{"id":161416,"date":"2025-04-08T14:43:54","date_gmt":"2025-04-08T09:13:54","guid":{"rendered":"https:\/\/pwonlyias.com\/stage\/?post_type=mains-answer-writing&#038;p=161416"},"modified":"2025-04-09T11:41:43","modified_gmt":"2025-04-09T06:11:43","slug":"examine-the-policy-and-regulatory-framework-in-india-for-rare-diseases","status":"publish","type":"mains-answer-writing","link":"https:\/\/pwonlyias.com\/stage\/mains-answer-writing\/examine-the-policy-and-regulatory-framework-in-india-for-rare-diseases","title":{"rendered":"Critically examine the policy and regulatory framework in India for rare diseases. How can India balance affordability, accessibility, and innovation in this domain? (15 Marks, 250 Words)"},"content":{"rendered":"<table style=\"width: 99.8932%;\">\n<tbody>\n<tr>\n<td style=\"width: 100%;\">\n<h3><span style=\"font-size: 16pt;\"><b>Core Demand of the Question<\/b><\/span><\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Examine the positives of policy and regulatory framework in India for rare diseases<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Examine the limitations of policy and regulatory framework in India for rare diseases<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Suggest how India can balance affordability, accessibility, and innovation in this domain<\/span><\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2><span style=\"font-size: 18pt;\"><b>Answer<\/b><\/span><\/h2>\n<p><b>Rare diseases<\/b><span style=\"font-weight: 400;\">, often defined as conditions affecting fewer than 1 in 2,500 individuals, collectively impact over <\/span><b>70 million people in India<\/b><span style=\"font-weight: 400;\">. Despite their low individual prevalence, their cumulative burden is significant. In 2021, India launched the <\/span><b>National Policy for Rare Diseases<\/b><span style=\"font-weight: 400;\">, yet concerns remain around <\/span><b>regulatory clarity<\/b><span style=\"font-weight: 400;\">, <\/span><b>affordability of orphan drugs<\/b><span style=\"font-weight: 400;\">, and <\/span><b>incentivizing research<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<h2><span style=\"font-size: 18pt;\"><b>Positives of Policy and Regulatory Framework in India for Rare Diseases<\/b><\/span><\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Constitutional Backing<\/b><span style=\"font-weight: 400;\">: The right to health under Article 21 strengthens the legal foundation for rare disease care, ensuring health is treated as a <\/span><b>fundamental right<\/b><span style=\"font-weight: 400;\">.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span> <b>For example:<\/b><span style=\"font-weight: 400;\"> In <\/span><b>Paschim Banga Khet Mazdoor Samity v. State of West Bengal (1996)<\/b><span style=\"font-weight: 400;\">, the Supreme Court emphasized that the state must provide timely medical treatment to protect the right to life.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Dedicated National Policy<\/b><span style=\"font-weight: 400;\">: The <\/span><b>National Policy for Rare Diseases (NPRD) 2021<\/b><span style=\"font-weight: 400;\"> provides a structured approach to classifying and managing rare diseases in India.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span> <b>For example:<\/b><span style=\"font-weight: 400;\"> The policy classifies rare diseases into three groups and outlines the mechanism for financial assistance, offering up to <\/span><b>Rs 50 lakh<\/b><span style=\"font-weight: 400;\"> for specific treatments.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Registry for Patients<\/b><span style=\"font-weight: 400;\">: The <\/span><b>National Registry for Rare and Other Inherited Disorders<\/b><span style=\"font-weight: 400;\"> helps in collecting data for effective planning and intervention strategies.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Judicial Interventions<\/b><span style=\"font-weight: 400;\">: Indian courts have actively ensured policy implementation and directed the government to act swiftly in individual cases of rare disease treatment.