Environmental Risk Assessment in Pharmaceutical Regulation: A Comparative Review of EMA, U.S. FDA and CDSCO Guidelines.

Environmental contamination by pharmaceutical residues accumulation in water bodies, risk of ecological disturbance and development of antimicrobial resistance have become a serious global threat. Pharmaceutical active ingredients and metabolites of these substances expelled into the surrounding environment by excretion, industrial wastewater and improper disposal practices result in measurable levels in surface waters and wastewater globally. In response, regulatory authorities incorporated Environmental Risk Assessment (ERA) requirements into the drug licensing system. For human medicinal products, a product-specific, tiered Environmental Risk Assessment (ERA) has been applied by the European Medicines Agency (EMA). NEPA-based environmental review involving applicable categorical exclusions and Environmental Assessments (EAs) has been utilized by the US Food and Drug Administration (FDA), whereas there is no dedicated medicinal-product ERA guideline within the NDCTR framework currently for India's Central Drugs Standard Control Organisation (CDSCO), but have a broader environmental legislation addressing environmental protection. This article mainly compares the scope, methodology, requirements for data, how the data should be reported, and challenges of implementation of the ERA regulatory infrastructure among the EMA, FDA, and CDSCO. To show similarities and differences, comparison tables and flow diagrams are added. Regulatory gaps, mainly in India, and possibilities for harmonised ERA frameworks that can safeguard global health and biodiversity by encouraging regulatory consolidation are discovered by this study.