Setting standards for proactive pharmacovigilance in India: The way forward

Indian Journal of Pharmacology

Volumn 39, Issue 3, 2007, Pages 124-128

  Biswas, Pipasha ^a   Biswas, Arun R ^a  

^a Symogen Ltd   (United Kingdom)

Author keywords

Pharmacovigilance training and knowledge; Proactive pharmacovigilance; Risk management; Robust pharmacovigilance system; Signal detection; Strategies and Proposals

Indexed keywords

NON PRESCRIPTION DRUG;

DRUG INDUSTRY; DRUG MONITORING; DRUG RESEARCH; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; HISTORY; HOSPITALIZATION; INDIA; PHARMACOEPIDEMIOLOGY; PRESCRIPTION; REVIEW; RISK BENEFIT ANALYSIS; SELF MEDICATION; STANDARDIZATION; TRAINING;

EID: 34447622329     PISSN: 02537613     EISSN: None     Source Type: Journal    
DOI: 10.4103/0253-7613.33431     Document Type: Review

References (8)

1. WHO Definition of Pharmacovigilance. 2002.
2. Kulkarni RD. Reporting system for rare side effects of non-narcotic analgesics in India: Problems and opportunities. Med Toxicol 1986;1:110-3.
3. Protocol for National Pharmacovigilance Program. CDSCO, Ministry of Health and Family Welfare, Government of India. November 2004.
4. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA 1998;279:1200-5.
5. Gandhi TK, Weigngart SN, Borus J, et al. Adverse drug events in ambulatory care. N Engl J Med 2003;348:1556-64.
6. Nair MD. Pharmacovigilance: The need for a formal system in India. Available from: http://www.pharmabiz.com.
7. The Erice Declaration on Communicating Information. Drug Safety, Sept 27, 1997.
8. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official Journal of the European Union 30 April 2004: L136/34-L 136/57.