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The value of the herbal medicine market size was USD 71.19 billion globally in 2016 and is expected to grow even more in the near future. The main obstacle to the growth of herbal medicine is its quality control. The scientific validation by standardization, evaluation of purity, and demonstration of its efficacy in animal models and in humans will increase the trust of users and increase its acceptability. There are various guidelines available for standardization of herbal medicines. Globally each country has its own rules and regulations. In the USA, guidelines for botanical drugs have been revised in 2016. The phytopharma guidelines also came in existence in India in 2015. The scientific validation of herbal drugs requires information regarding pharmacognostic description like taxonomic classification and quality specifications in which heavy metals, ash, and impurity data are important. The herbal medicines which are already used in human do not require any animal studies but if there are any changes in method of extraction and formulation then animal safety data is essential. The toxicity studies in two species are minimally required. The clinical trials are necessary to demonstrate its efficacy for newer drugs. The phase I clinical studies are conducted to assess the maximum tolerated dose of medicine and its safety. The proof of concept and confirmatory clinical trials should be conducted as randomized placebo control trials and as per good clinical practice norms. The regulatory requirements of herbal drugs for clinical trials and marketing permission may be abbreviated, modified or relaxed based on adequate evidence from market or research published in peer-reviewed journals. The current book chapter will discuss the requirements of herbal drugs and practical issue in scientific validation of herbal medicines.

Fungal infections are one of the most common infections in humans and other animals. Fungal diseases are more common in tropical and subtropical countries. Worldwide more than a billion people suffer from fungal infections annually. Fungal pathogens (yeasts and molds) are diverse in their pathogenesis and they can cause mild infections to life-threatening fungal diseases. For the treatment of fungal infections, only a few classes of antifungal drugs are available because there are many similarities between fungal and human cells. Treatment of fungal infections is becoming more challenging because of the emergence of resistance to currently available drugs. Azole drug is the most common class of antifungal drug which is widely used for the treatment of superficial to systemic infections but unfortunately, many fungal pathogens (e.g., Candida, Aspergillus, Histoplasma, and Paracoccidioides etc.) have developed resistance. Most of the azole resistant fungi also develop resistance against the echinocandin class of drugs. The most common drug-resistance mechanisms include hyphal switching, alteration of drug targets, increased drug efflux by transporter proteins (ABC transporters or Facilitated diffusion superfamily transporter), and permeability barriers associated with biofilms. Thus, this area is in need of some outstanding work to control drug resistant fungal infections. Recently some new therapeutic approaches such as new formulations for antifungal agents, nanoparticle based drugs and immunotherapy (such as vaccines) are under trial to prevent and treat fungal diseases and inducing the production of host antimicrobial molecules. In this book chapter, we describe common fungal diseases, fungal pathogens, disease-causing factors, drug resistant fungal pathogens, mechanisms involved in the emergence of drug resistance, epidemiology of fungal diseases, advanced diagnostic techniques, current and future treatment plans and discuss new approaches for the management of fungal diseases.

Probiotics are live microorganisms like bacteria and yeast that are consumed along with food for various health benefits. These microorganisms play a very important role not only in intestinal microbial balance but also in maintaining health protection of the host organism against harmful microbiota. Probiotic term means “for life.” The sale of these products has increased worldwide, and sale figures are estimated to cross $45B by the year 2018 due to its wide range of health profits. Humans have used probiotics for decades and centuries involuntarily. Food additives like fermented milk and yogurt have been a major part in regular meals and diet in several parts of the world. Nowadays, probiotics are the most important prescription by gastrointestinal physicians’ because of its potential role in curing certain diseases for which treatment options are limited. The use of probiotics that were initially restricted for antibiotic-associated diarrhea now extends as powerful anti-allergic and anti-inflammatory factors. Lactobacillus and Bifidobacterium are the most important probiotic groups; however, the probiotic potential of Pediococcus, Lactococcus, Bacillus, and yeast is also well known. Probiotics are not only used as food to enhance health but also to cure specific gastrointestinal conditions such as irritable bowel syndrome, inflammatory bowel disease (IBD), and infectious diarrhea (caused by viruses, bacteria, or parasites). They also play an important role in improving skin conditions like eczema. Urinary and vaginal health, allergy prevention, colds, and oral health can be treated with probiotics. This chapter throws light on different probiotics, their health benefits, and regulatory or safety issues linked with their usage.