📜 History of Pharmacovigilance

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⚠️ 1. Before Pharmacovigilance (Pre-1960s)

  • Drugs were marketed without strict safety testing
  • No proper clinical trial systems
  • No regulatory frameworks
  • Patients often acted as “test subjects”

🔴 Major Incident:

  • 1937 – Sulfanilamide disaster
    • Drug dissolved in toxic solvent (diethylene glycol)
    • Over 100 deaths, many children
    • Led to stronger drug laws

👉 Result:

  • US FDA gained more authority (1938 Federal Food, Drug, and Cosmetic Act)

💊 2. Turning Point – Thalidomide Tragedy (1960s)


  • Drug: Thalidomide
  • Used for:
    • Morning sickness in pregnant women
  • Outcome:
    • Severe birth defects (phocomelia – limb deformities)
    • ~10,000+ babies affected globally

👉 This is the birth of modern pharmacovigilance                  

Impact:

  • Strict drug safety regulations introduced
  • Mandatory clinical trials
  • Focus on drug safety monitoring





🌍 3. Global Pharmacovigilance Begins (1968)

  • WHO launched:👉 Programme for International Drug Monitoring (PIDM)
  • Established:
    • Global ADR reporting system
    • Collaboration between countries
  • Uppsala Monitoring Centre created:
    • Global ADR database (VigiBase)

    📊 4. Development Phase (1970s–1990s)

    • ADR reporting systems expanded
    • Countries developed national PV centers
    • Introduction of:
      • Spontaneous reporting systems
      • Case documentation (ICSR basics)

    Key Progress:

    • Standardization of reporting
    • Growing awareness among healthcare profession


    💻 5. Modernization Era (1990s–2000s)








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    • Introduction of:
      • Electronic databases
      • PV software (Argus, ArisG)
    • Development of:
      • MedDRA coding system
    • Regulatory strengthening by:
      • European Medicines Agency
      • US FDA

    🇮🇳 6. Pharmacovigilance in India

    Early Phase:

    • 1986: ADR monitoring started (limited success)

    Major Step:

    • 2010: Launch of PvPI (Pharmacovigilance Programme of India)
    • Coordinated by:
      • Indian Pharmacopoeia Commission
    • Regulated by:
      • CDSCO

    Features:

    • ADR Monitoring Centres (AMCs)
    • Reporting by doctors, pharmacists, patients











    🧬 7. Recent Advances (2010–Present)




    • Use of:
      • Artificial Intelligence (AI)
      • Big Data analytics
    • Real-time safety monitoring
    • Social media signal detection
    • Increased patient reporting

    Example:

    • COVID-19 vaccine safety monitoring globally

    🎯 Key Timeline Summary 

    • 1937 → Sulfanilamide tragedy
    • 1960s → Thalidomide disaster
    • 1968 → WHO global PV program
    • 1990s → Computerized PV systems
    • 2010 → PvPI launched in India
    • Present → AI & advanced analytics
    💡 Important Interview Line
    “Pharmacovigilance evolved after the Thalidomide tragedy, leading to global drug safety monitoring systems established by WHO, and today it uses advanced technologies like AI for real-time signal detection.”

     



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