{"id":85375,"date":"2019-10-26T17:20:47","date_gmt":"2019-10-26T11:50:47","guid":{"rendered":"http:\/\/factly.forumias.com\/?p=11204"},"modified":"2019-10-26T17:20:47","modified_gmt":"2019-10-26T11:50:47","slug":"guidelines-for-evaluation-of-nanopharmaceuticals-in-india","status":"publish","type":"post","link":"https:\/\/forumias.com\/blog\/guidelines-for-evaluation-of-nanopharmaceuticals-in-india\/","title":{"rendered":"Guidelines for Evaluation of Nanopharmaceuticals in India"},"content":{"rendered":"\n<p><strong>News:<\/strong>Union Minister for Science &amp; Technology has released the Guidelines for Evaluation of Nanopharmaceuticals in India.<br><\/p>\n\n\n\n<p><strong>Facts:<\/strong><br><\/p>\n\n\n\n<p><strong>What are Nanopharmaceuticals?<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Nanopharmaceuticals represent an emerging field where the sizes of the drug particle or a therapeutic delivery system work at the nanoscale.&nbsp;<\/li><li>In the pharmaceutical industry, a long standing issue is the difficulty of delivering the appropriate dose of a particular active agent to specific disease site.&nbsp;<\/li><li>Nanopharmaceuticals have enormous potential in addressing this failure of traditional therapeutics which offers site-specific targeting of active agents.&nbsp;<\/li><li>Such precision targeting via nanopharmaceuticals reduces higher efficacy, lower toxicity and are safer than the conventional drugs.<\/li><\/ul>\n\n\n\n<p><strong>Guidelines on Nanopharmaceuticals:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>These Guidelines were prepared to provide transparent, consistent and predictable regulatory pathways for nanopharmaceuticals in India.<\/li><li>They were framed by the inter-ministerial expert committee constituted by the Department of Biotechnology in May 2019.<\/li><li>It was prepared in line with the provisions of Schedule Y of Drugs and Cosmetics Rules,1945 as well as Second Schedule of the New Drugs and Clinical Trials Rules, 2019 with specific requirements for nanopharmaceuticals.<\/li><\/ul>\n\n\n\n<p><strong>Key points of the Guidelines:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The impact of nano material waste disposal on environment should be declared.<\/li><li>The stability testing for Nanoformulations should focus on functionality, integrity, size range of nanopharmaceuticals.<\/li><li>It makes it compulsory for the pharma companies to present the data on how the plasma, off-target tissue and disease sites are affected by repeated dosing.<\/li><li>It provides guidelines for animal toxicology data.It allows the toxicology studies to be performed only on rodent species and dogs in both sexes.<\/li><\/ul>\n\n\n\n<p><strong>Significance of the guidelines:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The guidelines will help to facilitate research in line with the regulatory requirements.<\/li><li>It will help in making decision in clearing new products based on nanotechnology and would also help in attracting new private investments.<\/li><li>It will help to initiate activities for developing safety guidelines for other domains like agri-inputs, cosmetics, implantable devices.<\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>News:Union Minister for Science &amp; Technology has released the Guidelines for Evaluation of Nanopharmaceuticals in India. Facts: What are Nanopharmaceuticals? Nanopharmaceuticals represent an emerging field where the sizes of the drug particle or a therapeutic delivery system work at the nanoscale.&nbsp; In the pharmaceutical industry, a long standing issue is the difficulty of delivering the&hellip; <a class=\"more-link\" href=\"https:\/\/forumias.com\/blog\/guidelines-for-evaluation-of-nanopharmaceuticals-in-india\/\">Continue reading <span class=\"screen-reader-text\">Guidelines for Evaluation of Nanopharmaceuticals in India<\/span><\/a><\/p>\n","protected":false},"author":61,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"footnotes":""},"categories":[1738],"tags":[2710,2711],"class_list":["post-85375","post","type-post","status-publish","format-standard","hentry","category-science-and-technology-daily-factly-articles","tag-guidelines","tag-nanopharmaceuticals","entry"],"jetpack_featured_media_url":"","views":{"total":0,"cached_at":1700780052,"cached_date":1704675663},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/85375","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\/61"}],"replies":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/comments?post=85375"}],"version-history":[{"count":0,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/85375\/revisions"}],"wp:attachment":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media?parent=85375"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/categories?post=85375"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/tags?post=85375"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}