{"id":46005,"date":"2022-08-03T11:44:14","date_gmt":"2022-08-03T06:14:14","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=46005"},"modified":"2024-10-19T17:52:31","modified_gmt":"2024-10-19T12:22:31","slug":"basic-requirements-for-wholesale-drug-license","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/basic-requirements-for-wholesale-drug-license\/","title":{"rendered":"What are the Basic Requirements for Wholesale Drug License?"},"content":{"rendered":"\n<p class=\"has-drop-cap\">If anyone wants to start a Pharma business in India, a Drug License is required. The CDSCO (Central Drugs Standard Control Organisation) issues Drug License in India. However, the Drug Control Organisation issues 2 types of Drug licenses in India: <strong><a href=\"https:\/\/corpbiz.io\/retail-drug-license\">Retail Drug License<\/a><\/strong> and Wholesale Drug License. For an independent agent or distributor or company to be an authorised Indian agent for foreign or local manufacturing at the CDSCO, they must have a valid <a href=\"https:\/\/corpbiz.io\/wholesale-drug-license\"><strong>Wholesale Drug License<\/strong><\/a>. But before obtaining a Wholesale Drug License, one must know all the basic requirements for Wholesale Drug License. In this write-up, we will discuss the basic requirements for Wholesale Drug License.<\/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\/basic-requirements-for-wholesale-drug-license\/#Qualification_to_Obtain_Wholesale_Drug_License\" >Qualification to Obtain\nWholesale Drug 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:\/\/corpbiz.io\/learning\/basic-requirements-for-wholesale-drug-license\/#Requirements_for_Wholesale_Drug_License_in_India\" >Requirements for Wholesale Drug\nLicense in India<\/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\/basic-requirements-for-wholesale-drug-license\/#Document_Requirements_for_Wholesale_Drug_License_in_India\" >Document Requirements for\nWholesale 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-4\" href=\"https:\/\/corpbiz.io\/learning\/basic-requirements-for-wholesale-drug-license\/#Document_Requirements_for_Wholesale_Drug_License_Renewal\" >Document Requirements for\nWholesale Drug License Renewal<\/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\/basic-requirements-for-wholesale-drug-license\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Qualification_to_Obtain_Wholesale_Drug_License\"><\/span>Qualification to Obtain\nWholesale Drug License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>An individual who applies for <a href=\"https:\/\/corpbiz.io\/drug-license\"><strong>Drug Licenses<\/strong><\/a> should possess one of the following qualifications:<\/p>\n\n\n\n<ol>\n<li>A minimum of one year of experience as a salesman\nin a registered Wholesale Drug Licensed firm after graduation;<\/li>\n\n\n\n<li>The pharmacist must be registered person under the\nPharma Council;<\/li>\n\n\n\n<li>For non-graduates, the experience tenure has been\ncapped at 4 years.<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Requirements_for_Wholesale_Drug_License_in_India\"><\/span>Requirements for Wholesale Drug\nLicense in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following\nare the requirements for Wholesale Drug License in India:<\/p>\n\n\n\n<ol>\n<li><strong>Area<\/strong>: To\nstart a Wholesale outlet, the minimum area required is 15 square meters.<\/li>\n\n\n\n<li><strong>Storage\nFacility<\/strong>: Certain drugs such as vaccines, insulin injection, sera,\netc., need to be stored refrigerated. So, it is compulsory that there must have\nan air conditioner and refrigerator on the premises.<\/li>\n\n\n\n<li><strong>Technical\nStaff<\/strong>: The sale of the drug by wholesale shall be made either in\nthe presence of registered pharmacists or in the presence of a competent person\nor individual who shall be a graduate SSLC with one year of experience in\ndealing with drugs or an individual who has passed SSLC with four years of\nexperience in dealing in drugs, specially approved by the department of drug\ncontrol.<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Document_Requirements_for_Wholesale_Drug_License_in_India\"><\/span>Document Requirements for\nWholesale Drug License in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The\nrequired documents may vary state by state. However, the following is the list\nof document requirements for Wholesale Drug License in India:<\/p>\n\n\n\n<ol>\n<li>Application in Form-19 along with the declaration;<\/li>\n\n\n\n<li>Applicant\u2019s qualification;<\/li>\n\n\n\n<li>Copy of Board Resolution;<\/li>\n\n\n\n<li>Key Plan &amp; Site Plan;<\/li>\n\n\n\n<li><strong><a href=\"https:\/\/corpbiz.io\/noc-from-assistant-drug-controller\">(No Objection Certificate) NOC<\/a><\/strong> from the Property Owner, in case the premises are rented property;<\/li>\n\n\n\n<li>Copy of