A Review on Pharmacovigilance Process In India

Authors

  • Preti Mishra Raja Balwant Singh Engineering Technical Campus, Bichpuri – Agra, U.P., India
  • Pawan Upadhyay Arya college of Pharmacy, Kookas, Jaipur, Rajasthan, India
  • Ravi Rawat Arya college of Pharmacy, Kookas, Jaipur, Rajasthan, India
  • Tajamul Ashraf dar Arya college of Pharmacy, Kookas, Jaipur, Rajasthan, India
  • Kapil Dev Arya college of Pharmacy, Kookas, Jaipur, Rajasthan, India
  • Nidhi Chauhan Arya college of Pharmacy, Kookas, Jaipur, Rajasthan, India

DOI:

https://doi.org/10.22270/ajprd.v8i3.735

Keywords:

Pharmacovigilance, Thalidomide Disaster, anti-inflammatory drugs.

Abstract

Peoples are using more potent drugs with various medical conditions. pharmacovigilance helps in safe and convenient use of pharmaceutical drugs. Voluntary recording of adverse drug reactions (ADRs) is a chief component of pharmacovigilance. Adverse drug reactions have become a dominant health related problems in developing countries like India. The main objective of pharmacovigilance is the assessment of benefit-risk profile of drug for better potency and safety in patients. In terms of volume India pharmaceutical industries is third largest in the world so India has a core of clinical research and drug design & development. This review article explains the need of pharmacovigilance in pharma companies, the growth of pharmacovigilance in different centuries and current status of pharmacovigilance in the country.

 

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Author Biographies

Preti Mishra, Raja Balwant Singh Engineering Technical Campus, Bichpuri – Agra, U.P., India

