Background: Pharmacovigilance (PV) deals with the detection, collection, assessment, understanding, and prevention of adverse effects associated with drugs. The objective of PV is to ensure the safety of the medicines and patients by monitoring and reporting 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, of which 3.7% of patients have lethal ADRs. The reasons include the number of prescribed drugs, an increased number of new medicines in the market, an inadequate PV system for ADR monitoring, and a need for more awareness and knowledge about ADR reporting. Severe ADRs lead to enhanced hospital stays, increased treatment costs, risk of death, and many medical and economic consequences. Therefore, ADR reporting at its first instance is essential 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 a need for more awareness about PV and ADR monitoring among healthcare providers and patients. Aim: The main objective of this review is to highlight the current scenario and possible futuristic ways of ADR reporting methods in rural areas of India. Method: We have searched the literature using PubMed, Google scholar, Indian citation index to retrieve the resources related to ADR monitoring and reporting in India's urban and rural areas. Results: Spontaneous reporting is the most commonly used PV method to report ADRs in India's urban and rural areas. Evidence revealed that no effective ADR reporting mechanisms developed in rural areas causing underreporting of ADR, thus increasing the threat to the rural population. Conclusion: 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.

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