{"id":201546,"date":"2022-08-23T19:11:53","date_gmt":"2022-08-23T13:41:53","guid":{"rendered":"https:\/\/blog.forumias.com\/?p=201546"},"modified":"2022-08-23T21:14:06","modified_gmt":"2022-08-23T15:44:06","slug":"the-new-drugs-bill","status":"publish","type":"post","link":"https:\/\/forumias.com\/blog\/the-new-drugs-bill\/","title":{"rendered":"The New Drugs Bill"},"content":{"rendered":"\n<p><strong>Source<\/strong>: The post is based on the article\u00a0<strong>\u201c<\/strong><strong>The New Drugs Bill\u201d\u00a0<\/strong>published in\u00a0<strong>The Business Standard\u00a0<\/strong>on\u00a0<strong>22<sup>nd<\/sup>\u00a0August 2022<\/strong>.<\/p>\n<p><strong>Syllabus<\/strong>: GS 2 \u2013 Governance.<\/p>\n<p><strong>News: <\/strong>The recently unveiled New Drugs, Cosmetics and Medical Devices Bill, 2022, has left many issues unaddressed.<\/p>\n<h5><strong>History of laws associated with the AYUSH industry.<\/strong><\/h5>\n<p><strong>1940 &#8211;<\/strong> The parliament enacted the Drugs Act in 1940. But the definition of \u201cdrugs\u201d in that law excluded Ayurvedic and Unani (Ayush) medicines. It was because <strong>standardization of traditional medicine was not possible like modern medicine<\/strong>. Ayush drugs are prepared from plants and herbs with little knowledge of the \u201cactive pharmaceutical ingredient\u201d.<\/p>\n<p><strong>1964 \u2013<\/strong> The government brought Ayush drugs within the purview of the Drugs &amp; Cosmetics Act, 1940, but without standardization.<\/p>\n<p><strong>1982 \u2013<\/strong> The law was amended to introduce the concept of \u201cpatent &amp; proprietary\u201d Ayush drugs, which allowed for the creation of new Ayush medicines using ingredients mentioned in the traditional texts.<\/p>\n<h5><strong>Provisions under New Drugs, Cosmetics and Medical Devices Bill, 2022 and issues associated with it.<\/strong><\/h5>\n<p><strong>First, <\/strong>it requires Ayush drugs to meet the \u201cstandards of identity, purity, and strength specified in Ayurveda or Siddha, or Sowa- Rigpa or Unani Pharmacopoeia of India\u201d.<\/p>\n<p><strong>Issues: a) <\/strong>Ayush pharmacopeias are exceptionally vague and very different from the rigorous standardization introduced by modern pharmacopeias.<strong> b)<\/strong> Most Ayush products in the market are \u201cpatent or proprietary\u201d and are not included in the Pharmacopoeia. <strong>c)<\/strong> Also, this requirement has existed since 1995 in the Drugs and Cosmetic Rules, the drafting committee merely relocated it from the rules to the main law.<\/p>\n<p><strong>Second,<\/strong> it creates a new category called <strong>\u201cinnovative drug of Ayurveda or Unani\u201d. <\/strong>It does not require Ayush medicines seeking <strong>\u201cpatent &amp; proprietary\u201d,<\/strong> to undergo the same testing and evaluation in clinical trials as for modern medicine. Instead, AYUSH medicines will be tested in accordance with the guidelines to be laid down by a new body called the <strong>\u201cScientific Research Board\u201d (SRB)<\/strong> which will be staffed by Ayush experts.<\/p>\n<p><strong>Issues: <\/strong>It is not clear why these drugs cannot be approved by the same experts approving modern medicine.<\/p>\n<p><strong>Third, <\/strong>Section 108(a) of the new Bill treats the issue of safety such as the presence of heavy metals in Ayurvedic drugs in a light manner. It has reduced the punishment for this offense to a mere fine of Rs 50,000 despite the dire health consequences.<\/p>\n<p><strong>Issues: <\/strong>Causing harm to patients due to heavy metal contamination deserves to be punished with jail time and not a mere fine.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Source: The post is based on the article\u00a0\u201cThe New Drugs Bill\u201d\u00a0published in\u00a0The Business Standard\u00a0on\u00a022nd\u00a0August 2022. Syllabus: GS 2 \u2013 Governance. News: The recently unveiled New Drugs, Cosmetics and Medical Devices Bill, 2022, has left many issues unaddressed. History of laws associated with the AYUSH industry. 1940 &#8211; The parliament enacted the Drugs Act in 1940.&hellip; <a class=\"more-link\" href=\"https:\/\/forumias.com\/blog\/the-new-drugs-bill\/\">Continue reading <span class=\"screen-reader-text\">The New Drugs Bill<\/span><\/a><\/p>\n","protected":false},"author":10308,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"footnotes":""},"categories":[1230,9],"tags":[10503,212],"class_list":["post-201546","post","type-post","status-publish","format-standard","hentry","category-9-pm-daily-articles","category-public","tag-business-standard","tag-gs-paper-2","entry"],"jetpack_featured_media_url":"","views":{"total":0,"cached_at":"","cached_date":1704927063},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/201546","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\/10308"}],"replies":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/comments?post=201546"}],"version-history":[{"count":0,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/201546\/revisions"}],"wp:attachment":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media?parent=201546"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/categories?post=201546"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/tags?post=201546"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}