Abstract
India is the fourth largest manufacturer and the second largest consumer of pharmaceuticals in the world. Hospitalizations due to adverse drug reactions (ADRs) lead to a considerable burden on the health-care system and economy of the country. Pharmacovigilance in India faces considerable hurdles due to overburdened hospitals, underreporting of ADRs, variations in reporting formats, etc. To augment ADR reporting, many countries are exploring the option of mobile- and web-based solutions. The National Coordination Centre for Pharmacovigilance Program of India, Indian Pharmacopoeia Commission has released a mobile application (app) called “ADR PvPI” to mitigate some of these issues and both standardize and enhance the reporting of ADRs. This is in line with global focus on patient-reported outcomes and real-world data in pharmacovigilance. However, this approach has many implementation challenges including lack of awareness about mobile app, the use of English language in app, low smartphone adoption among the elderly, and in rural areas.
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