{"id":23471,"date":"2021-01-05T12:31:39","date_gmt":"2021-01-05T07:01:39","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=23471"},"modified":"2021-01-05T12:31:41","modified_gmt":"2021-01-05T07:01:41","slug":"list-of-particulars-demanded-at-the-time-of-registration-of-drug-license","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/list-of-particulars-demanded-at-the-time-of-registration-of-drug-license\/","title":{"rendered":"List of Particulars Demanded At the Time of Registration of Drug License"},"content":{"rendered":"\n<p class=\"has-drop-cap\">To ensure the good health of a nation, access\nto medicines and drugs are indispensable. However, access to medicines and\ndrugs should be controlled to ensure that individuals do not misuse such\nessential drugs. <\/p>\n\n\n\n<p>Therefore, the government has laid down strict laws and regulations for the production and distribution of drugs in India. Manufacture and sale of drugs are regulated by the Laws and Regulations given in the Drugs and Cosmetics Act, 1940. The production and distribution of drugs in India can be done after obtaining the <a href=\"https:\/\/corpbiz.io\/drug-license\"><strong>drug license<\/strong><\/a>. The individual needs to submit the list of particulars discussed below to get the 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\/list-of-particulars-demanded-at-the-time-of-registration-of-drug-license\/#Registration_Process_of_Drug_License\" >Registration\nProcess of 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\/list-of-particulars-demanded-at-the-time-of-registration-of-drug-license\/#Classification_Of_Drug_License\" >Classification\nOf 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\/list-of-particulars-demanded-at-the-time-of-registration-of-drug-license\/#Forms_for_Drug_License\" >Forms 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:\/\/corpbiz.io\/learning\/list-of-particulars-demanded-at-the-time-of-registration-of-drug-license\/#List_Of_Particulars_For_Drug_License\" >List Of\nParticulars For 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\/list-of-particulars-demanded-at-the-time-of-registration-of-drug-license\/#Concluding_Remark\" >Concluding Remark<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Registration_Process_of_Drug_License\"><\/span>Registration\nProcess of Drug License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Registration of Drug Licenses and everything associated with drugs is governed and controlled by the Drugs and Cosmetics Rules 1945. The act controls every aspect of the drugs, from raw material procurement during production to distribution and sale, until it reaches the customer or patient. Drug license is important for all sorts of drugs, cosmetics, medicines businesses, including Homeopathic, Allopathic, Unani or Ayurvedic drugs, etc. This Act even deals with Pharmacist, hospital, or a dispensary regarding usage of drugs. The act also involves the Ayurvedic and Unani drugs in it.<\/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\/what-are-the-conditions-required-to-obtain-drug-license\/\">What Are the Conditions Required To Obtain Drug License under Drugs &#038; Cosmetic Act, 1940<\/a><\/mark><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Classification_Of_Drug_License\"><\/span>Classification\nOf Drug License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The classification of drug license depends on the nature of pharmaceutical business. There are primarily 2 categories of drug license\u00a0usedto obtain the drug license i.e, drug distribution or sale in India. But, overall, there are 7 types of Drug License authorized in India.<\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter is-resized\"><img decoding=\"async\" src=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/01\/Classification-Of-Drug-License.png\" alt=\"Classification Of Drug License\" class=\"wp-image-23472\" width=\"564\" height=\"267\" srcset=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/01\/Classification-Of-Drug-License.png 985w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/01\/Classification-Of-Drug-License-300x143.png 300w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2021\/01\/Classification-Of-Drug-License-768x365.png 768w\" sizes=\"(max-width: 564px) 100vw, 564px\" \/><\/figure><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Retail License&nbsp;<\/h3>\n\n\n\n<p>This license is authorized to Individuals\/ agencies involved in the\nretail business of the drugs.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Wholesale Drug License&nbsp;<\/h3>\n\n\n\n<p>This License is granted to Individuals\/ agencies involved in the\nWholesale distribution or sale of drugs. The License in India is granted by the\nCentral Drugs Standard Control Organization (CDSCO) to those wholesalers\ninvolved in the business of pharmaceuticals.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Manufacturing License <\/h3>\n\n\n\n<p><a href=\"https:\/\/corpbiz.io\/manufacturing-drug-license\"><strong>Manufacturing drug Licenses<\/strong><\/a> must be obtained by the manufacturers of Ayurvedic, Allopathic, Cosmetics products, or any other drugs under the <em><strong>Drugs and Cosmetics Act, 1940<\/strong><\/em><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Act,_1940\"><em><strong>[1]<\/strong><\/em><\/a><\/sup>. The concerned State Government grants this License to the applicant.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Loan License <\/h3>\n\n\n\n<p>This License is got by those industrialists who do not have their\nown land or property for the production of their drugs but want to manufacture\nthe drugs with their brand-name on land or property of those who are already allowed\nto do so with the License of manufacturing.