{"id":1591,"date":"2019-12-09T13:36:21","date_gmt":"2019-12-09T13:36:21","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=1591"},"modified":"2021-04-06T16:35:37","modified_gmt":"2021-04-06T11:05:37","slug":"get-drug-license-in-india","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/get-drug-license-in-india\/","title":{"rendered":"How to Obtain Drug License in India?"},"content":{"rendered":"\n<p class=\"has-drop-cap\">To ensure a healthy condition when you are sick, you need to consume medicines or drugs. \u00a0But how can you be so sure that the medication you are purchasing from a Medical Store is genuine? The first and foremost thing that any person should check while buying medicines from the pharmacy\/drugstore is that whether it is Drug Licensed or not. With a perspective to give this an edge, the Indian Government has laid down strict laws and regulations for the manufacturing and distribution of drugs and medicines across the drugstores and pharmacies in our country. In this article, we will have a look at how can you obtain a Drug License in India.<\/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\/get-drug-license-in-india\/#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-2\" href=\"https:\/\/corpbiz.io\/learning\/get-drug-license-in-india\/#Prerequisites_for_Obtaining_a_License\" >Prerequisites\nfor Obtaining a 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\/get-drug-license-in-india\/#A_brief_about_Drug_License_and_Drug_License_Registration\" >A brief about Drug License and Drug License Registration<\/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\/get-drug-license-in-india\/#What_is_the_difference_between_a_pharmacy_and_a_Drugstore\" >What is the difference between a pharmacy and a Drugstore?<\/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\/get-drug-license-in-india\/#What_are_the_types_of_Drug_License_issued_in_India\" >What are the types of Drug License issued in\nIndia?<\/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\/get-drug-license-in-india\/#Drug_License\" >Drug License<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/corpbiz.io\/learning\/get-drug-license-in-india\/#What_are_the_Documents_required_for_Drug_License_Registration\" >What are the Documents required for Drug License\nRegistration?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/corpbiz.io\/learning\/get-drug-license-in-india\/#What_is_the_Procedure_for_applying_for_Drug_License\" >What is the Procedure for applying for Drug License?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/corpbiz.io\/learning\/get-drug-license-in-india\/#What_if_you_violate_the_law\" >What if you violate the law?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/corpbiz.io\/learning\/get-drug-license-in-india\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\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><a href=\"https:\/\/corpbiz.io\/drug-license\"><strong>Drug license<\/strong><\/a>\u00a0is the permission given by the Government to the owner of the pharmacy or a drugstore. The\u00a0<strong><em>Drugs and the Cosmetics Act, 1940<\/em><\/strong><a rel=\"noreferrer noopener\" href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Act,_1940\" target=\"_blank\"><sup>[1]<\/sup><\/a>\u00a0governs the licensing of the drugs in India under which provisions are made to carry out the business of drugs, medicines or cosmetics.<\/p>\n\n\n\n<p><strong><em>The Drug license is issued by the authorities at the following two levels:<\/em><\/strong><\/p>\n\n\n\n<ul><li>\u00a0<strong>State Drugs Standard Control Organization (SDSCO)<\/strong> \u2013 According      to the Drugs and Cosmetics Act, sales and distribution and the regulation of manufacture are looked by the state authorities.<\/li><li><strong>Central Drugs Standard Control Organization (CDSCO)<\/strong> \u2013  under the Drugs and Cosmetics Act, the CDSCO is responsible for the approval of newly made drugs, clinical trials of the drugs in the country, control over the quality of imported drugs and coordinating with the SDSCO. <\/li><\/ul>\n\n\n\n<p>But many of us are not aware that there is a difference between pharmacy and drugstore. In this article, we will briefly discuss the drug license in India.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Prerequisites_for_Obtaining_a_License\"><\/span>Prerequisites\nfor Obtaining a License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li><strong><em>Pharmacist\/ Competent Individual:<\/em><\/strong>\u00a0The pharmacist is required to be eligible in the cases of retail business. Whereas, in wholesale business, the individual ought to be a graduate with an experience of one year or an undergraduate having  4 years experience.<\/li><li><strong><em>Space Requirement:<\/em>\u00a0<\/strong>The other significant requirement is space, which is the vicinity of the pharmacy or the unit for both the retail and wholesale license \u2013 15 square meters.<\/li><\/ul>\n\n\n\n<ul><li>\u00a010 square meters \u2013 In all other cases.<\/li><li>The apparent height of the premises of sales shall be in accordance with the guidelines given down under the National Building Code of India, 2005.<\/li><li><strong><em>Storage Facility:<\/em><\/strong>\u00a0The further imperative obligation is the storage facility in view of the fact that a few drugs needs to be stored in refrigerators, low temperatures and air conditioners.