{"id":23151,"date":"2020-12-31T12:28:22","date_gmt":"2020-12-31T06:58:22","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=23151"},"modified":"2024-10-19T18:20:24","modified_gmt":"2024-10-19T12:50:24","slug":"what-are-the-conditions-required-to-obtain-drug-license","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/what-are-the-conditions-required-to-obtain-drug-license\/","title":{"rendered":"What Are the Conditions Required To Obtain Drug License under Drugs &#038; Cosmetic Act, 1940"},"content":{"rendered":"\n<p class=\"has-drop-cap\">A drug license is a legal permit issued by the government for businesses related to drugs and cosmetics. <a href=\"https:\/\/corpbiz.io\/drug-license\"><strong>Drug License<\/strong><\/a> ensures that everyone has equal and fair access to drugs and medicine is the government&#8217;s primary concern. But the legal right to manufacture and sell drugs and medicines has to be provided carefully.<\/p>\n\n\n\n<p>Therefore, the government has stringent rules for\nlicensing of the manufacture and sale of drugs and medicines. The Drugs and\nCosmetics Act, 1940 is the act regulating the process from manufacture to sell\ndrugs 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\/what-are-the-conditions-required-to-obtain-drug-license\/#Types_of_Drug_License_Mentioned_Under_Drug_License_under_Drugs_Cosmetic_Act_1940\" >Types of Drug License Mentioned Under Drug License under Drugs &amp;\nCosmetic Act, 1940<\/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\/what-are-the-conditions-required-to-obtain-drug-license\/#Terms_Conditions_to_Obtain_Drug_License\" >Terms &amp; Conditions to Obtain Drug 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\/what-are-the-conditions-required-to-obtain-drug-license\/#Prerequisites_for_Obtaining_a_Drug_License\" >Prerequisites for Obtaining a\nDrug 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:\/\/corpbiz.io\/learning\/what-are-the-conditions-required-to-obtain-drug-license\/#Documents_Required_To_Obtain_Drug_License\" >Documents Required To Obtain 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:\/\/corpbiz.io\/learning\/what-are-the-conditions-required-to-obtain-drug-license\/#List_of_Application_Forms\" >List of Application Forms<\/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\/what-are-the-conditions-required-to-obtain-drug-license\/#Concluding_Remark\" >Concluding Remark<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Types_of_Drug_License_Mentioned_Under_Drug_License_under_Drugs_Cosmetic_Act_1940\"><\/span>Types of Drug License Mentioned Under Drug License under Drugs &amp;\nCosmetic Act, 1940<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter\"><img decoding=\"async\" width=\"865\" height=\"337\" src=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/12\/Types-of-Drug-License-Mentioned-Under-Drug-License-under-Drugs-Cosmetic-Act-1940.png\" alt=\"Types of Drug License\" class=\"wp-image-23152\" srcset=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/12\/Types-of-Drug-License-Mentioned-Under-Drug-License-under-Drugs-Cosmetic-Act-1940.png 865w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/12\/Types-of-Drug-License-Mentioned-Under-Drug-License-under-Drugs-Cosmetic-Act-1940-300x117.png 300w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/12\/Types-of-Drug-License-Mentioned-Under-Drug-License-under-Drugs-Cosmetic-Act-1940-768x299.png 768w\" sizes=\"(max-width: 865px) 100vw, 865px\" \/><\/figure><\/div>\n\n\n<p>The\nbelow discussed are the types of drugs license requires by individual to run a\npharmaceutical business in India.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Manufacturing\nLicense<\/h3>\n\n\n\n<p><strong><a href=\"https:\/\/corpbiz.io\/manufacturing-drug-license\">Manufacturing Drug License<\/a><\/strong> granted to a business that involves in the process of manufacturing drugs inclusive of homeopathy medicines\/ allopathic.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Sale\nLicense&nbsp;<\/h3>\n\n\n\n<p>Sale licenses\ngranted for the purpose of sale of drugs. Sale license have the below mentioned\nramifications:-<\/p>\n\n\n\n<ol>\n<li><strong><a href=\"https:\/\/corpbiz.io\/wholesale-drug-license\">Wholesale Drug License<\/a><\/strong><\/li>\n\n\n\n<li><a href=\"https:\/\/corpbiz.io\/retail-drug-license\"><strong>Retail Drug License<\/strong><\/a><\/li>\n\n\n\n<li>Restricted Drugs License.<\/li>\n<\/ol>\n\n\n\n<h3 class=\"wp-block-heading\">Loan\nLicense&nbsp;<\/h3>\n\n\n\n<p>License is\ngranted to a business that does not own the manufacturing unit but uses another\nlicensee&#8217;s manufacturing facilities.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><a href=\"https:\/\/corpbiz.io\/cdsco-drugs-import-license\">Import Drug License<\/a><\/h3>\n\n\n\n<p>&nbsp;License granted for the purpose of the import\nof drugs.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Multi-Drug\nLicense&nbsp;<\/h3>\n\n\n\n<p>License\nauthorized to businesses that own pharmacies in multiple states with the same\nname.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Terms_Conditions_to_Obtain_Drug_License\"><\/span>Terms &amp; Conditions to Obtain Drug License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><em><strong>The below-mentioned are the terms &amp; conditions to obtain drug license under Drugs &amp; Cosmetic Act, 1940;<\/strong><\/em><\/p>\n\n\n\n<ul>\n<li>An applicant to obtain drug license must have at\nleast four years of practical experience in drug distribution.