{"id":77403,"date":"2026-06-19T18:20:48","date_gmt":"2026-06-19T12:50:48","guid":{"rendered":"https:\/\/www.nextias.com\/ca\/?p=77403"},"modified":"2026-06-19T18:21:58","modified_gmt":"2026-06-19T12:51:58","slug":"pharmaceutical-regulation-india","status":"publish","type":"post","link":"https:\/\/www.nextias.com\/ca\/current-affairs\/19-06-2026\/pharmaceutical-regulation-india","title":{"rendered":"India&#8217;s Regulatory Oversight of the Pharmaceutical Sector"},"content":{"rendered":"\n<p><strong>Syllabus: GS2\/ Health<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Context<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The Union Health Ministry has removed the term syrup from <strong>Schedule K of the Drugs Rules 1945<\/strong> thus requiring cough syrups to be <strong>sold only with a prescription.<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Background<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The step has been taken after <strong>multiple fatalities caused by cough syrups adulterated with industrial solvents<\/strong> including the death of children across several countries since 2022.<\/li>\n\n\n\n<li>The measure has raised concerns <strong>regarding pharmaceutical regulation<\/strong>, public health governance, and India&#8217;s role in the global healthcare ecosystem.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Pharmaceutical Sector of India<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>India stands as the Pharmacy of the World due to\u00a0 its unique <strong>combination of affordable pricing and assured quality<\/strong>, which has made Indian medicines widely preferred across global markets.<\/li>\n\n\n\n<li>India hosts the highest number of manufacturing plants approved by the <strong>United States Food and Drug Administration (USFDA)<\/strong> outside the United States of America, reinforcing international confidence in the safety and quality of Indian pharmaceuticals.\n<ul class=\"wp-block-list\">\n<li>There are about <strong>500<\/strong> active <strong>pharmaceutical ingredient (API) manufacturers, <\/strong>accounting for nearly 8 per cent of the global API industry.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img data-dominant-color=\"adcee0\" data-has-transparency=\"false\" loading=\"lazy\" decoding=\"async\" width=\"604\" height=\"359\" src=\"https:\/\/wp-images.nextias.com\/cdn-cgi\/image\/format=auto\/ca\/uploads\/2026\/06\/image-153.png\" alt=\"pharmaceutical sector of india\" class=\"not-transparent wp-image-77404\" style=\"--dominant-color: #adcee0; width:512px;height:auto\" srcset=\"https:\/\/wp-images.nextias.com\/cdn-cgi\/image\/format=auto\/ca\/uploads\/2026\/06\/image-153.png 604w, https:\/\/wp-images.nextias.com\/cdn-cgi\/image\/format=auto\/ca\/uploads\/2026\/06\/image-153-300x178.png 300w\" sizes=\"auto, (max-width: 604px) 100vw, 604px\" \/><\/figure>\n<\/div>\n\n\n<h2 class=\"wp-block-heading\"><strong>Concerns regarding India&#8217;s Pharmaceutical Regulatory Ecosystem<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Manufacturing Quality Concerns:<\/strong> There are instances of contamination and quality lapses highlighting weaknesses in adherence to manufacturing standards.<\/li>\n\n\n\n<li><strong>Fragmented Oversight:<\/strong> Multiple regulatory authorities and varying enforcement standards create inconsistencies in monitoring.<\/li>\n\n\n\n<li><strong>Over-the-Counter Drug Culture:<\/strong> Widespread self-medication increases the risk of irrational and unsafe use of medicines.<\/li>\n\n\n\n<li><strong>Regulatory Capacity Constraints: <\/strong>In India, drug regulation is a dual responsibility shared between the Union and State governments. Many State drug control departments face shortages of inspectors, laboratories, and technical personnel.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Regulation of Drugs in India<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>The Central Drugs Standard Control Organization (CDSCO)<\/strong> headed by the Drugs Controller General (India) is the Central Authority for regulating the quality of drugs marketed in the country under the <strong>Drugs and Cosmetics Act, 1940 <\/strong>and Rules thereunder.<\/li>\n\n\n\n<li><strong>The import, manufacture, distribution and sale of Drugs, Cosmetics and Medical Devices<\/strong> in the country are regulated under the provisions of the Drugs and Cosmetics Act, 1940 &amp; Rules made thereunder i.e.<strong> Drugs Rules, 1945, Medical Devices Rules, 2017, New Drugs &amp; Clinical Trials Rules, 2019 <\/strong>and <strong>Cosmetics Rules, 2020.