Drug Safety Assessment in Ayurveda Clinical Trial and Practice: An Approach towards Concepts and Issues

Drug safety of Ayurveda formulations is one of the hottest topic now a day. The magnitude of Adverse Drug Reaction (ADR) is under reported in Ayurveda practice and research. Ayurveda always emphasized on safe treatment which includes alleviates the disease by not creating another disease. The information and terminologies narrated in ancient texts are not properly accessible and convincible by others. The terminologies of drug safety are not covered in the Ayurveda undergraduate and post graduate curriculum for identification of ADR. Therefore an attempt was made to review the Drug safety concept and issue of Ayurveda in the light of modern understanding of pharmacology. Drug safety is one of the components of Rogi surakshya which may be due to bhesaja dosa or abhesaja. Adverse Drug reaction or event is termed as dravya Vyapad, virudha or ahita in Ayurveda. National Pharmacovigilance Programme for reporting the adverse drug reaction for Ayurveda, Siddha and Unani (ASU) drugs was lunched in the year 2008. The modern terminology of drug safety was introduced in this review along with the component responsible for ADR. The dosha vidha parikshya (Tenfold of clinical examination) have more holistic approach in the concept of ADR of Ayurveda medicine. The presence of heavy metal beyond permissible limit, harmful microbes, pesticide residue and aflatoxin can also very harmful to human health. Predicable adverse drug reaction of metallic and plant based drugs are described in this review. Drug and herb interaction is also mentioned in this review. Panchakarma procedure (Detoxification therapy) is the Ayurveda treatment procedure where maximum ADR were reported in a study. Skin rashes, diarrhoea and vomiting said to be the most common presenting symptom due to ADR in Ayurveda treatment. The standardization of Ayurveda formulation is also a challenge for ADR. The protocol for ADR is proposed for research and practice. This topic may put forth some insight of prevention, diagnosis, reporting and management of adverse drug reaction in current clinical practice and research.