{"id":8607,"date":"2020-05-15T13:59:35","date_gmt":"2020-05-15T08:29:35","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=8607"},"modified":"2020-12-30T12:39:34","modified_gmt":"2020-12-30T07:09:34","slug":"retail-drug-license-essential-for-pharmacy-business","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/retail-drug-license-essential-for-pharmacy-business\/","title":{"rendered":"How Retail Drug License essential for Pharmacy Business?"},"content":{"rendered":"\n<p class=\"has-drop-cap\">Drugs are different from other commodities due to which the government has laid down stringent law. The <a href=\"https:\/\/corpbiz.io\/drug-license\"><strong>drug license<\/strong><\/a> is provided to the pharmacy business to regulate and govern the manufacturing and selling of drugs. Drug license is basically a permission granted by the competent authority under <strong><em>Drugs and Cosmetic Act, 1940<\/em><\/strong> to carry out a business concerning drugs\/medicines or cosmetics. The regulation is necessary from the stage of the raw material stage to the stage of manufacture, sale, and distribution of retail drug license to owners. It is further passed on to a patient or consumer by a Pharmacist in retail Pharmacy, Hospital, or a Dispensary. <\/p>\n\n\n\n<p>In other words, no one can start or continue a business dealing with drugs or cosmetics in India, unless an appropriate license is aquire for the conduct of such activity. Under the purview of provisions of <strong>Drugs and Cosmetics Act, 1940<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Act,_1940\"><strong>[1]<\/strong><\/a><\/sup>, all types of drugs or cosmetics businesses are covered, including allopathic, homeopathic, ayurvedic, or Unani drugs. In the year 1964, the Act was amended to include Ayurvedic &amp; Unani drugs. However, it is the responsibility of all persons to maintain the quality of drugs and cosmetics with which they are dealing. If any person consuming or using drugs that suffer any harm due to the negligence on the part of the manufacturer or seller, the same is an offense, and the person would be punishable under the eyes of the law.&nbsp; <\/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\/retail-drug-license-essential-for-pharmacy-business\/#Why_Drug_License_is_important_for_Retail_Medical_Business\" >Why Drug License is\nimportant for Retail Medical Business?<\/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\/retail-drug-license-essential-for-pharmacy-business\/#Advantages_of_Drug_License\" >Advantages of Drug\nLicense<\/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\/retail-drug-license-essential-for-pharmacy-business\/#Deciding_upon_the_type_of_medical_store\" >Deciding upon the type\nof medical store:<\/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\/retail-drug-license-essential-for-pharmacy-business\/#Registering_for_Drug_License\" >Registering for Drug\nLicense<\/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\/retail-drug-license-essential-for-pharmacy-business\/#Minimum_requirements_for_obtaining_Drug_License\" >Minimum requirements for obtaining Drug License<\/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\/retail-drug-license-essential-for-pharmacy-business\/#Documents_needed_to_obtain_a_Retail_Drug_License\" >Documents needed to obtain a Retail 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\/retail-drug-license-essential-for-pharmacy-business\/#Legal_Procedures_regarding_Online_Medical_Stores\" >Legal Procedures\nregarding Online Medical Stores<\/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\/retail-drug-license-essential-for-pharmacy-business\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Why_Drug_License_is_important_for_Retail_Medical_Business\"><\/span>Why Drug License is\nimportant for Retail Medical Business?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Health\nis the most important part of personal life. The evergreen business that is\nunaffected by the economic cycles is the business in medicine or the medical\nsector. Healthcare and pharmacy business today in India is facing tremendous\ngrowth and also gaining popularity in corporate hospitals and multi-specialty\nhospitals. Having a medical store is a good option for those entrepreneurs who\nwant to invest in the healthcare segment, having less space and low capital.<\/p>\n\n\n\n<p>Despite having the remarkable importance, every medical store also has a big responsibility. A little mistake on their part may become fatal for the customers. Therefore, this is the reason that medical stores are often required to follow many legal procedures before they start selling medicines to the customers.