India’s Leap Into Digitized Pharmacovigilance Systems

Background: Why Digitization Is Needed

India has a huge pharmaceutical industry, producing generic drugs and vaccines for the world. With more clinical trials and drug distribution, traditional manual pharmacovigilance (PV) systems can’t keep up. The COVID-19 pandemic accelerated the need for digital PV systems to track safety in real time.

Main Drivers for Digital PV

Mass Vaccination Programs

• Large campaigns like COVID-19 required real-time monitoring of adverse events (AEFI).

Global Regulatory Expectations

• Agencies like WHO and US FDA require transparent, efficient safety monitoring.

Growth in Clinical Trials

• India’s growing research sector needs fast and reliable local safety tracking.

National Health Digitization Initiatives

• Programs like Digital India and Ayushman Bharat push modern, integrated digital health systems, including PV.

Key Digital PV Developments

a. Integrated Adverse Event Reporting Systems

• CDSCO and IPC created online reporting portals for doctors, patients, and vaccine recipients.
• Mobile apps and SMS make reporting easy, even in rural areas.

b. PvPI’s Vigiflow Integration

• Managed by the Indian Pharmacopoeia Commission, Vigiflow (a WHO system) handles:
  • Online case intake
  • Safety signal detection
  • Sharing India’s PV data globally

c. e-AEFI Module by MoHFW & WHO India

• Tracks adverse events after vaccination
• Linked with CoWIN platform for COVID-19
• Enables faster investigation and root cause analysis

d. AI & Automation Pilots

• AI and automation are being tested for:
  • Detecting safety signals
  • Automating case processing
• Currently in early pilot stages by pharma companies and CROs

Key Agencies and Their Roles

Outcomes, Benefits, and Ongoing Challenges

Benefits:

• More reporting: Over 500 Adverse Drug Reaction Monitoring Centre's (AMCs) active
• Faster case processing: Digital systems reduce intake and triage time
• Global recognition: India shares PV data with VigiBase, helping worldwide safety monitoring

Challenges:

• Underreporting: Many events go unreported
• Awareness gaps: Some healthcare professionals lack training
• Infrastructure gaps: Rural areas still face digital limitations

Future Outlook

AI and Machine Learning

• Will help classify cases and prioritize safety signals
• Adoption is still early

Blockchain

• Being explored for audit trails and compliance
• Not widely used yet

Interoperability

• Plans to integrate PV with National Health Stack and ABHA digital health ID

Conclusion

India is rapidly modernizing pharmacovigilance through digital systems, real-time reporting, and global collaboration. Despite challenges like underreporting and rural infrastructure gaps, these changes are improving patient safety, regulatory efficiency, and alignment with international standards.