{"id":42050,"date":"2024-08-23T04:31:26","date_gmt":"2024-08-22T23:01:26","guid":{"rendered":"https:\/\/vajiramandravi.com\/current-affairs\/?p=42050"},"modified":"2025-05-01T03:44:37","modified_gmt":"2025-04-30T22:14:37","slug":"government-bans-156-fixed-dose-combination-drugs-a-major-crackdown-on-irrational-fdcs","status":"publish","type":"post","link":"https:\/\/vajiramandravi.com\/current-affairs\/government-bans-156-fixed-dose-combination-drugs-a-major-crackdown-on-irrational-fdcs\/","title":{"rendered":"Government Bans 156 Fixed Dose Combination Drugs: A Major Crackdown on Irrational FDCs"},"content":{"rendered":"<p><strong>What\u2019s in today\u2019s article?<\/strong><\/p>\n<ul>\n<li><strong>Why in News?<\/strong><\/li>\n<li><strong>Fixed Dose Combination (FDC) Drugs<\/strong><\/li>\n<li><strong>156 fixed dose combination drugs banned<\/strong><\/li>\n<\/ul>\n<h2><strong>Why in News?<\/strong><\/h2>\n<p>The Union Health Ministry has banned 156 fixed dose combination (FDC) medicines, citing &#8220;no therapeutic justification&#8221; and potential risks to patients.\u00a0FDC drugs combine multiple active ingredients, which can be helpful for conditions like tuberculosis and diabetes but may also deliver unnecessary or harmful components.\u00a0<\/p>\n<h2><strong>Fixed Dose Combination (FDC) Drugs:\u00a0<\/strong><\/h2>\n<h3><strong>About<\/strong><\/h3>\n<ul>\n<li>Combination products, also known as fixed dose drug combinations (FDCs), are combinations of two or more active drugs in a single dosage form.\u00a0<\/li>\n<li>They are also referred to as cocktail drugs.\n<ul>\n<li>The Food and Drug Administration, USA defines a combination product as \u2018<i>a product composed of any combination of a drug and a device or a biological product and a device or a drug and a biological product or a drug, device, and a biological product<\/i>\u2019.<\/li>\n<\/ul>\n<\/li>\n<li>It is widely accepted that most drugs should be formulated as single compounds.\u00a0<\/li>\n<\/ul>\n<h3><strong>Acceptability\u00a0<\/strong><\/h3>\n<ul>\n<li>Fixed ratio combination products are acceptable only when \u2013\n<ul>\n<li>The dosage of each ingredient meets the requirement of a defined population group and\u00a0<\/li>\n<li>The combination has a proven advantage over single compounds administered separately in therapeutic effect, safety or compliance.\u00a0<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h3><strong>Advantages of FDC Drugs\u00a0<\/strong><\/h3>\n<ul>\n<li>FDC formulations have unique advantages such as complementary mechanism of action, <strong>synergistic effects<\/strong>, <strong>better tolerability<\/strong>, <strong>elongated product life-cycle management<\/strong>, and <strong>cost savings<\/strong>.<\/li>\n<li>Use of FDCs is a rational approach for achieving optimal therapeutic benefits while minimizing pill-burden.<\/li>\n<\/ul>\n<h3><strong>Challenges\/Demerits of FDC Drugs<\/strong><\/h3>\n<ul>\n<li>There are increased chances of adverse drug effects and drug interactions compared with both drugs given individually.<\/li>\n<li>Unfortunately, many FDCs being introduced in India are usually irrational.\n<ul>\n<li>The most pressing concern with irrational FDCs is that <strong>they expose patients to unnecessary risk of adverse drug reactions<\/strong>.<\/li>\n<\/ul>\n<\/li>\n<li>Irrational FDCs also impose unnecessary <strong>financial burden on consumers<\/strong>.\n<ul>\n<li>Medical practitioners who patronize such combinations could be the centre of controversy when subjected to litigation in consumer forums.<\/li>\n<li>This is due to the fact that these combinations do not find mention in standard text or reference books and reputed medical journals.\u00a0<\/li>\n<\/ul>\n<\/li>\n<li>Pharmaceutical manufacturers, however, continue to reap the benefits of huge sales, and therefore continue to promote combinations with vigour.<\/li>\n<\/ul>\n<h2><strong>156 fixed dose combination drugs banned<\/strong><\/h2>\n<ul>\n<li><strong>About the news<\/strong><\/li>\n<li>The government has banned 156 fixed-dose combination (FDC) medicines, including antibiotics for fevers and colds, painkillers, and multivitamins, citing potential risks to human health.<\/li>\n<li>The Union Health Ministry issued a gazette notification under <strong>Section 26 A of the Drugs and Cosmetics Act of 1940<\/strong>, prohibiting the manufacture, sale, and distribution of these medicines.<\/li>\n<li>The ban follows recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB), both of which found no therapeutic justification for the ingredients in these FDCs.<\/li>\n<li><strong>Key highlights<\/strong><\/li>\n<li>The banned drugs include common combinations like anti-allergic medicines with nasal decongestants, antibiotics with acne creams, and migraine medicines with anti-nausea drugs.\u00a0<\/li>\n<li>Notably, the ban also includes the mefenamic acid-tranexamic acid combination and sildenafil with blood vessel relaxants.\u00a0<\/li>\n<li>This is the largest crackdown on FDCs since 2016 when 344 drugs were banned, a decision later upheld for 328 combinations in 2018.\u00a0<\/li>\n<li>Some pre-1988 drugs previously exempt from the ban are now included, which has surprised the pharmaceutical industry, raising concerns about the immediate withdrawal of these long-used products from the market.<\/li>\n<\/ul>\n<hr \/>\n<h3><strong>Q1. Why did the Indian government ban 156 fixed-dose combination drugs?<\/strong><br \/>\n\u00a0<\/h3>\n<p>The Indian government banned 156 fixed-dose combination drugs due to the lack of therapeutic justification and potential risks to patients, based on recommendations from an expert committee and the Drugs Technical Advisory Board.<\/p>\n<h3><strong>Q2. What is the impact of the ban on the pharmaceutical industry?<\/strong><\/h3>\n<p>The ban on 156 fixed-dose combination drugs has taken the pharmaceutical industry by surprise, raising concerns over the immediate withdrawal of long-used products and questioning the inclusion of pre-1988 medicines.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Union Health Ministry has banned 156 fixed-dose combination drugs, citing risks to patients and lack of therapeutic justification.<\/p>\n","protected":false},"author":5,"featured_media":42051,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[18],"tags":[],"class_list":{"0":"post-42050","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-upsc-mains-current-affairs","8":"no-featured-image-padding"},"acf":[],"_links":{"self":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts\/42050","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/comments?post=42050"}],"version-history":[{"count":0,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts\/42050\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/media\/42051"}],"wp:attachment":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/media?parent=42050"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/categories?post=42050"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/tags?post=42050"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}