{"id":255171,"date":"2021-10-05T11:30:08","date_gmt":"2021-10-05T06:00:08","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=255171"},"modified":"2021-10-05T11:37:51","modified_gmt":"2021-10-05T06:07:51","slug":"drugs-4th-amendment-rules-2021","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2021\/10\/05\/drugs-4th-amendment-rules-2021\/","title":{"rendered":"Drugs (4th Amendment) Rules, 2021"},"content":{"rendered":"<p style=\"text-align: justify;\"><span id=\"page32R_mcid7\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">The Central Government<\/span><span dir=\"ltr\" role=\"presentation\"> after consultation w<\/span><span dir=\"ltr\" role=\"presentation\">ith the Ayurveda, Siddha, Unani Drugs Technical <\/span><span dir=\"ltr\" role=\"presentation\">Advisory Board, notifies Drugs (4th Amendment) Rules, 2021 to amend the Drugs Rules, 1945.<\/span><\/span><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\">The amendment modifies the following provisions:<\/p>\n<ol>\n<li style=\"text-align: justify;\">Rule 153 dealing with <b>Application for licence to manufacture Ayurvedic<\/b> (<b>including Siddha<\/b>) <b>or Unani drugs. The fee has been revised from one thousand to two thousand. <\/b><\/li>\n<li style=\"text-align: justify;\">Inserted a new provision Rules 153 B dealing with <span id=\"page35R_mcid5\" class=\"markedContent\"><strong><span dir=\"ltr\" role=\"presentation\">Application for Certificate of Good Manufacturing Practices for Ayurvedic, Siddha or Unani drugs <\/span><span dir=\"ltr\" role=\"presentation\">manufa<\/span><\/strong><span dir=\"ltr\" role=\"presentation\"><strong>cturing unit<\/strong>. <\/span><\/span><\/li>\n<li style=\"text-align: justify;\">Rule 154 dealing with <b>Form of licence to manufacture Ayurvedic<\/b> (<b>including Siddha<\/b>) <b>or Unani drugs<\/b> has been amended to make modifications in the period in which <span id=\"page35R_mcid11\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">a licence to manufacture for sale of any Ayurvedic, Siddha or Unani drugs shall be issued in <\/span><span dir=\"ltr\" role=\"presentation\">Form <\/span><span dir=\"ltr\" role=\"presentation\">25D<\/span>\u00a0<span dir=\"ltr\" role=\"presentation\"> from the<\/span> <span dir=\"ltr\" role=\"presentation\">date of receipt of the application or from the date of compliance by the <\/span><span dir=\"ltr\" role=\"presentation\">applicant of shortcomings. Earlier, the period was 3 months but now the period has been modified to two months. <\/span><\/span><\/li>\n<li style=\"text-align: justify;\">Rule 154 A dealing with <strong><span id=\"page35R_mcid17\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">Form of loan licence to manufacture fo<\/span><span dir=\"ltr\" role=\"presentation\">r sale of Ayurvedic, Siddha or Unani drugs<\/span><\/span><\/strong> has been modified to insert the period within which a<span id=\"page35R_mcid17\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\"> loan licence <\/span><span dir=\"ltr\" role=\"presentation\">to manufacture for sale of any Ayurvedic, Siddha or Unani drugs shall be issued in <\/span> <span dir=\"ltr\" role=\"presentation\">Form 25E. The Loan License shall be issued<\/span> <span dir=\"ltr\" role=\"presentation\">within a period of two <\/span><span dir=\"ltr\" role=\"presentation\">months from the date of receipt of the application or from the date of complia<\/span><span dir=\"ltr\" role=\"presentation\">nce of shortcomings.<\/span><\/span><\/li>\n<li style=\"text-align: justify;\"><span id=\"page35R_mcid23\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">Rules 155 dealing with <b>Certificate of renewal<\/b> and 155A dealing with <b>Certificate of renewal of a loan licence<\/b> of the prin<\/span><span dir=\"ltr\" role=\"presentation\">cipal rules, shall be omitted.<\/span><\/span><\/li>\n<li style=\"text-align: justify;\">Rule 156 dealing with <strong>duration of license<\/strong> has been amended to modify the vaildity period from 5 years to remain perpetually valid.<\/li>\n<\/ol>\n<p style=\"padding-left: 40px; text-align: justify;\"><span id=\"page35R_mcid29\" class=\"markedContent\"><span dir=\"ltr\" role=\"presentation\">Provided that the licencee shall submit a self declaration of adherence to the conditions of licence and the <\/span><br role=\"presentation\" \/><span dir=\"ltr\" role=\"presentation\">provisions of the Drugs and Cosmetics Act and the rules made thereunder, every year from the date of issue of licence <\/span><span dir=\"ltr\" role=\"presentation\">in <\/span><span dir=\"ltr\" role=\"presentation\">form 25 D or from the date of submission of last self declaration, as the case may be . <\/span> <\/span><\/p>\n<p style=\"text-align: justify;\">\n","protected":false},"excerpt":{"rendered":"<p>The Central Government after consultation with the Ayurveda, Siddha, Unani Drugs Technical Advisory Board, notifies Drugs (4th Amendment) Rules, 2021 to amend <\/p>\n","protected":false},"author":8808,"featured_media":154904,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[4,15],"tags":[20201,11151,9541],"class_list":["post-255171","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legislationupdates","category-rules_regulations","tag-central-government","tag-drugs","tag-licence"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Drugs (4th Amendment) Rules, 2021 | SCC Times<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.scconline.com\/blog\/post\/2021\/10\/05\/drugs-4th-amendment-rules-2021\/\" \/>\n<meta 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