A REVIEW ON COMPARATIVE STUDY OF NEW DRUG APPLICATION (NDA) REQUIREMENTS FOR PHYTOPHARMACEUTICALS AND SYNTHETIC DRUGS

Rushikesh Kumbhar*, Dr. Sudarshan Nagarale, Dr. Vishal Babar, Prof. Amit Pondkule

Phytopharmaceuticals sit somewhere between traditional herbal medicine and synthetic new chemical entities (NCEs), and the New Drug Application (NDA) or marketing authorisation requirements built around them differ greatly from those for synthetic drugs, with these differences shifting depending on which jurisdiction you're looking at. This review compares NDA-equivalent requirements for phytopharmaceuticals and synthetic drugs across three major regulatory systems: India's Central Drugs Standard Control Organisation (CDSCO), the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA). Working from primary regulatory texts, the New Drugs and Clinical Trials Rules 2019, 21 CFR Part 314, and Directive 2004/24/EC, alongside peer-reviewed literature found through a structured search of PubMed, ScienceDirect, Google Scholar, and the agencies' own databases, the analysis maps out the preclinical, clinical, CMC, and post-marketing data each pathway actually demands. India turns out to be the outlier among the three: it's the only jurisdiction that requires full Phase I–III clinical trial data for phytopharmaceuticals on terms close to those a synthetic NCE would need. The US, by contrast, channels botanical products mainly through a dedicated Botanical Drug Guidance pathway that comparatively few products make it through (just two approved Botanical NDAs against more than 800 Investigational New Drug submissions), while the EU leans heavily, 71.1% of registered products, on a simplified traditional-use registration that asks for no clinical trial data at all. This divergence carries real consequences for development cost, timeline, and where a company chooses to launch a plant-derived medicine first. The review also points to specific gaps in India's current framework, among them the absence of phytopharmaceutical-specific toxicological thresholds and clearer standardisation guidance, and argues that closer alignment with ICH and WHO principles, paired with something like the EU's tiered evidentiary model, could make India's approval process more predictable and more productive without loosening patient safety standards.