{"id":46020,"date":"2022-08-03T11:57:32","date_gmt":"2022-08-03T06:27:32","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=46020"},"modified":"2022-08-03T11:57:34","modified_gmt":"2022-08-03T06:27:34","slug":"what-is-form-42-and-form-43","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/what-is-form-42-and-form-43\/","title":{"rendered":"What is FORM-42 and FORM-43?"},"content":{"rendered":"\n<p>The term &#8220;cosmetic&#8221; is defined in section 3(aaa) of the <strong>Drugs and Cosmetics Act of 1940<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Drugs_and_Cosmetics_Act,_1940\"><strong>[1]<\/strong><\/a><\/sup>. It states that &#8220;cosmetic&#8221; includes any item intended to be used as a cosmetic ingredient as well as any object meant to be rubbed, poured, sprinkled, sprayed, applied to the human body or any part for cleansing, beautifying, promoting beauty, or altering the appearance. Anyone or any organization wishing to import cosmetics into India must register with the CDSCO first. Form-42 and Form-43 are used in the registration process; Form 42 is an application for the issuance of a Registration Certificate for the Import of Cosmetics into India under the Drugs and Cosmetics Rules of 1945, and Form 43 is a Registration Certificate to be issued for the Import of Cosmetics into India under the Drugs and Cosmetics Rules of 1945.<\/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\/what-is-form-42-and-form-43\/#Types_of_Cosmetic_Registration_in_India\" >Types of Cosmetic Registration in 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\/what-is-form-42-and-form-43\/#CDSCOs_Function_in_Cosmetic_Imports\" >CDSCO&#8217;s Function in Cosmetic Imports<\/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\/what-is-form-42-and-form-43\/#Information_Required_for_Application_of_Cosmetic_Registration_%E2%80%93_Form-42_and_Form-43\" >Information Required for Application of Cosmetic Registration &#8211; Form-42 and\nForm-43<\/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\/what-is-form-42-and-form-43\/#Documents_Required_for_Cosmetic_Registration\" >Documents Required for Cosmetic Registration<\/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\/what-is-form-42-and-form-43\/#Documents_Required_for_Re-Registration_of_Cosmetic_Products\" >Documents Required for Re-Registration of Cosmetic Products<\/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\/what-is-form-42-and-form-43\/#Validity\" >Validity<\/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\/what-is-form-42-and-form-43\/#Conclusion\" >Conclusion:<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Types_of_Cosmetic_Registration_in_India\"><\/span>Types of Cosmetic Registration in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>There are two types of registration of cosmetic products in India-<\/strong><\/p>\n\n\n\n<ul><li><strong>Manufacturing\nLicense: &nbsp;<\/strong>When planning to\nmanufacture cosmetics, you must have a manufacturing licence. Therefore, in\norder to manufacture and market cosmetic products in India, the following\nlicence is required by the D &amp; C Act, 1940:<\/li><\/ul>\n\n\n\n<p>1.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; A request\nis made in Form-31 and a licence in Form-32 is issued for the manufacturing of\ncosmetics for sale or distribution.<\/p>\n\n\n\n<p>2.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Application\nis submitted in Form No. 31-A, and License in Form 32-A is issued for Loan\nLicense for Manufacturing Cosmetics for Sale and Distribution.<\/p>\n\n\n\n<p>3.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; On behalf\nof the licence for manufacture for sale of drugs and cosmetics, the licence on\nForm 37 is issued for the grant or renewal of approval for conducting tests on\ndrugs, cosmetics, or raw materials used in their manufacturing.<\/p>\n\n\n\n<ul><li><strong>Importing\nlicence: <\/strong>When an organization imports and resells cosmetics in India but\ndoes not manufacture them, they need a licence as a cosmetic importer. The\nimporting license is obtained through form-42 and form-43; to get the licence\nfor the import of cosmetics, importers must submit Form 42 to the central\nlicencing authority, which is an application for the issue of registration\ncertificate for the import of cosmetics into India. According to the Rules,\nForm 43 is used to issue registration certificates for importing cosmetics into\nIndia from other countries.