{"id":7106,"date":"2015-02-18T16:02:00","date_gmt":"2015-02-18T16:02:00","guid":{"rendered":"http:\/\/localhost\/sccblog\/?p=7106"},"modified":"2015-10-14T14:36:19","modified_gmt":"2015-10-14T09:06:19","slug":"draft-of-drugs-and-cosmetics-second-amendment-rules-2015","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2015\/02\/18\/draft-of-drugs-and-cosmetics-second-amendment-rules-2015\/","title":{"rendered":"Draft of Drugs and Cosmetics (Second Amendment) Rules, 2015"},"content":{"rendered":"<p   ><span  >On 03-02-2015, the Central Government published the draft Drugs and Cosmetics (Second Amendment) Rules, 2015 and sought for objections and suggestions from any person with respect to the said draft rules within 45 days from the date of publication of the draft. The objective of the draft Rules is to further amend the Drugs and Cosmetics Rules, 1945 in order to assure that the licensed manufactured drugs are stable for proposed shelf life under the condition of storage. The draft Rules proposes following amendments in the Drugs and Cosmetics Rules, 1945:<o:p><\/o:p><\/span><\/p>\n<ul  type=\"disc\">\n<li   ><span  >Insertion of sub-Rule (6A)      after sub-Rule 6 in Rule 71, insertion of sub-Rule (2) after Rule 71-B      which shall be numbered as sub-Rule (1), insertion of sub-Rule (7A)      after sub-Rule 7 in Rule 76, insertion of sub-Rule (2) after Rule 76A      which shall be numbered as sub-Rule (1), and all of which provides that \u201cthe      applicant shall, while applying for licence to manufacture drugs, furnish      to the Licensing Authority evidence and data justifying that the drugs are      stable for proposed shelf life under the condition of storage recommended      and the data shall be generated as per Appendix IX of Schedule Y\u201d.<o:p><\/o:p><\/span><\/li>\n<li   ><span  >Substitution of following entry      \u201cSubstances not intended for medicinal use excluding those intended to be      used as drugs after further purification or rendering them sterile\u201d in      place of \u201cSubstances not intended for medicinal use\u201d, in Schedule D,      against item number 1, under the column \u201cClass of drugs\u201d.<o:p><\/o:p><\/span><\/li>\n<\/ul>\n<p  align=\"right\"><b><span  >&nbsp;<\/span><\/b><\/p>\n<p  align=\"right\"><b><span  >-Ministry of Health and Family Welfare<o:p><\/o:p><\/span><\/b><\/p>\n<p   ><span  >&nbsp;<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 03-02-2015, the Central Government published the draft Drugs and Cosmetics (Second Amendment) Rules, 2015 and sought for objections and suggestions from <\/p>\n","protected":false},"author":3,"featured_media":7321,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[14],"tags":[3007],"class_list":["post-7106","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-foreign","tag-drugs_and_cosmetics"],"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>Draft of Drugs and Cosmetics (Second Amendment) Rules, 2015 | 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\/2015\/02\/18\/draft-of-drugs-and-cosmetics-second-amendment-rules-2015\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta 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and Cosmetics (Draft Amendment) Rules, 2021; consultation launched","author":"Prachi Bhardwaj","date":"September 30, 2021","format":false,"excerpt":"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: No New Homoeopathic medicine shall be imported without the permission\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\/2021\/09\/MicrosoftTeams-image-55.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-55.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-55.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-55.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-55.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":116811,"url":"https:\/\/www.scconline.com\/blog\/post\/2017\/03\/29\/drugs-and-cosmetics-5th-amendment-rules-2017-notified\/","url_meta":{"origin":7106,"position":1},"title":"Drugs and Cosmetics (5th Amendment) Rules, 2017, notified","author":"Saba","date":"March 29, 2017","format":false,"excerpt":"G.S.R. 250(E).\u2014Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules,\u00a01945 was published as required by Section 12 and Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare\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\/12\/DSC_4762-e1474523869607.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=1050%2C600&ssl=1 3x"},"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":7106,"position":2},"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":252345,"url":"https:\/\/www.scconline.com\/blog\/post\/2021\/08\/06\/an-overview-of-health-tech-regulation-in-india-part-1\/","url_meta":{"origin":7106,"position":3},"title":"An Overview of Health-tech Regulation in India [Part 1]","author":"Bhumika Indulia","date":"August 6, 2021","format":false,"excerpt":"by Shantanu Mukherjee\u2020 Cite as: 2021 SCC OnLine Blog Exp 62","rel":"","context":"In &quot;Op Eds&quot;","block_context":{"text":"Op Eds","link":"https:\/\/www.scconline.com\/blog\/post\/category\/op-ed\/legal-analysis\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/08\/MicrosoftTeams-image-130.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/08\/MicrosoftTeams-image-130.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/08\/MicrosoftTeams-image-130.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/08\/MicrosoftTeams-image-130.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/08\/MicrosoftTeams-image-130.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":257901,"url":"https:\/\/www.scconline.com\/blog\/post\/2021\/11\/30\/amendment-in-drugs-rules-1945-to-omit-provisions-for-issuing-duplicate-copy-of-import-licence-and-registration-certificate\/","url_meta":{"origin":7106,"position":4},"title":"Amendment in Drugs Rules, 1945 to omit provisions for issuing duplicate copy of import licence and registration certificate","author":"Bhumika Indulia","date":"November 30, 2021","format":false,"excerpt":"The Central Government, after consultation with the Drugs Technical Advisory Board makes Drugs (6th Amendment) Rules, 2021 further to amend the Drugs Rules, 1945. They shall come into force on the date of their publication in the Official Gazette. \u00a0 Key amendments: In the Drugs Rules, 1945, in rule 24,\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":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":7106,"position":5},"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":[]}],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/7106","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/comments?post=7106"}],"version-history":[{"count":0,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/7106\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media\/7321"}],"wp:attachment":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media?parent=7106"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/categories?post=7106"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/tags?post=7106"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}