{"id":3877,"date":"2020-02-20T13:00:15","date_gmt":"2020-02-20T13:00:15","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=3877"},"modified":"2024-06-18T11:27:31","modified_gmt":"2024-06-18T05:57:31","slug":"punishment-for-selling-of-medicine-without-drug-license-in-india","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/punishment-for-selling-of-medicine-without-drug-license-in-india\/","title":{"rendered":"Punishment for Selling of Medicines Without a Drug License"},"content":{"rendered":"\n<p class=\"has-drop-cap\">The Drug License Process in India is simple yet a lengthy process. To start a business of the pharmaceutical business, it is mandatory to follow the Drug License Process. <a href=\"https:\/\/corpbiz.io\/drug-license\"><strong>Drug License<\/strong><\/a> process is an initial step to take a permit by the concerned state Authority to start a Pharmaceutical business and to carry out the activities related to the pharmaceutical industry. <\/p>\n\n\n\n<p>Any person without obtaining the drug license cannot start the business which directly or indirectly relates to the pharmaceutical industry. Failure to obtain the drug license in India<strong> <\/strong>can be a costly mistake which results in Penal Provisions and Punishments.<\/p>\n\n\n\n<p>Further, for ensuring the\ngood health of the nation and to avoid that the drugs are not being misused by\nthe individual, it is important to have access to drugs and medicines.<\/p>\n\n\n\n<p>In this topic, we will discuss\nthe Drug license Process, why drug license is important for the individuals\ndealing in Pharmaceutical Industry, Types of Drug License issued by the\nauthority and what are the penal provisions for selling the medicines without a\nDrug 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\/punishment-for-selling-of-medicine-without-drug-license-in-india\/#Importance_of_Drug_License\" >Importance 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\/punishment-for-selling-of-medicine-without-drug-license-in-india\/#Key_factors_to_obtain_the_Drug_License_in_India\" >Key\nfactors to obtain the 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-3\" href=\"https:\/\/corpbiz.io\/learning\/punishment-for-selling-of-medicine-without-drug-license-in-india\/#Types_of_Drug_License_in_India\" >Types of 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\/punishment-for-selling-of-medicine-without-drug-license-in-india\/#Steps_involved_in_Drug_License_Process_in_India\" >Steps involved in Drug License Process in India<\/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\/punishment-for-selling-of-medicine-without-drug-license-in-india\/#Documents_required_along_with_the_application\" >Documents required along with the application<\/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\/punishment-for-selling-of-medicine-without-drug-license-in-india\/#Punishment_for_selling_of_medicines_without_a_Drug_License\" >Punishment\nfor selling of medicines without a 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\/punishment-for-selling-of-medicine-without-drug-license-in-india\/#Takeaway\" >Takeaway<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Importance_of_Drug_License\"><\/span>Importance of Drug License <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Before the Drug has been used by the\npatients, it has to go through a lengthy process, i.e. various testing and cost-effective\nobservations and various stages, i.e. from the laboratory, clinical test,\nmarketing to sampling. Drug License Process is mandatory for starting a\nbusiness in Drugs and Cosmetics in India. <\/p>\n\n\n\n<p>Drug License is issued to the manufacturers, retailers, wholesalers,\ndistributors who are engaged in the business of pharmaceuticals\/or carrying out\nthe business activities related to the pharmaceutical industry.<\/p>\n\n\n\n<p>The license is issued by the respective State Drug License Authority under the Drugs and Cosmetics Act, 1940. <strong><em>Drug and Cosmetics Act 1940<\/em><\/strong> is an act to combine all the laws related to the drugs. Though the Act was amended in 1964, to involve Ayurvedic and Unani Drugs<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Key_factors_to_obtain_the_Drug_License_in_India\"><\/span>Key\nfactors to obtain the Drug License in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul>\n<li><strong>Working Space-<\/strong> To set up a medical shop, or retail pharmacy, a minimum area of 10 square meters, is required. However, in the case of the wholesale business of Pharmaceutical, a minimum of 15 square meters is mandatory.<\/li>\n<\/ul>\n\n\n\n<div class=\"shadow1\"><strong>Note:<\/strong> For obtaining a license in Form 20 or 21 or both the working space (Premise) shall not be less than 10 sq. mtrs. The Same is the criteria for obtaining the license in form 20-B or form 21-B.<\/div>\n\n\n\n<ul>\n<li><strong>Proper Space for Storage<\/strong>-There is a\nrequirement of proper storage for several medicines and vaccines which need to\nbe stored at cool places and for the same A\/C and refrigerators is necessary.<\/li>\n\n\n\n<li><strong>Expertise Staff<\/strong>-For smooth and efficient working\nqualified and experienced person is required to operate the pharmacy business.<\/li>\n\n\n\n<li><strong>Proper License by the State Authority<\/strong>-Once the Drug license process is done; it is approved by the\nState Drug License Authority.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Types_of_Drug_License_in_India\"><\/span>Types of Drug License in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong><em>Types of Drug license depends on the\nparticular business entity. <\/em><\/strong><strong><em>There are two types of Drug License \u2013<\/em><\/strong><\/p>\n\n\n\n<ul>\n<li><strong>Manufacturing License<\/strong><\/li>\n<\/ul>\n\n\n\n<p>Manufacturing Drug License is a license issued by the respective\nState Authority\/Government under<strong> Drugs and\nCosmetics Act, 1940<\/strong> to the manufacturers of Allopathic, Ayurvedic,\nCosmetics products. Manufacturing of drugs includes the process or part of the process\nof making, altering, labelling and finishing any drug or drug-related products\nin the ordinary course of business.<\/p>\n\n\n\n<ul>\n<li><strong>Sale and Loan License<\/strong><\/li>\n<\/ul>\n\n\n\n<p>Loan License is issued to the applicant not having his area of\nworking but who plans to avail himself of the manufacturing facilities granted\nto another licensee. <\/p>\n\n\n\n<p>Sale Drug License is acquired by the retailers and wholesalers\nwho are involved in the drug distribution in India, i.e.Wholesale Drug License,\nRetail Drug License. For Sale Drug license, a requisite area of at least 10 sqr.