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Abstract

Pharmacovigilance is a practice aimed at monitoring drug safety in real-life situations as well as capturing adverse drug reactions during post-marketing drug life cycles. But under-reporting of adverse reactions is a major cause for concern and a threat to pharmacovigilance systems. The current article looks at major obstacles affecting the automatic reporting of drug response (ADRs) in India and possible solutions. In line with available scientific literature, major barriers to ADR reporting are inadequate information and awareness of health professionals, the views of clinicians in reporting, problems in establishing hospital reporting systems and inadequate training to monitor ADRs. Measures to improve the situation include greater involvement of nurses, pharmacists and consumers in reporting ADR the most common cause of ADR was antimicrobial agents such as Penicillin and the Cephalosporin group of antibiotics. Oral drugs were often involved in causing ADR.

Keywords

Adverse drug reaction monitoring centre (AMCs), ADR reporting pattern in pharmacovigilance,adverse drug reaction, pharmacovigilance programme in India,PvPI, CDSCO, NCC.

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