{"id":254977,"date":"2021-09-30T18:30:28","date_gmt":"2021-09-30T13:00:28","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=254977"},"modified":"2021-10-08T10:26:25","modified_gmt":"2021-10-08T04:56:25","slug":"drugs-and-cosmetics-draft-amendment-rules-2021-consultation-launched","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2021\/09\/30\/drugs-and-cosmetics-draft-amendment-rules-2021-consultation-launched\/","title":{"rendered":"Drugs and Cosmetics (Draft Amendment) Rules, 2021; consultation launched"},"content":{"rendered":"<p style=\"text-align: justify;\">The Ministry of Ayush has notified the Drugs and Cosmetics (Draft Amendment) Rules, 2021 on 23rd September 2021. The draft Rules amend the Drugs and Cosmetics Rules, 1945 by substitution of Rule 30AA. The key points under Rule 30AA are:<\/p>\n<ul style=\"text-align: justify;\">\n<li>No New Homoeopathic medicine shall be imported without the permission in writing by the Licensing Authority.<\/li>\n<li>The importer of a New Homoeopathic medicine when applying for permission shall produce before the Licensing Authority such documentary and other evidence as may be required by the Licensing Authority for assessing the safety, therapeutic efficacy of the medicine including the minimum homoeopathic provings carried out with it.<\/li>\n<li>The New Homoeopathic Medicine shall continue to be considered as New Homoeopathic Medicine for a period of four years from the date of its first approval.<\/li>\n<li>The Licensing Authority after being satisfied that the drug shall be effective and safe for use in the country shall issue approval subject to the conditions stated therein.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\">The Ministry has launched the consultation inviting objections and suggestions from the public which shall be addressed to the Secretary, Ministry of AYUSH, AYUSH Bhawan, \u2018B\u2019 Block, GPO Complex, INA, New Delhi \u2013 110023 or emailed at dcc-ayush@nic.in. within 30 days.<\/p>\n<p>&nbsp;<\/p>\n<hr \/>\n<p><span style=\"color: #0000ff;\">*Tanvi Singh, Editorial Assistant has reported this brief.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Ministry of Ayush has notified the Drugs and Cosmetics (Draft Amendment) Rules, 2021 on 23rd September 2021. The draft Rules amend <\/p>\n","protected":false},"author":121,"featured_media":254988,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[4],"tags":[3007,47334,29717],"class_list":["post-254977","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legislationupdates","tag-drugs_and_cosmetics","tag-homepathic-medicines","tag-ministry-of-ayush"],"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 and Cosmetics (Draft Amendment) Rules, 2021; consultation launched | 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\/09\/30\/drugs-and-cosmetics-draft-amendment-rules-2021-consultation-launched\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Drugs and Cosmetics (Draft Amendment) Rules, 2021; consultation launched\" \/>\n<meta property=\"og:description\" content=\"The Ministry of Ayush has notified the Drugs and Cosmetics (Draft Amendment) Rules, 2021 on 23rd September 2021. The draft Rules amend\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.scconline.com\/blog\/post\/2021\/09\/30\/drugs-and-cosmetics-draft-amendment-rules-2021-consultation-launched\/\" \/>\n<meta property=\"og:site_name\" content=\"SCC Times\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/scc.online\/\" \/>\n<meta property=\"article:published_time\" content=\"2021-09-30T13:00:28+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-10-08T04:56:25+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-55.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1331\" \/>\n\t<meta property=\"og:image:height\" content=\"888\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Prachi Bhardwaj\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Prachi Bhardwaj\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.scconline.com\/blog\/post\/2021\/09\/30\/drugs-and-cosmetics-draft-amendment-rules-2021-consultation-launched\/\",\"url\":\"https:\/\/www.scconline.com\/blog\/post\/2021\/09\/30\/drugs-and-cosmetics-draft-amendment-rules-2021-consultation-launched\/\",\"name\":\"Drugs and Cosmetics (Draft Amendment) Rules, 2021; 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The objective of the draft Rules is to\u2026","rel":"","context":"In &quot;Foreign Legislation&quot;","block_context":{"text":"Foreign Legislation","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/foreign\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/10\/scc-blog_Page_9.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/10\/scc-blog_Page_9.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/10\/scc-blog_Page_9.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/10\/scc-blog_Page_9.