Abstract

Nutraceuticals 2018: Phytopharmaceutical: A new drug category & an emerging platform in modern medicine Dilip Ghosh, Trigonella Labsâ�?

Author(s): Dilip Ghosh

Globally, herbal medicine has been considered an important alternative to modern allopathic medicine. Although the herbal medicines are very popular in the society, only few medicinal herbs have been scientifically evaluated for their potential in medical treatment. The new drug, called Veregenâ„¢ (Polyphenon® E) Ointment is the first prescription botanical (herbal) drug approved by FDA US under the “new” drug amendments of 1962 that required drugs to be proven both safe and effective prior to being marketed in the U.S. In most countries, the herbal drugs are poorly regulated and are often neither registered nor controlled by the health authorities. The safety of herbal medicines remains a major concern. In the United States, the FDA has estimated that over 50,000 adverse events are caused by botanical and other dietary supplements (GAO 2009, Accessed on 2/9/2016 http://www.gao.gov/products/GAO-09-250). In addition, for most herbal drugs, the efficacy is not proved and the quality is not assured. The World Health Organization's (WHO) Traditional Medicine (TM) Strategy 2014–2023 focuses on promoting the safety, efficacy, and quality of TM (WHO 2013, accessed on 02/9/2016,