Regulatory Approval of Botanical Products Including Herbal Drugs, Food, and Insecticides for Commercialization

Abstract

India, with its enormous topographic and climatic diversity, is home to a large number of herbs with medicinal properties. The great herbal healers of India were pioneers in the use of herbs as medicine, and the modern medical research is greatly benefitted by their findings. After post-Vedic era the traditional medicine system of India was renamed as Ayurveda. The modern Ayurvedic system is more scientific in all respects including safety, toxicity, dose accuracy, clinical evidences, efficacy, etc. Botanicals are also explored as food supplements and nutraceuticals, and now the concept of value-added specialized foods has arisen. Food supplements from plants, algae, fungi, or lichens have become widely available in the Indian market. Many countries including India regulate the use of botanicals as dietary supplements, foods, and medicines, and these should fulfill the specific requirements for consideration and regulatory clearance. Botanical insecticides are now widely accepted as attractive alternatives as compared to the synthetic chemical insecticides as they are less toxic and safer to health and environment. The chapter elaborates the regulatory process for botanical products including herbal drugs, food, and insecticides in India.