Abstract

INTRODUCTION TO PHARMACOVIGILANCE

Kalyani Dhamal*, Omkar Bhalekar, Phadke Pragati, Gadade Aarti and Durgude Vishakha

Abstract

Pharmacovigilance (drug safety) is pharmacological science deals with study of collection, detection, assessment, monitoring, prevention of adverse effect of pharmaceutical product. Generally PV focus on to increase the benefit by reducing the side effects. Any drug or pharmaceutical dosage form related adverse effects from patients to pharmacovigilance provided via healthcare providers/profession. Every company needed a Qualified Person For Pharmacovigilance (QPPV) for to ensure that company meets own legal obligation for monitoring product safety on market. The history of pharmacovigilance was started 170 years ago, 29Jan 1848. In England a little baby (Hannah Greener) was died taking chloroform as anesthetic before removal of infected toenail. The origin of pharmacovigilance in India goes back to 1986, but nothing but happen until 1997. In 2005 WHO sponsored the national pharmacovigilance programmed for INDIA, Central Drug Standard Control Organization (CDSCO), New Delhi. Current status of PV in India accepted as a continuous process for to improve safety of medicines including pharmaceutical companies, regulatory authorities, healthcare profession, and patients.

Keywords: Pharmacovigilance, CDSCO, QPPV, healthcare profession.