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Advantages_of_Drug_License\"><\/span>Advantages of Drug\nLicense<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>With the rise of medical issues in recent times, it is necessary for the government to take control over those dealing in this sector. There are many entities that, after obtaining retail drug license, can do their business without any fear of being caught.<\/li><li>Entity working in the pharmacy sector can easily expand their retail business as retailers will not hesitate in dealing with customers after obtaining a valid license with the concerned authority. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Deciding_upon_the_type_of_medical_store\"><\/span>Deciding upon the type\nof medical store:<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong><em>Before\nproceeding for the registration process, an individual has to decide the type\nof medical store that he wants to own. The following are the options available:<\/em><\/strong><\/p>\n\n\n\n<ul><li><strong><em>Hospital medical store:<\/em><\/strong> It is store inside the hospitals developed to cater to meet the\ndemands of the patients treated inside the hospitals. <\/li><li><strong><em>Standalone medical store:<\/em><\/strong> Mostly open for 24 hours as it is the most common form of store\nthat is present in any residential area for its customers. <\/li><li><strong><em>Chain Pharmacy\/ Franchise\noutlets:<\/em><\/strong> Medical stores that are present in the\nmalls, and these are part of the chain of pharmacies.<\/li><li><strong><em>Township medical stores:<\/em><\/strong> It is a build-up for the people living in a township area to cater\nto their needs.<\/li><li><strong><em>Stores in Government\nPremises:<\/em><\/strong><em>\nThese stores helpful for the employees working in government offices or\nproviding services to a country like army camps have their own medical stores.<\/em><\/li><\/ul>\n\n\n\n<p><strong><em>Before applying\nfor registration of business, an individual must fulfill the following\nnecessary requirements:<\/em><\/strong><\/p>\n\n\n\n<ul><li><strong><em>Pharmacy Licence:<\/em><\/strong> In order to have a Pharmacy License, a person requires being\nqualified as a pharmacist having a degree of B. Pharm or M. Pharm.<\/li><\/ul>\n\n\n\n<ul><li><strong><em>Land Registration:<\/em><\/strong> Every business has to be decided upon the investment that it would\nrequire. Depending upon the budget, one has to choose whether to have a rented\nshop or to own a shop. There is a requirement of either of the Rent deed or the\nsales agreement. A person may seek legal assistance for this purpose.&nbsp; <\/li><\/ul>\n\n\n\n<ul><li><strong><em>Registration of Medical\nStore Business:<\/em><\/strong> The Indian Pharmacy Act, 1948,\ngoverns the registration of medical stores in India. This Act states that the\nmedical stores and pharmacies have to get registered with all the particulars\ngiven by the state government. Thereafter Post submission of a registration\napplication, the tribunal will decide on the matters pertaining to it.<\/li><\/ul>\n\n\n\n<p>The constitution for the business of the medical store is important. While in other cases, the hospitals, chain pharmacies, and township medical stores prefer to set up a private limited company. The standalone medical store is preferably set up as a proprietorship or maybe as a partnership firm. Recently, since Limited Liability Partnerships (LLPs) are gaining popularity, medical stores are also considering it as a preferred form of business. The change is mainly attributed to the promotion of the rights of the partners, which is mentioned in the LLP form of constitution. <\/p>\n\n\n\n<ul><li><em><a href=\"https:\/\/corpbiz.io\/company-registration\"><strong>Company Registration<\/strong><\/a><\/em><strong><em>:<\/em><\/strong><em> <\/em>It important to register the business as a proprietorship or partnership or full-fledged company since day one for the retail stores. Depending on which mode one wants to operate the business. The following can be probable options for the medical stores:&nbsp;  <\/li><\/ul>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter\"><img decoding=\"async\" width=\"633\" height=\"340\" src=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/05\/image-62.png\" alt=\"Registration of Medical Store Business\" class=\"wp-image-8608\" srcset=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/05\/image-62.png 633w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/05\/image-62-300x161.png 300w\" sizes=\"(max-width: 633px) 100vw, 633px\" \/><\/figure><\/div>\n\n\n\n<ul><li><strong><em>Shop and Establishment Registration\/ Gumasta Registration:<\/em><\/strong><em> <\/em>According to the municipal rules of the respective municipal corporation, one needs to get the <a href=\"https:\/\/corpbiz.io\/shop-establishment-license\"><strong>shop and establishment registration<\/strong><\/a> done in order to run a business without any hassle made by the authorities. Also, this particular certificate is required as a supporting document from drug licensing and registrations. <\/li><\/ul>\n\n\n\n<ul><li><strong><em>GST Registration:<\/em><\/strong> As other business entities, including a medical store, to start a retail business, one must get <a href=\"https:\/\/corpbiz.io\/gst-registration\"><strong>GST registration<\/strong><\/a>. The GST number is required if the aggregate turnover in a financial year exceeds the given threshold limit. The limit prescribed by the GST Council is Rs 20 lakhs for all states other than the North-Easter Hilly states where the limit is Rs 10 lakhs.