<\/li>\n\n\n\n<li>A drug licensee can only manufacture a drug\nunder the supervision of an experienced pharmacist.<\/li>\n\n\n\n<li>It is forbidden by the law to stock or sells any\ndrug after its expiry.<\/li>\n\n\n\n<li>A drug retailer cannot provide any drug to a\nminor or a child below 18 years.<\/li>\n\n\n\n<li>The drug retailers should make entry in the\nregister each time they sell any drug to maintain the record for future\nreference.<\/li>\n\n\n\n<li>The medicaments to cure animals must be labeled\nas \u201cNot for human use, for treating animals only.\u201d<\/li>\n\n\n\n<li>Drugs that fall under Schedule H or Schedule X\nclassification or have a validity of period of 2 years. Thus, such drugs should\nonly be supplied to registered medical centers such as nursing homes,\ndispensaries, hospitals, and medical practitioners. Moreover, it is important\nto sign a written permission to supply such drugs.<\/li>\n\n\n\n<li>A drug licensee cannot be preserved any drugs at\nhis place intended for the free sample distribution to a certified physician.<\/li>\n\n\n\n<li>If a medical practitioner suggests any medicine,\nit should be under the supervision of a registered pharmacist before its supply\nor retailing.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Point to Remember<\/h3>\n\n\n\n<p>In case the licensee has preserved any expired drugs to claim a rebate from the Income Tax Department, then&nbsp;it&nbsp;shall not be considered an offence under the&nbsp;<strong>Drug and Cosmetic Act, 1940<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Act,_1940\"><strong>[1]<\/strong><\/a><\/sup>,&nbsp;unless not intended for sale.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Prerequisites_for_Obtaining_a_Drug_License\"><\/span><strong>Prerequisites for Obtaining a\nDrug License<\/strong><strong><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The below stated are the prerequisites to obtain a drug license<\/p>\n\n\n\n<p><strong>Pharmacist\/Competent Individual<\/strong><\/p>\n\n\n\n<p><strong>1. <\/strong>An individual can only conduct the pharmaceutical business activities in the presence of competent person. <\/p>\n\n\n\n<ul>\n<li>Any Registered Pharmacist under State Pharmacy\nCouncil.<\/li>\n\n\n\n<li>An individual must be a graduate with a minimum\nof 1-year work experience in drugs sales and marketing in a reputed pharmacy.<\/li>\n\n\n\n<li>A person who have four years of work experience\nin pharmaceutical marketing and has passed S.S.L.C (Secondary Level School\nCertificate).<\/li>\n\n\n\n<li>In case an individual get approval by the department of drug control, he will be eligible to do drug business.  <\/li>\n<\/ul>\n\n\n\n<p><strong>2. <\/strong>For wholesale business activities, the individual must be a graduated with 1-year work experience or an undergraduate with 4 years experience.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Area<\/h3>\n\n\n\n<p>The other essential\nrequirement is space that is the area of the pharmacy unit.<\/p>\n\n\n\n<ul>\n<li>15 square meters area is required in the case of\nwholesale and retail license.<\/li>\n\n\n\n<li>10 square meters area is required in all other\ncases.<\/li>\n\n\n\n<li>The height of the sales premises will be as per\nthe guidelines provided under Drugs &amp; Cosmetic Rules, 1945<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Storage Facility<\/strong><strong><\/strong><\/h3>\n\n\n\n<p>The other essential\nrequirement is storage facility since some drugs need being stored in low\ntemperatures; refrigerators and air conditioners are a must.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_Required_To_Obtain_Drug_License\"><\/span>Documents Required To Obtain Drug License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The documents\nessential for obtaining a drug license are as follows:-<\/p>\n\n\n\n<ul>\n<li>Form: For wholesale form no. 19\/ retail form no.\n19\/ restricted form no. 19A<\/li>\n\n\n\n<li>Challan: For wholesale Rs. 1500\/ retail Rs.\n1500\/ restricted Rs. 500<\/li>\n\n\n\n<li>Affidavit of proprietor on stamp paper of 20Rs.<\/li>\n\n\n\n<li>Educational certificate copies of proprietor\n(Self attested)<\/li>\n\n\n\n<li>Self attested copies of Identity proof of\napplicant ( Domicile\/ Driving license\/ Voter ID card)<\/li>\n\n\n\n<li>Affidavit of Regd. Pharmacist.<\/li>\n\n\n\n<li>Educational certificate copies of registered Pharmacist\n(Self attested)<\/li>\n\n\n\n<li>Self attested copies of Identity proof of\nregistered Pharmacist (Domicile\/ Voter ID card \/Driving license)<\/li>\n\n\n\n<li>Blue print of Plan layout of premises \/proposed\narea.<\/li>\n\n\n\n<li>Electricity bill of proposed area\/premises.<\/li>\n\n\n\n<li>Copy of Refrigerator bill.<\/li>\n\n\n\n<li>Rent agreement ( 50 Rs. Stamp paper)<\/li>\n\n\n\n<li>Property document justifying the ownership of\nthat premises including the copy of tax receipt of proposed area\/premises.<\/li>\n\n\n\n<li>Covering letter.<\/li>\n\n\n\n<li>Photo 5-5 each of Regd. Pharmacist and proprietor.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"List_of_Application_Forms\"><\/span><strong>List of Application Forms<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  Form 19\n  <\/td><td>\n  Application\n  for authorized or renewal of a license to stock, sell, offer for sale or\n  exhibit , or supply drugs apart from those specified under the category of Schedule\n  X.