{"id":306856,"date":"2024-08-09T19:05:24","date_gmt":"2024-08-09T13:35:24","guid":{"rendered":"https:\/\/forumias.com\/blog\/?p=306856"},"modified":"2024-08-09T19:05:24","modified_gmt":"2024-08-09T13:35:24","slug":"waiver-for-clinical-trials-in-india","status":"publish","type":"post","link":"https:\/\/forumias.com\/blog\/waiver-for-clinical-trials-in-india\/","title":{"rendered":"Waiver for Clinical Trials in India"},"content":{"rendered":"<p><strong>Source-<\/strong> This post on<strong> Waiver for Clinical Trials in India\u00a0<\/strong>has been created based on the article &#8220;<a href=\"https:\/\/epaper.thehindu.com\/ccidist-ws\/th\/th_delhi\/issues\/94368\/OPS\/GA6D62CBA.1+GTPD63R21.1.html\" target=\"_blank\" rel=\"noopener\">No clinical trial for drugs approved in select nations<\/a>&#8221;\u00a0published in \u201c<strong>The Hindu\u201d<\/strong> on 9 August 2024.<\/p>\n<h2>Why in News?<\/h2>\n<p>The Indian government has decided to waive off\u00a0 the requirement for clinical trials within India for certain drugs if they are already approved in specific countries like the U.S., U.K., Japan, Australia, Canada, and the European Union.<\/p>\n<h2>About Waiver for Clinical Trials in India<\/h2>\n<p><strong>1. Purpose of the Waiver:<\/strong> This waiver aims to make drugs manufactured outside of India more accessible and affordable for Indian patients.<\/p>\n<p><strong>2. Categories of Drugs Considered for Waiver:<\/strong> There are five drug categories:<\/p>\n<table style=\"height: 243px; width: 100%; border-collapse: collapse; border-style: solid;\">\n<tbody>\n<tr style=\"height: 30px;\">\n<td style=\"width: 31.4448%; height: 30px;\"><strong>Drug Category<\/strong><\/td>\n<td style=\"width: 68.5552%; height: 30px;\"><strong>Uses<\/strong><\/td>\n<\/tr>\n<tr style=\"height: 30px;\">\n<td style=\"width: 31.4448%; height: 30px;\">Rare Disease Drugs<\/td>\n<td style=\"width: 68.5552%; height: 30px;\">Drugs used to treat rare diseases.<\/td>\n<\/tr>\n<tr style=\"height: 60px;\">\n<td style=\"width: 31.4448%; height: 60px;\">Gene and Cellular Therapy Products<\/td>\n<td style=\"width: 68.5552%; height: 60px;\">Advanced therapies involving genes and cells.<\/td>\n<\/tr>\n<tr style=\"height: 30px;\">\n<td style=\"width: 31.4448%; height: 30px;\">Pandemic Situation Drugs<\/td>\n<td style=\"width: 68.5552%; height: 30px;\">New drugs specifically used during pandemics.<\/td>\n<\/tr>\n<tr style=\"height: 63px;\">\n<td style=\"width: 31.4448%; height: 63px;\">Special Defence Purpose Drugs<\/td>\n<td style=\"width: 68.5552%; height: 63px;\">Drugs developed for defence or military purposes.<\/td>\n<\/tr>\n<tr style=\"height: 30px;\">\n<td style=\"width: 31.4448%; height: 30px;\">Significant Therapeutic Advances<\/td>\n<td style=\"width: 68.5552%; height: 30px;\">New drugs that offer major improvements over current treatments.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>Government Regulations for Waive off<\/h2>\n<p>Rule 101: The waiver is authorized under Rule 101 of the New Drugs and Clinical Trial Rules, 2019. This rule allows the government to exempt local clinical trials if the drug is already approved in the listed countries.<\/p>\n<p><strong>UPSC Syllabus: Governance<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Source- This post on Waiver for Clinical Trials in India\u00a0has been created based on the article &#8220;No clinical trial for drugs approved in select nations&#8221;\u00a0published in \u201cThe Hindu\u201d on 9 August 2024. Why in News? The Indian government has decided to waive off\u00a0 the requirement for clinical trials within India for certain drugs if they&hellip; <a class=\"more-link\" href=\"https:\/\/forumias.com\/blog\/waiver-for-clinical-trials-in-india\/\">Continue reading <span class=\"screen-reader-text\">Waiver for Clinical Trials in India<\/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],"tags":[11872,10498],"class_list":["post-306856","post","type-post","status-publish","format-standard","hentry","category-daily-factly-articles","tag-9pm-daily-factly","tag-the-hindu","entry"],"jetpack_featured_media_url":"","views":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/306856","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=306856"}],"version-history":[{"count":0,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/306856\/revisions"}],"wp:attachment":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media?parent=306856"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/categories?post=306856"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/tags?post=306856"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}