{"id":33824,"date":"2021-08-02T12:17:53","date_gmt":"2021-08-02T06:47:53","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=33824"},"modified":"2021-10-26T16:38:52","modified_gmt":"2021-10-26T11:08:52","slug":"set-up-a-hand-sanitizer-manufacturing-unit-in-india","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/set-up-a-hand-sanitizer-manufacturing-unit-in-india\/","title":{"rendered":"How to set up a Hand Sanitizer manufacturing unit in India?"},"content":{"rendered":"\n<p class=\"has-drop-cap\">Hand sanitizer was treated as an optional medicinal and cosmetic product in the pre-Covid era. But the demand for hand sanitizer in India has been surging ever since the Covid 19 virus hit this country. Owing to the skyrocketing demand, existing manufacturers are finding it hard to attain the desired production level. Given this pressing issue, the government has took several decisions to boost the production of hand sanitizer such as exempting alcohol makers to produce sanitizer via ethyl alcohol and enforcing state authorities to speed up the licensing process. In this write-up we will talk about the legalities that <a href=\"https:\/\/corpbiz.io\/startup-india-registration\"><strong>start-ups<\/strong><\/a> need to address for the establishment of Hand Sanitizer Manufacturing Unit in 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\/set-up-a-hand-sanitizer-manufacturing-unit-in-india\/#An_overview_on_Hand_Sanitizers\" >An overview on Hand Sanitizers<\/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\/set-up-a-hand-sanitizer-manufacturing-unit-in-india\/#Ayurvedic_manufacturing_license_for_Hand_sanitizer_manufacturing_unit\" >Ayurvedic manufacturing license for Hand sanitizer\nmanufacturing unit<\/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\/set-up-a-hand-sanitizer-manufacturing-unit-in-india\/#Drug_manufacturing_license_for_Hand_sanitizer_manufacturing_unit\" >Drug manufacturing license for Hand sanitizer manufacturing\nunit<\/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\/set-up-a-hand-sanitizer-manufacturing-unit-in-india\/#Documents_to_be_arranged_for_Drug_Manufacturing_License\" >Documents to be arranged for Drug Manufacturing 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\/set-up-a-hand-sanitizer-manufacturing-unit-in-india\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"An_overview_on_Hand_Sanitizers\"><\/span>An overview on Hand Sanitizers <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><em><strong>Hand Sanitizers typically fall under three important categories: <\/strong><\/em><\/p>\n\n\n\n<ul><li>Pharmaceutical\nHand Sanitizer<\/li><li>Cosmetic\nHand Sanitizer<\/li><li>Ayurvedic\nHand Sanitizer<\/li><\/ul>\n\n\n\n<p>As implied by their types, hand sanitizers\nmight be produced under these industries. <\/p>\n\n\n\n<p>The type of license required for Hand\nsanitizer manufacturing will differ in accordance with the classification of\nthe hand sanitizer. For instance, if you intend to produce pharma-based hand\nsanitizer, then you will require availing drug manufacturing license. <\/p>\n\n\n\n<p>Likewise, if you wish to engage with the manufacturing of cosmetic-based hand sanitizer, then you will require obtaining an ayurvedic manufacturing 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\/procedure-for-start-up-registration-india\/\">What is the Procedure for Start-up Registration India? <\/a><\/mark><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ayurvedic_manufacturing_license_for_Hand_sanitizer_manufacturing_unit\"><\/span>Ayurvedic manufacturing license for Hand sanitizer\nmanufacturing unit <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A manufacturing facility dealing with herbal\/ayurvedic products is mandated to avail registration from the <em><strong>Ministry of Ayush<\/strong><\/em><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Ministry_of_AYUSH\"><em><strong>[1]<\/strong><\/em><\/a><\/sup>. Ministry of Ayush has underpinned some fundamental prerequisites for availing the aforesaid registration: <\/p>\n\n\n\n<p>Your manufacturing facility ought to be of a minimum\nsize of 1200 sqft and it should be located industrial area.&nbsp; <\/p>\n\n\n\n<ul><li>There is a compulsion of appointing 2 Ayurvedic experts and 2 Pharmacists.<\/li><li>The manufacturing facility should have <a href=\"https:\/\/corpbiz.io\/gmp-certification\"><strong>GMP certification<\/strong><\/a> in place. <\/li><li>The manufacturing facility should be outfitted with the required machinery and equipment. <\/li><li>The place of manufacturing will be subjected to periodic inspection, which will be done by the official appointed by the Drug controller. <\/li><li>The manufacturing unit should have the required paperwork in place. <\/li><\/ul>\n\n\n\n<div class=\"shadow1\"> GMP*, i.e. Good manufacturing practice is a framework that enables ayurvedic drug manufacturers to produce the drug in accordance with WHO\u2019s guidelines. This framework aims to mitigate risks engaged with pharmaceutical production.<\/div>\n\n\n\n<h3 class=\"wp-block-heading\">How to apply for an Ayush license? <\/h3>\n\n\n\n<ul><li>Visit the respective state portal of <a href=\"https:\/\/corpbiz.io\/ayush-license\"><strong>AYUSH<\/strong><\/a>.<\/li><li>Download the required e-form, attachments, documents, including affidavits &amp; other licenses such as CoPP &amp; GMP, as the case may be. <\/li><li>Apply for CoPP &amp; GMP if applicable. <\/li><li>Submit the aforesaid documents and e-form before the Directorate of the AYUSH, located in the respective jurisdiction<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Drug_manufacturing_license_for_Hand_sanitizer_manufacturing_unit\"><\/span>Drug manufacturing license for Hand sanitizer manufacturing\nunit<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Steps to avail Drug Manufacturing License (Fresh)<\/h3>\n\n\n\n<p><strong>Stage 1<\/strong>: The Applicant has to make an online application to the State&nbsp;<strong><em>Drugs Controller. The documentation has to be submitted and to be handed over to the<\/em> <\/strong>Drug Control Officer during the verification. The applicant is required to apply in the prescribed form. The details of application forms &amp; standard fees are mention below: <\/p>\n\n\n\n<ul><li>Application on form 24 related to Non-biological drugs      manufacturing license with a standard fee of INR 7500 for 10      items\/category &amp; INR 300\/item for more than ten items\/category.      