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Restricted License for General Store <\/h3>\n\n\n\n<p>This Restricted License is granted under Forms 20A and 21A to the\nrespective dealers to sell drugs without the supervision and control of any\nqualified person.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Import Drug License <\/h3>\n\n\n\n<p>Import Drug License must received by those entrepreneurs who are\navailing imported products for the production of drugs or those involved in the\nsale or distribution of imported drugs in India.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Multi License for Drugs <\/h3>\n\n\n\n<p>This License must be obtained by those industrialists who are doing\nbusiness activities in more than one State. No one can sell drugs at more than\none location or state without getting this Multi-Drug License<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Forms_for_Drug_License\"><\/span>Forms for Drug License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The below mentioned are the forms needs to be filled by the\napplicant at the time of registration of drug license<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Form 19<\/h3>\n\n\n\n<p><strong>Form 19<\/strong> is authorized to renew of a license to sell, stock, exhibit or\noffer for sale, or distribute drugs apart from those specified in Schedule X.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Form 19A<\/h3>\n\n\n\n<p><strong>Form 19 A<\/strong> is authorizing for renewing a restricted license to sell, stock,\nexhibit or offer for sale, or distribute drugs by retail via dealers who don\u2019t\ninvolve the service of a qualified individual.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Form 19B<\/h3>\n\n\n\n<p><strong>Form 19 B<\/strong> is authorized for license to sell stock or exhibit or offer for\nsale, or distribute Homoeopathic Medicines.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Form 19C<\/h3>\n\n\n\n<p>An application for authorizing or renewing a stock license, sell,\noffer for sale or exhibit, or distribute drugs mentioned under the Schedule X.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Form 24<\/h3>\n\n\n\n<p>An application is for either authorization of a license or for the\nrenewal of a drug license for distribution of drugs\/medicines or to manufacture\nfor sale other than those which are specified under Schedule C, C (1) and X.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Form 24A<\/h3>\n\n\n\n<p>An application is for either the authorization of a loan license or\nrenewal of a loan license to distribution of drugs\/medicines or manufacture for\nsale other than those specified under Schedule C, C (1) and X.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Form 24B<\/h3>\n\n\n\n<p>An application is for authorization or renewal of a licensee to\nrepack for sale or distribution of drugs\/medicines, being drugs other than\nthose specified under Schedule C and C (1) excluding those specified in\nSchedule X.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Form 24C<\/h3>\n\n\n\n<p>An application is for the authorization or renewal of a license to\nmanufacture for sale or distribution of Homoeopathic medicines.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Form 24F<\/h3>\n\n\n\n<p>Application is authorized for renewal of a license to manufacture\nfor sale or for distribution of drugs specified under Schedule X and not\nspecified in Schedule C and C(1).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Form 27<\/h3>\n\n\n\n<p>Application is authorized or renewal of a license to manufacture for\nsale or for distribution of drugs specified under Schedule C and C (1)\nexcluding those specified in part XB and Schedule X<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"List_Of_Particulars_For_Drug_License\"><\/span>List Of\nParticulars For Drug License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><em><strong>The below discussed are the list of particulars asked to submit by the applicant at the time of drug license registration.<\/strong><\/em><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">List Of Particulars For New Retail\nDrug License<\/h3>\n\n\n\n<p><strong>(Drug Licence No. 20, 21) <\/strong><\/p>\n\n\n\n<ul><li>Form No. 19 <\/li><li>Fee challan Rs. 3000\/- <\/li><li>Affidavit duly signed by applicant on stamp paper of 20 Rs. <\/li><li>Educational certificate copies of applicant (Self attested) <\/li><li>Self attested copies of Identity proof of applicant ( Domicile\/\nDriving license\/ Voter ID card)<\/li><li>Affidavit duly signed by registered pharmacist. <\/li><li>Educational certificate copies of registered pharmacist (Self\nattested) <\/li><li>Self attested copies of Id&nbsp;\nproof of registered pharmacist (Voter ID card \/Domicile\/ Driving\nlicense) <\/li><li>Blueprint of proposed area for performing business activities.<\/li><li>Electricity bill of proposed area for performing business\nactivities.<\/li><li>Copy of Refrigerator bill (Proof of Existence of Refrigerator to\npreserve the Drugs)<\/li><li>Rent agreement of the premises<\/li><li>Property document justifying the ownership of that premises\nincluding the copy of tax receipt of proposed area for performing business\nactivities.<\/li><li>Covering letter along with the statement of purpose of business. <\/li><li>Photo 5-5 each of Regd. Pharmacist and applicant.<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">List Of Particulars For New\nWholesale Drug License <\/h3>\n\n\n\n<p><strong>(Drug License No. 20B, 21B)<\/strong><\/p>\n\n\n\n<ul><li>Form No. 19 <\/li><li>Fee challan Rs.\n3000\/- <\/li><li>Affidavit of\napplicant on stamp paper of 20 Rs. <\/li><li>Educational\ncertificate copies of applicant (Self attested) <\/li><li>Self attested\ncopies of Identity proof of applicant (Voter ID card \/Domicile\/ Driving\nlicense) <\/li><li>Affidavit of\nCompetent person. <\/li><li>Academic\ncertificate copies of Competent person (Self attested) <\/li><li>Identity proof of\nCompetent person (Voter ID card\/ Domicile\/ Driving license) <\/li><li>Work experience\ncertificate of competent person. <\/li><li>Electricity bill\nof proposed area for performing business activities.