| SHORT COMMUNICATION |
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| Year : 2015 | Volume
: 47
| Issue : 3 | Page : 325-327 |
Status of documentation grading and completeness score for Indian individual case safety reports
Kalaiselvan Vivekanandan, Kumar Rishi, Thota Prasad, Tripathi Arunabh, GN Singh
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
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/0253-7613.157133
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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