Regulatory requirements for the approval of anti-cancer drugs as per CDSCO in India comparison with Singapore
Department of Regulatory Affairs, Sree Siddaganda College of Pharmacy, 1st Left Cross, 3rd Block, Mahalakshmi Nagar, Near Railway Gate, 80 feet Road, Batwadi, Tumkur-572103. Karnataka, India.
Review Article
World Journal of Advanced Research and Reviews, 2024, 23(03), 2969–2978
Publication history:
Received on 14 August 2024; revised on 25 September 2024; accepted on 28 September 2024
Abstract:
This study examines the regulatory requirements for anticancer medications in Singapore and India are compared in this abstract. It draws attention to the frameworks set up by Singapore's Health Sciences Authority (HSA) and India's Central Drugs Standard Control Organization (CDSCO). The procedures for clinical studies, approval schedules, and post-marketing surveillance are among the main distinctions. Singapore places a strong emphasis on strict safety and efficacy criteria, whereas India stresses a quicker clearance process to address pressing healthcare needs. The investigation highlights how various regulatory methods affect patient access, innovation, and medicine supply in both nations.
Recent decades have seen extraordinary improvements in the discovery of anticancer medications, transforming both cancer treatment and patient outcomes. With an emphasis on the main areas of anticancer therapeutics—chemotherapy, targeted therapy, immunotherapy, and hormone therapy—this study offers a thorough summary of the state of the field. We examine each drug class's methods of action, effectiveness, and difficulties while showcasing more recent developments like immune checkpoint inhibitors and CAR-T cell therapy. We also go over side effects, drug resistance, and how tailored medicine might improve the effectiveness of treatment. A look is also given to new developments in drug research, such as the application of nanotechnology and AI-driven drug discovery. The review attempts to shed light on the changing tactics used to fight cancer and the potential paths for anticancer medication development.
Keywords:
Anticancer; Regulatory requirements; Singapore; CDSCO; Chemotherapy; Immunotherapy
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Copyright © 2024 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0