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Registering_for_Drug_License\"><\/span>Registering for Drug\nLicense<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Before\nthe operations begin, every medical store, whether it&#8217;s big or small, requires\na drug license from the Central Drugs Standards Control Organization and from\nthe State Drugs Standard Control Organization. <\/p>\n\n\n\n<p><strong><em>These both\norganizations are responsible for issuing two major drug licenses:<\/em><\/strong><\/p>\n\n\n\n<ul><li><strong><em>Retail Drug License:<\/em> <\/strong><a href=\"https:\/\/corpbiz.io\/retail-drug-license\"><strong>Retail drug license<\/strong><\/a> is needed to start a medical store\/ chemist shop. A prescribed fee has to be deposited. The registration can only be done in the name of an individual who possesses a degree or a diploma in pharmacy from a recognized university or institute.<\/li><li><strong><em>Wholesale Drug License:<\/em><\/strong> <a href=\"https:\/\/corpbiz.io\/wholesale-drug-license\"><strong>wholesale drug license<\/strong><\/a> is issued for those medical stores, dealing in the wholesale business regarding drugs and medicines. Unlike Retail Drug License, there are no more stringent conditions that one has to meet in order to get this license. <\/li><\/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\/punishment-for-selling-of-medicine-without-drug-license-in-india\/\">Punishment for Selling of Medicines Without a Drug License<\/a><\/mark><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Minimum_requirements_for_obtaining_Drug_License\"><\/span>Minimum requirements for obtaining Drug License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter\"><img decoding=\"async\" width=\"567\" height=\"331\" src=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/05\/image-63.png\" alt=\"requirements for Drug License\" class=\"wp-image-8609\" srcset=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/05\/image-63.png 567w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/05\/image-63-300x175.png 300w\" sizes=\"(max-width: 567px) 100vw, 567px\" \/><\/figure><\/div>\n\n\n\n<ul><li><strong><em>Area specification:<\/em><\/strong> <\/li><\/ul>\n\n\n\n<p>The\nminimum area requirement is 10 square meters in order to start a medical shop\nor pharmacy outlet. In case, the pharmacy business combines both the retail and\nwholesale, a minimum of 15 square meters is required.<\/p>\n\n\n\n<ul><li><strong><em>Storage Facility:<\/em><\/strong> <\/li><\/ul>\n\n\n\n<p>The\nmedical store must be equipped with the refrigerator and also an air\nconditioner. According to the labeling specifications, certain drugs like\nvaccines, Sera, Insulin Injections, etc., are required to be stored in the\nrefrigerator.<\/p>\n\n\n\n<ul><li><strong><em>Inspection by Drug\nInspector:<\/em><\/strong><em> <\/em><\/li><\/ul>\n\n\n\n<p>Before the permit of a drug license, the drug inspector having jurisdiction of the area visits the place where retail drug license is required and verify the particulars furnished with the application. If required, take measurement of the premises and also interview the competent person.<\/p>\n\n\n\n<ul><li><strong><em>Technical Staff:<\/em><\/strong> <\/li><\/ul>\n\n\n\n<p>All\ntypes of medical stores require technical staff that must have the\nqualification in the medical field. <\/p>\n\n\n\n<ul><li><strong><em>Wholesale business:<\/em><\/strong> <\/li><\/ul>\n\n\n\n<p>The sale\nof drugs must be made in the presence of registered pharmacist or in the\npresence of a competent person who must be a graduate with 1 yr experience in\ndealing with the drugs. Either a person who has passed SSLC with the experience\nof 4 years dealing in drugs, specially approved by the department of drug\ncontrol for this purpose.<\/p>\n\n\n\n<ul><li><strong><em>Retail business:<\/em><\/strong> <\/li><\/ul>\n\n\n\n<p>The sale of the drug by retail must be made in the presence of a registered pharmacist approved by the department. The registered pharmacist has to be present at the time of sale of medicines during all the working hours.