{"id":14090,"date":"2026-07-04T14:35:30","date_gmt":"2026-07-04T09:05:30","guid":{"rendered":"https:\/\/www.class24.study\/current-affairs\/?p=14090"},"modified":"2026-07-04T14:35:30","modified_gmt":"2026-07-04T09:05:30","slug":"centre-amends-drugs-rules-1945","status":"publish","type":"post","link":"https:\/\/www.class24.study\/current-affairs\/centre-amends-drugs-rules-1945\/","title":{"rendered":"Centre Amends Drugs Rules, 1945 to Regulate Advanced Therapies"},"content":{"rendered":"<p><span style=\"font-weight: 400\">The Centre Amends Drugs Rules, 1945 to Regulate Advanced Therapies is a major move in the direction of bolstering India&#8217;s rules for next-generation drugs. The amendment provides a specific approach to advanced therapy medicinal products (ATMPs) such as gene and cell therapies, tissue-engineered products, and ART, but a combination of two. Cutting-edge treatments provided here provide welcome hope for patients with rare genetic conditions and disorders, cancers and chronic diseases.<\/span><\/p>\n<p><span style=\"font-weight: 400\">The government is aiming to incentivise innovation better while ensuring patient safety, product quality and ethical standards through updating the Drugs Rules, 1945. In this regard, India is likely to be better equipped to develop, test, manufacture and market high-tech biological drugs once the Drugs Rules are amended by the Central Government of India.<\/span><\/p>\n<h2><span style=\"font-weight: 400\">What are Advanced Therapy Medicinal Products (ATMPs)?<\/span><\/h2>\n<p><span style=\"font-weight: 400\">Based on the changes made in the Drugs Rules, 1945, by the Ministry of Health and Family Welfare (MoHFW), Government of India, under the amended rules.<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Advanced Therapy Medicinal Products (ATMPs) are innovative medicinal products with a novel biological technology that are applied for the treatment, prevention or diagnosis of a disease.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">They consist of Gene Therapy Products (GTPs) \u2013 which are used to modify or replace genes to treat inherited or acquired diseases.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Cell Therapy Products (CTPs) are living human cells that have been significantly processed, altered or would have a different essential function when administered to the recipient.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Tissue-Engineered Products (TEPs) are engineered cells or tissues that will regenerate, repair, or replace human tissue.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">The new rules also include Combined ATMPs, which contain one or more medical devices and one ATMP.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">ATMPs are regulated under a specific framework in India for ensuring quality, safety, efficacy and ethical aspects before use in a clinical trial and marketing.<\/span><\/li>\n<\/ul>\n<h2><span style=\"font-weight: 400\">PYQs Related to Advanced Therapy Medicinal Products &#8211; Drugs Rules<\/span><\/h2>\n<table>\n<tbody>\n<tr>\n<td><b>Year<\/b><\/td>\n<td><b>Exam<\/b><\/td>\n<td><b>Question<\/b><\/td>\n<td><b>Options<\/b><\/td>\n<td><b>Answer<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400\">2023<\/span><\/td>\n<td><span style=\"font-weight: 400\">UPSC Prelims<\/span><\/td>\n<td><span style=\"font-weight: 400\">With reference to <\/span><b>mRNA vaccines<\/b><span style=\"font-weight: 400\">, consider the following statements: 1. They use messenger RNA to instruct cells to produce a specific protein. 2. They alter the recipient&#8217;s DNA permanently. Which of the statements given above is\/are correct?<\/span><\/td>\n<td><span style=\"font-weight: 400\">(A) 1 only (B) 2 only (C) Both 1 and 2 (D) Neither 1 nor 2<\/span><\/td>\n<td><b>(A) 1 only<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400\">2022<\/span><\/td>\n<td><span style=\"font-weight: 400\">UPSC Prelims<\/span><\/td>\n<td><span style=\"font-weight: 400\">Which one of the following techniques allows scientists to <\/span><b>edit genes<\/b><span style=\"font-weight: 400\"> with high precision?<\/span><\/td>\n<td><span style=\"font-weight: 400\">(A) ELISA (B) PCR (C) CRISPR-Cas9 (D) Electrophoresis<\/span><\/td>\n<td><b>(C) CRISPR-Cas9<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400\">2021<\/span><\/td>\n<td><span style=\"font-weight: 400\">UPSC Prelims<\/span><\/td>\n<td><span style=\"font-weight: 400\">Which one of the following enzymes is primarily used to <\/span><b>amplify DNA<\/b><span style=\"font-weight: 400\"> in the Polymerase Chain Reaction (PCR)?