{"id":1633,"date":"2021-01-23T09:23:07","date_gmt":"2021-01-23T09:23:07","guid":{"rendered":"https:\/\/swaritadvisors.com\/blog\/?p=1633"},"modified":"2021-01-23T09:23:10","modified_gmt":"2021-01-23T09:23:10","slug":"process-to-apply-for-wholesale-drug-license-in-india","status":"publish","type":"post","link":"https:\/\/swaritadvisors.com\/blog\/process-to-apply-for-wholesale-drug-license-in-india\/","title":{"rendered":"Complete Process to Apply for Wholesale Drug License in India"},"content":{"rendered":"\n<p class=\"has-drop-cap\">To start the business of manufacturing and selling drugs, it is important for a business to obtain drug license in India. The person who is willing to undertake a wholesale drug business must obtain a license from the Food Safety and Drug Administration. <strong><em>Form 20B, 20G<\/em><\/strong> can be filed by the applicant to obtain wholesale drug license. It is granted by the respective State Licensing Authority. The business of manufacturing and selling of drugs is governed by the provisions of <strong><em>Drugs and Cosmetics Act, 1940<sup><a href=\"http:\/\/legislative.gov.in\/sites\/default\/files\/A1940-23.pdf\" class=\"text-primary\"><strong><em>[1]<\/em><\/strong><\/a><\/sup><\/em><\/strong>. This article will discuss about the complete process to apply for wholesale drug license in India. <\/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-6a34a80a3ca76\" 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-6a34a80a3ca76\"  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\/blog\/process-to-apply-for-wholesale-drug-license-in-india\/#Need_for_the_Wholesale_Drug_License_in_India\" title=\"Need for the Wholesale Drug\nLicense in India\">Need for the 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-2\" href=\"https:\/\/swaritadvisors.com\/blog\/process-to-apply-for-wholesale-drug-license-in-india\/#Conditions_to_obtain_Wholesale_Drug_License_in_India\" title=\"Conditions to obtain Wholesale\nDrug License in India\">Conditions to obtain Wholesale\nDrug License 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:\/\/swaritadvisors.com\/blog\/process-to-apply-for-wholesale-drug-license-in-india\/#How_to_Apply_for_Wholesale_Drug_License_in_India\" title=\"How to Apply for Wholesale Drug\nLicense in India?\">How to Apply for Wholesale Drug\nLicense 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-4\" href=\"https:\/\/swaritadvisors.com\/blog\/process-to-apply-for-wholesale-drug-license-in-india\/#Documents_filing\" title=\"Documents filing\">Documents filing<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/swaritadvisors.com\/blog\/process-to-apply-for-wholesale-drug-license-in-india\/#Application_filing\" title=\"Application filing\">Application filing<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/swaritadvisors.com\/blog\/process-to-apply-for-wholesale-drug-license-in-india\/#Inspection_by_a_Drug_Inspector\" title=\"Inspection by a Drug Inspector \">Inspection by a Drug Inspector <\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/swaritadvisors.com\/blog\/process-to-apply-for-wholesale-drug-license-in-india\/#Approval_and_Grant\" title=\"Approval and Grant\">Approval and Grant<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/swaritadvisors.com\/blog\/process-to-apply-for-wholesale-drug-license-in-india\/#Documents_required_to_apply_for_wholesale_drug_license_in_India\" title=\"Documents required to apply for\nwholesale drug license in India \">Documents required to apply 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-9\" href=\"https:\/\/swaritadvisors.com\/blog\/process-to-apply-for-wholesale-drug-license-in-india\/#Eligibility_to_apply_for_wholesale_drug_license\" title=\"Eligibility to apply for\nwholesale drug license\">Eligibility to apply for\nwholesale drug license<\/a><\/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\/blog\/process-to-apply-for-wholesale-drug-license-in-india\/#Validity_of_the_license\" title=\"Validity of the license\">Validity of the license<\/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\/blog\/process-to-apply-for-wholesale-drug-license-in-india\/#Conclusion\" title=\"Conclusion \">Conclusion <\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Need_for_the_Wholesale_Drug_License_in_India\"><\/span>Need for the Wholesale Drug\nLicense in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A wholesale drug\nlicense is required to distribute, sell and store the medicines. It can be\nissued from the appropriate government authority. The license is helpful to\nfollow all the rules and regulations laid down by the regulatory authority. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conditions_to_obtain_Wholesale_Drug_License_in_India\"><\/span>Conditions to obtain Wholesale\nDrug License in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In order to\nobtain wholesale drug license in India the below mentioned conditions are\nrequired to be fulfilled: &#8211; <\/p>\n\n\n\n<ul><li>The business premises should be a minimum of <strong><em>15 square meters<\/em><\/strong>. <\/li><li>The business premises must have air conditioner and refrigerator on the premises. <\/li><li>The application for the wholesale drug license can be made under the personal supervision of the registered pharmacist or the competent person. In certain states a wholesale drug license is provided to only those entities or companies who have persons with a diploma or degree in pharmacy from a reputed and recognized university or institution. <\/li><li>The competent person or the pharmacist must be a graduate with at least 1 year experience in dealing with drugs or be SSLC passed have 4 years experience in dealing with drugs. <\/li><li>The <strong><a href=\"https:\/\/swaritadvisors.com\/drug-license\" class=\"text-primary\">drug license<\/a><\/strong>, after it has been obtained must be displayed clearly on the premises for the purpose of any inspection in future. <\/li><li>The business premised must not be an open-roofed area that is, it must be closed and well-sanitized area. <\/li><li>The applicant is required to get mandatory GST registration number. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"How_to_Apply_for_Wholesale_Drug_License_in_India\"><\/span>How to Apply for Wholesale Drug\nLicense in India?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In order to apply for the wholesale drug license in India, the below mentioned steps are required to be followed:<\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter is-resized\"><img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/swaritadvisors.com\/blog\/wp-content\/uploads\/2021\/01\/swarit-1-d.png\" alt=\"Apply for Wholesale Drug License\" class=\"wp-image-1635\" width=\"718\" height=\"249\" srcset=\"https:\/\/swaritadvisors.com\/blog\/wp-content\/uploads\/2021\/01\/swarit-1-d.png 800w, https:\/\/swaritadvisors.com\/blog\/wp-content\/uploads\/2021\/01\/swarit-1-d-300x104.png 300w, https:\/\/swaritadvisors.com\/blog\/wp-content\/uploads\/2021\/01\/swarit-1-d-768x267.png 768w\" sizes=\"(max-width: 718px) 100vw, 718px\" \/><\/figure><\/div>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_filing\"><\/span>Documents filing<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>The applicant\nmust ensure that he has all the required documents that are needed to be\nsubmitted and must ensure that he meets the prescribed requirements and\nconditions.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Application_filing\"><\/span>Application filing<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>The applicant\nshall file the application for drug license online. While filing the\napplication, the applicant is required to upload all the scanned copies of the\nrequired documents. The application shall be accepted once the payment of the\nrequired fees has been done. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Inspection_by_a_Drug_Inspector\"><\/span>Inspection by a Drug Inspector <span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Once the\napplication is filed, the documents and the application shall be reviewed by\nthe drug inspector in person. The drug inspector shall visit the store and\nensure that the business meets all the prescribed requirement. Post the\nverification, an approval is given by the drug inspector to proceed further. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Approval_and_Grant\"><\/span>Approval and Grant<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>The final step\nin obtaining wholesale drug license in India is when the documents are verified\nand all the requirements are met, the application shall be approved by the Drug\nLicensing Authority and the license is granted. However, the license is required\nto be renewed. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_required_to_apply_for_wholesale_drug_license_in_India\"><\/span>Documents required to apply for\nwholesale drug license in India <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The documents required to apply for wholesale drug license in India are generally:<\/p>\n\n\n\n<ul><li>Two applications filed through Form 19. <\/li><li>Challan fees deposited for the license.