\n  <\/td><\/tr><tr><td>\n  Form 19A\n  <\/td><td>\n  Application\n  for authorizing or renewing a restricted license to stock,&nbsp; sell, offer for sale, exhibit , or supply drugs\n  by retail via dealers who don\u2019t engaged in the service of a qualified\n  individual.\n  <\/td><\/tr><tr><td>\n  Form 19B\n  <\/td><td>\n  Application\n  for license to sell, stock, offer for sale or exhibit, or supply Homoeopathic\n  Medicines.\n  <\/td><\/tr><tr><td>\n  Form 19C\n  <\/td><td>\n  Application\n  for authorize or renewal of a drugs specified under the category of &nbsp;Schedule X.\n  <\/td><\/tr><tr><td>\n  Form 24\n  <\/td><td>\n  Application\n  for either authorize of a license or for the renewal of a license for\n  distribution of drugs or to manufacture for sale other than those drugs which\n  are specified under the category of &nbsp;[Schedule C, C (1) and X].\n  <\/td><\/tr><tr><td>\n  Form 24A\n  <\/td><td>\n  Application\n  for either the authorize of a loan license or renewal of a loan license to\n  manufacture for sale or distribution of drugs other than those specified under\n  the category of Schedule C, C (1) and X.\n  <\/td><\/tr><tr><td>\n  Form 24B\n  <\/td><td>\n  Application\n  for authorize or renewal of a licensee to distribution of drugs or &nbsp;repack for sale , being drugs other than\n  those specified under the catego0ry of &nbsp;Schedule C and C (1) excluding those\n  specified in Schedule X.\n  <\/td><\/tr><tr><td>\n  Form 24C\n  <\/td><td>\n  Application\n  for granting or renewal of a license to manufacture for sale [or for supply]\n  of Homoeopathic medicines or a license to manufacture potentize preparations\n  from back potencies by licensees holding a license in Form 20-C\n  <\/td><\/tr><tr><td>\n  Form 24F\n  <\/td><td>\n  Application\n  for authorized for renewal of a license to &nbsp;distribution of drugs or manufacture for\n  sale &nbsp;specified under the category of Schedule\n  X and not specified in Schedule C and C(1).\n  <\/td><\/tr><tr><td>\n  Form 27\n  <\/td><td>\n  Application\n  for authorized or renewal of a license to distribution of drugs or&nbsp; manufacture for sale or specified under the\n  category of &nbsp;Schedule C and C (1)\n  excluding those specified in part XB and Schedule X\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Concluding_Remark\"><\/span>Concluding Remark<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>As\nwe knew that the drug license is a legal permit provided by the central and\nstate drugs association governmental bodies. The said License is allotted after\nevaluating several mandates points and guidelines furnished under the said\ncodified act of drugs. The drug is a boon for humankind, and sometimes it\nbecomes a curse for humans if it is usually handled negligently. <\/p>\n\n\n\n<p>These central and state drug bodies have their own well-established parameters to find the eligible person to circulate the standard quantity of drugs among a Nation&#8217;s subjects. Being the responsible individual, we must follow the mandated rules and perceptions established by such bodies to create harmony in public safety, such as a Nobel cause. Kindly contact our <a href=\"https:\/\/corpbiz.io\/\"><strong>Corpbiz<\/strong><\/a> experts to know more about the process to obtain a drug license. <\/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\/complete-overview-on-drug-license-rules-in-india\/\">\nA Complete Overview on Drug License Rules in India\n<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A drug license is a legal permit issued by the government for businesses related to drugs and cosmetics. Drug License ensures that everyone has equal and fair access to drugs and medicine is the government&#8217;s primary concern. But the legal right to manufacture and sell drugs and medicines has to be provided carefully. Therefore, the [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":23173,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[223],"tags":[1377],"acf":{"service_id":"98"},"authorName":"Komal Singh","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/12\/processed.jpeg","authorDescription":"Komal Singh is a Legal scholar, having diverse experience in scripting research papers, articles &amp; dissertations, which serves her main interest &amp; competent in drafting legal documents. She has polished her skills in dealing with the matter related to consumer affairs and now building intelligible Legal Content for Corpbiz.","postViews":18558,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/23151"}],"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\/32"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=23151"}],"version-history":[{"count":24,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/23151\/revisions"}],"predecessor-version":[{"id":66951,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/23151\/revisions\/66951"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/23173"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=23151"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=23151"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=23151"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}