An overview of the pharmacovigilance system in India

References

• World Health Organization (WHO). The importance of pharmacovigilance: safety monitoring of medicinal products. Geneva: WHO; 2002.
   Google Scholar
• The WHO Programme. http://www.who-umc.org/DynPage.aspx?id=98078&mn1=7347&mn2=7252&mn3=7322. The WHO Programme.
   Google Scholar
• Kulkarni RD. Reporting system for rare side effects of non-narcotic analgesics in India: problems and opportunities. Med Toxicol 1986;1:110–113.
   PubMedGoogle Scholar
• Biswas P. Pharmacovigilance in Asia. J Pharmacol Pharmacother 2013;4:7–19.
   PubMedGoogle Scholar
• Protocol for National Pharmacovigilance Programme. CDSCO, Ministry of Health and Family Welfare, Government of India, New Delhi, India. November, 2004.
   Google Scholar
• http://www.ipc.gov.in/PvPI/pv_about.html/Functions of PvPI
   Google Scholar
• Kalaiselvan V, Prasad T, Bisht A, Singh S, Singh GN. Adverse drug reactions reporting culture in Pharmacovigilance Programmeme of India. Indian J Med Res 2014;140:563–564.
   PubMed Web of Science ®Google Scholar
• Bandekar MS, Anwikar SR, Kshirsagar NA. Quality check of spontaneous adverse drug reaction reporting forms of different countries. Pharmacoepidemiol Drug Saf 2010;19:1181–1185.
   PubMed Web of Science ®Google Scholar
• Vivekanandan K, Rishi K, Prasad T, Arunabh T, Singh GN. Status of documentation grading and completeness score for Indian individual case safety reports. Indian J Pharmacol 2015;47:325–327.
   PubMed Web of Science ®Google Scholar
• Tandon VR, Mahajan V, Khajuria V, Gillani Z. Underreporting of adverse drug reactions: a challenge for pharmacovigilance in India. Indian J Pharmacol 2015;47:65–71.
   PubMed Web of Science ®Google Scholar
• Khan SA, Goyal C, Chandel N, Rafi M. Knowledge, attitudes, and practice of doctors to adverse drug reaction reporting in a teaching hospital in India: an observational study. J Nat Sci Biol Med 2013;4:191–196.
   PubMedGoogle Scholar
• Irujo M, Beitia G, Bes-Rastrollo M, Figueiras A, Hernández-Díaz S, Lasheras B. Factors that influence under-reporting of suspected adverse drug reactions among community pharmacists in a Spanish region. Drug Saf 2007;30:1073–1082.
   PubMed Web of Science ®Google Scholar
• Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006;29:385–396.
   PubMed Web of Science ®Google Scholar
• Klopotowska JE, Wierenga PC, Smorenburg SM, Stuijt CC, Arisz L, Kuks PF, Dijkgraaf MG, Lie-A-Huen L, de Rooij SE; WINGS study group. Recognition of adverse drug events in older hospitalized medical patients. Eur J Clin Pharmacol 2013;69:75–85.
   PubMed Web of Science ®Google Scholar
• Jha N, Rathore DS, Shankar PR, Thapa BB, Bhuju G, Alshakka M. Need for involving consumers in Nepal’s pharmacovigilance system. AMJ 2014;7(4):191–195.
   Google Scholar
• Pharmacovigilance Programmeme of India (PvPI) Newsletter. 2013 December issue. Vol. 3 (7). page no. 2. Growth of PvPI safety database since 2010.
   Google Scholar
• Olsson S, Pal SN, Dodoo A. Pharmacovigilance in resource-limited countries. Expert Rev Clin Pharmacol 2015;8:449–460.
   PubMed Web of Science ®Google Scholar
• Adams SA. Using patient-reported experiences for pharmacovigilance? Stud Health Technol Inform 2013;194:63–68.
   PubMedGoogle Scholar
• Hazell L, Cornelius V, Hannaford P, Shakir S, Avery AJ. Yellow Card Study Collaboration. How do patients contribute to signal detection? A retrospective analysis of spontaneous reporting of adverse drug reactions in the UK’s Yellow Card Scheme. Drug Saf 2013;36:199–206.
   PubMed Web of Science ®Google Scholar
• Leone R, Moretti U, D’Incau P, Conforti A, Magro L, Lora R, Velo G. Effect of pharmacist involvement on patient reporting of adverse drug reactions: First Italian study. Drug Saf 2013;36:267–276.
   PubMed Web of Science ®Google Scholar
• Goldstein LH, Berlin M, Saliba W, Elias M, Berkovitch M. Founding an adverse drug reaction (ADR) network: A method for improving doctors spontaneous ADR reporting in a general hospital. J Clin Pharmacol 2013;53:1220–1225.
   PubMed Web of Science ®Google Scholar
• Brashier DBS, Sharma S. An adverse drug reaction clinic: breathing fresh life into the pharmacovigilance Programmeme. J Pharmacol Pharmacother 2012;3:74–75.
   PubMedGoogle Scholar