| PHARMACOVIGILANCE PERSPECTIVES |
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| Year : 2018 | Volume
: 9
| Issue : 1 | Page : 51-55 |
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Drug safety alerts of pharmacovigilance programme of India: A scope for targeted spontaneous reporting in India
Prasad Thota1, Anusha Thota2, Bikash Medhi3, Shabir Sidhu1, Pramod Kumar2, V Kalai Selvan2, Gyanendra Nath Singh2
1 Department of Life Sciences, IKG Punjab Technical University, Jalandhar, Punjab, India
2 Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh, India
3 Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India
Correspondence Address:
Prasad Thota
Research Scholar, Department of Life Sciences, IKG Punjab Technical University, Jalandhar, Punjab
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/picr.PICR_29_17
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Background: The National Coordination Centre-Pharmacovigilance Programme of India (NCC-PvPI), Indian Pharmacopoeia Commission works under the aegis of Ministry of Health and Family Welfare, Government of India. It promotes patient safety in India and also supports postmarketing surveillance programs. Currently, almost hundred thousand case reports are submitted to NCC-PvPI each year through its 250 ADR Monitoring Centers (AMCs) located across India, and India is the one of the top ten contributor countries under WHO-Uppsala Monitoring Centre since 2012 and start issuing drug safety alerts from March 2016.
Aim: This study aims to highlight the drug safety alerts issued by NCC-PvPI from March 2016 to June 2017 and urgent need for further monitoring by adopting targeted spontaneous reporting (TSR) methodology at AMCs and its impact on the NCC's drug safety database, i.e., VigiFlow in India.
Methodology: A retrospective analysis was done for the reported unlisted ADRs by various AMCs to PvPI through VigiFlow, i.e., individual case safety report (ICSR) management system at NCC, where these unlisted drug-ADR combinations considered and issued as drug safety alerts for further reporting these to NCC, if any detected at healthcare settings during routine clinical practice by healthcare professionals.
Results: From July 2011 to June 2017, NCC-PvPI was collated 250,787 ICSRs and contributed to WHO international drug safety database, i.e., VigiBase, from these ICSRs; NCC-PvPI was issued 56 drug safety alerts from March 2016 to June 2017.
Conclusion: In India, spontaneous reporting of ADRs existed since 1998 under passive surveillance method, but there is an urgent need to initiate TSR, which is a complementary method to spontaneous reporting on these drug safety alerts for further regulatory action by Central Drugs Standard Control Organization. |
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