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_needed_to_obtain_a_Retail_Drug_License\"><\/span>Documents needed to obtain a Retail Drug License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong><em>Here is a list of documents needed for procuring <\/em><\/strong><em><strong>drug license in India<\/strong><\/em><strong><em> which may vary across different states:<\/em><\/strong><\/p>\n\n\n\n<ul><li>Application form in the\nprescribed format in the Act<\/li><li>A cover letter with the\napplication duly signed with all details of name and also designation of an\napplicant<\/li><li>Challan of fees deposited for\nregistration<\/li><li>Blueprint of the premises<\/li><li>Declaration form in the\nprescribed format in the Act<\/li><li>Proof of ownership of the\npremises<\/li><li>Proof of business constitution\nand its registration certificate<\/li><li>Affidavit regarding\nnon-conviction of the proprietor or the partners or the directors under the\nDrug and Cosmetics Act, 1940<\/li><li>Affidavit of the registered\npharmacist or a person equally competent who works the whole time<\/li><li>Appointment letter from the\nregistered pharmacist or any competent person, in case, if employed<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Legal_Procedures_regarding_Online_Medical_Stores\"><\/span>Legal Procedures\nregarding Online Medical Stores<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The\npeople are shifting towards online things, and online medical stores have also\ndeveloped the most common medium of buying medicines. Consumers can get the\nrarest of rare drugs with utmost ease and privacy. <\/p>\n\n\n\n<p><strong><em>Here are a few\npractices which are legal for an online medical store:<\/em><\/strong><\/p>\n\n\n\n<ul><li>All drugs, other than\nover-the-counter drugs, require the prescription. <\/li><li>Contact details of online\nmedical stores must be stated in the form in which the drug license has been\nprocured.<\/li><li>Verify and certify of delivery\nof drugs.<\/li><li>There are provisions in the\nIndian law regarding the shipping of medicines from one state to another and in\nthe provision of taking money prior to the delivery of medicines.<\/li><\/ul>\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>Licensing\nis mandatory to deal with Drugs &amp; Cosmetics in India. The provisions for\nthis have been made in the Drugs &amp; Cosmetics Act, 1940, which is applicable\nto the whole of India. It is an Act that consolidates all the laws relating to\ndrugs &amp; cosmetics, and it established the Drugs Control Department. If drugs\nare sold or stocked for sale at more than one place, the application shall be\nmade, and license shall be issued, in respect of each such place except migrant\nvendors.<\/p>\n\n\n\n<p>Once the license is granted to the business, all such license must ensure that all the conditions in the drug license complied at all the time during the course of the business. All the records \/registers \/Forms must be maintained in the manner specified by the licensing authorities, and authorities shall be kept informed for all the changes or modifications in the business activities.<\/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\/\">A Complete Overview on Drug License Rules in India<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Drugs are different from other commodities due to which the government has laid down stringent law. The drug license is provided to the pharmacy business to regulate and govern the manufacturing and selling of drugs. Drug license is basically a permission granted by the competent authority under Drugs and Cosmetic Act, 1940 to carry out [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":8630,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[223],"tags":[569],"acf":{"service_id":"98"},"authorName":"Soumya Bajpai","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/01\/0.jpg","authorDescription":"Soumya has done LLB (Hons) and has a 2+years experience in writing. Her main interest is in reading judgments, new enactments and amendments taking around in law. She always strives to bring the best to work that she does.","postViews":15777,"readingTime":7,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/8607"}],"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\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=8607"}],"version-history":[{"count":22,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/8607\/revisions"}],"predecessor-version":[{"id":23095,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/8607\/revisions\/23095"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/8630"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=8607"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=8607"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=8607"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}