{"id":23076,"date":"2020-12-30T12:37:19","date_gmt":"2020-12-30T07:07:19","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=23076"},"modified":"2020-12-30T12:43:40","modified_gmt":"2020-12-30T07:13:40","slug":"amendments-for-retention-of-drug-license-under-drugs-cosmetics-act-1940","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/amendments-for-retention-of-drug-license-under-drugs-cosmetics-act-1940\/","title":{"rendered":"Comprehensive Amendments for Retention of Drug License under Drugs &#038; Cosmetics Act, 1940"},"content":{"rendered":"\n<p class=\"has-drop-cap\">Drugs are\nplaying an important role in assuring the good health of citizens of any\ncountry. Drugs are different from other merchandise, and because of that, the\nGovernment has laid down inflexible laws. The regulation governing the\nmanufacture &amp; sale of drugs is provided in the Drugs and Cosmetics Act,\n1940 and Rules framed under it.&nbsp; <\/p>\n\n\n\n<p>The rules made\nunder the Drugs &amp; Cosmetic Rules, 1945 exercise control over drugs at the\nraw material stage during manufacture, sale, and distribution. It is up to the\ntime it is supplied to a patient or consumer by a Pharmacist in a retail\nPharmacy, Hospital or Dispensary.<\/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\/amendments-for-retention-of-drug-license-under-drugs-cosmetics-act-1940\/#The_Principles_Related_To_Drug_License_Registration_under_Drugs_Cosmetic_Act_1940\" >The Principles Related To Drug License Registration 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\/amendments-for-retention-of-drug-license-under-drugs-cosmetics-act-1940\/#Provisions_Related_to_Retention_of_Drug_License_in_India\" >Provisions Related to Retention of Drug License in\nIndia<\/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\/amendments-for-retention-of-drug-license-under-drugs-cosmetics-act-1940\/#Amendments_under_Drugs_Cosmetic_Act_1940\" >Amendments under Drugs &amp; Cosmetic Act, 1940<\/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\/amendments-for-retention-of-drug-license-under-drugs-cosmetics-act-1940\/#Effect_of_Amendments_for_Retention_of_Drug_License\" >Effect of Amendments for Retention of 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\/amendments-for-retention-of-drug-license-under-drugs-cosmetics-act-1940\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"The_Principles_Related_To_Drug_License_Registration_under_Drugs_Cosmetic_Act_1940\"><\/span>The Principles Related To Drug License Registration under Drugs &amp;\nCosmetic Act, 1940 <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Drug and Cosmetic Act regulates the manufacture, sale, distribution, and import of drugs since 1940. The <a href=\"https:\/\/corpbiz.io\/drug-license\"><strong>drug license<\/strong><\/a> allows doing business activities related to pharmaceutical products. Drug license depends on certain terms of conditions provided under the Act that every druggist needs to follow for the retention of a drug license. The Government main objective was to protect the public interest by imposing such conditions under the Act.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Provisions_Related_to_Retention_of_Drug_License_in_India\"><\/span>Provisions Related to Retention of Drug License in\nIndia<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>When you are planning for retention of drug license, then you should check the below-mentioned criteria that you are fulfilling the conditions of <strong>Drugs &amp; Cosmetic Act, 1940<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Act,_1940\"><strong>[1]<\/strong><\/a><\/sup> or not;<\/p>\n\n\n\n<ul><li>An applicant for retention of drug license must\nhave at least four years of practical experience in drug distribution.<\/li><li>A drug licensee can only manufacture a drug\nunder the supervision of an experienced pharmacist.<\/li><li>It is forbidden by the law to stock or sells any\ndrug after its expiry.<\/li><li>A drug retailer cannot provide any drug to a\nminor or a child below 18 years.<\/li><li>The drug retailers should make entry in the\nregister each time they sell any drug to maintain the record for future\nreference.<\/li><li>The medicaments to cure animals must be labeled\nas \u201cNot for human use, for treating animals only.\u201d<\/li><li>Drugs that fall under Schedule H or Schedule X\ncategory or have a validity of period of 2 years. Thus, such drugs should only\nbe provided to registered medical stores like dispensaries, nursing homes,\nhospitals, and medical practitioners. Moreover, it is essential to sign a\nwritten order to provide these drugs.<\/li><li>A drug licensee cannot preserve any drugs at his\nplace intended for the free sample distribution to a certified physician.<\/li><li>If a medical practitioner prescribes any\nmedicine, it should be under the guidance of a Regd. Pharmacist before its\nsupply or retailing.<\/li><li>If a pharmacist has stored an expired medicine\nto claim a rebate from the Income Tax Department, it shall not be regarded as\nan offense unless the drug is not indented for sale purposes.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Amendments_under_Drugs_Cosmetic_Act_1940\"><\/span>Amendments under Drugs &amp; Cosmetic Act, 1940<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter\"><img decoding=\"async\" width=\"985\" height=\"662\" src=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/12\/Amendments-under-Drugs-Cosmetic-Act-1940.png\" alt=\"Amendments under Drugs \" class=\"wp-image-23077\" srcset=\"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/12\/Amendments-under-Drugs-Cosmetic-Act-1940.png 985w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/12\/Amendments-under-Drugs-Cosmetic-Act-1940-300x202.png 300w, https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2020\/12\/Amendments-under-Drugs-Cosmetic-Act-1940-768x516.png 768w\" sizes=\"(max-width: 985px) 100vw, 985px\" \/><\/figure><\/div>\n\n\n\n<p>The primary objective\nto amend the Act is to provide the safeguard to licensee in terms of retention\nof drug license.