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"A_brief_about_Drug_License_and_Drug_License_Registration\"><\/span>A brief about Drug License and Drug License Registration <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Drugs are\nused in the formation of the medicine in a medically defined ratio to cure the\nhealth of an individual. So, specific standards have been set up by the State\nand Central Drug Standard Organization for using the correct amount of drugs\nthat do not harm the body.<\/p>\n\n\n\n<p>Therefore,\nany violation in the medically defined limits can have a severe effect on the\nhealth of the person using that medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_the_difference_between_a_pharmacy_and_a_Drugstore\"><\/span>What is the difference between a pharmacy and a Drugstore?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Pharmacy or Dispensary<\/strong>\n  <\/td><td>\n  <strong>Drugstore<\/strong>\n  <\/td><\/tr><tr><td>\n  A\n  place where prescription drugs are dispensed\n  <\/td><td>\n  A\n  retail store where both prescription and non-prescription drugs are sold\n  along with other first aid and similar products.\n  <\/td><\/tr><tr><td>\n  The\n  only source of income is the prescribed medicines of individuals.\n  <\/td><td>\n  These\n  drugstores earn a majority of their revenue from these products, which\n  includes health and beauty products.\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_the_types_of_Drug_License_issued_in_India\"><\/span>What are the types of Drug License issued in\nIndia?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Retail Drug License<\/h3>\n\n\n\n<p><a href=\"https:\/\/corpbiz.io\/retail-drug-license\"><strong>Retail Drug license<\/strong><\/a>\u00a0is issued to the persons involved in chemist shops.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Wholesale Drug License<\/h3>\n\n\n\n<p> <a href=\"https:\/\/corpbiz.io\/wholesale-drug-license\"><strong>Wholesale drug license<\/strong><\/a>\u00a0is issued to the persons or agencies who are involved in the wholesale distribution of drugs.<\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter\"><img decoding=\"async\" width=\"583\" height=\"309\" src=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2019\/12\/image-10.png\" alt=\"types of Drug License issued in India\" class=\"wp-image-1592\" srcset=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2019\/12\/image-10.png 583w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2019\/12\/image-10-300x159.png 300w\" sizes=\"(max-width: 583px) 100vw, 583px\" \/><\/figure><\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Drug_License\"><\/span>Drug License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">Forms for Drug Licenses for sale and wholesale of Drugs<\/h4>\n\n\n\n<p><strong><em>Different licenses are required for obtaining different kinds of licenses which can be obtained by filing various forms:<\/em><\/strong><\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong><em>FORM<\/em><\/strong><strong><\/strong>\n  <\/td><td>\n  <strong><em>Types of Drugs<\/em><\/strong><strong><\/strong>\n  <\/td><\/tr><tr><td>\n  FORM\n  20\n  <\/td><td>\n  Allopathic\n  Drugs\n  <\/td><\/tr><tr><td>\n  FORM\n  20-A\n  <\/td><td>\n  Restricted\n  Allopathic Drugs\n  <\/td><\/tr><tr><td>\n  FORM\n  20-B\n  <\/td><td>\n  Wholesale\n  of Allopathic Drugs\n  <\/td><\/tr><tr><td>\n  FORM\n  20-C\n  <\/td><td>\n  Homoeopathic\n  medicines by retail &nbsp;\n  <\/td><\/tr><tr><td>\n  FORM\n  21\n  <\/td><td>\n  Allopathic\n  drugs specified in Sch C &amp; C (1). &nbsp;\n  <\/td><\/tr><tr><td>\n  FORM\n  21-B\n  <\/td><td>\n  &nbsp;Wholesale\n  of Allopathic drugs specified in Sch C &amp; C(1). &nbsp;\n  <\/td><\/tr><tr><td>\n  FORM\n  21-A\n  <\/td><td>\n  &nbsp;Retail\n  sale of restricted Allopathic drugs specified in Schedule C (I). &nbsp;\n  <\/td><\/tr><tr><td>\n  FORM\n  20-F\n  <\/td><td>\n  Retail\n  sale of drugs specified in Sch. \u2018X\u2019.&nbsp;\n  <\/td><\/tr><tr><td>\n  FORM\n  20-G\n  <\/td><td>\n  Wholesale\n  of drugs Specified in Sch. \u2018X\u2019.&nbsp;\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<p class=\"text-left\"><b>Read our article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/drug-distribution-sale-and-manufacture\/\">How to get a Manufacturing License of Drugs in India?\n<\/a><\/mark><\/p>\n\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_the_Documents_required_for_Drug_License_Registration\"><\/span>What are the Documents required for Drug License\nRegistration?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong><em>The documents required for the Drug License Registration in India are as\nfollow:<\/em><\/strong><\/p>\n\n\n\n<ul><li>Application form in the prescribed format duly signed by the concerned authority.<\/li><li>Copy of Challan which will act as evidence that you have deposited the requisite fee.<\/li><li>Id proofs such as PAN, Voter Id, Driving license, Passport, etc. in case an applicant is a proprietor<\/li><li>\u00a0Id proof of every partner along with the copy of partnership deed \u2013 for the partnership firm.<\/li><li>Copy of MOA, AOA, and COI in case of private\/public\/OPC<\/li><li>CTC of Board Resolution for authorizing the company for obtaining the license.