{"id":51259,"date":"2022-12-13T12:26:49","date_gmt":"2022-12-13T06:56:49","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=51259"},"modified":"2024-07-02T17:53:34","modified_gmt":"2024-07-02T12:23:34","slug":"legalities-of-pharmaceutical-export-from-india","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/legalities-of-pharmaceutical-export-from-india\/","title":{"rendered":"Pharmaceutical Export from India: Know the Legalities"},"content":{"rendered":"\n<p>The Indian pharmaceuticals\nindustry is poised at the third position in terms of global production. And in\nterms of overall valuation, it sits at the 13th position. India is now\nrecognized as a global production and research hub. The Indian drug sector is\nanticipated to grow at a CAGR of 22 percent, with an overall valuation of US 55\nbillion dollars by 2020. Generic drugs rule the Indian drug sector, which\ncomprises almost 70 percent of the market. Meanwhile,\n&#8220;over-the-counter&#8221; medicines and patented medicines accounted for 21%\nand 9%, respectively. Given the present growth and global presence, the\npharmaceutical export from India can help manufacturers to reap additional\nprofit. The drug export business is profitable, but it revolves around hefty\ncompliances. This write-up will take a close look at the legalities around\npharmaceutical export from India, along with other facts. <\/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\/legalities-of-pharmaceutical-export-from-india\/#A_Market_Analysis_of_Pharmaceutical_Export_From_India\" >A Market Analysis of\nPharmaceutical Export From India<\/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\/legalities-of-pharmaceutical-export-from-india\/#Common_permits_required_for_pharmaceutical_export_from_India\" >Common permits required for pharmaceutical export from 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\/legalities-of-pharmaceutical-export-from-india\/#How_to_start_pharmaceutical_export_from_India\" >How to start pharmaceutical export from 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\/legalities-of-pharmaceutical-export-from-india\/#Role_of_the_Drug_Controller_Offices_NOC_in_drug_export\" >Role of the Drug Controller Office\u2019s NOC in drug export<\/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\/legalities-of-pharmaceutical-export-from-india\/#Understanding_the_significance_of_PHARMEXCILs_permits_in_drug_export\" >Understanding the significance of PHARMEXCIL\u2019s permits in drug\nexport<\/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\/legalities-of-pharmaceutical-export-from-india\/#Labelling_Norms_to_Ponder_for_Shipping_Drugs_abroad\" >Labelling Norms to Ponder for Shipping Drugs abroad<\/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\/legalities-of-pharmaceutical-export-from-india\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"A_Market_Analysis_of_Pharmaceutical_Export_From_India\"><\/span><strong>A Market Analysis of\nPharmaceutical Export From India<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following is the market\nanalysis of pharmaceutical export from India:<\/p>\n\n\n\n<ul>\n<li>Pharmaceutical export from\nIndia accounted for 17$ billion in 2017-18. It is anticipated to grow by 50% to\nreach a market valuation of 25$ billion by the end of the year 2025.<\/li>\n\n\n\n<li>India exports drugs to\nAfrica, North America, the EU, Latin America, the Middle East, and other\nEuropean regions. Almost 2\/3rd of India\u2019s export finds their way to Europe,\nNAFTA, and Africa. The top five export avenues for the Indian drug sector in\n2021-22 were USA, Russia, UK, and Nigeria.<\/li>\n\n\n\n<li>USA, Russia, and the UK\nare among the frontline importers of Indian drugs with a share of 29%, 2.4%,\nand 3%, respectively 2021-22. India\u2019s export of drugs to these nations in 2021-22\nwas: the USA with $7101 m, the UK with $704 m, South Africa with $612 m, Russia\nwith $597 m, and Nigeria with $588 m. <\/li>\n\n\n\n<li>India\u2019s drug shipping to\nthe USA in value has thrived at a CAGR of almost 7 percent over the past three\nyears. Besides, for Russia and UK, it thrived at a CAGR of 4% and 7.2 %,\nrespectively over the same timeline. <\/li>\n\n\n\n<li>As of August 2021, the no.