Vaccine Adverse Event Monitoring and Compliance Documentation Service
The Opportunity
The Supreme Court has mandated a no-fault compensation policy for Covid vaccine adverse events and directed continuous AEFI (Adverse Events Following Immunisation) monitoring with periodic public data disclosure. Hospitals, clinics, and government health departments lack standardized systems to systematically collect, document, verify, and report adverse event data to meet compliance requirements.
Market Size
₹800 crore - ₹1,200 crore across India's 800,000+ registered medical facilities requiring AEFI compliance infrastructure and ongoing monitoring services
Business Model
B2B compliance-as-a-service: Provide hospitals and state health departments with AEFI documentation platforms, staff training, case verification protocols, and periodic regulatory reporting to ensure adherence to Supreme Court directives and central government guidelines.
1) Annual licensing fee from hospitals (₹2-5 lakh per 100-bed facility), 2) Per-case documentation and verification fees (₹500-1,000 per adverse event report), 3) Government contracts for state-level AEFI data aggregation and public reporting
Your 30-Day Action Plan
Research existing AEFI reporting systems, identify 5-10 major hospital chains in Mumbai/Delhi, and document their current adverse event documentation gaps
Consult with medical-legal experts and pharmacovigilance specialists to design compliant documentation templates aligned with Supreme Court directives
Develop prototype digital intake form and reporting dashboard; approach 2 mid-sized hospitals for pilot testing
Register as compliance consulting firm, secure initial pilot contracts, and outline roadmap for state health department partnerships
Compliance & Regulatory Angle
Medical device/software regulation (CDSCO approval for any diagnostic tool), pharmacovigilance compliance (IPC Schedule Y), HIPAA-equivalent data privacy, GST 18% on consulting services, government health department certifications
Ready to Act on This Opportunity?
Generate a 7-step execution plan — validate the market, build the MVP, model the financials, map the risks, and ship in 30 days.