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"CDSCOs_Function_in_Cosmetic_Imports\"><\/span>CDSCO&#8217;s Function in Cosmetic Imports<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u2022 Modifying the Cosmetic Rules, 2020 regarding the import and\nregistration of cosmetic products;<\/p>\n\n\n\n<p>\u2022Amendment of the Cosmetic Rules, 2020 considering the import and\nregistration of cosmetic products;<\/p>\n\n\n\n<p>\u2022Analysing various requests for NOCs (No Objection Certificates) or\nclarifications relating to the import of cosmetics;<\/p>\n\n\n\n<p>\u2022Handling complaints from NGOs, the general public, or consumer forums\nabout the quality of cosmetic products;<\/p>\n\n\n\n<p>\u2022Responding as necessary to correspondence from the government or BIS;<\/p>\n\n\n\n<p>\u2022Analysing applications for <a href=\"https:\/\/corpbiz.io\/cdsco-cosmetic-import-registration\"><strong>CDSCO Cosmetic Import Registration<\/strong><\/a> by the rules and requirements of the 1940 Drugs and Cosmetics Act;<\/p>\n\n\n\n<p>\u2022Responding to public questions, PMOPGs, or hearings about the CDSCO\nCosmetic Import Registration process and offering assistance therein;<\/p>\n\n\n\n<p>\u2022Creating draught responses to questions from the Parliament about\ncosmetics and RTI, VIP references, legal cases, and court cases.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Information_Required_for_Application_of_Cosmetic_Registration_%E2%80%93_Form-42_and_Form-43\"><\/span>Information Required for Application of Cosmetic Registration &#8211; Form-42 and\nForm-43<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u2022 Information about the producer and the location of the factory.<\/p>\n\n\n\n<p>\u2022 Evidence of registration fee payment.<\/p>\n\n\n\n<p>\u2022 Information on cosmetics.<\/p>\n\n\n\n<p>\u2022 Product Details.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_Required_for_Cosmetic_Registration\"><\/span>Documents Required for Cosmetic Registration<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>\u2022 Covering letter: The application&#8217;s goal must be stated in detail.\nThe importer provides this document.<\/p>\n\n\n\n<p>\u2022 Form 42: This is made online after the importer pays the government\nfee. The importer must give a stamped and signed copy of the same form.<\/p>\n\n\n\n<p>\u2022 Challan: A document containing information about the applicant as\nwell as the payment made for the application in Indian rupees.<\/p>\n\n\n\n<p>\u2022 Power of Attorney by the Manufacturer: This document outlines the\ncontractual arrangement between the Manufacturer and the importer and lists the\ngoods to be imported, along with the categories for which they are being\nregistered and the pack sizes.<\/p>\n\n\n\n<p>\u2022 Schedule D (III): Provides information on the manufacturer and\nmanufacturing facilities<\/p>\n\n\n\n<p>\u2022 A product label that is either original or a copy.<\/p>\n\n\n\n<p>\u2022 For each variant, a Free Sale Certificate (FSC), a letter of\nmarketing authorization, and a manufacturing licence must be submitted: lists\nthe goods and states that they can be bought and sold without restriction in\nthe nation of origin.<\/p>\n\n\n\n<p>\u2022 Product testing procedures and product specifications.<\/p>\n\n\n\n<p>\u2022 A list of the nations to which import authorization, registration,\nor market authorization has been granted.<\/p>\n\n\n\n<p>\u2022 Product inserts in packages.<\/p>\n\n\n\n<p>\u2022 Digital copies of information on product manufacturers, brands, and\nproducts.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_Required_for_Re-Registration_of_Cosmetic_Products\"><\/span>Documents Required for Re-Registration of Cosmetic Products<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Central Drugs Standard Control\nOrganization (CDSCO) introduced a new set of clarifications along with the\ncurrent regulations on October 15, 2015, emphasising the import and\nregistration of cosmetic products. A list of additional documents needed to\nrenew the registration certificate is also included. The group of papers\nconsists of:<\/p>\n\n\n\n<ul><li>An original power of attorney; <\/li><li>Required fees;<\/li><li>Form 42- properly completed and signed, along\nwith the list of items that need to be renewed;<\/li><li>A letter of marketing authorization, a\nmanufacturing licence, or a certificate of free sale, as applicable;<\/li><li>Copies of earlier-issued original RC and\nendorsement certificates; and<\/li><li>An undertaking or self-declaration stating the\ninformation previously shared regarding the product&#8217;s details.