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/10\/scc-blog_Page_9.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":249522,"url":"https:\/\/www.scconline.com\/blog\/post\/2021\/06\/10\/homeopathy-doctors\/","url_meta":{"origin":254977,"position":1},"title":"Ker HC | Homeopathy doctors can prescribe adjuvant medicine for Covid-19; HC upholds right to practice of Homeopathic practitioners","author":"Editor","date":"June 10, 2021","format":false,"excerpt":"Kerala High Court: N.Nagaresh, J., upheld the right to practice of homoeopathic practitioners and clarified that the Homeopathy doctors can prescribe adjuvant medicine for Covid-19. Background The petitioner, a Homoeopathic Practitioner had sought the issuance of writ of Mandamus directing the State to ensure that the petitioner was not obstructed\u2026","rel":"","context":"In &quot;Case Briefs&quot;","block_context":{"text":"Case Briefs","link":"https:\/\/www.scconline.com\/blog\/post\/category\/casebriefs\/"},"img":{"alt_text":"","src":"","width":0,"height":0},"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":254977,"position":2},"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":72142,"url":"https:\/\/www.scconline.com\/blog\/post\/2016\/09\/22\/the-drugs-and-cosmetics-sixth-amendment-rules-2016-notified\/","url_meta":{"origin":254977,"position":3},"title":"The Drugs and Cosmetics (Sixth Amendment) Rules, 2016 notified","author":"Saba","date":"September 22, 2016","format":false,"excerpt":"NOTIFICATION New Delhi, the 21st September, 2016 G.S.R. 897(E).\u2014Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules,\u00a01945, was published, as required by Section 12 read with Section 33 of the Drugs and Cosmetics Act, 1940\u00a0(23 of 1940), vide notification of the Government of India in\u2026","rel":"","context":"In &quot;Foreign Legislation&quot;","block_context":{"text":"Foreign Legislation","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/foreign\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2016\/05\/Drugs.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2016\/05\/Drugs.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2016\/05\/Drugs.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2016\/05\/Drugs.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2016\/05\/Drugs.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":223252,"url":"https:\/\/www.scconline.com\/blog\/post\/2019\/12\/13\/in-lok-sabha-online-selling-of-medicines-without-qualification\/","url_meta":{"origin":254977,"position":4},"title":"In Lok Sabha | Online Selling of Medicines without qualification","author":"Bhumika Indulia","date":"December 13, 2019","format":false,"excerpt":"Sale of drugs in the country is regulated under the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945 thereunder by the State Licensing Authorities (SLAs) through a system of licensing and inspection. SLAs are legally empowered to take stringent action against violation of provisions of the Act and\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\/2017\/02\/PARLIAMENT.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2017\/02\/PARLIAMENT.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2017\/02\/PARLIAMENT.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2017\/02\/PARLIAMENT.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2017\/02\/PARLIAMENT.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":256319,"url":"https:\/\/www.scconline.com\/blog\/post\/2021\/10\/29\/license-to-be-granted-within-7-days-vide-drugs-5th-amendment-rules-2021\/","url_meta":{"origin":254977,"position":5},"title":"License to be granted within 7 days vide Drugs (5th Amendment) Rules, 2021","author":"Editor","date":"October 29, 2021","format":false,"excerpt":"The Ministry of Health and Family Welfare has notified the Drugs (5th Amendment) Rules, 2021 to further amend the Drugs Rules, 1945 vide notification dated October 27, 2021. Key amendment: Form of Application: A new rule 90(3) has been inserted: Rule 90(3) states that the license in Form 29 may\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":"","width":0,"height":0},"classes":[]}],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/254977","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\/121"}],"replies":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/comments?post=254977"}],"version-history":[{"count":0,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/254977\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media\/254988"}],"wp:attachment":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media?parent=254977"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/categories?post=254977"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/tags?post=254977"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}