{"id":46338,"date":"2022-08-08T11:48:04","date_gmt":"2022-08-08T06:18:04","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=46338"},"modified":"2022-08-25T11:21:10","modified_gmt":"2022-08-25T05:51:10","slug":"how-to-import-new-drugs-in-india","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/how-to-import-new-drugs-in-india\/","title":{"rendered":"How to Import New Drugs in India?"},"content":{"rendered":"\n<p>In India, the manufacturing, Import, distribution and sale of drugs are regulated by the <strong><em>Drugs &amp; Cosmetics Act, 1940 and Drugs &amp; Cosmetics Rules, 1945<\/em><\/strong>. License is provided for the Import of new drugs &amp; cosmetics subject to those specified in Rule 10 &amp; 10A. No new drug is allowed to import into India without the sanction of the Licensing Authority in writing. Each drug whose composition is not recognized as safe for use by the experts and that has not been used to any extent or for any appreciable period are to be regarded as a new drug. This blog will discuss how to Import New Drugs into India.<\/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\/how-to-import-new-drugs-in-india\/#Application_for_Import_License\" >Application for Import 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\/how-to-import-new-drugs-in-india\/#Requirements_for_Grant_of_License_for_Import_New_Drugs\" >Requirements for Grant of\nLicense for Import New Drugs<\/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\/how-to-import-new-drugs-in-india\/#Documents_for_Obtaining_License_for_Import_New_Drugs_in_India\" >Documents for Obtaining License\nfor Import New Drugs 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\/how-to-import-new-drugs-in-india\/#Prohibition_on_Import_new_drugs_into_India\" >Prohibition on Import new drugs\ninto 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\/how-to-import-new-drugs-in-india\/#Central_Government_of_India_Power_of_Prohibition\" >Central Government of India\nPower of Prohibition<\/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\/how-to-import-new-drugs-in-india\/#Offences\" >Offences<\/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\/how-to-import-new-drugs-in-india\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Application_for_Import_License\"><\/span>Application for Import License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>An application for import license is made in Forms 8 &amp; 9, respectively, for obtaining an import license in Form 10. The CDSCO Portal should make each application. Rule 24 of the Drugs &amp; Cosmetics Rules with procedural requirements for getting a license.<\/p>\n\n\n\n<p>Following are the procedural requirements for obtaining a license to Import new drugs in India:<\/p>\n\n\n\n<ul><li>The application file by the manufacturer himself\nhaving a valid wholesale drug license for sale or distribution of drugs &amp;\ncosmetics rules 1945.<\/li><li>In a Power of Attorney, the agreement from the\nmanufacturer to his Indian Agent has to be documented &amp; verified either in\nIndia before a first-class magistrate or in the origin country.<\/li><li>The importer (manufacturer&#8217;s Agent) in India\neither has a valid license by the Drug &amp; Cosmetics rules to manufacture a\nnew drug or a valid wholesale license for distribution\/sale of new drugs under\nthese Rules.<\/li><li>The import license application must be followed\nby a copy of the registration certification grant in <strong><em>Form 42 issued under Rule 27A<\/em><\/strong>.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Requirements_for_Grant_of_License_for_Import_New_Drugs\"><\/span>Requirements for Grant of\nLicense for Import New Drugs<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>Imported substances shall be sorted properly to\nmaintain the properties of the Drugs applied for a license.<\/li><li>Where any charge in the constitution of the\nmanufacturer address takes place, the current registration certificate is valid\nfor three months. In the meantime, a fresh registration certificate shall be\nissued Form the licensing authority with the charged information.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_for_Obtaining_License_for_Import_New_Drugs_in_India\"><\/span>Documents for Obtaining License\nfor Import New Drugs in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are the Documents for getting a License to Import New Drugs in India:<\/p>\n\n\n\n<ul><li>Cover Letter;<\/li><li>Form-8 and Form-8A are duly Stamped &amp; Signed by the applicant;<\/li><li>Notarized copy of manufacturing <a href=\"https:\/\/corpbiz.io\/drug-license\"><strong>drug license<\/strong><\/a> or wholesale;<\/li><li>Permission under Rule 122A (Application for permission to import new drugs) if a new drug is in the name of the importer;<\/li><li>Form-9 (Undertaking given from the manufacturer or on behalf of the manufacturer);<\/li><li>Copy of valid registration certificate (RC) on Form-41 duly attested from the importer or Indian Agent;<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Prohibition_on_Import_new_drugs_into_India\"><\/span>Prohibition on Import new drugs\ninto India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Section 10 of the <strong>Drugs &amp; Cosmetics Act, 1940<\/strong><sup><a href=\"https:\/\/www.indiacode.nic.in\/handle\/123456789\/2409?sam_handle=123456789\/1362\"><strong>[1]<\/strong><\/a><\/sup> has made the restriction on the Import of the following:<\/p>\n\n\n\n<ul><li>Drugs of substandard quality.