{"id":6366,"date":"2020-02-19T20:33:06","date_gmt":"2020-02-19T15:03:06","guid":{"rendered":"https:\/\/triumphias.com\/blog\/?p=6366"},"modified":"2020-02-19T20:33:06","modified_gmt":"2020-02-19T15:03:06","slug":"importance-of-the-regulation-of-medical-devices","status":"publish","type":"post","link":"https:\/\/triumphias.com\/blog\/importance-of-the-regulation-of-medical-devices\/","title":{"rendered":"Importance of the regulation of medical devices"},"content":{"rendered":"<p><span style=\"color: #0000ff;\"><strong>Relevance: Mains: G.S paper II: Polity: Governance: Health<\/strong><\/span><\/p>\n<p><span style=\"color: #ff0000;\"><strong>Context:<\/strong><\/span><\/p>\n<ul>\n<li>The Centre brings virtually \u201call\u201d medical devices under regulation for quality and safety.<br \/>\n\u2022 A gazette notification was issued to this effect on February 11, bringing all devices under the scope of Section 3 (b) of the Drugs and Cosmetics Act, 1940, which pertains to medical devices.<\/li>\n<\/ul>\n<p><span style=\"color: #ff0000;\"><strong>Present scenario:<\/strong><\/span><\/p>\n<ul>\n<li>At present, over 35 devices are regulated or notified under the Medical Devices Rules, which came into force two years ago.<br \/>\n\u2022 The new categories of devices are likely to be notified from April this year. They will come under regulation after a period of 30-42 months.<br \/>\n\u2022 The domestic industry in particular has been given this window of adjustment to meet the required standards, the grace period rising with the levels of risk of the device.<br \/>\n\u2022 The nebulisers, blood-pressure monitoring devices, glucometers, disinfectants and insecticides, and digital thermometers, notified earlier as low risk devices, are likely to come under regulation from January 1, 2021.<br \/>\n\u2022 The high risk devices such as implants, CT scan equipment, MRI equipment, X-Ray machines, dialysis machines, also notified earlier, may come under the new regime from April 2021.<\/li>\n<\/ul>\n<p><a href=\"https:\/\/triumphias.com\/blog\/wp-content\/uploads\/2020\/02\/Medical-Devices.png\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-large wp-image-6367\" src=\"https:\/\/triumphias.com\/blog\/wp-content\/uploads\/2020\/02\/Medical-Devices-1024x525.png\" alt=\"\" width=\"810\" height=\"415\" srcset=\"https:\/\/triumphias.com\/blog\/wp-content\/uploads\/2020\/02\/Medical-Devices-1024x525.png 1024w, https:\/\/triumphias.com\/blog\/wp-content\/uploads\/2020\/02\/Medical-Devices-150x77.png 150w, https:\/\/triumphias.com\/blog\/wp-content\/uploads\/2020\/02\/Medical-Devices-300x154.png 300w, https:\/\/triumphias.com\/blog\/wp-content\/uploads\/2020\/02\/Medical-Devices-768x394.png 768w, https:\/\/triumphias.com\/blog\/wp-content\/uploads\/2020\/02\/Medical-Devices.png 1194w\" sizes=\"auto, (max-width: 810px) 100vw, 810px\" \/><\/a><\/p>\n<p><span style=\"color: #ff0000;\"><strong>Boosting domestic medical equipment sector:<\/strong><\/span><\/p>\n<ul>\n<li>In another boost to the domestic medical equipment sector, many of whom are MSMEs, the Centre has imposed a health cess on imported medical devices, with exceptions in the case of life-saving equipment.<br \/>\n\u2022 Any cess is, in principle, to be opposed, a levy in this case, coupled with the application of the Medical Devices Rules across the board, is expected to improve the competitiveness of the domestic industry.<br \/>\n\u2022 About 70 per cent of India\u2019s \u20b970,000-crore medical devices market is dominated by imports, with US and EU being key suppliers.<\/li>\n<\/ul>\n<p><span style=\"color: #ff0000;\"><strong>Enhance capabilities in regulation:<\/strong><\/span><\/p>\n<ul>\n<li>A NITI Aayog Bill is in the works for effective regulation of medical devices, in the process removing them from the Drugs and Cosmetics Act.<br \/>\n\u2022 This might be necessary in view of the fact that drugs and devices are quite dissimilar in nature. It is also worth looking at whether quality certification of imported devices is to be accepted under all circumstances, without subjecting them to trials in the Indian context.<br \/>\n\u2022 The Johnson and Johnson hip transplant episode is instructive here. Norms for operational trials should be defined, and a sample size that is too small may not be reliable.<br \/>\n\u2022 The penal provisions should be applied with respect to the risk of a product, and not across the board. The most serious issue with regulating medical devices pertains to the lack of data.<br \/>\n\u2022 This is despite a \u2018materio-vigilance programme\u2019 having been in force since July 2015 to collect data through \u2018material device adverse event monitoring centres\u2019.<\/li>\n<\/ul>\n<p><span style=\"color: #ff0000;\"><strong>Conclusion:<\/strong><\/span><\/p>\n<ul>\n<li>A move to create a \u2018national registry\u2019 of surgeons, as in the UK, should be expedited, with the Centre taking the lead.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Relevance: Mains: G.S paper II: Polity: Governance: Health Context: The Centre brings virtually \u201call\u201d medical devices under regulation for quality<\/p>\n","protected":false},"author":1,"featured_media":3530,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[123,18],"tags":[392],"class_list":["post-6366","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-current-affairs","category-general-studies-ii","tag-union-public-service-commission-upsc"],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/triumphias.com\/blog\/wp-json\/wp\/v2\/posts\/6366","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/triumphias.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/triumphias.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/triumphias.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/triumphias.com\/blog\/wp-json\/wp\/v2\/comments?post=6366"}],"version-history":[{"count":1,"href":"https:\/\/triumphias.com\/blog\/wp-json\/wp\/v2\/posts\/6366\/revisions"}],"predecessor-version":[{"id":6368,"href":"https:\/\/triumphias.com\/blog\/wp-json\/wp\/v2\/posts\/6366\/revisions\/6368"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/triumphias.com\/blog\/wp-json\/wp\/v2\/media\/3530"}],"wp:attachment":[{"href":"https:\/\/triumphias.com\/blog\/wp-json\/wp\/v2\/media?parent=6366"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/triumphias.com\/blog\/wp-json\/wp\/v2\/categories?post=6366"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/triumphias.com\/blog\/wp-json\/wp\/v2\/tags?post=6366"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}