By: ABRS- Academic Team
Introduction
The word pharmacovigilance originates from the Greek pharmakon (medicine) and the Latin vigilare (to keep watch), accurately reflecting its core purpose: to monitor medicines to protect patients. As highlighted by Anuja Bharati in her review on pharmacovigilance and clinical research, this field has evolved from a reactive response to past medical crises into a structured, strategic discipline integrated throughout the drug lifecycle.
Beyond commercial trials, non-profit research also requires robust pharmacovigilance systems. However, as Celeste Cagnazzo and Veronica Franchina point out, these initiatives often face significant challenges due to limited resources, insufficient training, and lack of multidisciplinary teams. A 2022 survey by GIDMcrc revealed that over 66% of non-profit research centers lacked formal pharmacovigilance support, and only 12% offered continuous, specialized training.
Rooted in Experience
Modern pharmacovigilance emerged in response to medical tragedies like the thalidomide disaster in the 1950s and 60s, which led to thousands of birth defects. This crisis drove the creation of the World Health Organization’s International Drug Monitoring Program in 1968. Since then, agencies such as the FDA, EMA, and ICH have introduced reporting systems, regulatory frameworks, and harmonized standards to ensure the continuous monitoring of drug-related risks.
Pharmacovigilance in Non-Commercial Research: Equal Standards, Greater Challenges
Although not driven by profit, non-commercial studies are held to the same regulatory standards in pharmacovigilance as industry-sponsored trials.
Yet, many centers lack qualified personnel, technical infrastructure, and ongoing training programs. Addressing these gaps is essential—not only for regulatory compliance but to ensure patient protection and scientific integrity.
A Continuous Commitment to Patient Safety
Pharmacovigilance is not just a post-marketing activity. As emphasized by Vishal Rai, Shekhar Singh, and colleagues in their 2024 review, it is a comprehensive scientific discipline that tracks the safety of medications from development through real-world use. Its objectives include identifying, evaluating, and preventing adverse effects—both short- and long-term—while enhancing therapeutic outcomes and promoting patient safety.
Key functions of pharmacovigilance include:
• Early detection of adverse drug reactions (ADRs)
• Ongoing benefit-risk assessment of medications
• Promotion of rational and cost-effective drug use
• Continuous training for healthcare professionals
• Clear and effective risk communication to the public
Technology is reshaping how pharmacovigilance is practiced. Tools like Electronic Health Records (EHRs) and Clinical Decision Support Systems (CDSS) enable real-time detection of adverse events, enhancing timely and personalized interventions.
A Global Perspective: The Case of India and Emerging Opportunities
The rapid expansion of clinical research in countries like India has tested the adaptability of pharmacovigilance systems. Chauhan, Yadav, and Kirodian argue that India’s increasing participation in global trials has highlighted the urgent need for safety frameworks aligned with international standards. While initial regulatory reforms—such as India’s GCP guidelines and updates to Schedule Y—marked progress, challenges persist in real-time safety monitoring, workforce training, and post-marketing surveillance.
India’s Pharmacovigilance Programme of India (PvPI), launched in 2010 and integrated with WHO platforms like VigiBase, reflects a significant step toward a more collaborative and proactive system. This case illustrates that success in pharmacovigilance depends not only on regulatory structures but on operational capability, continuous education, and ethical commitment.
Conclusion:
Pharmacovigilance has shifted from a peripheral function to a core pillar of modern clinical research. From its reactive beginnings to its current role as a proactive, collaborative, and technologically enhanced discipline, it now safeguards the entire drug development lifecycle. Global examples—like India’s evolving framework or the challenges of non-commercial trials in Europe—underscore a universal truth: without robust pharmacovigilance, there is no reliable science or protected public health.
At ABRS, we recognize that pharmacovigilance is not an isolated task—it is a strategic and cross-functional commitment throughout every stage of clinical development. Through our FullSpectrum model (FSP), we integrate highly trained safety professionals capable of managing risks proactively, ensuring regulatory compliance, and strengthening the scientific validity of clinical trials.
Pharmacovigilance is more than a regulatory obligation; it is an ethical and operational pillar. Strengthening it means advancing safer, more humane, and more sustainable clinical research.