Drug Prescribing and Global Comparison of Drug Categorization in Pregnancy

Published on: September 2025Indian Journal of Pharmacy Practice, 2026; 19(1):1-6. Review Article| doi: 10.5530/ijopp.20260424Authors and affiliation (s): Satish Kumar Bassattikoppalu Puttegowda, Saniya Shaikh*, Amarmani Shivapur, Sowjanya Annajappa Department of Pharmacy Practice, Sri Adichunchanagiri College of Pharmacy, B.G. Nagara, Mandya, Karnataka, INDIA. ABSTRACT Background: Prescribing drugs during pregnancy requires careful evaluation to ensure maternal health and fetal safety. Drug pharmacokinetics are altered during pregnancy, and certain medications pose teratogenic risks. Despite the critical importance of safe drug use in this population, inconsistencies exist in prescribing patterns and drug categorization frameworks globally. Objectives: This review evaluates drug prescribing patterns during pregnancy, comparing global drug categorization systems, and establishing the need for harmonization for better maternal and fetal outcomes. Materials and Methods: Literature from main regulatory guidelines, research articles, and global reports was reviewed systematically. Global practices' variations and gaps were analyzed comparatively by conducting a comparative analysis of categorization frameworks set forth by the U.S. FDA, EMA, and Australian TGA. Results: The review demonstrates that drug classification systems vary significantly by region, while risk estimates and classifications are inconsistent. Although off-label use is still prevalent since there is a dearth of pregnancy-specific data, prescribing patterns show a preference for critical drugs. The results highlight the necessity of unified regulatory strategies and stronger pharmacovigilance. Conclusion: Developing standardized drug categories requires international cooperation to improve evidence-based prescribing during pregnancy. Pregnant women can be treated effectively while minimizing potential risks with the help of improved regulatory guidance and comprehensive research into pharmacokinetics during pregnancy. Keywords: Drug Prescribing Pattern, Pregnancy Risk Categories, Pregnancy Drug Categorization, Maternal-Fetal Safety.