{"id":46528,"date":"2022-08-10T12:04:51","date_gmt":"2022-08-10T06:34:51","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=46528"},"modified":"2022-08-10T12:04:52","modified_gmt":"2022-08-10T06:34:52","slug":"how-to-import-registered-drugs-in-india","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/how-to-import-registered-drugs-in-india\/","title":{"rendered":"How to Import Registered Drugs in India?"},"content":{"rendered":"\n<p>The Drugs and Cosmetics Acts, 1940 and <strong>The Drugs and Cosmetics Rules, 1945<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Rules,_1945\"><strong>[1]<\/strong><\/a><\/sup> are the two laws governing the Import, sales, manufacture and distribution of Drugs in India. Any product falling under the category of Drugs or Medical related devices needs to be registered before getting imported to India. It is also required to register the manufacturing site for the purpose of importing to India. If the drug which is to be Imported falls under the category of New drug, then before the submission of the application of registration and Import of that drug, it is important to get New drug approval for the product. The CDSCO provides license and registration certificates for the Import, export, manufacturing, sales, distribution etc., of the drugs.<\/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-registered-drugs-in-india\/#Need_for_Drugs\" >Need for Drugs<\/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-registered-drugs-in-india\/#Role_of_CDSCO_to_Import_Registered_Drugs_in_India\" >Role of CDSCO to Import Registered Drugs 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\/how-to-import-registered-drugs-in-india\/#Eligibility_to_Import_Registered_Drugs_in_India\" >Eligibility to Import Registered 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-registered-drugs-in-india\/#Documents_required_to_Import_Registered_Drugs_in_India\" >Documents required to Import Registered Drugs 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\/how-to-import-registered-drugs-in-india\/#Procedure_to_Obtain_a_License_to_Import_Registered_Drugs_in_India\" >Procedure to Obtain a License to Import Registered Drugs in India<\/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-registered-drugs-in-india\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Need_for_Drugs\"><\/span>Need for Drugs<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Medicines and Medicinal products\nand devices are demanded throughout the world. There are some products that are\nmanufactured all over the world, whilst there are certain products that are\nmanufactured only in a particular country, region or by a particular\nmanufacturer. Due to this, the drugs are imported from one place to another for\na variety of uses. All the drugs must be registered before importing them to\nIndia. India holds the third largest place in the world in the pharmaceutical\nIndustry. All the activities related to registration, licensing, Import, export\netc., of drugs are governed by the Drugs and Cosmetics Acts, 1940 and Drugs and\nCosmetics Rules, 1945, under CDSCO in India. <\/p>\n\n\n\n<p>All the products falling under\nthe definition of Drugs needs to be registered first under CDSCO, along with\nregistration of the Manufacturing Site. The Indian medical Industry has been\ngrowing at a huge rate. With the rise in population, there is a huge rise in\nhealth problems. New diseases, pandemics etc., are being introduced every now\nand then. Due to this, there has been a huge demand for medicines and\nmedicine-related products in India. As the growth in demand persists, there\nstill stands a problem of the basic infrastructure and resources to combat the\nproblems and ailments in the pharmaceutical sector. This Industry is, however,\nthe most profitable Industry for the purpose of Investment globally. There is a\nhuge demand and profit in setting up pf Pharmacy shops, Hospitals,\nManufacturing sites, etc.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Role_of_CDSCO_to_Import_Registered_Drugs_in_India\"><\/span>Role of CDSCO to Import Registered Drugs in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO<\/strong><\/a> is also known as Central Drug Standard Control Organisation. It works under the Ministry of Health and Family Welfare, Governed by the Government of India. It is the National Drug Regulatory Authority of India. CDSCO is authorized to maintain and regulate all the procedures related to the Import, Export, Registration, manufacturing, and Licensing of Drugs, Medicines, Medical Devices, IVDs and Medical related products in India. CDSCO is responsible for Import Registered Drugs in India. The application for obtaining an Import or Registration License has to be submitted to the Drug Controller General or DGI at CDSCO. For the purpose of Import Registered Drugs in India of bulk quantity, it is also required for a Manufacturing site and product to be registered with CDSCO. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Eligibility_to_Import_Registered_Drugs_in_India\"><\/span>Eligibility to Import Registered Drugs in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The following are eligible to Import\nregistered drugs in India:<\/p>\n\n\n\n<ul><li>The Foreign manufacturers who have obtained a\nlicense for the sale or distribution of drugs in India<\/li><li>Local authorized Agent of the foreign\nmanufacturers who has obtained manufacturing or sales license <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_required_to_Import_Registered_Drugs_in_India\"><\/span>Documents required to Import Registered Drugs in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The following documents are\nrequired to Import registered Drugs in India:<\/p>\n\n\n\n<ul><li>Covering Letter<\/li><li>Power of Attorney (original) <\/li><li>Application Form<\/li><li>Copy of Import permission<\/li><li>Copy of wholesale\/manufacturing license of the\nIndian Agent<\/li><li>Authorization letter <\/li><li>Schedule D (I) and Undertaking are duly signed,\nsealed and stamped by the Authorized person of the manufacturer or by his\nIndian Agent.