AMEI's Current Trends in Diagnosis & Treatment

Register      Login

VOLUME 1 , ISSUE 1 ( January-June, 2017 ) > List of Articles

REVIEW ARTICLE

Pharmacovigilance in India and its Impact in Patient Management

Narinder Singh, Geeta Sharma, Rahat Kumar, Vikram Bhandari

Citation Information : Singh N, Sharma G, Kumar R, Bhandari V. Pharmacovigilance in India and its Impact in Patient Management. Curr Trends Diagn Treat 2017; 1 (1):27-33.

DOI: 10.5005/jp-journals-10055-0006

License: CC BY 3.0

Published Online: 00-06-2017

Copyright Statement:  Copyright © 2017; Jaypee Brothers Medical Publishers (P) Ltd.


Abstract

How to cite this article

Sharma G, Kumar R, Singh J, Bhandari V, Singh N. Pharmacovigilance in India and its Impact in Patient Management. Curr Trends Diagn Treat 2017;1(1):27-33.


PDF Share
  1. The importance of pharmacovigilance – safety monitoring of medicinal products [Internet]. Geneva: World Health Organization; 2002 [cited 2016 Sep 21]. Available from: http://apps.who.int/medicinedocs/pdf/s4893e/s4893e.pdf.
  2. World Health Organization. [cited 2016 Sep 21]. Available from: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/.
  3. History [Internet]. Silver Spring: US Food and Drug Administration; 2013 [cited 2016 Sep 21]. Available from: http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm.
  4. Wikipedia, The Free Encyclopedia; 2012 Jun, at 15:27 UTC [cited 2016 Sep 21]. Available from: http://en.wikipedia.org/wiki/Elixir_sulfanilamide; http://www.ivtnetwork.com/sites/default/files/IVTGXPxxxx_CoverStory-2%20pr1.pdf.
  5. The thalidomide disaster, lessons from the past. Methods Mol Biol 2013;947:575-586.
  6. U.S. Food and Drug Administration. [cited 2016 Sep 21]. Available from: http://www.fda.gov/AboutFDA/WhatWeDo/History/CentennialofFDA/CentennialEditionofFDAConsumer/ucm093787.htm.
  7. Past, present and future of pharmacovigilance in India. Syst Rev Pharm 2011 Jan;2(1):55-58.
  8. European Medicines Agency. [cited 2016 Sep 21]. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000199.jsp.
  9. Version 1.0 Published by Indian Pharmacopoeia Commission. National Coordination Centre – Pharmacovigilance Programme of India, Ministry of Health & Family Welfare, Government of India. Printed by Nutech Photolithographers, B-240, Okhla Industrial Area, Phase-I, New Delhi.
  10. Reporting systems for rare side effects of non-narcotic analgesics in India. Problems and opportunities. Med Toxicol 1986;1(1 Suppl 1):110-113.
  11. CDSCO, Ministry of Health and Family Welfare, Government of India; 2004 Nov [cited 2015 May 25]. Available from: http://www.cdsco.nic.in/html/Pharmacovigilance%20Protocol%20.pdf.
  12. Adverse drug reaction monitoring in India. J Assoc Physicians India 1993 Jun;41(6):374-376.
  13. Role of pharmacovigilance in India: an overview. Online J Public Health Inform 2015 Jul;7(2):e223.
  14. National pharmacovigilance program. Indian Pediatr 2006 Jan;43(1):27-32.
  15. Benefit-risk balance for marketed drugs: evaluating safety signals – report of CIOMS working group IV. Geneva: CIOMS; 1998 [cited 2016 Sep 21]. Available from: http://www.cioms.ch/publications/g4-benefit-risk.pdf.
  16. Clioquinol-subacutemyelo-opticoneuropathy (SMON) in Indians. Some observations on SMON from Bombay. J Neurol Neurosurg Psychiatry 1977;40(3):268-275.
  17. Phenylpropanolamine-induced intraventricular hemorrhage. Neurol India 2003 Mar;51(1):117-118.
  18. [cited 2016 Sep 21]. Available from: http://www.cdsco.nic.in/writereaddata/drugs%20banned%20in%20the%20country2.pdf.m.
  19. WHO Library Cataloguing-in-Publication Data 2006. [cited 2016 Sep 21]. Available from: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/Pharmacovigilance_B.pdf.
  20. 009 [Internet]; 2004 Oct [cited 2016 Sep 21];6. Available from: http://apps.who.int/medicinedocs/en/d/Js6164e/3.1.html.
  21. Transmission of hepatitis B, hepatitis C and human immunodeficiency viruses through unsafe injections in the developing world: model-based regional estimates. Bull World Health Organ 1999;77(10):801-807.
  22. Geneva: World Health Organization; 2004 [cited 2016 Sep 21]. Available from: http://www.whqlibdoc.who.int/hq/2004/WHO_EDM_2004.8.pdf.
  23. Drug utilisation patterns in the Third World. Pharmacoeconomics 1996 Apr;9(4):286-294.
  24. Changing prescribing in the light of tolerability concerns: how is this best achieved? Drug Saf 1999 Sep;21(3):153-160.
  25. The selection of essential drugs. Technical report series 615. Geneva: World Health Organization; 1977.
  26. Drug utilization studies – an overview. Int J Pharm Sci Nanotechnol 2010 Apr;3(1):803-810.
  27. Multidisciplinary team care for CKD-MBD. Achieving KDIGO guideline recommendations in the bundling era. Nephrol News Issues 2014 Apr;28(4):24-26.
  28. [Risk of hypercalcemia and hipervitaminosis D induced by calcifediol. Review of cases reported to the Spanish Pharmacovigilance System]. Med Clin (Barc). 2013 Jul;141(2):88-89.
  29. Angiotensin-converting-enzyme inhibitors and anaphylactoid reactions to high-flux membrane dialysis. Lancet 1990 Dec;336(8727):1360-1362.
  30. French Association of Regional Pharmacovigilance Centers. Exposure to inhibitors of the renin-angiotensin system is a major independent risk factor for acute renal failure induced by sucrose-containing intravenous immunoglobulins: a case-control study. Pharmacoepidemiol Drug Saf 2012 Mar;21(3):314-319.
  31. ASN Chronic Kidney Disease Advisory Group. Finding a common language for patient safety in CKD. Clin J Am Soc Nephrol 2012 Apr;7(4):689-695.
  32. European Medicines Agency recommends action plan to deal with possible presence of endotoxins in Baxter peritoneal dialysis solutions [Internet]. [cited 2016 Sep]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2010/12/news_detail_001170.jsp&mid=WC0b01ac058004d5c1.
  33. com. Extraneal company core data sheet. Deerfield (IL): Baxter Healthcare Corporation; 2007 [cited 2016 Sep 21]. Available from: http://www.glucosesafety.com/us/pdf/extraneal_pi.pdf.
  34. Pharmacovigilance as a tool for safety and monitoring: a review of general issues and the specific challenges with end-stage renal failure patients. Drug Healthc Patient Saf 2013 Apr;5:105-112.
  35. Significant hypoglycemia secondary to icodextrin peritoneal dialysate in a diabetic patient. Anesth Analg 2007 Jun;104(6):14731474.
  36. Spontaneous tendon ruptures in patients with end-stage renal disease. Kidney Blood Press Res 2009;32(1):32-36.
  37. Newly licensed drugs. BMJ 1996 Nov;313(7066):1157-1158.
  38. Incidence of drug-induced hepatic injuries: a French population-based study. Hepatology 2002 Aug;36(2):451-455.
PDF Share

© Jaypee Brothers Medical Publishers (P) LTD.