World Health Organization’s Pharmacovigilance Database

• India has significantly improved its global standing in pharmacovigilance reporting.
• India moved to 8th position in 2025 in contributions to the World Health Organization’s pharmacovigilance database.
• India was ranked 123rd in 2014, indicating substantial progress over a decade.
• This ranking improvement occurred under the WHO Programme for International Drug Monitoring (WHO PIDM).

Role of the Pharmacovigilance Programme of India (PvPI)

• The improvement in India’s ranking is primarily attributed to the Pharmacovigilance Programme of India (PvPI).
  • PvPI was launched in 2010 by the Government of India.
  • PvPI is India’s flagship drug safety monitoring programme.
  • Pharmacovigilance refers to the science of detecting, assessing, understanding, and preventing adverse effects of medicines.
• PvPI analyses drug-related adverse events, which are unintended or harmful reactions to medicines.
• PvPI forwards evidence-based recommendations to the Central Drugs Standard Control Organisation (CDSCO).
  • CDSCO is India’s national drug regulatory authority.
  • CDSCO takes appropriate regulatory actions based on PvPI recommendations.

WHO Programme for International Drug Monitoring (WHO PIDM)

• The WHO Programme for International Drug Monitoring (WHO PIDM) was established in 1968.
• The programme aims to place medicine and vaccine safety at the core of global healthcare systems.
• WHO PIDM facilitates international collaboration on drug safety surveillance.
• VigiBase is the WHO’s global database under WHO PIDM.
• VigiBase contains adverse event reports for medicines and vaccines from participating countries worldwide.