<\/span><\/td>\n<td><span style=\"font-weight: 400\">(A) DNA Ligase (B) Taq DNA Polymerase (C) Restriction Endonuclease (D) Reverse Transcriptase<\/span><\/td>\n<td><b>(B) Taq DNA Polymerase<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400\">2020<\/span><\/td>\n<td><span style=\"font-weight: 400\">UPSC Prelims<\/span><\/td>\n<td><span style=\"font-weight: 400\">Which of the following are applications of <\/span><b>stem cells<\/b><span style=\"font-weight: 400\">? 1. Regeneration of damaged tissues 2. Treatment of certain blood disorders 3. Drug testing and research<\/span><\/td>\n<td><span style=\"font-weight: 400\">(A) 1 only (B) 1 and 2 only (C) 2 and 3 only (D) 1, 2 and 3<\/span><\/td>\n<td><b>(D) 1, 2 and 3<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400\">2019<\/span><\/td>\n<td><span style=\"font-weight: 400\">UPSC Prelims<\/span><\/td>\n<td><span style=\"font-weight: 400\">Which one of the following is <\/span><b>NOT<\/b><span style=\"font-weight: 400\"> a component of recombinant DNA technology?<\/span><\/td>\n<td><span style=\"font-weight: 400\">(A) Restriction Enzymes (B) DNA Ligase (C) Ribosomes (D) Cloning Vectors<\/span><\/td>\n<td><b>(C) Ribosomes<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400\">2018<\/span><\/td>\n<td><span style=\"font-weight: 400\">UPSC Prelims<\/span><\/td>\n<td><span style=\"font-weight: 400\">Which branch of biotechnology focuses on <\/span><b>repairing or replacing damaged tissues and organs<\/b><span style=\"font-weight: 400\">?<\/span><\/td>\n<td><span style=\"font-weight: 400\">(A) Tissue Engineering (B) Nanotechnology (C) Fermentation Technology (D) Immunology<\/span><\/td>\n<td><b>(A) Tissue Engineering<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400\">2017<\/span><\/td>\n<td><span style=\"font-weight: 400\">UPSC Prelims<\/span><\/td>\n<td><span style=\"font-weight: 400\">Consider the following statements regarding <\/span><b>stem cells<\/b><span style=\"font-weight: 400\">: 1. They can self-renew. 2. They can differentiate into specialised cell types. Which of the statements given above is\/are correct?<\/span><\/td>\n<td><span style=\"font-weight: 400\">(A) 1 only (B) 2 only (C) Both 1 and 2 (D) Neither 1 nor 2<\/span><\/td>\n<td><b>(C) Both 1 and 2<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400\">2016<\/span><\/td>\n<td><span style=\"font-weight: 400\">UPSC Prelims<\/span><\/td>\n<td><span style=\"font-weight: 400\">Which one of the following diseases has been treated using <\/span><b>gene therapy<\/b><span style=\"font-weight: 400\"> in clinical research?<\/span><\/td>\n<td><span style=\"font-weight: 400\">(A) Haemophilia (B) Sickle Cell Disease (C) Severe Combined Immunodeficiency (SCID) (D) All of the above<\/span><\/td>\n<td><b>(D) All of the above<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400\">2015<\/span><\/td>\n<td><span style=\"font-weight: 400\">UPSC Prelims<\/span><\/td>\n<td><span style=\"font-weight: 400\">Which of the following best describes <\/span><b>regenerative medicine<\/b><span style=\"font-weight: 400\">?<\/span><\/td>\n<td><span style=\"font-weight: 400\">(A) Development of antibiotics (B) Repair, replacement or regeneration of cells, tissues and organs (C) Manufacture of vaccines only (D) Food preservation<\/span><\/td>\n<td><b>(B) Repair, replacement or regeneration of cells, tissues and organs<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400\">2013<\/span><\/td>\n<td><span style=\"font-weight: 400\">UPSC Prelims<\/span><\/td>\n<td><span style=\"font-weight: 400\">Which of the following biological products are classified as <\/span><b>Advanced Therapy Medicinal Products (ATMPs)<\/b><span style=\"font-weight: 400\"> in modern medicine?<\/span><\/td>\n<td><span style=\"font-weight: 400\">(A) Gene Therapy Products (B) Cell Therapy Products (C) Tissue-Engineered Products (D) All of the above<\/span><\/td>\n<td><b>(D) All of the above<\/b><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p style=\"text-align: center\"><a href=\"https:\/\/www.class24.study\/current-affairs\/submarine-cable-system\/\" target=\"_blank\" rel=\"noopener\">India, Malaysia, and Singapore Unveil I-2SEA Submarine Cable System<\/a><\/p>\n<h2><span style=\"font-weight: 400\">Conclusion on Drugs Rules, 1945, amended by Centre<\/span><\/h2>\n<p><span style=\"font-weight: 400\">Centre Amends Drugs Rules, 1945 to Regulate Advanced Therapies is a significant reform in the healthcare industry of India. The amendment takes forward a specific system for Advanced Therapy Medicinal Products, fostering innovation whilst maintaining safety, quality and ethical benefits. This reform equips India to become a more active member of the biotechnology and precision medicine chain, as technology advances. Ultimately, the Centre Amends Drugs Rules, 1945 to Regulate Advanced Therapies lays the foundation for safer, more effective, and innovative healthcare solutions.