{"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 v26.4 (Yoast SEO v26.4) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\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 property=\"og:locale\" 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This has come into force on April 4, 2022. \u00a0 Key points: In Rule 153 and 153 A which deals with\u00a0 'Application for licence to manufacture Ayurvedic (including\u2026","rel":"","context":"In &quot;Legislation Updates&quot;","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/04\/MicrosoftTeams-image-161.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/04\/MicrosoftTeams-image-161.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/04\/MicrosoftTeams-image-161.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/04\/MicrosoftTeams-image-161.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/04\/MicrosoftTeams-image-161.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":270224,"url":"https:\/\/www.scconline.com\/blog\/post\/2022\/07\/16\/ccpa-issues-advisory-to-e-commerce-platforms-on-sale-of-ayurvedic-siddha-and-unani-drugs\/","url_meta":{"origin":255171,"position":1},"title":"CCPA issues Advisory to e-commerce platforms on sale of Ayurvedic, Siddha and Unani drugs","author":"Bhumika Indulia","date":"July 16, 2022","format":false,"excerpt":"\u00a0 \u00a0 The Central Consumer Protection Authority (CCPA) has issued an Advisory to e-commerce entities concerning the sale of Ayurvedic, Siddha and Unani drugs containing ingredients listed in Schedule E (1) of the Drugs and Cosmetics Rules, 1945. E-commerce platforms have been advised that the sale or facilitating the sale\u2026","rel":"","context":"In &quot;Hot Off The Press&quot;","block_context":{"text":"Hot Off The Press","link":"https:\/\/www.scconline.com\/blog\/post\/category\/news\/hot_off_the_press\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2019\/03\/consumer-protection.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2019\/03\/consumer-protection.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2019\/03\/consumer-protection.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2019\/03\/consumer-protection.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2019\/03\/consumer-protection.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":329450,"url":"https:\/\/www.scconline.com\/blog\/post\/2024\/08\/27\/sc-stays-notification-omitting-rule-170-drug-rules-which-prohibited-ads-ayurvedic-drugs\/","url_meta":{"origin":255171,"position":2},"title":"Supreme Court stays Ayush Ministry&#8217;s Notification omitting Rule 170 of Drug Rules which prohibited ads of Ayurvedic, Siddha or Unani drugs without approval","author":"Editor","date":"August 27, 2024","format":false,"excerpt":"Vide notification dated 01-07-2024, the Ministry of Ayush amended Drug Rules, 1945, omitting Rule 170.","rel":"","context":"In &quot;Hot Off The Press&quot;","block_context":{"text":"Hot Off The Press","link":"https:\/\/www.scconline.com\/blog\/post\/category\/news\/hot_off_the_press\/"},"img":{"alt_text":"Rule 170 of Drug Rules","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2024\/08\/Rule-170-of-Drug-Rules.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2024\/08\/Rule-170-of-Drug-Rules.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2024\/08\/Rule-170-of-Drug-Rules.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2024\/08\/Rule-170-of-Drug-Rules.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":292633,"url":"https:\/\/www.scconline.com\/blog\/post\/2023\/05\/19\/delhi-high-court-directs-trademark-registry-to-proceed-as-per-law-in-reviewing-use-of-hamdard-in-hamdard-roghan-badam-shirin-legal-updates\/","url_meta":{"origin":255171,"position":3},"title":"Request to review trademark \u2018HAMDARD\u2019 in \u2018HAMDARD ROGHAN BADAM SHIRIN\u2019 for its descriptive use; Delhi High Court directs Trademark Registry to proceed as per law","author":"Arunima","date":"May 19, 2023","format":false,"excerpt":"Under section 3(a) of Drugs & Cosmetics Act, 1940, Raughan-E-Badam Shireen\/ Badani Shireen is mentioned as Unani Medicine in the authoritative book of First Schedule of Drugs and Cosmetics Act, 1940.","rel":"","context":"In &quot;Case Briefs&quot;","block_context":{"text":"Case Briefs","link":"https:\/\/www.scconline.com\/blog\/post\/category\/casebriefs\/"},"img":{"alt_text":"delhi high court","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/04\/delhi-high-court.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/04\/delhi-high-court.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/04\/delhi-high-court.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/04\/delhi-high-court.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":247069,"url":"https:\/\/www.scconline.com\/blog\/post\/2021\/04\/14\/government-of-india-allocation-of-business-three-hundred-and-sixtieth-amendment-rules-2021\/","url_meta":{"origin":255171,"position":4},"title":"Government of India (Allocation of Business) Three Hundred and Sixtieth Amendment Rules, 2021","author":"Bhumika Indulia","date":"April 14, 2021","format":false,"excerpt":"On April 13, 2021, the President makes the Government of India (Allocation of Business) Three Hundred and Sixtieth Amendment Rules, 2021 to amend the Government of India (Allocation of Business) Rules, 1961. It shall come into force upon publication in official gazette. Key Amendments in the Rules are discussed below:\u2026","rel":"","context":"In &quot;Legislation Updates&quot;","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2017\/09\/Parliament_Colour.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2017\/09\/Parliament_Colour.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2017\/09\/Parliament_Colour.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2017\/09\/Parliament_Colour.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2017\/09\/Parliament_Colour.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":228762,"url":"https:\/\/www.scconline.com\/blog\/post\/2020\/04\/27\/ministry-of-ayush-allows-research-on-covid-19-through-indian-traditional-medicines-specifies-conditions\/","url_meta":{"origin":255171,"position":5},"title":"Ministry of AYUSH allows research on COVID-19 through Indian traditional medicines, specifies conditions","author":"Bhumika Indulia","date":"April 27, 2020","format":false,"excerpt":"F. No. L.11011\/8\/2020\/AS.\u2014In the wake of COVID-19 caused by SARS CoV 2, there has been surge in proposals received by Ministry of AYUSH for claiming possible treatment of COVID19. At present, there is no approved treatment for COVID 19 infection. Indian Traditional Medicines have wide potential for usage in such\u2026","rel":"","context":"In &quot;Legislation Updates&quot;","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2020\/03\/outbreak-coronavirus-world-1024x506px-1.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2020\/03\/outbreak-coronavirus-world-1024x506px-1.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2020\/03\/outbreak-coronavirus-world-1024x506px-1.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2020\/03\/outbreak-coronavirus-world-1024x506px-1.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2020\/03\/outbreak-coronavirus-world-1024x506px-1.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]}],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/255171","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/users\/8808"}],"replies":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/comments?post=255171"}],"version-history":[{"count":0,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/255171\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media\/154904"}],"wp:attachment":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media?parent=255171"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/categories?post=255171"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/tags?post=255171"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}