Satendra Pradhan¹, Suchita Kujur¹, Rajendra Kumar¹, Mayank Borkar¹, Jyoti Prakash¹, Harish Sharma², Gyanesh Kumar Sahu²*

¹Rungta Institute of Pharmaceutical Sciences, Kohka, Kurud, Bhilai, India
²Rungta Institute of Pharmaceutical Sciences and Research, Kohka, Kurud, Bhilai, India

*Corresponding Author: Gyanesh Kumar Sahu, Dean and Professor, Rungta Institute of Pharmaceutical Sciences and Research, Kohka, Kurud, Bhilai, India.

Received: December 05, 2023; Published: March 13, 2024

Abstract

A pharmaceutical company's Drug Regulatory Affairs (DRA) department is essential. This pertains to the lifecycle of healthcare products; it offers guidance on strategic, tactical, and operational matters as well as support in adhering to regulatory requirements in order to hasten the development and distribution of safe and effective pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics, and complementary and alternative medicine products to people worldwide. Professionals in regulatory affairs (RA) work for the government, the pharmaceutical sector, academic research centres, and healthcare facilities. India's pharmaceutical industry is expanding quickly, thus the country requires more regulatory affairs specialists to meet the demands of the global marketplace. Regulatory affairs specialists serve as the intermediary between global regulatory authorities and the pharmaceutical industry. and worldwide regulatory agencies. A relatively recent profession, regulatory affairs sprang from governments' aim to protect public health. These kinds of submissions necessitate much data and documentation, which makes for big, complicated applications.

Keywords: Drug Regulatory Affairs; Regulatory Affair Departments; Drug and Cosmetics Act and Rules; GMP; GLP; WHO Guidelines and ISO 9000 Series

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Citation

Citation: Gyanesh Kumar Sahu., et al.“Importance of Drug Regulatory Affairs in Pharmaceutical Industry".Acta Scientific Pharmaceutical Sciences 8.4 (2024): 64-70.

Copyright

Copyright: © 2024 Gyanesh Kumar Sahu., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.