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span> <b>For example:<\/b><span style=\"font-weight: 400;\"> The <\/span><b>Delhi High Court<\/b><span style=\"font-weight: 400;\"> ordered the formation of a committee to oversee <\/span><b>NPRD <\/b><span style=\"font-weight: 400;\">implementation and highlighted the need for government action in rare disease cases.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Provision for Local Production<\/b><span style=\"font-weight: 400;\">: NPRD\u2019s implementation strategy directs MoHFW to coordinate with industrial departments to <\/span><b>promote domestic manufacturing<\/b><span style=\"font-weight: 400;\"> of orphan drugs.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><\/li>\n<\/ul>\n<h2><span style=\"font-size: 18pt;\"><b>Limitations of Policy and Regulatory Framework in India for Rare Diseases<\/b><\/span><\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Inadequate Funding Support<\/b><span style=\"font-weight: 400;\">: The financial cap of <\/span><b>Rs 50 lakh per patient<\/b><span style=\"font-weight: 400;\"> is often insufficient for lifelong treatments of high-cost rare diseases like <\/span><b>Spinal Muscular Atrophy<\/b><span style=\"font-weight: 400;\">.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span> <b>For example:<\/b><span style=\"font-weight: 400;\"> A child undergoing treatment with <\/span><b>risdiplam<\/b><span style=\"font-weight: 400;\">, costing <\/span><b>Rs 72 lakh annually<\/b><span style=\"font-weight: 400;\">, had to discontinue due to exhausted NPRD funds and lack of extended aid.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Slow Policy Implementation<\/b><span style=\"font-weight: 400;\">: Policy measures often come only after <\/span><b>court intervention<\/b><span style=\"font-weight: 400;\">, reflecting bureaucratic apathy and delays in government response.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span> <b>For example:<\/b><span style=\"font-weight: 400;\"> The MoHFW approved the NPRD only after a <\/span><b>Delhi HC<\/b><span style=\"font-weight: 400;\"> directive in 2021, showing lack of proactive governance.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Legal Ambiguity on Patents<\/b><span style=\"font-weight: 400;\">: India\u2019s current framework does not aggressively tackle <\/span><b>patent monopolies<\/b><span style=\"font-weight: 400;\"> that block the production of affordable generics for rare diseases.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span> <b>For example:<\/b><span style=\"font-weight: 400;\"> Patentees often <\/span><b>refuse to market<\/b><span style=\"font-weight: 400;\"> essential drugs like risdiplam in India, making them unaffordable and inaccessible to most patients.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Lack of Incentives for Innovation<\/b><span style=\"font-weight: 400;\">: There is minimal government support for <\/span><b>R&#038;D in orphan drugs<\/b><span style=\"font-weight: 400;\">, limiting India\u2019s potential to develop innovative, affordable treatments locally.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Poor Awareness and Identification<\/b><span style=\"font-weight: 400;\">: Most rare disease patients remain <\/span><b>undiagnosed or unregistered<\/b><span style=\"font-weight: 400;\">, making it difficult to assess the real burden and provide timely support.<\/span><\/li>\n<\/ul>\n<h2><span style=\"font-size: 18pt;\"><b>How India Can Balance Affordability, Accessibility, and Innovation<\/b><\/span><\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Enforce Compulsory Licensing<\/b><span style=\"font-weight: 400;\">: The government should use <\/span><b>compulsory licensing provisions<\/b><span style=\"font-weight: 400;\"> under the Patents Act to allow generic production of high-cost rare disease drugs.