\nof USFDA-certified units stood at 741. Also, the number of ANDs won by the\nIndian-based companies till Dec 2020 stood at 4,346. USFDA vetting was not\nperformed during the past few years owing to the COVID-19 outbreak; however,\nthe vetting has now become active and is anticipated to further augment Indian\nexports to the USA. <\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Common_permits_required_for_pharmaceutical_export_from_India\"><\/span><strong>Common permits required for pharmaceutical export from India<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The following are some common permits\nrequired for pharmaceutical\nexport from India:<\/p>\n\n\n\n<ul>\n<li>Import-Export Code\n(granted by the Directorate General of Foreign Trade) <\/li>\n\n\n\n<li>Certificate\/NOC granted by\nthe State licensing authority operating under CDSCO <\/li>\n\n\n\n<li>RCMC certificate accorded\nby Pharmaceutical Export Promotion Council<\/li>\n\n\n\n<li>Drug manufacturing license\naccorded by CDSCO<\/li>\n\n\n\n<li>Exportation documents such\nas proforma invoices, commercial invoices, bills of lading, packing list,\ncertificate of origin, and letter of credit<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"How_to_start_pharmaceutical_export_from_India\"><\/span><strong>How to start pharmaceutical export from India? <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul>\n<li>The first step is to\napproach DGFT to apply for Import Export Code<\/li>\n\n\n\n<li>Get in touch with the\nprospect interested in importing Indian-based pharmaceutical products.<\/li>\n\n\n\n<li>Avail of the required\napproval from the importing nation before shipping the consignment. <\/li>\n\n\n\n<li>Get the export\ncertification\/NOC from the licensing authority i.e. Drug Controller General of\nIndia. <\/li>\n\n\n\n<li>Select the viable shipping\nmethod. Don\u2019t forget to take the importer&#8217;s consent for the same. Some\nwidespread shipping methods include Expedite Shipping, international freight,\netc. <\/li>\n\n\n\n<li>Prompt the importer to\nsend the Purchase order enclosing the type and amount of drugs. In response,\nthe exporter should send the proforma invoice, which must include details\nconcerning packing type, product pricing, and freight information. <\/li>\n\n\n\n<li>Team up with a freight\nforwarder to ship the consignment <\/li>\n\n\n\n<li>Complete the paperwork\nlike the bill of lading, packing list, commercial invoice, etc. <\/li>\n\n\n\n<li>After availing of\nclearance, the consignment will make its way to the importing nation, wherein\ncustom checks shall be performed. <\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Role_of_the_Drug_Controller_Offices_NOC_in_drug_export\"><\/span><strong>Role of the Drug Controller Office\u2019s NOC in drug export<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Drug exports outside India\nrequire a legal permit in the form of a NOC granted by the Drug Controller\nOffice of India. Without this, no manufacturers can ship their pharma products\nabroad. In India, this NOC is only available to registered drug manufacturers.\nThe State Licensing Authority (operating under the aegis of the Central Drugs\nStandard Control Organisation) can accord such a NOC. The applicant can head to\nthe zonal office of the CDSCO to apply for this export NOC. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Understanding_the_significance_of_PHARMEXCILs_permits_in_drug_export\"><\/span><strong>Understanding the significance of PHARMEXCIL\u2019s permits in drug\nexport<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>PHARMEXCIL\n(Pharmaceuticals Export Promotion Council of India) is a government institution\naccountable for advocating drug exports from India. Launched in 2004, the\nPHARMEXCIL falls under the ambit of FTP (Foreign Trade Policy).&nbsp; PHARMEXCIL often releases various schemes and\ninitiatives for strengthening the cross-border presence of Indian drugs. The\ninstitution seldom organizes events for domestic and international drug\ncompanies to boost cross-border trade. Exporters intending to leverage such\nopportunities need to apply for <strong><a class=\"text-primary\" href=\"https:\/\/corpbiz.io\/pharmexcil-registration\">PHARMEXCIL Registration<\/a><\/strong>.