Pharmacovigilance Services in India
Pharmacovigilance (PV) is the science of detecting, assessing, understanding, and preventing adverse effects of pharmaceutical products. In India, pharmacovigilance is mandated by CDSCO under the New Drugs and Clinical Trials Rules, 2019, for all marketed drugs. The Pharmacovigilance Programme of India (PvPI), coordinated by the Indian Pharmacopoeia Commission (IPC), forms the backbone of India’s national drug safety surveillance system.
With digital reporting systems expanding and regulatory scrutiny intensifying, robust pharmacovigilance services are no longer optional — they are a regulatory requirement and a business imperative. ACPL provides end-to-end PV support for pharmaceutical companies operating in India.
Comprehensive PV Support
- Individual Case Safety Report (ICSR) processing, quality review, and submission
- Periodic Safety Update Report (PSUR) preparation and filing
- Risk Management Plan (RMP) development and implementation
- Signal detection, evaluation, and safety data analysis
- Qualified Person for Pharmacovigilance (QPPV) services
- Pharmacovigilance System Master File (PSMF) creation and maintenance
- Regulatory authority inspection readiness and mock audits
- PV training programs for client teams
- Literature surveillance and medical information services
Regulatory Framework
India’s pharmacovigilance requirements are governed by:
- New Drugs and Clinical Trials Rules, 2019 — Mandates adverse event reporting, PSUR submission, and signal detection
- PvPI (Pharmacovigilance Programme of India) — National surveillance network with 400+ adverse drug reaction monitoring centres across India
- Schedule Y and CDSCO Guidelines — Specific requirements for post-marketing surveillance
Recent PV Updates (2025–2026)
- Digital ADR reporting — Mobile apps and online portals making adverse event reporting easier for professionals and patients
- India-specific signals — PvPI identified 16 India-specific safety signals communicated to CDSCO for regulatory action
- 183 drug safety alerts — Issued by PvPI towards patient safety
- eCTD integration — Modernized dossier management for pharmacovigilance submissions
Why Pharmacovigilance Matters
Robust pharmacovigilance protects patients, maintains market authorization, and demonstrates your commitment to drug safety. Non-compliance can lead to product suspension, financial penalties, import license revocation, and significant reputational damage.
Related Services
- CDSCO Registration — Drug registration and import licensing that triggers PV obligations
- Clinical Trials — Clinical safety reporting and SAE management
- Materiovigilance — Post-market safety monitoring for medical devices
- Cosmetovigilance — Safety monitoring for cosmetic products