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span> <b>For example:<\/b><span style=\"font-weight: 400;\"> In 2012, India granted <\/span><b>Natco Pharma<\/b><span style=\"font-weight: 400;\"> a compulsory license to produce <\/span><b>Nexavar<\/b><span style=\"font-weight: 400;\">, slashing the cost by over 95% for liver cancer patients.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Public-Private Partnerships (PPPs)<\/b><span style=\"font-weight: 400;\">: Encourage collaborations between government, academia, and industry for <\/span><b>affordable R&#038;D<\/b><span style=\"font-weight: 400;\"> and domestic manufacturing of orphan drugs.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span> <b>For example:<\/b><span style=\"font-weight: 400;\"> A PPP model like the one used for <\/span><b>COVAXIN<\/b><span style=\"font-weight: 400;\"> can be replicated for rare disease drugs, reducing costs and accelerating innovation.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Tax and Regulatory Incentives<\/b><span style=\"font-weight: 400;\">: Introduce <\/span><b>financial incentives<\/b><span style=\"font-weight: 400;\">, such as tax deductions, market exclusivity, and fast-track approvals for firms developing orphan drugs.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Expand Insurance and CSR Funding<\/b><span style=\"font-weight: 400;\">: Include rare disease treatment in <\/span><b>public and private insurance schemes<\/b><span style=\"font-weight: 400;\"> and promote <\/span><b>CSR funding<\/b><span style=\"font-weight: 400;\"> from corporates to fill financial gaps.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span> <b>For example:<\/b><span style=\"font-weight: 400;\"> In 2022, the Kerala HC directed the Centre to fund rare disease treatment through <\/span><b>CSR and crowdfunding<\/b><span style=\"font-weight: 400;\">, showcasing alternative funding models.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Strengthen Medical Infrastructure<\/b><span style=\"font-weight: 400;\">: Invest in <\/span><b>diagnostic centres<\/b><span style=\"font-weight: 400;\">, training for healthcare workers, and public awareness campaigns to ensure early diagnosis and intervention.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span> <b>For example:<\/b><span style=\"font-weight: 400;\"> The <\/span><b>All India Institute of Medical Sciences (AIIMS)<\/b><span style=\"font-weight: 400;\"> can be upgraded into a <\/span><b>national centre for rare diseases<\/b><span style=\"font-weight: 400;\">, aiding early detection and better treatment outcomes.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">In order to provide systemic support for <\/span><b>diagnosis<\/b><span style=\"font-weight: 400;\">, <\/span><b>treatment<\/b><span style=\"font-weight: 400;\">, and <\/span><b>research<\/b><span style=\"font-weight: 400;\">, a strong rare disease policy must go beyond <\/span><b>tokenism<\/b><span style=\"font-weight: 400;\">. By encouraging public-private partnerships, providing incentives for the development of orphan drugs, incorporating rare diseases into primary healthcare, and increasing financial risk protection, India can strike a balance between affordability, accessibility, and innovation, leading to the <\/span><b>transformation of care <\/b><span style=\"font-weight: 400;\">into <\/span><b>inclusive <\/b><span style=\"font-weight: 400;\">and <\/span><b>equitable<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<div class=\"vc_table_green\"><\/p>\n<table style=\"width: 99.6375%;\">\n<tbody>\n<tr>\n<td style=\"width: 111.19%; text-align: center;\" colspan=\"2\"><span style=\"font-size: 18pt;\"><b>Also Read<\/b><\/span><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 49.797%; text-align: center;\"><a href=\"https:\/\/pwonlyias.com\/stage\/editorial-analysis\/\" target=\"_blank\" rel=\"noopener\"><b>UPSC Daily Editorials<\/b><\/a><\/td>\n<td style=\"width: 61.393%; text-align: center;\"><a