<\/li><li>Appointment letter of the person who is being authorized by the company<\/li><li>Proof of availability of storage space such as cold storage, refrigerator, etc.<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Additional documents if the applicant is registered,\npharmacist:<\/h3>\n\n\n\n<ul><li>Registration certificate issued by pharmacy council<\/li><li>Diploma pharmacy<\/li><li>Appointment letter<\/li><li>Affidavit of pharmacist<\/li><li>Education qualification certificates such as high school &amp; intermediary mark sheets, graduation certificate, post-graduation degree, etc.<\/li><li>Minimum, one year of experience, is mandatory in drug sales and marketing of any pharmaceutical company.<\/li><li>Plan the layout of the premise for which the license is applied<\/li><li>There shall be an area of minimum of 10 square meters in case the license is applied for the wholesale or retail sale of drugs.<\/li><li>A minimum of 15 square meters of area in case the license is applied for both wholesale and retail sales of drugs.<\/li><li>Electricity availability and related installation in the premise.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_the_Procedure_for_applying_for_Drug_License\"><\/span>What is the Procedure for applying for Drug License?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Food\nSafety and Drug Administration of the concerned state Government governs the\nrules and regulations related to the Drug License:<\/p>\n\n\n\n<p><strong><em>Following steps need to be followed for obtaining the Drug License \u2013<\/em><\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Visit the site<\/h3>\n\n\n\n<p>For issuance\nof every drug license, the particular authority has been provided to the\nrespective state authorities.<\/p>\n\n\n\n<p>Visit the\nsite which connects to the state of yours, for example, a person who wishes to\nstart the drugstore in UP needs to visit the government portal of the UP\n\u2013&nbsp;<a href=\"http:\/\/fsdaup.gov.in\/online-licensing.htm\" target=\"_blank\" rel=\"noreferrer noopener\">http:\/\/fsdaup.gov.in\/online-licensing.htm<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Filing of Application<\/h3>\n\n\n\n<p>Fill the\nonline application form online and upload the scanned copy of all the\ndocuments.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">A visit by Drug Inspector<\/h3>\n\n\n\n<p>After\nreceiving the application form, the Drug Inspector will personally visit the\nshop or the drugstore for the verification of documents.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Grant of the license<\/h3>\n\n\n\n<p>After\nsuccessful inspection by the Drug Inspector, the Controller of the Drugs will\nissue the drug license.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_if_you_violate_the_law\"><\/span>What if you violate the law?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Under Section\n18(C) of the Drugs and Cosmetics Act, 1940, any person who violates the law and\nsells drugs without a valid license is liable for the punishment. The\npunishment can be a term not less than one year and it may extend to three\nyears or a fine not less than Five Thousand Rupees.<\/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>Well to\nconclude, one can say that if someone wishes to open a drugstore in India,\nneeds to obtain Drug license before commencing the Business. Government of\nIndia, at its state and Central level, has set some basic standards and Norms\nwhich must be followed by every drugstore in India. After all, health is wealth\nis the main motto of every individual.<\/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\/drug-distribution-sale-and-manufacture\/\">Drug Distribution, Sale and Manufacture under Drugs and Cosmetics Act\n<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>To ensure a healthy condition when you are sick, you need to consume medicines or drugs. \u00a0But how can you be so sure that the medication you are purchasing from a Medical Store is genuine? The first and foremost thing that any person should check while buying medicines from the pharmacy\/drugstore is that whether it [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":1595,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[223],"tags":[224],"acf":{"service_id":"98"},"authorName":"Shalini Singh","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2019\/09\/MEE.jpeg","authorDescription":"Shalini is a B.tech graduate but her keen interest in writing impelled her to continue as a content writer. Further, She has a rich experience in Companies Act and Ammendment related topics.","postViews":17124,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/1591"}],"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\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=1591"}],"version-history":[{"count":18,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/1591\/revisions"}],"predecessor-version":[{"id":28642,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/1591\/revisions\/28642"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/1595"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=1591"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=1591"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=1591"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}