System setup
PV governance design, role definition, escalation matrix, quality interfaces, and implementation roadmap for manufacturers, marketers, importers, and CMOs.
Build an inspection-ready Pharmacovigilance system under Schedule M.
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.
6.11Schedule M paragraph requiring a PV system.
RoutineInspection verification flagged by regulators.
Cross-functionalQuality, RA, medical, commercial, and vendors all need alignment.
What the regulation expects
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.
Typical gap areas
- No designated PV responsible person or governance structure.
- Missing SOPs for intake, triage, follow-up, escalation, and reporting.
- No workflow for market complaints that may include adverse reactions.
- Weak vendor oversight and absent pharmacovigilance clauses in agreements.
- No inspection evidence trail, metrics, or training records.
How CLINIMINDS helps
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.
SOPs & quality documents
Master procedures, forms, logs, templates, policy documents, site responsibility matrices, and documentation packages aligned to Indian requirements.
Training deployment
Role-based training for QA, RA, medical, business teams, field force, distributors, and service partners with competency checks and evidence records.
Case intake workflows
Structured processes for adverse event receipt from email, phone, medical information, complaints, market feedback, and partner channels.
Partner oversight
Support for safety data exchange expectations, PV clauses, vendor governance, and oversight mechanisms for outsourced or shared activities.
Inspection readiness
Mock reviews, gap assessments, document traceability checks, and CAPA plans so the PV system is defensible during regulatory inspection.
Safety database
Support for safety database procurement, vendor evaluation, configuration planning, implementation coordination, and operational fit with case handling workflows.
Implementation pathway
1. Baseline assessment
Review licenses, products, current complaint handling, quality systems, and outsourced activities.
Review licenses, products, current complaint handling, quality systems, and outsourced activities.
2. Design & documentation
Build the governance model, SOP set, reporting logic, templates, and training plan.
Build the governance model, SOP set, reporting logic, templates, and training plan.
3. Operational rollout
Launch intake channels, case workflows, escalation rules, and internal accountability.
Launch intake channels, case workflows, escalation rules, and internal accountability.
4. Readiness & monitoring
Run drills, internal checks, periodic review support, and corrective action follow-through.
Run drills, internal checks, periodic review support, and corrective action follow-through.
Deliverables can include
- PV system setup framework and governance structure.
- PV SOPs, policies, forms, logs, and quality documents.
- Role-based PV training materials and training evidence tools.
- Adverse event intake and case processing workflow maps.
- Vendor, partner, and PV agreement guidance pack.
- Inspection readiness, audit, and gap assessment toolkit.
- Safety database procurement and implementation support.
