Pharmacovigilance programme of India: revival of the renaissance
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20184338Keywords:
ADRs, Adverse events, IPC, NCC, PharmacovigilanceAbstract
Adverse drug reactions (ADRs) are the fourth leading cause of morbidity in the world. In order to safeguard the health of the community, Pharmacovigilance Programme of India (PvPI) is implemented as the monitoring body by Indian Pharmacopoeia Commission (IPC). It is leading national authority. National Coordinating Centre (NCC) PvPI works as the World Health Organization (WHO) collaborating centre for pharmacovigilance. Adverse drug reactions are reported to NCC PvPI which are then directed towards WHO Uppsala Monitoring Centre (UMC) Sweden which is the global monitoring centre for worldwide data. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority of India under the Ministry of Health and Family Welfare (MOHFW), Government of India. This article focusses on the various strands of pharmacovigilance at the healthcare professional and consumer level. It also discusses the pitfalls in the journey of pharmacovigilance thus helping in enhancing the quality of health safety. Even a minuscule contribution by a health care professional or a consumer can voluminously help in promotion of drug safety. Therefore, there is a need of inculcating the culture of adverse drug reaction reporting for the welfare of the vulnerable masses.
References
Tripathi KD. Adverse Drug Effects. In: Essentials of Medical Pharmacology. 6th ed. India, Jaypee Brothers Medical Publishers (P) Ltd; 2010:78-86.
Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004 Jul 1;329(7456):15-9.
Patel TK, Patel BP. Incidence of adverse drug reactions in Indian hospitals: a systematic review of prospective studies. Curr Drug Saf. 2016 Apr 1;11(2):128-36.
Mcbride WG. Thalidomide and congenital abnormalities. Lancet. 1961;278(7216):1358.
Sharma G, Kumar R, Singh J, Bhandari V, Singh N. Pharmacovigilance in India and it’s impact in patient management. J Curr Trends Diagnosis Treatment. 2017;1(1):27-33.
Thota P, Thota A, Medhi B, Sidhu S, Kumar P, Selvan VK, et al. Drug safety alerts of pharmacovigilance programme of India: a scope for targeted spontaneous reporting in India. Perspectives Clin Res. 2018 Jan;9(1):51.
Kalaiselvan V, Thota P, Singh GN. Pharmacovigilance Programme of India: Recent developments and future perspectives. Indian J Pharmacol. 2016 Nov;48(6):624.
Kalaivani M, Kalaiselvan V, Dabhi K, Singh GN. Direct consumer reporting of adverse drug reactions to PvPI, a position paper of IPC. Adv Pharmacoepidemiol Drug Saf. 2015;4(3):184.
Pharmacovigilance programme of India, 2010. Available at: www.who.umc.org/pharmacovigilance.html. Accessed 14 May 2018.
Indian Pharmacopoeia Commission Newsletter PvPI. 2015;5(12):4 Available at: www.ipc.gov.in/PvPI/newsletter/Newsletter%20Vol%205%20Issue%2012%202015%20PDF.pdf
Singh KNM, Kanase HR. Pharmacovigilance Programme of India: the beginning, current status and recent progress. Adv Pharmacoepidemiol Drug Saf. 2017;6(4):219.
Indian Pharmacopoeia Commission Newsletter PvPI. 2015;5(11):6-8. Available at: www.ipc.gov.in/PvPI/newsletter/Newsletter%20Vol%205%20Issue%2011%202015%20PDF.pdf Accessed 14 May 2018.
Pharmacovigilance guidelines for marketing authorization holders of pharmaceutical products in India, 2018. Available at: www.ipc.gov.in. Accessed 14 May 2018.
Pharmacovigilance programme of India, 2010. Available at: http://www.ipc.gov.in/PvPI/adr.html. Accessed 14 May 2018.
Power outage at Puducherry hospital kills three dialysis patients. The Hindu dated 9 March 2017. Available at: http://www.thehindu.com. Accessed 25 May 2018.
Bacci MR, Santos JA, Nogueira LF. Case report: coronary stent stenosis in acute myocardial infarction. BMJ Case Reports. 2013;2013.
Trampuz A, Widmer AF. Infections associated with orthopedic implants. Curr Opinion Infect Dis. 2006 Aug 1;19(4):349-56.
NCC-Hemovigilance Programme of India Newsletter. 2015 July-December;3(6). Available at: http://nib.gov.in/haemovigilance1.html.0 and nib.gov.in/Haemovigilance/TRRF_Form.pdf. Accessed 25 May 2018
PvPI Newsletter. 2016 March;6(14):16-7. Available at: www.ipc.gov.in/PvPI/newsletter/Newsletter%20Vol%206%20Issue%2014%202016%20PDF.pdf. Accessed 25 May 2018.
Tandon VR, Mahajan V, Khajuria V, Gillani Z. Under-reporting of adverse drug reactions: a challenge for pharmacovigilance in India. Indian J Pharmacol. 2015 Jan;47(1):65.
Suke SG, Kosta P, Negi H. Role of pharmacovigilance in India: an overview. Online J Public Health Informatics. 2015;7(2).
Hornbuckle K, Wu HH, Fung MC. Evaluation of spontaneous adverse event reports by primary reporter: a 15-Year Review (1983 to 1997). Drug Information J. 1999 Oct;33(4):1117-24.
WHO Consumer Reporting of ADRs. WHO Drug Info. 2000;14:211-5. Available at: apps.who.int/medicinedocs/pdf/h1462e/h1462e.pdf. Accessed 25 May 2018.