\nmtrs is required with the proper storage facility<\/p>\n\n\n\n<p><strong><em>Apart from the above-mentioned license, different categories of\nDrug Licenses are-<\/em><\/strong><\/p>\n\n\n\n<ul>\n<li><strong>Import Drug License <\/strong>&#8211; Import Drug License is issued to the applicants who are using imported goods for manufacturing drugs or are engaged in the distribution of Imported Drugs.<\/li>\n\n\n\n<li><strong>Multi-Drug License <\/strong>&#8211; Multi-Drug License is required by that person who is dealing in more than one state. A person cannot operate in more than one state without obtaining the Multi-Drug License because the Drug license process is a location-specific.<\/li>\n<\/ul>\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<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Steps_involved_in_Drug_License_Process_in_India\"><\/span>Steps involved in Drug License Process in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following steps are\nrequired to complete the Drug License Process \u2013 <\/p>\n\n\n\n<p>Though the process is\nlengthy and time taking a person can directly file an application to the\nGovernment for Drug License-<\/p>\n\n\n\n<ol>\n<li><strong>To obtain a User ID and Password &#8211; <\/strong>The Applicant has to obtain user ID and Password\nby giving a request letter personally along with the details of the firm.<\/li>\n\n\n\n<li><strong>Submission\nof requisite documents &#8211; <\/strong>Applicant\nis required to upload the documents properly scanned (100 dpi and shall be in the\nblack and white form). The application shall be filled precisely and to be sent\nelectronically. In case of the absence of any document required for the Drug\nlicense process, the authority can ask for the same.<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_required_along_with_the_application\"><\/span>Documents required along with the application<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul>\n<li>In\ncase, if the applicant is the Company -Memorandum of Association\/Article of\nAssociation is required. In the case of a firm, Partnership Deed is required.<\/li>\n\n\n\n<li>Applicant\u2019s\nIdentity proof and Address Proof.<\/li>\n\n\n\n<li>Proof\nof Place of Working. (Owned Property (Property Papers)\/Rent agreement (In case\nof lease Agreement)<\/li>\n\n\n\n<li>Area\nPlan and layout plan of the premises<\/li>\n\n\n\n<li>For\nstorage (Details of Refrigerator)<\/li>\n\n\n\n<li>In\ncase the premise is situated on DDA residential flat\/ plot\/ building (Affidavit\nregarding the compliance of MPD 2021) is also to be attached.<\/li>\n<\/ul>\n\n\n\n<div class=\"shadow1\"><strong>Note:<\/strong> Additional Documents like-Proof of Qualification, Registration of Pharmacy and Appointment Letter is required in the case of Retail Sale Registered Pharmacist and for Wholesale Competent person.<\/div>\n\n\n\n<ul>\n<li><strong>Follow up\nwith the Authority &#8211; <\/strong>For any update\nor status, the applicant needs to take a follow up with the authority. If in\ncase the application got rejected by the Government, the fees will be forfeited\nby the Government.<\/li>\n\n\n\n<li><strong>Complete\nreview of the Application &#8211; <\/strong>To review the complete application and to approve the same, the\ndepartment will take at least 45-60 working days.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Punishment_for_selling_of_medicines_without_a_Drug_License\"><\/span>Punishment\nfor selling of medicines without a Drug License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Running a business without\na drug license can be far outstretched and can have a bad impact on the\nbusiness. Non-compliances result in the punishment and imprisonment of the\nperson selling medicine without a Drug License.<\/p>\n\n\n\n<p>As required under clause (c) of Section\n18, If a person sale any medicine without Drug license and without complying\nwith the Drug license process, he shall be punishable with-<\/p>\n\n\n\n<ul>\n<li>Imprisonment for a period which shall not be less than 1 year, which may extend to 3 years, and in that case the period of limitation will come under Section 468 (2)(c) of Criminal Procedure Code and<\/li>\n\n\n\n<li>Fine which shall not be less than Rs.5000\/-<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Takeaway\"><\/span>Takeaway<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Drug License Process is mandatory for obtaining a Drug License and to run a business in Drugs and Cosmetics Products. Drug License Process helps in regulating the import of drugs in India by avoiding substandard products. It controls the sale and distribution of drugs. Running a business without a drug license at a minimum will result in Fines and Punishments. Absence of Drug License can bring lawsuits, business closure, and various penalties and punishments. The Drug license Process also includes an inspection by the representative of the Authority\/or Drug Inspector.<\/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\/get-drug-license-in-india\/\">How to Obtain Drug License in India?<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Drug License Process in India is simple yet a lengthy process. To start a business of the pharmaceutical business, it is mandatory to follow the Drug License Process. Drug License process is an initial step to take a permit by the concerned state Authority to start a Pharmaceutical business and to carry out the [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":3878,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[223,164],"tags":[224],"acf":{"service_id":"98"},"authorName":"Priyanka Bajpayee","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/03\/IMG-20220303-WA0005.jpg","authorDescription":"A Company Secretary together with PG in international Business, she has gained significant experience as legal content writer. She has keen interest in doing research and writing on legal and financial subject matters. She also holds work experience in legal compliances.","postViews":43178,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/3877"}],"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\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=3877"}],"version-history":[{"count":10,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/3877\/revisions"}],"predecessor-version":[{"id":64836,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/3877\/revisions\/64836"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/3878"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=3877"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=3877"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=3877"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}