KEY GMP AND GCP REQUIREMENTS FOR GENERIC DRUG REGULATIONS IN BRICS, MIST, AND ICH COUNTRIES: A COMPARATIVE REVIEW

Swapnil Shivaji Runje*, Dr. Sudarshan Nagarale, Dr. Vishal Babar, Prof. Amit Pondkule

Plant-derived medicines are licensed under regulatory categories that sit between traditional herbal preparations and fully synthetic new chemical entities, yet the data requirements attached to their market authorisation differ markedly across jurisdictions, and those differences are themselves inconsistent. BRICS nations — Brazil, Russia, India, China, and South Africa — together with MIST economies — Mexico, Indonesia, South Korea, and Turkey — collectively accounted for roughly 20% of global pharmaceutical sales by 2019 and are projected to represent over 30% by 2025. Despite sharing this growth trajectory, the Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) frameworks these countries apply to generic drug registrations diverge across dossier format, local language obligations, bioequivalence study design, and the degree of alignment with internationally harmonized standards. This review compares the key GMP and GCP requirements for generic drug approval across BRICS, MIST, and ICH-member nations, drawing on primary regulatory texts and peer-reviewed literature retrieved from PubMed, ScienceDirect, the International Journal of Drug Regulatory Affairs, and official agency websites. The analysis finds that ICH-member countries maintain the most coherent and predictable approval frameworks, while substantial heterogeneity persists within and across the BRICS and MIST groupings. South Korea and Turkey, both full ICH and PIC/S members, most closely mirror Western regulatory norms within MIST, whereas Russia, Indonesia, and China retain requirements that depart from international consensus. Within BRICS, India and Brazil have advanced furthest toward harmonization. The review closes by identifying actionable convergence opportunities and proposing concrete measures to improve GMP/GCP alignment and, in turn, generic medicine access and patient safety.