Herbal Nanoscience: Challenges and Regulatory Perspective

For many centuries, herbal medications have been widely explored and utilized in almost all regions of the world. The progression in plant-based chemical and pharmacological sciences has provided a detailed explanation of many plant-based medications. Nanomedicine and other similar nano delivery systems are a comparatively novel but rapidly developing science, where materials in the range of nanoscale are utilized to serve as means of diagnostic tools or to deliver medicinal agents to predetermined targeted sites in a guided manner. Site-directed and tissue- targeted delivery of specific medications is among the different advantages offered by nanotechnology for treating numerous human ailments. Recently, scientists have developed numerous outstanding uses of nanomedicine, involving immunotherapeutic agents, chemotherapeutic agents, and other biological agents for the treatment of different ailments. World Health Organization (WHO) has categorized herbal drugs into the following three types: crude plant materials, prepared plant materials, and therapeutic herbal items. In India, herbal prescriptions are managed by the Service of Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy (AYUSH). Regulatory provisions associated with Ayurveda, Unani, Siddha medications are mentioned in the Drugs and Cosmetics Act and Rules 1945. Herbal drug items differ from country to country, including food sources, dietary supplements, and conventional prescriptions. To recognize lately introduced revisions in regulations, a comprehensive literature review for regulations of herbal-based drug products in India and Europe was carried out. Different advisory groups, including the Committee on Herbal Medicinal Products (HMPC) and the board of trustees of the European Medicines Agency (EMA), have created rules for evaluating quality and pre-clinical and clinical efficacy and safety of drugs. Drug and cosmetic acts and rules have been altered as of late to manage the safety, quality, and efficacy of herbal drug items in India. In this chapter, we have summed up all the central issues and progress made by scientists in the field of herbal nanomedicine , including quality control of nano-particles, herbal drug regulations and restrictions, and difficulties observed in the formation of herbal medication.

Keywords: AYUSH, Drug delivery, Drug targeting, Nanomaterials, Nanomedicine, Nanotechnology, Natural products, Quality control, Regulation.