This document discusses the history and current state of pharmacovigilance in India and internationally. It describes key events in pharmacovigilance including the establishment of drug safety monitoring committees in the UK and US in the 1960s, the creation of the yellow card system in the UK, and the founding of the Uppsala Monitoring Centre by the WHO in 1968. It outlines India's contribution to the WHO pharmacovigilance program, noting that India was the 7th highest contributor of safety reports to the global database in 2013. The document also provides guidance on what types of adverse drug reactions should be reported in India.

1. KARNATAKA COLLEGE OF PHARMACY
DEPARTMENT OF PHARMACOLOY
Clinical Research and Pharmacovigilance
PRESENTATION ON
“Pharmacovigilance in India and International Aspect”
Presented To: Dr. Balakeshwa Ramaiah
Department of Pharmacy Practice
Presented by: kashikant Yadav
M pharm (Pharmacology)

6. • 1962 USA revised law requiring to prove
safety and efficacy before issuing marketing
authorization
• 1963 British Committee on Safety of drug
monitoring
• 1964 UK starts “yellow cards” system
• 1964-65 National ADR reporting system UK,
Australia, New Zealand, Canada, West Germany,
Sweden.

7. Uppsala Monitoring Centre(UMC)
• 1968 - WHO Collaborating Centre for
International Drug Monitoring, Geneva
•1978- Moved to Uppsala after agreement between
Sweden and WHO
•Non-profit foundation with international
administrative board
•WHO Headquarters responsible for policy
•Self-financing
•Global Pharmacovigilance

24. What to report?
• All adverse events suspected to be caused by new drugs &
drugs of current interest(published by CDSCO from time to
time)
• All suspected drug interactions
• Any Drug or adverse event leading to:
 Death
 Life threatening reaction
 Hospitalisation
 Disability
 Congenital anomaly
 required intervention to prevent permanent impairment or
damage.

28. India’s contribution to WHO-UMC,
2013
• 117 countries participating in the WHO
programme for International Drug Monitoring
• India stood at 7th position in contributing to
global ICSRs safety database for the year 2013

40. A journey of thousand miles
must begin with a single step