Raja Balwant Singh Engineering Technical Campus, Bichpuri – Agra, U.P., India

Pawan Upadhyay, Arya college of Pharmacy, Kookas, Jaipur, Rajasthan, India

Arya college of Pharmacy, Kookas, Jaipur, Rajasthan, India

Ravi Rawat, Arya college of Pharmacy, Kookas, Jaipur, Rajasthan, India

Arya college of Pharmacy, Kookas, Jaipur, Rajasthan, India

Tajamul Ashraf dar, Arya college of Pharmacy, Kookas, Jaipur, Rajasthan, India

Arya college of Pharmacy, Kookas, Jaipur, Rajasthan, India

Kapil Dev, Arya college of Pharmacy, Kookas, Jaipur, Rajasthan, India

Arya college of Pharmacy, Kookas, Jaipur, Rajasthan, India

Nidhi Chauhan, Arya college of Pharmacy, Kookas, Jaipur, Rajasthan, India

Arya college of Pharmacy, Kookas, Jaipur, Rajasthan, India

References

1. 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.
2. 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.
3. Mcbride WG. Thalidomide and congenital abnormalities. Lancet. 1961; 278(7216):1358.
4. 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.
5. 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 ; 9(1):51.
6. Kalaiselvan V, Thota P, Singh GN. Pharmacovigilance Programme of India: Recent developments and future perspectives. Indian J Pharmacol. 2016; 48(6):624.
7. 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.
8. Pharmacovigilance programme of India, 2010. Available at: www.who.umc.org/pharmacovigilance.html. Accessed 14 May 2018.
9. 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
10. Singh KNM, Kanase HR. Pharmacovigilance Programme of India: the beginning, current status and recent progress. Adv Pharmacoepidemiol Drug Saf. 2017; 6(4):219.
11. 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.
12. Pharmacovigilance guidelines for marketing authorization holders of pharmaceutical products in India, 2018. Available at: www.ipc.gov.in. Accessed 14 May 2018.
13. Pharmacovigilance programme of India, 2010. Available at: http://www.ipc.gov.in/PvPI/adr.html. Accessed 14 May 2018.
14. Power outage at Puducherry hospital kills three dialysis patients. The Hindu dated 9 March 2017. Available at: http://www.thehindu.com. Accessed 25
15. 15.WHO Policy Perspectives on Medicines. Geneva: WHO; 2004. Geneva: World Health Organization. Looking at the Pharmacovigilance: ensuring the safe use of medicines.
16. Klepper MJ. The periodic safety updates report as a Pharmacovigilance tool. Drug Saf 2004; 27:569- 78. 3. Livio F, Renard D, Buclin T. Pharmacovigilance. Rev Med Suisse 2012; 8:116-9
17. 17.WHO, Safety of medicines in public health programmes: Pharmacovigilance an essential tool,WHO,2006.
18. Skalli S, Soulaymani Bencheikh R. Safety monitoring of herb-drug interactions: acomponent of pharmacovigilance. Drug Saf 2012; 35:785-91.
19. Arnott J, Hesselgreaves H, Nunn AJ, Peak M, Pirmohamed M, Smyth RL, et al. What can we learn from parents about enhancing participation in pharmacovigilance?. Br J Clin Pharmacol 2012; in press.
20. 20.WHO, Pharmacovigilance: ensuring the safe use of medicines, Geneva: WHO 2004.
21. WHO, Safety of medicines in public health programmes: pharmacovigilance an essential tool,WHO,2006.
22. WHO Medicines Strategy: Framework for Action in Essential Drugs and Medicines Policy 2000- 2003. 23. Olsson S. The role of the WHO Programme for International Drug Monitoring in coordinating worldwide drug safety efforts. Drug Saf 1998; 19:1- 10.
23. WHO, Pharmacovigilance: ensuring the safe use of medicines, Geneva: WHO 2004.
24. ICH Guideline E2D; Post-approval safety data management: definitions and standards for expedited reporting, 3.1.1 Spontaneous reports 2004. International Conference on Harmonisation.
25. Pinkston V, Swain EJ. Management of adverse drug reactions and adverse event data through collection, storage, and retrieval. In: Stephens MDB, Talbot JCC, Routledge PA, eds. Detection of new adverse drug reactions. 4th ed. London, MacMillan Reference Ltd, 1998:282. http://z.umn.edu/INNOVATIONS 2015, Vol. 6, No. 1, Article 189
26. Faich GA, U.S. adverse drug reaction surveillance 1989-1994. Pharmacoepidemiology Drug Safety, 1996, 393-398. 15. Goldman SA. Limitations and strengths of spontaneous reports data. Clinical Therapeutics, 1998, 20 (Suppl C):C40-C44.
27. Hartmann K, Doser AK, Kuhn M. Postmarketing safety information: How useful are spontaneous reports. Pharmacoepidemiology and Drug Safety, 1999, 8:S65-S71.
28. Waller PC, Arlett PA. Responding to signals. In: Mann RD, Andrews E, eds. Pharmacovigilance. Chichester, John Wiley and Sons Ltd, 2002:105-128.
29. DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA Spontaneous Reporting system. The American Statistician, 1999; 53:177-190.
30. Bate A, Lindquist M, Edwards IR. A Bayesian neural network method for adverse drug reaction signal generation. European Journal of Clinical Pharmacology, 1998; 54:315-321.
31. Van Puijenbroek E, Egberts ACG, Heerdink ER, Leufkens HGM. Detecting drug-drug interactions using a database for spontaneous adverse drug reactions: An example with diuretics and nonsteroidal anti-inflammatory drugs. European Journal of Clinical Pharmacology, 2000; 56:733-738.
32. Venning GR. Identification of adverse reactions to new drugs. III: Alerting processes and early warning systems. British Medical Journal, 1983; 286:458-460.
33. Edwards IR. The management of adverse drug reactions: from diagnosis to signal. Thérapie, 2001; 56:727-733.

Published

2020-06-15

How to Cite

Mishra, P., Upadhyay, P., Rawat, R., dar, T. A., Dev, K., & Chauhan, N. (2020). A Review on Pharmacovigilance Process In India. Asian Journal of Pharmaceutical Research and Development, 8(3), 190–195. https://doi.org/10.22270/ajprd.v8i3.735

Issue

Vol. 8 No. 3 (2020): Vol 8 No 3 (2020): Vol 8 No 3 (2020): Volume 8 Issue 3 May - June. 2020

Section

Review Articles

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