<\/strong><\/li>\n\n\n\n<li><strong>The National Pharmaceutical Pricing Authority (NPPA)<\/strong> is mandated to fix and revise drug prices under the provisions of the <strong>Drugs (Prices Control) Order (DPCO), 2013,<\/strong> while monitoring compliance, ensuring the availability of essential medicines, and advising on pharmaceutical policy.<\/li>\n\n\n\n<li><strong>Indian Pharmacopoeia Commission (IPC):<\/strong> It oversees the periodic publication of the Indian Pharmacopoeia, the official compendium of drug standards under the <strong>Drugs and Cosmetics Act, 1940.<\/strong>\n<ul class=\"wp-block-list\">\n<li>The Pharmacopoeia prescribes standards of identity, purity, and strength for medicines marketed in India.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>The regulatory control over <strong>manufacturing, sale and distribution of drugs <\/strong>is exercised through a system of <strong>licensing and inspection by State Licensing Authorities (SLAs)<\/strong> appointed by State Governments, while<strong> regulatory control over drugs<\/strong> imported into the country is exercised by the Central Government through the <strong>Central Drugs Standard Control Organisation (CDSCO).<\/strong><\/li>\n\n\n\n<li><strong>State Health Regulatory Excellence Index (SHRESTH):<\/strong> A first-of-its-kind national initiative to benchmark and strengthen state drug regulatory systems through a transparent, data-driven framework.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Way Ahead<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Quality assurance should be <strong>integrated throughout the manufacturing process <\/strong>rather than relying on end-product testing only.<\/li>\n\n\n\n<li>Public disclosure of <strong>inspection findings and regulatory actions<\/strong> is necessary to improve accountability.<\/li>\n\n\n\n<li>There is a need to<strong> use artificial intelligence, data analytics, and digital tracking <\/strong>systems for regulatory surveillance.<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n\n\n\n<div class=\"wp-block-group has-background\" style=\"background-color:#fff2cc\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<p><strong>Schedule K of the Drugs and Cosmetics Rules, 1945<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Schedule K contains a list of certain drugs that are <strong>exempted from some provisions of the Drugs and Cosmetics Rules, 1945,<\/strong> subject to specified conditions.<\/li>\n\n\n\n<li>It facilitates the <strong>sale and distribution of certain categories<\/strong> of medicines where strict licensing requirements are not necessary.<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<p><\/p>\n\n\n\n<p><strong>Source: <\/strong><a href=\"https:\/\/www.thehindu.com\/opinion\/editorial\/lopsided-solution-on-syrup-based-medicines-doctors-prescription\/article71117095.ece\" target=\"_blank\" rel=\"noopener\"><strong>TH<\/strong><\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p><strong> Context <\/strong><\/p>\n<li class=\"ms-5\"> The Union Health Ministry has removed the term syrup from Schedule K of the Drugs Rules 1945 thus requiring cough syrups to be sold only with a prescription. <\/li>\n<p><\/p>\n<p><strong> Background <\/strong><\/p>\n<li class=\"ms-5\"> The step has been taken after multiple fatalities caused by cough syrups adulterated with industrial solvents including the death of children across several countries since 2022. <\/li>\n<li class=\"ms-5\"> The measure has raised concerns regarding pharmaceutical regulation, public health governance, and India&#8217;s role in the global healthcare ecosystem. <\/li>\n<p><a href=\" https:\/\/www.nextias.com\/ca\/current-affairs\/19-06-2026\/pharmaceutical-regulation-india \" class=\"btn btn-primary btn-sm float-end\">Read More<\/a><\/p>\n","protected":false},"author":15,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[21],"tags":[],"class_list":["post-77403","post","type-post","status-publish","format-standard","hentry","category-current-affairs"],"acf":[],"jetpack_featured_media_url":"","_links":{"self":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts\/77403","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=77403"}],"version-history":[{"count":3,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts\/77403\/revisions"}],"predecessor-version":[{"id":77408,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts\/77403\/revisions\/77408"}],"wp:attachment":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/media?parent=77403"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/categories?post=77403"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/tags?post=77403"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}