<\/strong><\/p>\n\n\n\n<ul><li>Incorporation Certificate of\n\tthe Company \n\t\n\t<\/li><li>ID proof of Proprietor, Partner\n\tor Director (as the case may be)\n\t<\/li><li>Address proof of your office\n\tsuch as Rent Agreement or Sale Deed \n\t\n\t<\/li><li>A valid Affidavit that confirms\n\tnon-conviction of the Proprietor, Partner or Director of the\n\tPharmacy under Drugs and Cosmetics Act, 1940\n\t<\/li><li>Qualification proof, Experience\n\tLetter of the Pharmacist \n\t\n\t<\/li><li>An Affidavit issued from a\n\tproficient person or Registered Pharmacist\n\t<\/li><li>Memorandum\n\tof Association and Articles of Association \n\t\n\t<\/li><li>Drugstore details such as\n\tinvoices, air conditioner, refrigerator etc.\n\t<\/li><li> Appointment Letter for the\n\tperson who will carry out daily operations\n\t<\/li><li>Receipt of the online fee\n\tdeposited\n\t<\/li><li>A self-attested copy of the\n\tRegistered plant layout \n\t\n\t<\/li><li>Key plan and site plan of\n\tpremises \n\t\n<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Online_process_for_Drug_License_Registration\"><\/span>Online process for Drug License Registration \n<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>To\nacquire a Drug License Certificate, you need to follow the simple\nsteps mentioned below:<\/p>\n\n\n\n<ul><li>Visit the official portal of Food Safety and Drug Administration (<strong>fsdaup<\/strong>) <a href=\"http:\/\/fsdaup.gov.in\/online-licensing.htm\">[1]<\/a>  and select the online option of Registration for Drugs\/Cosmetics. <\/li><li><strong>File the appropriate Registration Application Form<\/strong> and attach a scanned copy of all essential documents. Also, submit the fees prescribed by the Authority. <\/li><li>Therefore, the Drug Inspector will pay a visit to your proposed Pharmacy shop or Drug store to validate the authenticity of the documents. <\/li><li>Once the inspection is complete, the concerned State Drug License Authority will issue the Drug License to you.  <\/li><\/ul>\n\n\n\n<p>The\nentire process of Drug License issuance usually takes a minimum 30\ndays if the applicant fulfills all the conditions and provides valid\ninformation. \n<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion \n<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<div class=\"shadow4\">The procedure of Drug License\nCertificate Registration might seem easy, but the preparation of\ndocuments and Form selection is a tedious task. Thus, take the\nassistance of some legal consultancy. \n<br><br>One of the reliable options for you would be Swarit Advisors which holds competence in resolving the queries related to the issuance of Drug License and its renewal.<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Stepping into Pharmaceutical industry is quite challenging, specifically in a country like India that already accommodates about 5, 50,000 Drug stores. The market of Indian Retail Pharmacy has tremendously grown over the recent years on an average of 18% per annum. The increasing health deterioration cases have prompted the need for multiple Drug stores &amp; [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":9518,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[494,561],"tags":[716],"_links":{"self":[{"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/posts\/9502"}],"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\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/comments?post=9502"}],"version-history":[{"count":13,"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/posts\/9502\/revisions"}],"predecessor-version":[{"id":11418,"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/posts\/9502\/revisions\/11418"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/media\/9518"}],"wp:attachment":[{"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/media?parent=9502"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/categories?post=9502"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/swaritadvisors.com\/learning\/wp-json\/wp\/v2\/tags?post=9502"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}