<\/li><li>Declaration Form. <\/li><li>Cover letter stating the purpose of the application. <\/li><li>Receipt of property tax. <\/li><li>Rent agreement if the premise is rented. <\/li><li>Ownership documents if the premise is self owned. <\/li><li>Memorandum of Association (MOA) and Articles of Association (AOA), Incorporation Certificate (if the business entity is an LLP or a Company).<\/li><li>If the entity is a partnership then a partnership deed. <\/li><li>If the entity is a <strong><a href=\"https:\/\/swaritadvisors.com\/private-limited-company-registration\" class=\"text-primary\">private limited company<\/a><\/strong> then the list of directors. <\/li><li>Board resolution. <\/li><li>Affidavit of the Pharmacist. <\/li><li>Affidavit of the Proprietor. <\/li><li>Qualification certificate of the pharmacist or the competent person.<\/li><li>Identity proof of the proprietor. <\/li><li>Appointment letter. <\/li><li>Proof of the availability of the storage space for items that are required to be stored in low temperature such as, refrigerator, air conditioners etc. <\/li><li>Photograph of the pharmacist\/ proprietor\/ competent person. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Eligibility_to_apply_for_wholesale_drug_license\"><\/span>Eligibility to apply for\nwholesale drug license<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The following persons\/entities are eligible to apply for wholesale drug license: &#8211; <\/p>\n\n\n\n<ul><li>Any company\/ LLP\/ partnership firm\/ person can\napply for the drug license.<\/li><li>A competent person (registered pharmacist from\nthe state pharmacy council) with experience can apply for the wholesale drug\nlicense. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Validity_of_the_license\"><\/span>Validity of the license<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The wholesale\ndrug license is valid for a period of <strong><em>3 years<\/em><\/strong>. The license should be\ndisplayed clearly at the place of the business during the business hours. <\/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>Drugs and medicines are a necessity and essential products. Understanding its importance the government has laid down a strict application process for obtain a drug license. Starting a wholesale drug business in India is not very complex but yet a person needs to prepare for it. All the formalities are required to be completed in the process of issuing drug license. This ensures that the drug wholesalers comply with all the provisions. To apply for wholesale drug license in India the applicant is required to apply in accordance with the rules and regulation of the Drugs and Cosmetics Act, 1940. The provisions ensure that the drug business is undertaken and performed by a qualified and competent person.<\/p>\n\n\n\n<p>Since the safety of the people is the most important priority, the government ensures that the drugs do not risk the lives of the people. The Central Drug Control Organization (CDSCO) is the regulatory body for pharmaceuticals and medical devices. CDSCO is responsible for the laying down the standards for drugs and coordinate with the activities of the State Drug Control Organization (SDCO) by providing expert advice to bring about uniformity in the enforcement of the provisions of the Drugs and Cosmetics Act.<\/p>\n\n\n\n<p><b>Also, Read:<\/b> <mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/swaritadvisors.com\/blog\/how-to-get-a-drug-distribution-license-in-india\/\">How to get a Drug Distribution License in India?<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>To start the business of manufacturing and selling drugs, it is important for a business to obtain drug license in India. The person who is willing to undertake a wholesale drug business must obtain a license from the Food Safety and Drug Administration. Form 20B, 20G can be filed by the applicant to obtain wholesale [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":1638,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[30],"tags":[288],"acf":[],"_links":{"self":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/1633"}],"collection":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/comments?post=1633"}],"version-history":[{"count":4,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/1633\/revisions"}],"predecessor-version":[{"id":1640,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/posts\/1633\/revisions\/1640"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media\/1638"}],"wp:attachment":[{"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/media?parent=1633"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/categories?post=1633"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/swaritadvisors.com\/blog\/wp-json\/wp\/v2\/tags?post=1633"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}