Application on Form 27 related to the manufacturing of Biological drugs with a standard fee of INR 7500 for 10 products\/category and INR 300\/product for a product more than 10 products\/category. <\/li><li>Application on Form 24A relating to the manufacturing license for Non-biological drugs as per norms cited and application for loan      license relating to bio-logical drugs is to be furnished on Form 27A. <\/li><li>Application on Form 24 for drug repacking with a fee of INR 700 up to products\/category &amp; INR 100\/product if the products are more than 10 products. <\/li><li>Application on Form 24C relating to Homeopathic manufacturing\n     license with a standard fee of INR 300 for mother tincture INR 300 for\n     potential preparations and INR 300 for potentized and INR 50 for\n     additional products if the products are more than 10. <\/li><\/ul>\n\n\n\n<p>Users\ncan pay the requested fee via an online portal by way of Net Banking\/Debit\nCard\/Credit Card. <\/p>\n\n\n\n<p><strong><em>Stage 2: The applicant shall furnish an application via an online portal after rendering requested documents to the <\/em><\/strong><em><strong>State Drugs Controller. <\/strong><\/em><\/p>\n\n\n\n<p>The\napplicationform undergoes a rigorous verification process, &amp; then makes its\nway to the Senior Drugs Control Officer of the respective region for the on-site\ninspection of the firm.<\/p>\n\n\n\n<p>During\nthe on-site inspection, the Senior Drugs Control Officer&nbsp; jot down his findings and then create a\nreport, which further makes its way to the Senior Drugs Control Officer<\/p>\n\n\n\n<p><strong><em>Stage\n3: Issuance of manufacturing drug license: if all norms as cited by the Act\nhave been met, the license is bestowed by<\/em><\/strong><strong><em>State\nDrugs Controller and the applicant gets informed via SMS\/email. <\/em><\/strong><strong><em><\/em><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_to_be_arranged_for_Drug_Manufacturing_License\"><\/span>Documents to be arranged for Drug Manufacturing License<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul><li>Schematic of the premises. It must enclose the signature of the firm\u2019s partner\/owner\/director. <\/li><li>Lease deed or rent receipt of the manufacturing facility (original or attested photocopies)<\/li><li>Certified copy of the partnership deed (applicable for partnership firm), MOA, and AOA (applicable for private and public limited      companies). These documents must entail the Director\u2019s signature. <\/li><li>List of existing directors manifesting their entire details such as name and address. <\/li><li>If there is a change in Directors (addition, registration,      replacement) as original with their certified Xerox of Form 32 in respect of such outgoing or incoming director.<\/li><li>Complete detail related to staff\/registered individuals along with the photocopies of the academic and professional education,      experience, and registration certificates.<\/li><li>Non-conviction affidavit of approved staff as needed with academic approval and qualification.<\/li><li>Certified copies of academic &amp; professional qualification and the approval of staff as per norms cited in Drugs and Cosmetics Act,      1940 and Rules, 1945<\/li><li>List of machinery and lab equipment available at the premises. <\/li><li>Purchase bills of the equipment and machinery (attest copy)<\/li><li>No objection certificate from the fire department and SPCB. <\/li><li>Proof of load approved<\/li><li>Certified Xerox of occupation certificate form<\/li><li>Affidavit pertaining to the partner\/Director accountable for      managing the daily operation.<\/li><li>Affidavit manifesting director\u2019s and partner\u2019s non-association with any felony under Drugs and Cosmetics Act, 1940 and Rules, 1945.<\/li><li>Resolution of BODs manifesting the appointment of an authorized signatory.<\/li><li>Non-conviction affidavit by an authorised signatory, <\/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>Setting up a Hand Sanitizer manufacturing unit in India attracts a tedious licensing process.&nbsp;Keep in mind that the likelihood of cancellation of application is considerably higher in this case since it is a matter of public health. Therefore, you need to remain cautious while handling the paperwork or meeting compliances. If possible, do prefer the availing service of a professional firm like <a href=\"https:\/\/corpbiz.io\/\"><strong>CorpBiz<\/strong><\/a> if you wish to skip the trouble of being rejected by the authority. <\/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\/10-best-startup-government-schemes-in-india-for-every-entrepreneur\/\">10 Best Startup Government Schemes in India for Every Entrepreneur <\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Hand sanitizer was treated as an optional medicinal and cosmetic product in the pre-Covid era. But the demand for hand sanitizer in India has been surging ever since the Covid 19 virus hit this country. Owing to the skyrocketing demand, existing manufacturers are finding it hard to attain the desired production level. Given this pressing [&hellip;]<\/p>\n","protected":false},"author":22,"featured_media":33835,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[968],"tags":[1893],"acf":{"service_id":"250"},"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":7441,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/33824"}],"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=33824"}],"version-history":[{"count":14,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/33824\/revisions"}],"predecessor-version":[{"id":37113,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/33824\/revisions\/37113"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/33835"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=33824"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=33824"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=33824"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}