<\/li><\/ul>\n\n\n\n<p><strong>Cosmetic Registration and Approval (FORM-42 and Form-43)<\/strong><strong><\/strong><\/p>\n\n\n\n<p>The following individuals or entities may\nsubmit Form-42 and Form-43 requests for Registration of Import of Cosmetics:&nbsp;<\/p>\n\n\n\n<ul><li>The Manufacturer\nhaving registered office in India&nbsp;<\/li><li>The Manufacturer&#8217;s\nauthorized representative&nbsp;<\/li><li>The Manufacturer&#8217;s\nAffiliate&nbsp;<\/li><li>Any additional\nimporter&nbsp;<\/li><\/ul>\n\n\n\n<p>Drugs Controller General (I), CDSCO, New\nDelhi, receives the registration application (Form-42) and the necessary\npaperwork. This application is submitted with the required fee, as well as the\ndata and commitment listed in Schedule D-III. Form-42 and Form-43 are required\nto register the import of cosmetics. For any number of brands produced at one\nor more locations by a single manufacturer, a single application in Form 42\nmust be submitted. The registration is valid for 3 years, the Registration\nCertificate (Form 43) can be obtained in roughly three months.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Validity\"><\/span>Validity<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The authority must issue a\ncertificate of registration within six months of receiving a complete\napplication, as stated in Rule 129C of the Drugs and Cosmetics Rules, 1945.\nStill, in some exceptional cases, the certificate may be issued three months\nafter the authority has recorded the reasons for it in writing. This is in line\nwith the time frame that the CDSCO aims for, which is 90 days.<\/p>\n\n\n\n<p>After being issued as Form-42 and\nForm-43, the certificate for import of cosmetics is valid for three years from\nthe date of issuance.<\/p>\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>With a sizable economy for cosmetic and personal care products, Today&#8217;s cosmetic industry is expanding quickly. To ensure the safety, quality of cosmetics imported into India, regulations should be in place. According to Rule 21 of the Drugs and Cosmetics Rule 1945, the Ministry of Health &amp; Family Welfare must issue a CDSCO Cosmetic Import Registration Certificate via Form-42 and Form-43. For CDSCO Cosmetic Import Registration in India, the certificate is necessary from the primary regulatory body, which is collected from the Central Drug Standard Control Organization (CDSCO). With this registration, selling and importing cosmetics can be done without difficulty in India. The 1940 Drugs and Cosmetics Act governs CDSCO Cosmetic Import Registration in India.<\/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\/cosmetic-product-manufacturer-license-in-india\/\">Cosmetic Product Manufacturer License in India<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The term &#8220;cosmetic&#8221; is defined in section 3(aaa) of the Drugs and Cosmetics Act of 1940[1]. It states that &#8220;cosmetic&#8221; includes any item intended to be used as a cosmetic ingredient as well as any object meant to be rubbed, poured, sprinkled, sprayed, applied to the human body or any part for cleansing, beautifying, promoting [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":46022,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2556],"acf":{"service_id":"254"},"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":7362,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46020"}],"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=46020"}],"version-history":[{"count":11,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46020\/revisions"}],"predecessor-version":[{"id":46033,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/46020\/revisions\/46033"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/46022"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=46020"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=46020"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=46020"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}