{"id":389810,"date":"2026-07-09T10:00:42","date_gmt":"2026-07-09T04:30:42","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=389810"},"modified":"2026-07-09T09:39:27","modified_gmt":"2026-07-09T04:09:27","slug":"cdsco-invites-stakeholder-consultation-for-drug-brand-name-extensions","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2026\/07\/09\/cdsco-invites-stakeholder-consultation-for-drug-brand-name-extensions\/","title":{"rendered":"CDSCO Examines Risks of Brand Name Extensions Across Different Drug Formulations"},"content":{"rendered":"<div style=\"text-align: justify; line-height: 150%;\">\n<p style=\"margin-bottom: 3%;\">On 6 July 2026, the <span style=\"font-weight: bold;\">Central Drugs Standard Control Organisation<\/span> (CDSCO) invited feedback and suggestions from stakeholders on the use of brand name extensions by pharmaceutical firms, signalling the regulator&#8217;s intent to examine concerns surrounding the practice and its potential implications for patient safety and the rational use of medicines.<\/p>\n<p style=\"font-weight: bold;\">Background:<\/p>\n<p style=\"margin-bottom: 3%;\">The Directorate General of Health Services (DGHS) received representations regarding the marketing of different drug formulations under the same established brand name through the use of various <span style=\"font-weight: bold;\">brand name extensions.<\/span><\/p>\n<p style=\"margin-bottom: 3%;\">The matter was subsequently deliberated by the <span style=\"font-weight: bold;\">67th Drugs Consultative Committee (DCC)<\/span> at its meeting held on <span style=\"font-weight: bold;\">17 November 2025<\/span>. During the deliberations, the DCC was informed of a representation alleging that a pharmaceutical company was marketing multiple drug formulations under a common brand name while using different extensions. Concerns were raised that the use of similar brand names for medicines containing different active pharmaceutical ingredients could mislead consumers and healthcare professionals, potentially creating confusion regarding their therapeutic indications and intended use.<\/p>\n<p style=\"font-weight: bold;\">Key takeaways:<\/p>\n<ol style=\"list-style-type: decimal;\">\n<li>\n<p>The DCC recommended undertaking a broader stakeholder consultation to examine the issue comprehensively.<\/p>\n<\/li>\n<li>\n<p>The Committee highlighted the need to assess the <span style=\"font-weight: bold;\">implications of brand name extensions<\/span> on prescribing practices, patient understanding, patient safety, and the potential for therapeutic confusion.<\/p>\n<\/li>\n<li>\n<p>As part of the consultation process, CDSCO has uploaded the <span style=\"font-weight: bold;\">DCC&#8217;s recommendations on its website<\/span> and <span style=\"font-weight: bold;\">invited comments from all stakeholders<\/span>, including pharmaceutical companies, healthcare professionals, industry associations, and consumer groups.<\/p>\n<\/li>\n<li>\n<p>The stakeholders are allowed to submit their comments and suggestions on or before <span class=\"Strong\">17 July 2026<\/span> via email at <a href=\"mailto:enforcecell.div@cdsco.nic.in\" target=\"_blank\">enforcecell.div@cdsco.nic.in<\/a>.<\/p>\n<\/li>\n<li>\n<p style=\"margin-bottom: 3%;\">The consultation is expected to help CDSCO determine whether additional regulatory measures are required to address concerns arising from the use of brand name extensions for medicines containing different active pharmaceutical ingredients and intended therapeutic uses.<\/p>\n<\/li>\n<\/ol>\n<p style=\"margin-bottom: 3%;\">Also Read: <a href=\"https:\/\/www.scconline.com\/blog\/post\/2026\/05\/29\/cdsco-prohibits-injectable-cosmetics\/\" target=\"_blank\">Cosmetics Are Not Medicines: CDSCO Prohibits Injectable Use<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>CDSCO has invited stakeholder feedback on drug brand name extensions amid concerns over therapeutic confusion and patient safety, with comments due by 17 July 2026.<\/p>\n","protected":false},"author":67525,"featured_media":389811,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,1193],"tags":[109341,109340,49088,109338,89110,109336,109343,109339,109337,60831,36074,109344,56712,109342],"class_list":["post-389810","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legislationupdates","category-notifications","tag-active-pharmaceutical-ingredients","tag-brand-extensions","tag-cdsco","tag-dcc","tag-dghs","tag-drug-brand-name-extensions","tag-drug-branding","tag-drug-formulations","tag-drugs-consultative-committee","tag-patient-safety","tag-pharmaceutical-companies","tag-pharmaceutical-regulation","tag-stakeholder-consultation","tag-therapeutic-confusion"],"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\/ 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