Abstract

COMPARATIVE STUDY FOR GENERIC DRUG APPROVAL PROCESS AND THEIR REGISTRATION AS PER CTD IN EUROPE, USA AND INDIA

Gade Santan Kumar*, M. V. Nagabhushanam and M. Beena Devi

ABSTRACT

The pharmaceutical industry plays a crucial role in ensuring public access to safe and affordable medicines. Generic drugs, as cost-effective alternatives to branded medications, must adhere to strict regulatory standards to guarantee their safety, efficacy, and quality. This comparative study analyzes the generic drug approval process and registration requirements in Europe, the USA, and India, focusing on the Common Technical Document (CTD) format. The study explores the regulatory frameworks of the European Medicines Agency (EMA), the United States Food and Drug Administration (USFDA), and the Central Drugs Standard Control Organization (CDSCO) in India. Key aspects include the dossier preparation process, bioequivalence studies, filing timelines, and post-approval requirements. Differences in administrative procedures, harmonization efforts under the International Council for Harmonisation (ICH), and region-specific challenges are highlighted. The findings aim to provide insights forpharmaceutical companies navigating the global regulatory landscape and to promote streamlined processes for faster generic drug market entry, ultimately enhancing patient access to affordable healthcare solutions.

Keywords: Generic drugs, Common Technical Document (CTD) format, Europe, the USA, and India, European Medicines Agency (EMA), the United States Food and Drug Administration (USFDA), and the Central Drugs Standard Control Organization (CDSCO).