<\/li><li>Any misbranded and spurious drugs.<\/li><li>Any adulterated drugs.<\/li><li>Any drug that needs to cure or mitigate any\ndisease.<\/li><li>Any drugs include an ingredient that may be\nharmful or unsafe for consumption.<\/li><li>Any proprietary or patent medicine with no\ndescription of the true formula or list of active ingredients is included.<\/li><li>Drugs are prohibited from imports under section\n10 of the Drug &amp; Cosmetics Act, 1940.<\/li><\/ul>\n\n\n\n<p><strong><em>Note:\nsection 10 has an exception related to any drugs in small quantities for the\naim of testing, examination or analysis for personal use and subject to\nprescribed conditions.<\/em><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Central_Government_of_India_Power_of_Prohibition\"><\/span>Central Government of India\nPower of Prohibition<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Central Government will prohibit the Import of new drugs if the government is satisfied that:<\/p>\n\n\n\n<ul><li>The use of such drugs involves risks to humans\nor any animal.<\/li><li>The drug lacks its therapeutic value.<\/li><li>The drugs include ingredients in such quantity,\nfor there is no therapeutic justification.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Offences\"><\/span>Offences<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following penal provisions are applicable for non-compliance with the provision for Import new drugs:<\/p>\n\n\n\n<ul><li>The Import of adulterated drugs that involves\nthe risk of human life has imprisonment for the team of three years or a fine\nthat can be a maximum up to Rs.5000, or both. And for the subsequent\nconviction, imprisonment for five years.<\/li><li>The Import of drugs against the provisions given\nin any notification issued under section 10A shall be liable for imprisonment\nfor three years or a fine up to Rs.5000 or both.<\/li><li>The Import of any drugs prohibited under any\nsection of the Act has imprisonment for six months or fine of Rs.5000 or both.\nAnd for the subsequent conviction, imprisonment for one year.<\/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 obtain a licence to import new drugs in India, the licensee must have a sufficient storage facility, and the applicant must be well-known in their field. The license granted must not be suspended or cancelled unless the licensee has not been convicted of any offence under the Drugs &amp; Cosmetics Act 1940 or the Drugs &amp; Cosmetics Act 1945.<\/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\/import-license-of-drugs-and-cosmetics-in-india\/\">Import License of Drugs and Cosmetics in India<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In India, the manufacturing, Import, distribution and sale of drugs are regulated by the Drugs &amp; Cosmetics Act, 1940 and Drugs &amp; Cosmetics Rules, 1945. License is provided for the Import of new drugs &amp; cosmetics subject to those specified in Rule 10 &amp; 10A. No new drug is allowed to import into India without [&hellip;]<\/p>\n","protected":false},"author":42,"featured_media":46340,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[223],"tags":[2576],"acf":{"service_id":"98"},"authorName":"Krishna Kumar","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/07\/MicrosoftTeams-image-62.jpg","authorDescription":"Krishna Kumar has completed BA-LLB with a specialization in constitutional Laws from ICFAI University. As a recent graduate, He has both legal research and content writing experience in various law firms. He secures good drafting skills for various legal documents in multiple fields of law.","postViews":4044,"readingTime":3,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46338"}],"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\/42"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=46338"}],"version-history":[{"count":14,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46338\/revisions"}],"predecessor-version":[{"id":47346,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46338\/revisions\/47346"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/46340"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=46338"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=46338"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=46338"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}