International Journal For Multidisciplinary Research

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Risk-Based Pharmacovigilance in India’s Diverse Healthcare Ecosystem: Implementation Strategies and Outcomes

Author(s) Ms. Aditi ripathi, Mr. Abhash kumar, Mr. Deep das
Country India
Abstract Pharmacovigilance (PV) systems globally are transitioning from traditional spontaneous reporting–based models to risk-based pharmacovigilance (RBPV) frameworks designed to prioritize regulatory, clinical, and public health actions based on differential product risk profiles. In India, this transition is particularly relevant due to the country’s highly diverse population, heterogeneous healthcare infrastructure, and rapidly expanding pharmaceutical market, which includes one of the world’s largest generic medicine industries, widespread use of biosimilars, and extensive consumption of fixed-dose combinations (FDCs). These factors collectively necessitate resource-optimized, targeted PV strategies capable of addressing national public health priorities while aligning with global regulatory expectations from ICH, FDA, and EMA.
This review evaluates the implementation strategies, challenges, and outcomes of RBPV within India’s complex healthcare ecosystem. It synthesizes recent regulatory updates, national PV data trends, empirical studies, and global best practices to examine how RBPV enhances the efficiency, responsiveness, and clinical relevance of safety surveillance activities. The paper outlines the theoretical foundations of RBPV, including proportionality, prioritization of important risks, and integration within quality management systems (QMS). It further analyzes India-specific challenges such as under-reporting, linguistic diversity, limited digital health penetration, and the need for India-specific risk management plans (iRMPs). Implementation frameworks related to AI-enabled signal detection, risk minimization tools, healthcare professional training, and stakeholder engagement are examined using national case studies.
The review additionally assesses early outcomes of RBPV adoption, including improvements in signal detection timelines, enhanced data completeness, targeted safety actions for high-risk products, and strengthened regulatory decision-making. Remaining gaps including inconsistent reporting quality, limited interoperability, and absence of standardized RBPV key performance indicators are discussed along with future opportunities for digital innovation, international harmonization, and integration with personalized medicine.
Overall, the paper highlights that India is positioned to become a regional leader in RBPV through collaborative governance, stronger digital infrastructure, and sustained regulatory evolution, ultimately strengthening public health protection.
Keywords Pharmacovigilance; Risk-Based Pharmacovigilance; India; Drug Safety; Signal Detection; Risk Management Plan; Public Health; Regulatory Science; PVPI; Quality Management; Healthcare Systems; Fixed-Dose Combinations.
Field Medical / Pharmacy
Published In Volume 7, Issue 6, November-December 2025
Published On 2025-12-10
DOI https://doi.org/10.36948/ijfmr.2025.v07i06.62787
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