{"id":34426,"date":"2024-12-28T16:31:33","date_gmt":"2024-12-28T11:01:33","guid":{"rendered":"https:\/\/www.nextias.com\/ca\/?p=34426"},"modified":"2024-12-28T17:57:52","modified_gmt":"2024-12-28T12:27:52","slug":"generic-drugs","status":"publish","type":"post","link":"https:\/\/www.nextias.com\/ca\/editorial-analysis\/28-12-2024\/generic-drugs","title":{"rendered":"Making affordable generics more reliable"},"content":{"rendered":"\n<p><strong>Syllabus : GS2\/Health<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>In News<\/strong><\/h2>\n\n\n\n<p>Now it has been observed that ensuring the quality of generic medicines in India is vital to make them affordable and effective as innovator drugs<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>About Generic drugs&nbsp;<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>They are marketed under a non-proprietary or approved name rather than a proprietary or brand name.<\/li>\n\n\n\n<li>&nbsp;Generic drugs are equally effective and inexpensive compared to their branded counterparts.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Importance of Generic Drugs:<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Generic drugs are crucial for <strong>making healthcare affordabl<\/strong>e, especially in countries with significant income disparities.<\/li>\n\n\n\n<li>They are bioequivalent to branded drugs and<strong> offer cost-effective alternatives.<\/strong><\/li>\n\n\n\n<li>India uses <strong>economies of scale<\/strong> and <strong>low production costs<\/strong> to supply affordable generic medicines both domestically and internationally.<\/li>\n\n\n\n<li><strong>Economic Impact of Generic Medicines: <\/strong>In 2021-22, out-of-pocket healthcare expenditure was 39.4% of total health expenditure in India.\n<ul class=\"wp-block-list\">\n<li>Generic medicines reduce financial burdens and improve treatment adherence.<\/li>\n\n\n\n<li>By August 2024, the<strong> <\/strong><a href=\"https:\/\/www.nextias.com\/ca\/current-affairs\/01-06-2022\/pradhan-mantri-bhartiya-janaushadhi-pariyojana-pmbjp\"><strong>Pradhan Mantri Bhartiya Janaushadhi Pariyojana<\/strong><\/a> saved consumers \u20b930,000 crore through generic medicines worth \u20b95,600 crore.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Issues and Concerns<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Quality Concerns with Generic Drugs: <\/strong>Quality control lapses sometimes compromise the efficacy and safety of generics.\n<ul class=\"wp-block-list\">\n<li>A study by PGIMER, Chandigarh, found that generic itraconazole formulations were less effective in treating chronic pulmonary aspergillosis than the innovator drug.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Issues with India\u2019s Decentralized Drug Regulation: <\/strong>State Drug Regulatory Authorities (SDRAs) have significant control over drug regulation, leading to <strong>inconsistent enforcement and quality standards<\/strong>.\n<ul class=\"wp-block-list\">\n<li>The Central Drugs Standard Control Organisation (CDSCO) lacks the authority to enforce regulations effectively at the state level.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Regulatory and Testing Gaps: <\/strong>The decentralised system allows regulatory arbitrage, where manufacturers exploit weaker state oversight.\n<ul class=\"wp-block-list\">\n<li>Stability testing, required by CDSCO in 2018, is inconsistently implemented, undermining compliance.<\/li>\n\n\n\n<li>Drugs approved before 2018 are not subject to mandatory stability testing, allowing substandard drugs to remain in the market.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>India\u2019s Pharmacopoeia Standards:<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>India\u2019s Pharmacopoeia allows higher impurity levels in drugs compared to U.S. and EU standards.<\/li>\n\n\n\n<li>The CDSCO and the Pharmacopoeia Commission (PC) have rejected stricter ICH guidelines due to cost concerns, leading to lower quality standards.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Suggestions and Way Forward<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Centralizing drug regulation <\/strong>and strengthening the CDSCO is essential to ensure consistent quality control and protect patients from substandard drugs.<\/li>\n\n\n\n<li>A <strong>more robust regulatory system <\/strong>with centralized oversight would help build confidence in generics and ensure drug safety.<\/li>\n\n\n\n<li>India must centralize drug regulation, enforce uniform stability testing protocols, and reassess all approved generics periodically.\n<ul class=\"wp-block-list\">\n<li>Centralized oversight is crucial to implement stringent regulations and safeguard public health.\n<ul class=\"wp-block-list\">\n<li>Committees like Bhatia (1954), Hathi (1975), and Mashelkar (2003) have&nbsp; also called for centralized control over drug regulation to improve drug quality and public confidence in generics.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p>Source: TH<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-background\" style=\"background-color:#fff2cc\"><tbody><tr><td><strong>Mains Practise Question<\/strong><br><strong>[Q] <\/strong>Critically analyze the advantages and challenges of promoting generic medicines in India.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/www.nextias.com\/ca\/wp-content\/uploads\/2024\/12\/UPSC-Editorial-Analysis-28-December-2024.pdf\">Download PDF<\/a><\/div>\n<\/div>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Now it has been observed that ensuring the quality of generic medicines in India is vital to make them affordable and effective as innovator drugs<\/p>\n","protected":false},"author":15,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[22],"tags":[],"class_list":["post-34426","post","type-post","status-publish","format-standard","hentry","category-editorial-analysis"],"acf":[],"jetpack_featured_media_url":"","_links":{"self":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts\/34426","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/users\/15"}],"replies":[{"embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/comments?post=34426"}],"version-history":[{"count":3,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts\/34426\/revisions"}],"predecessor-version":[{"id":34446,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts\/34426\/revisions\/34446"}],"wp:attachment":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/media?parent=34426"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/categories?post=34426"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/tags?post=34426"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}