twitter

Wednesday, 8 April 2015

Chapter 1 – Quality Related Safety Issue-Evidence-Based Validation of Herbal Medicine Farm to Pharma

Chapter 1 – Quality Related Safety Issue-Evidence-Based Validation of Herbal Medicine Farm to Pharma


Abstract

Because of their unique effects and relatively low side effects, herbal medicine has been gaining popularity all over the world. Quality control is a challenge to ensure safety, efficacy, and batch-to-batch consistency of herbal products due to the complexity of phytochemical constituents. Generally, it is believed that the risk associated with herbal drugs is very less, but several reports on serious reactions are indicating the need for the development of safety profiles; effective regulatory guidelines; and quality control systems for authentication, isolation, and standardization of herbal medicine. Lack of strict guidelines on the assessment of safety and efficacy, quality control, safety monitoring, and knowledge on traditional medicine (TM) are the main aspects that are found in different regulatory systems. Proper validation of herbs used in TM needs to be done for their promotion and development.

Keywords

  • Herb–drug interaction;
  • Marker profiling;
  • Pharmacovigilance;
  • Quality control;
  • Safety evaluation;
  • Standardization

Acknowledgments

The authors wish to express their gratitude to the National Medicinal Plant Board (NMPB), Department of AYUSH, Ministry of Health and Family Welfare, Government of India, for providing financial assistance to the School of Natural Product Studies, Jadavpur University, through project grant [F. No.: Z. 18017/187/CSS/R&D/WB-01/2009-10-NMPB].