<\/p>\n\n\n\n<p><strong><em>As a trade promotion\norganization, PHARMEXCIL performs the following functions: <\/em><\/strong><\/p>\n\n\n\n<ul>\n<li>Represent Government at\ndomestic and international levels to identify ideal solutions for widespread\nproblems concerning the drug industry. <\/li>\n\n\n\n<li>Bolster Government in\ndevising export-friendly policies. <\/li>\n\n\n\n<li>Accord legal documents to\nexporters such as COI&nbsp; and Registration\ncum Membership Certificate, aka RCMC. <\/li>\n\n\n\n<li>Organize seminars and\nevents concerning export-related subject matters. <\/li>\n\n\n\n<li>Help members to avail of\nMarket Access incentives (MAI) claim from the GOI.<\/li>\n\n\n\n<li>Organize export meets in\nIndia and abroad<\/li>\n\n\n\n<li>Organize Trade delegations\nabroad<\/li>\n<\/ul>\n\n\n\n<p><strong><em>As of now, Pharmexcil\u2019s\nservices to access the following products:<\/em><\/strong><\/p>\n\n\n\n<ul>\n<li>Active Pharmaceutical\nIngredients (API)<\/li>\n\n\n\n<li>Herbal\/ Ayurveda<\/li>\n\n\n\n<li>Finished Dosage Forms\n(FDF)<\/li>\n\n\n\n<li>Siddha<\/li>\n\n\n\n<li><strong>Unani<\/strong><\/li>\n\n\n\n<li>Homoeopathy<\/li>\n\n\n\n<li>Diagnostics<\/li>\n\n\n\n<li>Biologics<\/li>\n\n\n\n<li>Surgical<\/li>\n\n\n\n<li>Collaborative Research<\/li>\n\n\n\n<li>Nutraceuticals<\/li>\n\n\n\n<li>Clinical Trials &amp;\nConsultancy<\/li>\n\n\n\n<li>Contract Manufacturing<\/li>\n\n\n\n<li>Regulatory Services<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Labelling_Norms_to_Ponder_for_Shipping_Drugs_abroad\"><\/span><strong>Labelling Norms to Ponder for Shipping Drugs abroad <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Drugs and Cosmetics Act\n1945 entails the following norms concerning the labelling of drugs to be\nshipped abroad. Every exporter must take these norms into account before\nstarting pharmaceutical export from India. <\/p>\n\n\n\n<p>Labels on packages of\npharmaceutical products should be in line with the norms of the importing\nnation. The label must be legible and reflect the following particulars without\nfail; <\/p>\n\n\n\n<ul>\n<li>Drug\u2019s name; <\/li>\n\n\n\n<li>The name, and address of\nthe drug makers <\/li>\n\n\n\n<li>The license number of the\ndrug manufacturer<\/li>\n\n\n\n<li>Batch or lot number<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span><strong>Conclusion <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>India is all set to become a global hub for drug manufacturing and research. Owing to competitive pricing and on-par quality, the demand for Indian drugs is escalating rapidly every passing day. This underpins an ideal opportunity for drug manufacturers to reap more profit via pharmaceutical export from India. The compliance requirement for drug export in India is quite stringent. Therefore, adhering to underlying norms is of paramount importance for drug producers and exporters. It would be helpful to avail of professional help before shipping drugs abroad. <\/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\/how-to-export-medicine-globally-from-india\/\">How to Export Medicine Globally from India?<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Indian pharmaceuticals industry is poised at the third position in terms of global production. And in terms of overall valuation, it sits at the 13th position. India is now recognized as a global production and research hub. The Indian drug sector is anticipated to grow at a CAGR of 22 percent, with an overall [&hellip;]<\/p>\n","protected":false},"author":22,"featured_media":51261,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[165],"tags":[2951],"acf":{"service_id":"16"},"authorName":"Pankaj Tyagi","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/01\/MicrosoftTeams-image-42.jpg","authorDescription":"Pankaj has a diverse experience of writing research papers, blog, and articles during his college time. Earlier, he was working as a tax consultant in a financial firm, but his interest in writing drives him to pursue a career in the writing field.","postViews":10480,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51259"}],"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\/22"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=51259"}],"version-history":[{"count":4,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51259\/revisions"}],"predecessor-version":[{"id":65119,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51259\/revisions\/65119"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/51261"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=51259"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=51259"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=51259"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}