India’s pharmaceutical industry is rapidly expanding, making it a critical hub for drug development, manufacturing, and consumption. With this growth comes an even greater responsibility: safeguarding patient health. This is where a robust Pharmacovigilance Consultant in India becomes indispensable.
The Indian PV Landscape: Meeting the Mandate
The government of India, through the Central Drugs Standard Control Organisation (CDSCO) and the National Coordination Centre-Indian Pharmacopoeia Commission (NCC-PvPI), oversees the nation’s drug safety program. The core mission of the Pharmacovigilance Programme for India (PvPI) is to monitor the benefit-risk profile of medicines and ensure timely reporting of Adverse Drug Reactions (ADRs).
While the PvPI diligently collects Individual Case Safety Reports (ICSRs) from healthcare professionals, consumers, and Marketing Authorization Holders (MAHs) across the country, a significant challenge remains: the under-reporting of adverse events. For pharmaceutical companies operating in India, a proactive, quality-driven approach to PV is not just a regulatory requirement—it is a moral imperative.
DDReg’s End-to-End Pharmacovigilance Services for the Indian Market
As a leading global partner, DDReg Pharma understands the nuances of the Indian regulatory environment and the significance of patient safety, from early-stage clinical trials to post-marketing surveillance. We offer comprehensive, end-to-end pharmacovigilance solutions tailored to meet local requirements and international Good Pharmacovigilance Practices (GVP).
Our specialized PV portfolio for India includes:
1. Individual Case Safety Report (ICSR) Processing and Submission
Precise and timely ICSR handling is the foundation of any PV system. Our services cover:
- Triage of initial and follow-up reports, including SUSARs.
- Case Processing using E2B(R3) compliant databases integrated with medical coding dictionaries (WHO DD and MedDRA).
- Medical Review and Quality Check (QC).
- Submission of cases to the NCC-PvPI as per strict agency timelines.
- Maintaining ICSR monitoring, tracking sheets, and a robust Reconciliation Process with clients.
2. Aggregate Report Writing
A detailed benefit-risk evaluation is essential for periodic regulatory submissions. Our team expertly drafts, reviews, and submits all required aggregate safety reports:
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Periodic Safety Update Reports (PSURs)
- Development Safety Update Reports (DSURs)
- Annual Safety Reports (ASRs)
3. Signal Detection and Management
Proactively identifying new safety signals or changes in known risks is crucial. We manage the entire signal lifecycle:
- Identification of signals from ICSR databases, literature, aggregate reports, and regulatory agency websites.
- Utilization of in-house tools for signal detection and tracking.
- Assessment and performance of label update analysis.
- Providing actionable recommendations for risk minimization strategies.
4. Risk Management Plans (RMPs)
We help you proactively assess and manage potential drug-related risks in line with local requirements:
- Drafting, reviewing, and maintaining RMPs and Risk Evaluation and Mitigation Strategies (REMS).
- Developing customized procedures to classify safety risks.
- Implementing supplementary measures, including Post-Authorization Safety Studies (PASS), such as observational examinations and targeted follow-up questionnaires.
- Ensuring effective risk communication through appropriate labeling means (SmPC and PIL).
5. PV Audit, Compliance, and QPPV Services
Maintaining a compliant and high-quality PV system requires continuous oversight.
- PV Audit & Compliance: We conduct regular gap assessments, optimize audit plans, and perform mock audits to prepare organizations for inspections by the competent authority.
- PV Quality Management System (QMS) Oversight: Review of key documents like the Pharmacovigilance System Master File (PSMF), Safety Data Exchange Agreements (SDEAs), and PV SOPs.
- QPPV Retainer Services: Providing qualified personnel for Qualified Person for Pharmacovigilance (QPPV) and Deputy roles, ensuring continuous regulatory coverage.
