The present study was undertaken to evaluate any possibility of teratogenic effects in Boerhaavia diffusa (Punarnava), a widely used herbal medicine for renal and urinary tract diseases by Ayurvedic physicians in India. The ethanolic extract of Boerhaavia diffusa (BDE) was administered daily in a dose of 250 mg/kg, body weight p.o., to pregnant albino female rats during the entire period of gestation. BDE was found to be devoid of any teratogenic effect as litter size and survival rate of foetuses were the same as for the normal control group and no foetal anomaly could be detected.

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Pharmacovigilance (PV) deals with the detection, collection, assessment, understanding and prevention of adverse effects associated with the drugs. The objective of PV is to ensure safety of the medicines and patients by monitoring and reporting of all adverse drug reactions (ADRs) associated with prescribed medicine usage. Findings have indicated that about 0.2-24% of hospitalization cases are due to ADRs out of which 3.7% of patients have lethal ADRs. The reasons includes number of prescribing drugs, increased new drugs in the market, and inadequate PV system for ADRs monitoring, lack of awareness and knowledge about ADRs reporting. Serious ADRs leads to enhanced hospital stay, increased treatment cost, risk of death, and many medical and economic consequences. Therefore, ADR reporting at its first instance is important to avoid further harmful effects of the prescribed drugs. In India, the rate of ADR reporting is less than 1% whereas worldwide it is 5% due to lack of awareness about PV and ADR monitoring among healthcare providers and patients. Spontaneous reporting is the most commonly used PV method to report ADRs in both urban and rural areas of India. Evidences revealed that there is not any effective ADR reporting mechanisms developed in rural areas causing underreporting of ADR thus increasing threat to the rural population. Hence, PV and ADR reporting awareness among healthcare professionals and patients, telecommunication, telemedicine, use of social media and electronic medical records, and artificial intelligence are the potential approaches for prevention, monitoring and reporting of ADR in rural areas.