• Prashant Kumar
• Tushar Singh
• ZUBAIR AHMAD
• AAS MOHAMMAD

Drug Regulatory Affairs ensures that pharmaceutical products meet stringent safety, efficacy, and quality standards before reaching patients, serving as a critical link between industry and regulatory bodies like India’s Central Drugs Standard Control Organization (CDSCO) and global agencies such as the U.S. Food and Drug Administration (FDA). The increasing complexity of drug development, coupled with diverse regional regulations, poses challenges in achieving timely approvals while maintaining compliance. This research investigates strategies to streamline regulatory processes for new drug approvals in India, focusing on compliance with the New Drugs and Clinical Trials Rules, 2019, and alignment with international standards like those of the International Council for Harmonisation (ICH). The methodology involves a comparative analysis of regulatory frameworks, case studies of successful drug approvals, and interviews with regulatory professionals to identify bottlenecks and best practices. Findings reveal that harmonized documentation, early engagement with regulators, and adoption of digital submission platforms significantly reduce approval timelines. The study highlights the importance of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) in ensuring product quality and regulatory acceptance. These strategies have practical applications in accelerating access to innovative therapies, particularly generics and biosimilars, in India’s growing pharmaceutical market. The research also underscores the need for capacity building among regulatory professionals to navigate evolving guidelines. Future research should explore the integration of artificial intelligence in regulatory submissions and the impact of global harmonization on local markets. This work contributes to optimizing Drug Regulatory Affairs practices, enhancing India’s role in global pharmaceutical innovation while prioritizing patient safety.

CDSCO,FDA,ICH,GMP,GCP,MAA,INDA,GLP

"CURRENT TRENDS AND PERSPECTIVE IN PHARMACEUTICAL REGULATORY AFFAIRS", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 5, page no.k326-k341, May-2025, Available :http://www.jetir.org/papers/JETIR2505B22.pdf

"CURRENT TRENDS AND PERSPECTIVE IN PHARMACEUTICAL REGULATORY AFFAIRS", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 5, page no. ppk326-k341, May-2025, Available at : http://www.jetir.org/papers/JETIR2505B22.pdf