The WHO Programme for International Drug Monitoring provides a forum for WHO member states which includes INDIA to collaborate in the monitoring of drug safety. Within the Programme, individual case reports of suspected adverse drug reactions are collected and stored in a common database, presently containing over 3.7 million case reports. Adverse drug reaction reports are sent to UMC through the National pharmacovigilance programme.

As of July 1 2006, 81 countries had joined the WHO Drug Monitoring Programme. In addition, 17 countries were considered 'associate members' and are awaiting compatibility between the national and international reporting formats.

Functions of the WHO Programme for International Drug Monitoring include:

• Identification and analysis of new adverse reaction signals from the case report information submitted to the National Centres, and from them to the WHO database. A data-mining approach (BCPNN) is used at the UMC to support the clinical analysis made by a panel of signal reviewers


• Provision of the WHO database as a reference source for signal strengthening and ad hoc investigations. Web-based search facilities and customized services are available

• Information exchange between WHO and National Centres, mainly through 'Vigiflow', an e-mail information exchange system

• Publication of periodical newsletters , (WHO Pharmaceuticals Newsletter and Uppsala Reports), guidelines and books in the pharmacovigilance and risk management area

• Supply of tools for management of clinical information including adverse drug reaction case reports. The main products are the WHO Drug Dictionary and the WHO Adverse Reaction Terminology

• Provision of training and consultancy support to National Centres and countries establishing pharmacovigilance systems

• Computer software for case report management designed to suit the needs of National Centres (VigiFlow)

• Annual meetings for representatives of National Centres at which scientific and organizational matters are discussed

• Methodological research for the development of pharmacovigilance as a science.

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WHO - UMC & INDIA

The WHO International Drug Monitoring Programme was setup following the Thalidomide disaster. Since 1978 the Programme has been carried out by the Uppsala Monitoring Centre (UMC) in Sweden.

The Uppsala Monitoring Centre is responsible for the collection of data about adverse drug reactions from around the world, especially from countries that are members of the WHO including India.

INDIA is a country with a large pool of patients and healthcare professionals, yet the Adverse Drug Reaction reporting is in its infancy.The National Pharmacovigilance Programme was launched on November 23, 2004 by the Government of India to collect ADR reports across the country and create awareness about Pharmacovigilance, so far very few reports have been sent to UMC's Vigibase, which is relatively a less figure considering the number of healthcare professionals in our country.

WHO Key Dates & Establishments

  • 1968 WHO Programme established. International ADR terminology and drug dictionary
  • 1969 Definition of ADR
  • 1978 Operations transferred to the UMC; setting-up of relational ADR database. Regular WHO Programme member meetings
  • 1981 Computerised version of WHO Drug Dictionary available to all
  • 1982 ATC classification coding of all medicinal products
  • 1985 International expert review panel created
  • 1991 On-line WHO database search programme available to national centres
  • 1991 Definitions of adverse event, side effect and causality assessment terms
  • 1993 Windows-based client server program for online database searches
  • 1993 Regular training and educational activities
  • 1994 Methodology for use of denominator data for calculation of ADR reporting rates
  • 1997 Knowledge-detection tool for automated signal detection (BCPNN)
  • 1997 Promotion of communication as a necessary discipline
  • 1998 Internet discussion group for national centres
  • 2001 Start of Vigibase Online project
  • 2002 New database system (Vigiflow)
  • 2003 New Drug Dictionary with expanded data fields; agreement with IMS Health to increase information in DD
  • 2004 Pattern recognition using the BCPNN on health databases to find safety information.


SOURCE (WHO - UMC)