href=\"https:\/\/pwonlyias.com\/stage\/daily-current-affairs\/\" target=\"_blank\" rel=\"noopener\"><b>UPSC Daily Current Affairs<\/b><\/a><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 49.797%; text-align: center;\"><a href=\"https:\/\/pwonlyias.com\/stage\/quiz\/\" target=\"_blank\" rel=\"noopener\"><b>Daily Current Affairs Quiz<\/b><\/a><\/td>\n<td style=\"width: 61.393%; text-align: center;\"><a href=\"https:\/\/pwonlyias.com\/stage\/mains-answer-writing\/\" target=\"_blank\" rel=\"noopener\"><b>Daily Main Answer Writing<\/b><\/a><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 49.797%; text-align: center;\"><a href=\"https:\/\/store.pw.live\/govt-entrance-exams\/upsc-books\/upsc-previous-year-papers?utm_source=SEO&#038;utm_medium=PW+Live&#038;utm_campaign=UPSC+Previous+Year+Papers\" target=\"_blank\" rel=\"noopener\"><b>Check Out Previous Years Papers From PW Store<\/b><\/a><\/td>\n<td style=\"width: 61.393%; text-align: center;\"><a href=\"https:\/\/pwonlyias.com\/stage\/upsc-test-series-courses\/\" target=\"_blank\" rel=\"noopener\"><b>UPSC Test Series<\/b><\/a><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 49.797%; text-align: center;\"><a href=\"https:\/\/store.pw.live\/govt-entrance-exams\/upsc-books\/upsc-textbooks?utm_source=SEO&#038;utm_medium=PW+Live&#038;utm_campaign=UPSC+Textbooks\" target=\"_blank\" rel=\"noopener\"><b>Check Out UPSC NCERT Textbooks From PW Store<\/b><\/a><\/td>\n<td style=\"width: 61.393%; text-align: center;\"><a href=\"https:\/\/store.pw.live\/govt-entrance-exams\/upsc-books\/upsc-modules?utm_source=SEO&#038;utm_medium=PW+Live&#038;utm_campaign=UPSC+Modules\" target=\"_blank\" rel=\"noopener\"><b>Check Out UPSC Modules From PW Store<\/b><\/a><b>\u00a0<\/b><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Core Demand of the Question Examine the positives of policy and regulatory framework in India for rare diseases Examine the limitations of policy and regulatory framework in India for rare diseases Suggest how India can balance affordability, accessibility, and innovation in this domain Answer Rare diseases, often defined as conditions affecting fewer than 1 in&hellip; <a class=\"more-link\" href=\"https:\/\/pwonlyias.com\/stage\/mains-answer-writing\/examine-the-policy-and-regulatory-framework-in-india-for-rare-diseases\">Continue reading <span class=\"screen-reader-text\">Critically examine the policy and regulatory framework in India for rare diseases. How can India balance affordability, accessibility, and innovation in this domain? (15 Marks, 250 Words)<\/span><\/a><\/p>\n","protected":false},"author":11,"featured_media":0,"menu_order":0,"comment_status":"open","ping_status":"open","template":"","format":"standard","meta":{"rank_math_lock_modified_date":false,"footnotes":""},"paper-wise":[2084],"subject":[2121],"acf":[],"_links":{"self":[{"href":"https:\/\/pwonlyias.com\/stage\/wp-json\/wp\/v2\/mains-answer-writing\/161416"}],"collection":[{"href":"https:\/\/pwonlyias.com\/stage\/wp-json\/wp\/v2\/mains-answer-writing"}],"about":[{"href":"https:\/\/pwonlyias.com\/stage\/wp-json\/wp\/v2\/types\/mains-answer-writing"}],"author":[{"embeddable":true,"href":"https:\/\/pwonlyias.com\/stage\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/pwonlyias.com\/stage\/wp-json\/wp\/v2\/comments?post=161416"}],"version-history":[{"count":3,"href":"https:\/\/pwonlyias.com\/stage\/wp-json\/wp\/v2\/mains-answer-writing\/161416\/revisions"}],"predecessor-version":[{"id":161506,"href":"https:\/\/pwonlyias.com\/stage\/wp-json\/wp\/v2\/mains-answer-writing\/161416\/revisions\/161506"}],"wp:attachment":[{"href":"https:\/\/pwonlyias.com\/stage\/wp-json\/wp\/v2\/media?parent=161416"}],"wp:term":[{"taxonomy":"paper-wise","embeddable":true,"href":"https:\/\/pwonlyias.com\/stage\/wp-json\/wp\/v2\/paper-wise?post=161416"},{"taxonomy":"subject","embeddable":true,"href":"https:\/\/pwonlyias.com\/stage\/wp-json\/wp\/v2\/subject?post=161416"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}