<\/li><li>Copy of Refrigerator\nbill.<\/li><li>Rent agreement <\/li><li>Property document\nwhich justifies the ownership of the premises including the copy of tax receipt\nof the proposed area for performing business activities.<\/li><li>Covering letter\nalong with a statement of purpose of business. <\/li><li>Photo 5-5 each of\ncompetent person and applicant.<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">List of Particulars Required For the Issue of Wholesale Drug License<\/h3>\n\n\n\n<ul><li>Form Number\u2014 19<\/li><li>A letter declaring the purpose of acquiring the Wholesale Drug\nLicense<\/li><li>Receipt of Property Tax<\/li><li>Challan of fees of the amount of Rs. 15,00\/ <\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">List of Particulars Required For the Partnership Firm for Obtaining Wholesale Drug License<\/h3>\n\n\n\n<ul><li>List of Partners<\/li><li>Partnership Deed<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">List Of Particulars Required For The Public And Private Company For Acquiring Wholesale Drug License<\/h3>\n\n\n\n<ul><li>Certificate of Registration.<\/li><li>Memorandum of Association (MOA)<\/li><li>Article of Association (AOA)<\/li><li>Appointment of the authorized person who will be responsible for\ndaily affairs and operations.<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">List of the Directors and Shareholders<\/h4>\n\n\n\n<ul><li>An Affidavit from the Directors<\/li><li>Photograph, ID, and Address\nProof of the Directors<\/li><li>Cancelled Cheque and PAN Card<\/li><li>Copy of the Board resolution\nregarding the authorized person&#8217;s appointment, whowill be responsible for daily\naffairs and operations.<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">List of Particulars Required for the Pharmacist <\/h3>\n\n\n\n<ul><li>Bio-data of the Competent Person as per Performa<\/li><li>Certificate of Experience<\/li><li>Affidavit of Pharmacist<\/li><li>Registration Certificate issued by the Pharmacy Council<\/li><li>Details of Educational Qualification<\/li><li>Photograph, ID, and Address Proof of the Competent Person<\/li><li>Appointment Letter of the Competent Person<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>List of Particulars Required For\nthe Medical Shop for Drug License<\/strong><strong><\/strong><\/h3>\n\n\n\n<p><strong><em>There are two options to get the drug license for the medical shop is as follows; <\/em><\/strong><\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>For Self-owned Property<\/strong><strong><\/strong><\/h4>\n\n\n\n<ul><li>Registered Sale Deed<\/li><li>Registered General Power of\nAttorney<\/li><li>Document of transfer property &nbsp;in the name of the owner<\/li><li>For unregistered GPA,\nunregistered Sale Deed, it must be annexed with the Property Tax Receipt, Water\nBill, Electricity Bill.<\/li><li>In the case of Khasra, Khatauni\nwill be annexed.<\/li><\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>For Rented Premises<\/strong><strong><\/strong><\/h4>\n\n\n\n<ul><li>Registered Rent Agreement with\nthe Rent Receipt<\/li><li>In the case of Unregistered\nPremises, the Agreement must provide for owner documents.<\/li><li>Owner of the Premises has to\nprovide a No Objection Certificate (NOC)<\/li><li>Blueprint of the Premises<\/li><\/ul>\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>We are aware that the government is working for us and can ensure\npublic safety at large. Considering the public interest, the concerned\ngovernment has prepared and established various guidelines to ensure and secure\nevery individual health.<\/p>\n\n\n\n<p>The drugs used for medical purposes need to be observed under the influence of central authority; otherwise, an enormous supply of drugs can push our society in hazardous and threat to humans&#8217; endangered lives. We must follow the central government&#8217;s norms to benefit from such life-saving drugs in an organized way. It&#8217;s the duty and responsibility of every individual towards their Community. Kindly associate with <a href=\"https:\/\/corpbiz.io\/\"><strong>Corpbiz<\/strong><\/a> expert to know more about the particulars demanded at the time of registration of 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\/start-a-medical-store-business-in-india\/\">A Complete Guide to Start a Medical Store Business in India<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>To ensure the good health of a nation, access to medicines and drugs are indispensable. However, access to medicines and drugs should be controlled to ensure that individuals do not misuse such essential drugs. Therefore, the government has laid down strict laws and regulations for the production and distribution of drugs in India. Manufacture and [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":23476,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[223],"tags":[1392],"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":5515,"readingTime":6,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/23471"}],"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=23471"}],"version-history":[{"count":6,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/23471\/revisions"}],"predecessor-version":[{"id":23479,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/23471\/revisions\/23479"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/23476"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=23471"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=23471"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=23471"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}