{"id":132230,"date":"2026-11-06T11:49:06","date_gmt":"2026-11-06T06:19:06","guid":{"rendered":"https:\/\/vajiramandravi.com\/current-affairs\/?p=132230"},"modified":"2026-11-06T11:49:06","modified_gmt":"2026-11-06T06:19:06","slug":"bpal-patent-rejection-in-india-boost-for-affordable-tb-treatment","status":"publish","type":"post","link":"https:\/\/vajiramandravi.com\/current-affairs\/bpal-patent-rejection-in-india-boost-for-affordable-tb-treatment\/","title":{"rendered":"BPaL Patent Rejection in India: Boost for Affordable TB Treatment"},"content":{"rendered":"<h2><b>BPaL Patent Rejection in India Latest News<\/b><\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The Indian Patent Office has rejected a patent application for <\/span><b>BPaL<\/b><span style=\"font-weight: 400;\"> \u2014 a combination of three tuberculosis drugs (bedaquiline, pretomanid, linezolid) \u2014 filed by the US-based TB Alliance.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Experts have welcomed this as a major step toward making drug-resistant <\/span><strong><a href=\"https:\/\/vajiramandravi.com\/current-affairs\/tuberculosis-tb\/\" target=\"_blank\">TB<\/a><\/strong><span style=\"font-weight: 400;\"> treatment more affordable in India, which bears nearly a quarter of the world\u2019s TB burden, with an incidence rate of 187 cases per 100,000 people (2024).<\/span><\/li>\n<\/ul>\n<h2><b>What Is BPaL?<\/b><\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">A six-month, all-oral treatment regimen recommended by the WHO for eligible drug-resistant TB patients.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Combines three drugs<\/b><span style=\"font-weight: 400;\">: <\/span><i><span style=\"font-weight: 400;\">Bedaquiline, Pretomanid and Linezolid<\/span><\/i><span style=\"font-weight: 400;\">.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">A related regimen, BPaLM, adds a fourth drug, moxifloxacin, recording an 89% success rate \u2014 far higher than the 52\u201375% success of older regimens.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Over 15,000 patients have already started BPaLM treatment under India\u2019s National TB Programme.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Unlike older regimens requiring many months of antibiotics and painful injections, BPaL offers a shorter, oral course \u2014 reducing physical, financial and emotional burden.<\/span><\/li>\n<\/ul>\n<h2><b>Why Was the Patent Rejected?<\/b><\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The rejection followed <\/span><b>two pre-grant oppositions<\/b><span style=\"font-weight: 400;\"> filed in 2020 \u2014 formal legal challenges allowing individuals\/organisations to contest a patent before it\u2019s granted.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">With this ruling, every bedaquiline-related patent application challenged in India has now been refused \u2014 including the salt form (2023), paediatric formulation (2024), long-acting injectable, and now BPaL.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Experts call this a win against <\/span><b>\u201cevergreening<\/b><span style=\"font-weight: 400;\">\u201d \u2014 the practice of seeking additional patents on minor modifications of existing drugs to extend exclusivity and delay generic competition.<\/span><\/li>\n<\/ul>\n<h2><b>What Does This Mean for Patients?<\/b><\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">No single company can now claim exclusive rights over the BPaL combination in India.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Any TB drug manufacturer can produce it for India\u2019s national programme and for export.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">This removes a legal barrier to competition \u2014 but doesn\u2019t automatically lower prices or guarantee universal availability.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Actual impact depends on: number of quality-assured suppliers, government procurement, and uninterrupted supply chains.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Who Benefits Most<\/b><span style=\"font-weight: 400;\"> &#8211; Patients with multidrug-resistant or rifampicin-resistant TB (MDR\/RR-TB), especially those facing financial hardship, treatment delays, or poor access to treatment centres.<\/span><\/li>\n<\/ul>\n<h2><b>Will Treatment Become Cheaper?<\/b><\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Patients under India\u2019s public health system already receive TB medicines <\/span><b>free of cost<\/b><span style=\"font-weight: 400;\"> \u2014 so the immediate financial benefit accrues to the government, which procures these drugs.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Precedent exists: after the 2023 rejection of the bedaquiline salt patent, a six-month BPaLM course cost dropped from $588 (2022) to $284.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Lower procurement costs mean the same budget could treat more patients, and greater competition could ensure more reliable supply.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">However, patients still face out-of-pocket costs for travel, additional tests, nutrition, and lost income \u2014 lower drug prices alone won\u2019t eliminate these burdens.<\/span><\/li>\n<\/ul>\n<h2><b>Important Distinctions to Note<\/b><\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Patent approval \u2260 drug regulatory approval<\/b><span style=\"font-weight: 400;\">: A patent decides exclusivity rights; India\u2019s <\/span><a href=\"https:\/\/vajiramandravi.com\/current-affairs\/central-drugs-standard-control-organization-cdsco\/\" target=\"_blank\"><span style=\"font-weight: 400;\">CDSCO (Central Drugs Standard Control Organisation)<\/span><\/a><span style=\"font-weight: 400;\"> separately decides if a drug can be marketed.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">CDSCO has already approved bedaquiline and pretomanid for use under the National TB Elimination Programme (NTEP); linezolid and moxifloxacin are older, already-used antibiotics.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">WHO prequalification (assessing quality\/safety\/efficacy) also does not substitute for Indian regulatory marketing permission.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rejection of the patent is not automatic permission for unrestricted commercial sale.<\/span><\/li>\n<\/ul>\n<h2><b>Quality Concerns<\/b><\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Generic medicines must contain the same active pharmaceutical ingredients and meet regulatory standards.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Experts stress that quality checks must continue even as more manufacturers enter the market.<\/span><\/li>\n<\/ul>\n<h2><b>Conclusion<\/b><\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">India\u2019s rejection of the BPaL patent marks a significant victory against pharmaceutical \u201cevergreening\u201d and reinforces India\u2019s role as the \u201cpharmacy of the developing world.\u201d\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">While it opens the door to generic competition and potential cost savings for the government\u2019s TB programme, real impact for patients will depend on scaling up access, ensuring reliable supply chains, and maintaining drug quality \u2014 essential steps if India is to meaningfully advance its fight against drug-resistant tuberculosis.<\/span><\/li>\n<\/ul>\n<p><b>Source:<\/b> <strong><a href=\"https:\/\/indianexpress.com\/article\/explained\/explained-health\/tb-drug-patent-rejection-india-treatment-costs-10943445\/\" target=\"_blank\" rel=\"nofollow noopener\">IE<\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>BPaL patent rejection in India opens the door to generic competition and potentially lower procurement costs for drug-resistant TB treatment.<\/p>\n","protected":false},"author":18,"featured_media":132258,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[18],"tags":[11387,60,22,59],"class_list":["post-132230","post","type-post","status-publish","format-standard","has-post-thumbnail","category-upsc-mains-current-affairs","tag-bpal-patent-rejection-in-india","tag-mains-articles","tag-upsc-current-affairs","tag-upsc-mains-current-affairs","no-featured-image-padding"],"acf":[],"_links":{"self":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts\/132230","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\/18"}],"replies":[{"embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/comments?post=132230"}],"version-history":[{"count":4,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts\/132230\/revisions"}],"predecessor-version":[{"id":132264,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts\/132230\/revisions\/132264"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/media\/132258"}],"wp:attachment":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/media?parent=132230"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/categories?post=132230"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/tags?post=132230"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}