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Drug and Cosmetic Act, 1940 (10<sup>th<\/sup> Amendment) Rules,\n2017<\/h3>\n\n\n\n<p>On dated 27<sup>th<\/sup>&nbsp;October 2017, the\nauthority of Drugs and Cosmetics has announced the Drugs and Cosmetics (10<sup>th<\/sup>\nAmendment) Rules 2017 through notification no<strong>. G.S.R. 1337(E).<\/strong> <\/p>\n\n\n\n<ul><li>As per the amendment, the sale and manufacturing\nof the drug license shall have validity with no time restriction. The licensee\nshall have to pay the fee for the retention of drug licenses every five years.<\/li><li>The license shall not remain valid forever\nprovided that the licensing authority suspends or cancels it on certain\ngrounds.<\/li><li>Further, it stated that the Central and State\nDrug inspectors should inspect the place at least once in three for\nmanufacturing drug licenses.<\/li><li>The Government has also modernized the sale\nlicenses and renewal of manufacturing by easing the provisions. Thereby it assist\nthe licensees to continue their business for the long time.<\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Drugs &amp; Cosmetic Act, 1940 (11<sup>th<\/sup>\nAmendment) Rule, 2019<\/h3>\n\n\n\n<p>The <em>Ministry of Health and Family Welfare <\/em>on\ndated July 17, 2019, in consultation with the Drugs Technical Advisory Board\nhas announced the Drugs and Cosmetics (Eleventh Amendment) Rules, 2019 through <strong>notification no. G.S.R. 499(E) <\/strong>to\nfurther amend the Drugs and Cosmetics Rules, 1945. The Notification shall come\ninto force by the publication in the Official Gazette.<\/p>\n\n\n\n<p>The changes made\nin the Drugs and Cosmetics Rules, 1945 are as follows:-<\/p>\n\n\n\n<ul><li>A new Rules 77 and 83 has been inserted specifying\nduration of license and loan license where a license issued in Form 28, Form\n28B and Form 28D shall remain valid. It is valid if the licensee deposits a\ndrug license retention fee before the expiry of period of every succeeding five\nyears from the date of its issue, unless it is suspended or cancelled by the\nlicensing authority.<\/li><\/ul>\n\n\n\n<ul><li>The FORM 33 has been omitted and a new Form 32A\nhas been substituted.<\/li><\/ul>\n\n\n\n<ul><li>The Rule 150J which talks about renewal of\ncertificates has been omitted.<\/li><\/ul>\n\n\n\n<ul><li>Amendments are made in Schedule A, in Form 24C,\nForm 26J and Form 37.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Effect_of_Amendments_for_Retention_of_Drug_License\"><\/span>Effect of Amendments for Retention of Drug License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>Renewal was a time consuming process. It will prevent time consumption\nafter the announcement of new guidelines.<\/li><li>New guidelines will create a transparency in retention of\ndrug license process.<\/li><li>It will decrease the work overload of drug department.<\/li><li>After the announcement of new guidelines the inspection will\nbe compulsory. Due to this the licensee will be liable to fulfill all\nrequirements as drug department may conduct inspection on regular basis.<\/li><li>This amendment is made in order to implement good\nmanufacturing standards <\/li><li>After the releasing of notification the quality of products\nmanufactured in India may improve as manufacturing standard compliance could be\nregularly checked.<\/li><li>More control of Drug Authorities will be at ground level for\nmaintaining standards and availability of quality products.<\/li><li>Now Drug Department can concentrate at proper implementation\nof laws and rules according to Drug and Cosmetic Act.<\/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> To make the process of doing great business in the pharmaceutical industry in the easier way, the Central Drugs Standard Control Organization (CDSCO) has announced to make it mandatory for pharmaceutical companies and chemists to periodically pay a license retention fee instead of the current ambiguous practice of renewal of licenses.\u00a0The recent amendments under Drug and Cosmetic Act, 194o for retention of drug license will bring a positive change. Retention of drug license will be beneficial\u00a0for both the Drug Department and drug license holder. Kindly contact with <a href=\"https:\/\/corpbiz.io\/\"><strong>Corpbiz<\/strong><\/a> experts to know more about retention 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\/legal-obligation-under-cdsco-for-obtaining-wholesale-drug-license\/\">\nLegal Obligation under CDSCO for Obtaining Wholesale Drug License\n<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Drugs are playing an important role in assuring the good health of citizens of any country. Drugs are different from other merchandise, and because of that, the Government has laid down inflexible laws. The regulation governing the manufacture &amp; sale of drugs is provided in the Drugs and Cosmetics Act, 1940 and Rules framed under [&hellip;]<\/p>\n","protected":false},"author":32,"featured_media":23079,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[223],"tags":[1373],"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":23856,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/23076"}],"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=23076"}],"version-history":[{"count":15,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/23076\/revisions"}],"predecessor-version":[{"id":23097,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/23076\/revisions\/23097"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/23079"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=23076"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=23076"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=23076"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}