Abstract

Demand for natural products has been on the rise globally with botanical extracts getting incorporated in variety of products like dietary supplements, complementary medicines, food and cosmetics. Regulatory bodies all over world have accordingly tightened the statutory requirements towards ensuring quality and consistency of biological effects of botanical products being made available to the consumers. Unlike chemical drugs, the quality assessment of botanical products is more challenging keeping in mind that their biological actions are due to the presence of multiple chemical constituents, many of which are unknown and not characterized yet, with multiple mechanisms of action inside the human body. The natural variations of chemical constituents seen on account of factors like age, geography, environment etc are compounded by human interventions like use of pesticides, diverse processing conditions adopted from harvesting till manufacturing of finished products etc and add to the overall complexities in controlling quality of botanical products. Also, there is no harmonization of quality monographs on botanicals across the globe. This complex context has made the industry to spend more resources on research related to developing better understanding of quality, safety and efficacy of botanical products. This presentation gives an overview of the practical aspects of incorporation of quality concepts at different stages of development and manufacturing of botanical products.