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 SHORT COMMUNICATION
Year : 2015  |  Volume : 47  |  Issue : 3  |  Page : 325-327

Status of documentation grading and completeness score for Indian individual case safety reports


Pharmacovigilance Division, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghazibad, Uttar Pradesh, India

Correspondence Address:
Dr. Kalaiselvan Vivekanandan
Pharmacovigilance Division, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghazibad, Uttar Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0253-7613.157133

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The quality of individual case safety reports (ICSRs) generated under Pharmacovigilance Programme of India (PvPI) plays a pivotal role in detecting a signal from Indian drug safety data. Currently, more than hundred thousand ICSRs were generated under PvPI and reported to Uppsala Monitoring Centre. The documentation grading and completeness score of Indian ICSRs were rapidly increasing, and the current score was 0.94 out of 1.0. Periodical training on emphasizing the quality ICSRs is need of the hour.






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