STRATEGIC EVOLUTION OF DRUG REGULATORY AFFAIRS: A GLOBAL AND INDIAN PERSPECTIVE ON COMPLIANCE, INNOVATION, AND PUBLIC HEALTH

Mohit V. Pawar*, Rutik K. Jadhav, Harshada A. Ingle, Priti D. Kedar and Mohit M. Jadhav

ABSTRACT

Drug Regulatory Affairs (DRA) has become a fundamental component of the pharmaceutical and healthcare sectors, guaranteeing that medical products comply with rigorous safety, efficacy, and quality standards prior to their market release. Regulatory professionals play a variety of roles, including in regulatory strategy, dossier preparation, clinical trial oversight, product labelling, compliance, and post-marketing activities. This review examines these roles in detail. The growing globalization and technological progress are making the regulatory environment more intricate, necessitating that professionals adjust to international harmonization initiatives, digital advancements, and new risk-based regulatory frameworks. It also emphasizes the importance of national regulatory agencies like India’s CDSCO and their adherence to international standards. Alongside the increasing focus on real-world evidence and patient-centricity, key challenges such as data integrity, regulatory intelligence, and dynamic compliance frameworks are examined. The article emphasizes that regulatory affairs serve not only to ensure legal compliance but also as a strategic ally in drug development, promoting innovation and strengthening public health systems.

Keywords: Drug Regulatory Affairs, Regulatory Agencies, Drug Approval Process, Regulatory Submissions, CDSCO, Global Harmonization.