<\/li><li>Schedule D (II) and Undertaking are duly signed,\nsealed and stamped by the Authorized person of the manufacturer or by his\nIndian Agent.<\/li><li>Free sale certificate<\/li><li>Manufacturing License &amp; Market authorization\nCertificate<\/li><li>Establishment License <\/li><li>Inspection or Audit Report<\/li><li>An Undertaking from the proprietor of the firm\n(in case of proprietorship firm)<\/li><li>An Undertaking from the Board of Directors\n(BoDs) (in case of a Private Limited Company)<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_to_Obtain_a_License_to_Import_Registered_Drugs_in_India\"><\/span>Procedure to Obtain a License to Import Registered Drugs in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In order to obtain a license to\nImport Registered Drugs in India, the manufacturer or his Agent first needs to\nacquire a registration certificate, followed by the Import License. The\napplicant is required to apply for the Registration Certificate and Import\nLicense at CDSCO. <\/p>\n\n\n\n<p>Following is the procedure to obtain a license to Import Registered Drugs in India-<\/p>\n\n\n\n<ul><li>There is an Application form as Form-40 that\nneeds to be filled and submitted to the licensing authority, by the foreign\nmanufacturer or by his Authorized Agent in India, along with some undertakings\nmentioned in Schedule D (I) and D (II), which has to be duly signed by or on\nbehalf of the manufacturer. <\/li><li>Import registration certificate is then granted\nby CDSCO as Form-41. The Certificate of Registration is valid for a period of\nthree years. <\/li><li>After receiving the registration certificate, an\napplication for an Import license should be submitted to the Licensing\nAuthority (LA) in Form 8 for drugs excluding Schedule X and in Form 8-A for\ndrugs in Schedule X by the manufacturer or his Authorized Agent. The form is to\nbe accompanied by an application fee of 1000\/- for one drug, along with an\nadditional fee of 100\/- for each additional drug, along with an undertaking in\nForm-9 duly signed by the manufacturer or on his behalf. <\/li><li>The Import License is then obtained as Form-10\nfrom the CDSCO office. The license remains valid for the period of three years\nor until the period of expiry of the registration certificate. <\/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>As the drug and Medicine industry is rapidly growing in India, there is a strict need to regulate the actions and working of the Industry in order to avoid low quality and unsafe goods from reaching the common crowd. The government maintains strict entry rules to restrict the entry of new entrepreneurs into the drug business and to maintain the quality and standard of the drug and medicine industry in India. Thus the government has made it mandatory for manufacturers or Importers to obtain a license to Import Registered Drugs in India in order to avoid low-quality products which could affect the crowd in any possible way. License to Import Registered Drugs is a great way to put a barrier on the new competition and cut the illicit practices in the medical Industry by foreign manufacturers, and safeguard the health and Lives of people.\u00a0 <\/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\/cdsco-certificate-for-drugs-import-to-india\/\">CDSCO Certificate for Drugs Import to India: An Overview<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Drugs and Cosmetics Acts, 1940 and The Drugs and Cosmetics Rules, 1945[1] are the two laws governing the Import, sales, manufacture and distribution of Drugs in India. Any product falling under the category of Drugs or Medical related devices needs to be registered before getting imported to India. It is also required to register [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":46531,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[223],"tags":[2588],"acf":{"service_id":"98"},"authorName":"Snehita Shukla","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/07\/MicrosoftTeams-image-84.jpg","authorDescription":"Snehita has her qualifications in B.Com LLB and LLM, and holds a specialization in Corporate &amp; Financial Laws and Policy. She is hardworking, dedicated and sincere. She has a great command in english and has great problem solving, critical thinking  and writing skills which makes her stand out of the crowd. She has a keen interest in legal research work and content writing, she also has a hold in legal research methodology. She loves to take challenges and to explore new topics to research on. She aims to improve her knowledge and skills through her experience.","postViews":6570,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46528"}],"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\/45"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=46528"}],"version-history":[{"count":14,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46528\/revisions"}],"predecessor-version":[{"id":46544,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46528\/revisions\/46544"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/46531"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=46528"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=46528"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=46528"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}