Abstract

REGULATORY REQUIREMENTS FOR THE APPROVAL OF BIOMEDICAL PRODUCTS USING CELLS AND TISSUES IN INDIA AS PER CDSCO IN COMPARISON WITH SINGAPORE

Dr. Ashok Kumar P.*, Ananya H. S., Anusha B. D., Daniya Kouser, Pallavi K. S.

ABSTRACT

The Biologics is any pharmaceutical product manufacture in, extracted from, or synthesized from a biological source. Biologics are very complicated structurally as compared to drug molecules. These obtain from living things, several types of biologics which are used for diagnosis, prevention, and treatment also. The global advancement of cell and tissue-based therapies (CTBTs), including advanced therapy medicinal products (ATMPs) like stem cell therapies and genetically modified cells, presents significant regulatory challenges. This analysis provides a comprehensive comparison of the regulatory pathways for these innovative biological products in two key Asian markets: India, governed by the Central Drugs Standard Control Organization (CDSCO), and Singapore, overseen by the Health Sciences Authority (HSA). In India, the regulatory landscape is anchored by the New Drugs and Clinical Trials Rules, 2019, which specifically define and provide a framework for "stem cell-derived products" and other novel therapies. The CDSCO classifies these products as "New Drugs" andmandates a rigorous approval process. This involves submission of extensive non-clinical and clinical data, adherence to Good Manufacturing Practices (GMP) as per Schedule M, and oversight by regulatory committees like subject Expert Committee (SEC) for Cell & Gene Therapy. Conversely, Singapore's HSA employs a more centralized and internationally harmonized approach, closely aligned with guidelines from the International Council for Harmonisation (ICH), the European Medicines Agency (EMA), and the U.S. Food and Drug Administration (FDA). The HSA's Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021 provide a dedicated, robust pathway for CTGT products (Cell, Tissue, and Gene Therapy Products).

Keywords: Biological products, CDSCO, HSA, DCGI, GMP, Comparative study.