System setup
PV governance design, role definition, escalation matrix, quality interfaces, and implementation roadmap for manufacturers, marketers, importers, and CMOs.
CDSCO has reiterated that every licensee must have a pharmacovigilance system for collecting, processing, and forwarding adverse drug reaction information associated with products manufactured or marketed by them. The circular also notes that this requirement may be verified during routine inspections by CDSCO and State Licensing Authorities.
Schedule M now explicitly requires the licensee to keep a pharmacovigilance system in place for collecting, processing, and forwarding adverse drug reaction reports to the licensing authorities. This moves PV into the core GMP quality framework rather than leaving it as an optional post-marketing activity.
The revised Schedule M also ties complaints, recalls, technical agreements, documentation, training, and self-inspection to the broader pharmaceutical quality system. That means PV should not sit in isolation; it must connect with quality events, product complaints, distributors, partners, and management review.
We help organizations create a practical PV operating model that is proportionate to portfolio size, business model, and regulatory risk. The aim is a system that works day-to-day and stands up to inspection review.
PV governance design, role definition, escalation matrix, quality interfaces, and implementation roadmap for manufacturers, marketers, importers, and CMOs.
Master procedures, forms, logs, templates, policy documents, site responsibility matrices, and documentation packages aligned to Indian requirements.
Role-based training for QA, RA, medical, business teams, field force, distributors, and service partners with competency checks and evidence records.
Structured processes for adverse event receipt from email, phone, medical information, complaints, market feedback, and partner channels.
Support for safety data exchange expectations, PV clauses, vendor governance, and oversight mechanisms for outsourced or shared activities.
Mock reviews, gap assessments, document traceability checks, and CAPA plans so the PV system is defensible during regulatory inspection.
Support for safety database procurement, vendor evaluation, configuration planning, implementation coordination, and operational fit with case handling workflows.