{"id":294349,"date":"2024-05-04T17:08:55","date_gmt":"2024-05-04T11:38:55","guid":{"rendered":"https:\/\/forumias.com\/blog\/?p=294349"},"modified":"2024-05-04T17:08:55","modified_gmt":"2024-05-04T11:38:55","slug":"cdsco-to-issue-noc-for-export-of-drugs","status":"publish","type":"post","link":"https:\/\/forumias.com\/blog\/cdsco-to-issue-noc-for-export-of-drugs\/","title":{"rendered":"CDSCO to issue NOC for export of drugs"},"content":{"rendered":"<div class=\"content\" tabindex=\"0\" aria-description=\"\" aria-label=\"Sent by Copilot: Certainly! Here's the information regarding the recent change related to the issuance of No Objection Certificates (NOCs) for drug exports in India: The Union government has taken a significant step by assuming sole authority for issuing manufacturing licenses for new drugs meant for exports. This move withdraws the power from state governments and comes amid heightened global scrutiny of Indian-made drugs[^1^]. Here are the key points: 1. **Background**: - State drug controllers were given complete jurisdiction to issue NOC certificates from 2018. - However, due to global scrutiny and to streamline the process, the Central Drugs Standard Control Organisation (CDSCO), India's apex drug regulatory body, has now become the sole licensing authority. 2. **Recent Change**: - In an order issued by the Drug Controller General India Dr. Rajeev Raghuvanshi on April 30, 2024, the CDSCO has asked the industry to submit fresh applications for NOCs from May 15 onwards. - The power delegated to state\/UT Licensing authorities stands withdrawn with effect from May 15, 2024. - NOCs will now be granted by the Head of respective CDSCO Zonal offices. 3. **Process for Manufacturers**: - Manufacturers seeking NOCs for the manufacture of unapproved, approved new drugs, or banned drugs solely for export purposes must follow these steps: - Obtain the NOC from the respective zonal office of the CDSCO. - All state\/UT drug controllers are required to hand over all NOCs issued from August 20, 2018, to May 14, 2024, to the respective CDSCO Zonal offices. - The change will be overseen by Ranga Chandrashekhar Rao, Joint Drugs Controller at CDSCO. 4. **Ease of Doing Business**: - In 2018, the CDSCO had waived the provision of procuring NOCs by pharmaceutical companies for exporting drugs, medical devices, and cosmetics across ports in the country to ensure ease of doing business. This centralization of authority aims to enhance regulatory oversight and streamline the export process for pharmaceutical companies. If you have any further questions or need additional details, feel free to ask![^1^] [^3^].\">\n<div class=\"ac-container ac-adaptiveCard\">\n<div class=\"ac-textBlock\">\n<p style=\"text-align: justify;\"><strong>Source<\/strong>-This post on <strong>CDSCO to issue NOC for export of drugs\u00a0<\/strong>is based on the article <a href=\"https:\/\/www.livemint.com\/politics\/policy\/centre-takes-away-state-powers-for-issuing-noc-for-export-of-drugs-11714736259536.html\" target=\"_blank\" rel=\"noopener\">&#8220;Centre takes away state powers for issuing NOC for export of drugs&#8221;<\/a> published in \u201c<strong>The Mint<\/strong>\u201d on 4th May 2024.<\/p>\n<h2 style=\"text-align: justify;\">Why in the News?<\/h2>\n<p style=\"text-align: justify;\">In a significant development, <span style=\"color: #ff0000;\">CDSCO will be the sole licensing authority to issue NOC for drug export<\/span>. Earlier, state drug controllers had the jurisdiction to issue<span style=\"color: #333333;\"> NOC certificates. <\/span>This move <span style=\"color: #ff0000;\">comes amidst heightened global scrutiny of Indian-made drugs<\/span><span style=\"font-size: 16.6667px;\">. <\/span>This centralization of authority aims to enhance regulatory oversight and streamline the export process for pharmaceutical companies.<\/p>\n<h2 style=\"text-align: justify;\">What changes have been brought?<\/h2>\n<p style=\"text-align: justify;\">1.<strong> Regulatory Process for Manufacturers to obtain NOC-<\/strong>\u00a0Manufacturers seeking NOCs for the<span style=\"color: #333333;\"> manufacture of unapproved, approved new drugs, or banned drugs <\/span>solely for export purposes, must obtain it from the respective zonal office of the CDSCO.<\/p>\n<p style=\"text-align: justify;\"><strong>2. States to hand over NOCs issued to CDCSO-<\/strong> All state\/UT drug controllers are required to hand over all NOCs issued to the respective CDSCO Zonal offices.<\/p>\n<h2 style=\"text-align: justify;\">About CDSCO<\/h2>\n<p style=\"text-align: justify;\"><strong>1) About CDSCO:<\/strong> The <span style=\"color: #ff0000;\">Central Drugs Standard Control Organization (CDSCO)<\/span> is the<span style=\"color: #ff0000;\"> Central Drug Authority<\/span> for discharging functions assigned to the <span style=\"color: #ff0000;\">Central Government under the Drugs and Cosmetics Act.<\/span> It is the <span style=\"color: #ff0000;\">National Regulatory Authority (NRA) of India.<\/span><\/p>\n<p style=\"text-align: justify;\"><strong>2) Regulated under:<\/strong> The Central Drugs Standard Control Organisation (CDSCO) is <span style=\"color: #ff0000;\">under Directorate General of Health Services, Ministry of Health &amp; Family Welfare, Government of India. <\/span>It has nine zonal offices, seven sub zonal offices, eighteen Port offices, seven central laboratories and six mini labs spread across the country.<\/p>\n<p style=\"text-align: justify;\"><strong>3) Function:<\/strong> CDSCO is responsible for approving drugs, conducting clinical trials, setting standards, ensuring quality control of imported drugs. It also shares the responsibility of granting licences for specialized categories of critical drugs such as blood and blood products, IV fluids, vaccines, and sera.<\/p>\n<\/div>\n<div class=\"ac-horizontal-separator\" style=\"text-align: justify;\" aria-hidden=\"true\"><strong>UPSC Syllabus: Polity and nation<\/strong><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Source-This post on CDSCO to issue NOC for export of drugs\u00a0is based on the article &#8220;Centre takes away state powers for issuing NOC for export of drugs&#8221; published in \u201cThe Mint\u201d on 4th May 2024. Why in the News? In a significant development, CDSCO will be the sole licensing authority to issue NOC for drug&hellip; <a class=\"more-link\" href=\"https:\/\/forumias.com\/blog\/cdsco-to-issue-noc-for-export-of-drugs\/\">Continue reading <span class=\"screen-reader-text\">CDSCO to issue NOC for export of drugs<\/span><\/a><\/p>\n","protected":false},"author":10366,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"footnotes":""},"categories":[1566,1760],"tags":[11872,11126],"class_list":["post-294349","post","type-post","status-publish","format-standard","hentry","category-daily-factly-articles","category-polity-and-nation","tag-9pm-daily-factly","tag-the-mint","entry"],"jetpack_featured_media_url":"","views":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/294349","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/users\/10366"}],"replies":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/comments?post=294349"}],"version-history":[{"count":0,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/294349\/revisions"}],"wp:attachment":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media?parent=294349"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/categories?post=294349"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/tags?post=294349"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}