{"id":228481,"date":"2023-02-24T20:39:48","date_gmt":"2023-02-24T15:09:48","guid":{"rendered":"https:\/\/blog.forumias.com\/?p=228481"},"modified":"2023-02-24T20:39:48","modified_gmt":"2023-02-24T15:09:48","slug":"can-a-centralized-regulation-help-drug-quality","status":"publish","type":"post","link":"https:\/\/forumias.com\/blog\/can-a-centralized-regulation-help-drug-quality\/","title":{"rendered":"Can a centralized regulation help drug quality?"},"content":{"rendered":"\n

Source<\/strong>– The post is based on the article \u201cCan a centralised regulation help drug quality?\u201d <\/strong>published in the mint <\/strong>on 24th February 2023<\/strong>.<\/p>\n

Syllabus: <\/strong>GS3- Science and Technology<\/p>\n

Relevance:<\/strong> Regulatory system of drugs in India<\/p>\n

News- <\/strong>The Central government is planning to centralise drug regulation.<\/p>\n

What is the current regulatory landscape?<\/strong><\/h2>\n

The Central Drugs Standard Control Organization (CDSCO<\/strong>) is the apex regulatory body<\/strong>. It is responsible for approving new drugs, import of drugs and devices, clinical trials and laying down standards<\/strong> for drugs.<\/p>\n

Each state has its own regulato<\/strong>r as well, which is often conjoined with the food and drug administration in the state. It looks after licensing and auditing<\/strong> manufacturing facilities, and distribution and sale<\/strong> of drugs.<\/p>\n

They also grant licence for manufacturing drugs that have been around for 4 years or more.<\/p>\n

What is the new proposal?<\/strong><\/h2>\n

It is likely a step toward centralization of drug regulation<\/strong> in India. Currently, drugs older than four years can be registered in one state and sold in another.<\/p>\n

The health ministry may be planning a single centralized system<\/strong> for the registration of all kinds of drugs, under the CDSCO.<\/p>\n

Will it have a bearing on export quality?<\/strong><\/h2>\n

It will not have much impact. Drugs sold in the global market are subject to regulations of the buyer country<\/strong>. The US and Europe deploy vast resources to make pharma adhere to their own standards.<\/p>\n

Poorer countries such as Gambia often rely on a list of manufacturers and inputs of the World Health Organization (WHO)<\/strong>.<\/p>\n

A centralized repository can aid in better monitoring.<\/p>\n

Will it help improve drug quality?<\/strong><\/h2>\n

Even if drug registration is centralized<\/strong>, the regulation for manufacturing will continue to be decentralized<\/strong>.<\/p>\n

A plant is jointly inspected by the CDSCO and state regulators at the time of licensing of drugs, but regular auditing<\/strong> is usually done by state regulators.<\/p>\n

Lower-level bureaucrats and inspecting officials need capacity- raising and training<\/strong>. India needs greater accountability<\/strong> at the manufacturer level to adhere to norms.<\/p>\n

What else can be done to improve standards?<\/strong><\/h2>\n

Along with tighter regulation of manufacturing, there is a need for a national policy on recall of drugs<\/strong>. If a drug is found to be substandard in one state and recalled by the regulator there, it is not necessarily recalled in other states.<\/p>\n

It should be the job of the national regulator<\/strong> to ensure that a defective batch isn\u2019t sold in other markets.<\/p>\n

Last, the track record of prosecuting and penalizing<\/strong> drug manufacturers for violating norms is poor in India. It needs improvement.<\/p>\n","protected":false},"excerpt":{"rendered":"

Source– The post is based on the article \u201cCan a centralised regulation help drug quality?\u201d published in the mint on 24th February 2023. Syllabus: GS3- Science and Technology Relevance: Regulatory system of drugs in India News- The Central government is planning to centralise drug regulation. What is the current regulatory landscape? The Central Drugs Standard… Continue reading Can a centralized regulation help drug quality?<\/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":[1230,9],"tags":[216,11126],"class_list":["post-228481","post","type-post","status-publish","format-standard","hentry","category-9-pm-daily-articles","category-public","tag-gs-paper-3","tag-the-mint","entry"],"jetpack_featured_media_url":"","views":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/228481","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=228481"}],"version-history":[{"count":0,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/228481\/revisions"}],"wp:attachment":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media?parent=228481"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/categories?post=228481"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/tags?post=228481"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}