The regulatory framework for phytopharmaceuticals

Phytopharmaceuticals, classified as purified and standardized plant-based drugs containing multiple bioactive compounds, are emerging as a vital category in modern medicine. In India, the regulatory framework for these drugs, overseen by the Central Drugs Standard Control Organization (CDSCO), ensures that phytopharmaceuticals meet stringent standards for quality, safety, and efficacy, similar to synthetic drugs. This approach contrasts with traditional AYUSH medicines, as phytopharmaceuticals emphasize scientific validation and standardization of plant materials. The introduction of regulatory provisions through the Drugs and Cosmetics Act (D and C Act) supports the development of botanical-based drugs, fostering innovation in the field. Phytopharmaceuticals promoting their acceptance in the global market and encouraging research into plant-derived therapeutics. This regulatory framework presents a promising avenue for the integration of traditional knowledge with modern science, advancing the development of effective, plant-based therapies.