<\/span><\/p>\n<h2><span style=\"font-weight: 400\">FAQs &#8211; Centre Revises Drugs Rules<\/span><\/h2>\n<div class=\"cfaq-wrapper\" data-multiple=\"0\"><div class=\"cfaq-item cfaq-open\"><button class=\"cfaq-question\" aria-expanded=\"true\"><span class=\"cfaq-question-text\">1. Why did the Centre amend the Drugs Rules, 1945?<\/span><span class=\"cfaq-icon\"><\/span><\/button><div class=\"cfaq-answer\"><div class=\"cfaq-answer-inner\"><div><span style=\"font-size: 12.35px\">The amendment introduces a regulatory framework for Advanced Therapy Medicinal Products (ATMPs), ensuring their safety, quality, and efficacy.<\/span><\/div><\/div><\/div><\/div><div class=\"cfaq-item\"><button class=\"cfaq-question\" aria-expanded=\"false\"><span class=\"cfaq-question-text\">2. What are Advanced Therapy Medicinal Products (ATMPs)?<\/span><span class=\"cfaq-icon\"><\/span><\/button><div class=\"cfaq-answer\" hidden><div class=\"cfaq-answer-inner\"><div><span style=\"font-size: 12.35px\">ATMPs include innovative treatments such as gene therapy, cell therapy, tissue-engineered products, and combined advanced therapies.<\/span><\/div><\/div><\/div><\/div><div class=\"cfaq-item\"><button class=\"cfaq-question\" aria-expanded=\"false\"><span class=\"cfaq-question-text\">3. What is the objective of the amendment?<\/span><span class=\"cfaq-icon\"><\/span><\/button><div class=\"cfaq-answer\" hidden><div class=\"cfaq-answer-inner\"><div><span style=\"font-size: 12.35px\">The main objective is to regulate advanced therapies, promote innovation, protect patients, and establish clear approval procedures.<\/span><\/div><\/div><\/div><\/div><div class=\"cfaq-item\"><button class=\"cfaq-question\" aria-expanded=\"false\"><span class=\"cfaq-question-text\">4. How will the amendment benefit India?<\/span><span class=\"cfaq-icon\"><\/span><\/button><div class=\"cfaq-answer\" hidden><div class=\"cfaq-answer-inner\"><div><span style=\"font-size: 12.35px\">It strengthens biotechnology research, encourages investment, supports clinical trials, improves patient access to advanced therapies, and enhances India's global competitiveness.<\/span><\/div><\/div><\/div><\/div><div class=\"cfaq-item\"><button class=\"cfaq-question\" aria-expanded=\"false\"><span class=\"cfaq-question-text\">5. Which sectors will benefit the most?<\/span><span class=\"cfaq-icon\"><\/span><\/button><div class=\"cfaq-answer\" hidden><div class=\"cfaq-answer-inner\"><div><span style=\"font-size: 12.35px\">Patients, hospitals, researchers, biotechnology companies, pharmaceutical manufacturers, regulators, and the overall healthcare ecosystem will benefit from the new regulatory framework.<\/span><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>The Centre Amends Drugs Rules, 1945 to Regulate Advanced Therapies is a major move in the direction of bolstering India&#8217;s rules for next-generation drugs. The amendment provides a specific approach to advanced therapy medicinal products (ATMPs) such as gene and cell therapies, tissue-engineered products, and ART, but a combination of two. Cutting-edge treatments provided here [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":14091,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[18],"tags":[],"class_list":["post-14090","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pib-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.class24.study\/current-affairs\/wp-json\/wp\/v2\/posts\/14090","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.class24.study\/current-affairs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.class24.study\/current-affairs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.class24.study\/current-affairs\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.class24.study\/current-affairs\/wp-json\/wp\/v2\/comments?post=14090"}],"version-history":[{"count":1,"href":"https:\/\/www.class24.study\/current-affairs\/wp-json\/wp\/v2\/posts\/14090\/revisions"}],"predecessor-version":[{"id":14092,"href":"https:\/\/www.class24.study\/current-affairs\/wp-json\/wp\/v2\/posts\/14090\/revisions\/14092"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.class24.study\/current-affairs\/wp-json\/wp\/v2\/media\/14091"}],"wp:attachment":[{"href":"https:\/\/www.class24.study\/current-affairs\/wp-json\/wp\/v2\/media?parent=14090"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.class24.study\/current-affairs\/wp-json\/wp\/v2\/categories?post=14090"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.class24.study\/current-affairs\/wp-json\/wp\/v2\/tags?post=14090"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}