Guidelines for safety assessment of herbal medicines
3rd International Conference and Exhibition on Pharmacovigilance & Clinical Trials
October 27-29, 2014 Hyderabad International Convention Centre, India

Arjun Patra

Accepted Abstracts: J Pharmacovigilance

Abstract:

Herbal drugs have been used since ancient times as medicines for the treatment of a range of diseases. According to the World Health Organization because of poverty and lack of access to modern medicine as well as self belief, about 65-80% of the world?s population living in developing and developed countries depends essentially on plants for primary health care because of easy availability, low price, compatibility with human body, lesser side effects etc. Contrary to popular belief that ?natural are safe?, herbal medicines can cause significant toxic effects which range from allergic reactions to cardiovascular, hepatic, renal, neurological and dermatologic disorders. Hence, the herbal medicines or traditional medicaments need to be standardized. The challenge for herbal drug research and commerce in the country is to now focus on proper standardization and scientific validation of potential medicinal plants for realization of ?Health for All? goal by 2020. Misidentification of medicinal plants, herbals contains steroids, herbs with Adverse Drug Reactions and toxicity may create problems when used. Adverse effects reported in relation to herbal products are frequently attributable either to poor quality or to improper use, and it is therefore difficult to distinguish genuine adverse reactions to herbal medicines and herbal products until the cause of such events has been identified. Therefore, for safety of those herbal medicines proper identification of the nature of adverse effect, management of problems/risk, organizations to prevent adverse events and good communication of problems and safe use for maximum benefit of herbal medicines are very important. For the above we should learn from identified adverse effects through better reporting systems, skilful technical investigation of incidents and sharing of data; anticipate adverse events; identify existing knowledge resources, within and outside the health sector; and improve in the health-care delivery system, so that structures are reconfigured, and safety and quality are placed at the core of the system.