{"id":197939,"date":"2022-07-29T22:08:07","date_gmt":"2022-07-29T16:38:07","guid":{"rendered":"https:\/\/blog.forumias.com\/?p=197939"},"modified":"2022-09-27T13:22:37","modified_gmt":"2022-09-27T07:52:37","slug":"answered-how-does-the-new-drugs-medical-devices-and-cosmetics-bill-2022-ensure-that-the-medical-products-sold-in-the-country-are-safe-and-effective","status":"publish","type":"post","link":"https:\/\/forumias.com\/blog\/answered-how-does-the-new-drugs-medical-devices-and-cosmetics-bill-2022-ensure-that-the-medical-products-sold-in-the-country-are-safe-and-effective\/","title":{"rendered":"[Answered] How does the new Drugs, Medical Devices, and Cosmetics Bill 2022 ensure that the medical products sold in the country are safe and effective?"},"content":{"rendered":"<table>\n<tbody>\n<tr>\n<td width=\"616\"><strong>Introduction:\u00a0<\/strong>Contextual introduction.<br \/>\n<strong>Body:\u00a0<\/strong>Write some provisions of the new Drugs, Medical Devices, and Cosmetics Bill 2022 which ensure safe and effective selling of medical products.<br \/>\n<strong>Conclusion<\/strong>: Write a way forward.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>The Bill seeks to\u00a0replace the <strong>Drugs and Cosmetics Act of 1940<\/strong> with an updated law laying down strict regulatory guidelines to keep pace with changing needs and technology. Almost 80% of the medical devices currently sold in the country are imported, particularly high-end devices. The primary objective of this bill is to ensure that the medical products sold in a country are safe, effective and conform to prescribed quality standards.<\/p>\n<p><strong>Provisions for safe and effective selling of medical products:<\/strong><\/p>\n<ul>\n<li><strong>Bring in the required expertise<\/strong>: It proposed to establish a <strong>statutory Medical Device Technical Advisory Board<\/strong>, with experts from the fields of atomic energy, science and technology, electronics, and related fields like biomedical technology to guide the process.<\/li>\n<li><strong>Separate Definition of Medical Devices:\u00a0<\/strong>It includes diagnostic equipment, its software, implants, devices for assistance with disabilities, life support, instruments used for disinfection, and any reagents or kits.<\/li>\n<li><strong>Medical Devices Testing Centre<\/strong>: The Bill proposes medical device testing centres on the lines of drug laboratories in states and at the central level.<\/li>\n<li><strong>Clinical Trials:\u00a0<\/strong>It proposes <strong>compulsory permission<\/strong> <strong>of the<\/strong> <strong>central licensing authority<\/strong> for clinical trials or clinical investigation of drugs and medical devices.<\/li>\n<li><strong>Medical management and compensation:<\/strong> To persons who are injured while participating in clinical trials. And, in case of death, the legal heir of the participant should be awarded compensation.<\/li>\n<li><strong>Regulation of e-pharmacies:<\/strong>The Bill specifically states that the Central government must come up with rules to regulate the online sale of drugs and for online pharmacies to operate \u201cin accordance with a licence or permission issued\u201d.<\/li>\n<li>The draft Bill defines provisions for <strong>imprisonment or fines<\/strong> for \u201cadulterated\u201d or \u201cspurious\u201d medical devices.<\/li>\n<\/ul>\n<p>A modern regulatory system should be designed to guarantee citizens a right to participate in decision-making. There is need to create legal pathways, such as public hearings or citizen\u2019s petitions to enable citizens\u2019 participation in the regulatory process and to register their objections.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Introduction:\u00a0Contextual introduction. Body:\u00a0Write some provisions of the new Drugs, Medical Devices, and Cosmetics Bill 2022 which ensure safe and effective selling of medical products. Conclusion: Write a way forward. The Bill seeks to\u00a0replace the Drugs and Cosmetics Act of 1940 with an updated law laying down strict regulatory guidelines to keep pace with changing needs&hellip; <a class=\"more-link\" href=\"https:\/\/forumias.com\/blog\/answered-how-does-the-new-drugs-medical-devices-and-cosmetics-bill-2022-ensure-that-the-medical-products-sold-in-the-country-are-safe-and-effective\/\">Continue reading <span class=\"screen-reader-text\">[Answered] How does the new Drugs, Medical Devices, and Cosmetics Bill 2022 ensure that the medical products sold in the country are safe and effective?<\/span><\/a><\/p>\n","protected":false},"author":10320,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"footnotes":""},"categories":[9],"tags":[],"class_list":["post-197939","post","type-post","status-publish","format-standard","hentry","category-public","entry"],"jetpack_featured_media_url":"","views":{"total":0,"cached_at":"","cached_date":1704779744},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/197939","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/users\/10320"}],"replies":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/comments?post=197939"}],"version-history":[{"count":0,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/197939\/revisions"}],"wp:attachment":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media?parent=197939"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/categories?post=197939"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/tags?post=197939"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}