{"id":167194,"date":"2022-02-08T19:04:22","date_gmt":"2022-02-08T13:34:22","guid":{"rendered":"https:\/\/blog.forumias.com\/?p=167194"},"modified":"2022-02-08T19:04:22","modified_gmt":"2022-02-08T13:34:22","slug":"why-usfda-has-indian-generic-drug-cos-worried","status":"publish","type":"post","link":"https:\/\/forumias.com\/blog\/why-usfda-has-indian-generic-drug-cos-worried\/","title":{"rendered":"Why USFDA has Indian generic drug cos worried"},"content":{"rendered":"\n<h5><b>What is the News?<\/b><\/h5>\n<p><span style=\"font-weight: 400;\">The US Food and Drug Administration(USFDA) has decided to restart an old pilot project of conducting surprise inspections of foreign manufacturing plants. This could be a litmus test for Indian generic drug makers.<\/span><\/p>\n<h5><b>What is the surprise inspection \u200aproject announced by USFDA?<\/b><\/h5>\n<p><span style=\"font-weight: 400;\">The USFDA will conduct unannounced inspections of manufacturing plants in India and China in an attempt to uphold the quality standards of drugs that are supplied to the US market.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Under the current practice, the USFDA gives advance notice to foreign manufacturers before it begins its regulatory inspections.<\/span><\/p>\n<h5><b>How will this impact Indian generic firms?<\/b><\/h5>\n<p><span style=\"font-weight: 400;\">In 2014, a similar \u2018surprise\u2019 inspection pilot was started by the US FDA.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">This move led to a 60% increase in regulatory action against generic companies. Between 2014 and 2015, India\u2019s top five generic companies collectively lost a market cap of \u20b915 billion.<\/span><\/p>\n<table style=\"border-collapse: collapse; width: 100%;\">\n<tbody>\n<tr>\n<td style=\"width: 100%;\"><strong>Read more: <\/strong><a style=\"font-family: inherit; font-size: inherit; background-color: var(--global--color-background);\" title=\"Drug Regulations in India \u2013 Explained, pointwise\" href=\"https:\/\/forumias.com\/blog\/drug-regulation-in-india\/\"><strong>Drug Regulations in India \u2013 Explained, pointwise<\/strong><\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h5><b>Why has the US announced this surprise inspection \u200aproject again?<\/b><\/h5>\n<p><span style=\"font-weight: 400;\">Around 40% of the finished drugs sold in the US are made outside the country. The demand to safeguard the drug supply chain and bring manufacturing closer to the US has grown over the last few years.<\/span><\/p>\n<table style=\"border-collapse: collapse; width: 100%;\">\n<tbody>\n<tr>\n<td style=\"width: 100%;\"><strong>Read more: <\/strong><a style=\"font-family: inherit; font-size: inherit; background-color: var(--global--color-background);\" title=\"Emergency Use Authorisation of Drugs and the Issues Therein \u2013 Explained, pointwise\" href=\"https:\/\/forumias.com\/blog\/emergency-use-authorisation-of-drugs-and-their-impacts\/\"><strong>Emergency Use Authorisation of Drugs and the Issues Therein \u2013 Explained, pointwise<\/strong><\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><b>What can Indian drugmakers do?<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Large drugmakers have already started diversifying their business beyond the US market. This would continue.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">There is also a possibility of firms asking the Indian government to intervene and initiate dialogue with the US administration.<\/span><\/p>\n<p><b>Source<\/b>: This post is based on the article <b>\u201cWhy USFDA has Indian generic drug cos worried<\/b><b>\u201d <\/b>published in <b>Livemint <\/b>on <b>8th Feb 2022.<\/b><\/p>\n","protected":false},"excerpt":{"rendered":"<p>What is the News? The US Food and Drug Administration(USFDA) has decided to restart an old pilot project of conducting surprise inspections of foreign manufacturing plants. This could be a litmus test for Indian generic drug makers. What is the surprise inspection \u200aproject announced by USFDA? The USFDA will conduct unannounced inspections of manufacturing plants&hellip; <a class=\"more-link\" href=\"https:\/\/forumias.com\/blog\/why-usfda-has-indian-generic-drug-cos-worried\/\">Continue reading <span class=\"screen-reader-text\">Why USFDA has Indian generic drug cos worried<\/span><\/a><\/p>\n","protected":false},"author":10317,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"footnotes":""},"categories":[1566,164,9],"tags":[10501],"class_list":["post-167194","post","type-post","status-publish","format-standard","hentry","category-daily-factly-articles","category-international-relations-daily-factly-articles","category-public","tag-live-mint","entry"],"jetpack_featured_media_url":"","views":{"total":0,"cached_at":"","cached_date":1704820806},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/167194","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\/10317"}],"replies":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/comments?post=167194"}],"version-history":[{"count":0,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/167194\/revisions"}],"wp:attachment":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media?parent=167194"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/categories?post=167194"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/tags?post=167194"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}