challan (Proof of payment of a fee);<\/li>\n\n\n\n<li>Identity proof of a Partner or Director or Proprietor;<\/li>\n\n\n\n<li>MOA (Memorandum of Association) and AOA (Article of Association) in the case of a company;<\/li>\n\n\n\n<li>Submit Partnership Deed in case of a Partnership and Submit LLP Agreement in case of an LLP;<\/li>\n\n\n\n<li>Affidavit stating that the Partner or Director or Proprietor has never been convicted;<\/li>\n\n\n\n<li>Affidavit from the competent person or pharmacist;<\/li>\n\n\n\n<li>A cover letter containing the name &amp; designation of the applicant;<\/li>\n\n\n\n<li>Qualification certificate, experience certificate, and appointment letter of the pharmacists or the competent person;<\/li>\n\n\n\n<li>Proof of cold storage, refrigerator, air conditioner etc.<\/li>\n<\/ol>\n\n\n\n<p><strong>Note:<\/strong> After submission of all the document requirements for Wholesale Drug License as mentioned above, <strong><a href=\"https:\/\/corpbiz.io\/cdsco-registration\">CDSCO <\/a><\/strong>ensures that inspections are held by a Pharmacy Inspector. Strict norms or rules have been formulated to maintain the display, storage, and sale of drugs.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Document_Requirements_for_Wholesale_Drug_License_Renewal\"><\/span>Document Requirements for\nWholesale Drug License Renewal<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The\nregistered person seeking the renewal of a Wholesale Drug License must have the\nfollowing documents in place:<\/p>\n\n\n\n<ol>\n<li>Form-19 properly filled by the applicant;<\/li>\n\n\n\n<li>Copy of the receipt of the challan;<\/li>\n\n\n\n<li>Registration Certificate of the Pharmacist (not\nbeen in the expired state) issues by the pharmacy council;<\/li>\n\n\n\n<li>Copy of the latest certificate of renewal;<\/li>\n\n\n\n<li>Photo id such as Aadhar, PAN, Voter Id, etc.;<\/li>\n\n\n\n<li>Self-declaration of the applicant properly\nvalidated by the Notary Public, where the applicant is not serving as a\nregistered pharmacist;<\/li>\n\n\n\n<li>In case of any change or addition, the revised\nsite plan and layout plan of the proposed premises clearly show the shop size,\nfurniture details, adjoining areas, and fixtures provided, building location,\nif any;<\/li>\n\n\n\n<li>In case of change in the premises, ownership proof\nor possession of the proposed premises, i.e., the latest copy of the allotment\nletter or Rent Agreement or Deed in case of allotted or rented accommodation.<\/li>\n<\/ol>\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>Drugs are typical commodities and are widely used to cure human diseases; that&#8217;s the reason why the Government has introduced strict norms and regulations for its distribution, selling &amp; manufacturing. So, those who seek a Wholesale Drug License must have aforesaid requirements for a Wholesale Drug License in place. Drug License is issued by the competent authority under the Drugs &amp; Cosmetic Act, 1940 to carry out a business regarding drugs, medicines, or cosmetics.<\/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\/6-viable-benefits-of-wholesale-drug-license\/\">6 Viable Benefits of Wholesale Drug License that worth Your Attention<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>If anyone wants to start a Pharma business in India, a Drug License is required. The CDSCO (Central Drugs Standard Control Organisation) issues Drug License in India. However, the Drug Control Organisation issues 2 types of Drug licenses in India: Retail Drug License and Wholesale Drug License. For an independent agent or distributor or company [&hellip;]<\/p>\n","protected":false},"author":35,"featured_media":46006,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[223],"tags":[2555],"acf":{"service_id":"437"},"authorName":"Karan Singh","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/01\/processed-1-150x150.jpeg","authorDescription":"A legal writing enthusiast, a wanderer, and a zealous reader. After gaining a lot of knowledge about the diverse legal topics and developing research skills, Karan joined the league of legal content writers to deliver quality-rich blogs.","postViews":16973,"readingTime":3,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46005"}],"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\/35"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=46005"}],"version-history":[{"count":12,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46005\/revisions"}],"predecessor-version":[{"id":66936,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46005\/revisions\/66936"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/46006"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=46005"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=46005"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=46005"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}