Review on Pharmacovigilance

Abstract

In order to treat their illnesses and enhance their health, patients take medication. In addition to its therapeutic benefits, medicine can sometimes be harmful. Pharmacovigilance studies were conducted to control and monitor drug risk at every stage of a product\'s lifetime, from development to post-marketing for general public usage. In order to improve knowledge advancement through scientific theories, concepts, and ideas, this review was conducted to evaluate pharmacy students. Patients take medication to improve their health and treat their ailments. Medicine has therapeutic benefits, but it can also be dangerous at times. To regulate and monitor drug risk at every stage of a product\'s lifecycle, from development to post-marketing for general public use, pharmacovigilance studies were carried out. This evaluation was carried out to assess pharmacy students in order to enhance knowledge improvement through scientific theories, concepts, and ideas. This study was confirmed, modified, and adapted from previous studies

Introduction

I. Pharmacovigilance (PV)

• Definition: The study and practice of detecting, assessing, understanding, and preventing adverse effects of drugs and vaccines.

• Importance: Crucial for drug safety and reducing adverse drug reactions (ADRs), especially when new drugs are released with limited data.

• Methods: Reporting systems, automated reporting, data mining, and active surveillance.

• Historical Note: Triggered by incidents like thalidomide-induced birth defects.

• India’s Role: Limited contribution to WHO’s Uppsala Monitoring Centre, despite being a member.

• Timing: Primarily conducted in the post-marketing phase.

II. Clinical Research

• Focuses on evaluating new medications' safety and efficacy in human participants.

• Conducted in phases:

A. Phase 0

• Exploratory studies with minimal exposure to humans.

• Designed to bridge the gap between lab discoveries and market application.

B. Phase I

• Small groups (20–100 participants).

• Assesses safety, tolerability, pharmacokinetics, and pharmacodynamics.

• Starts with low doses based on animal data, increases cautiously.

C. Phase II

• Tests therapeutic potential in a larger group.

• Involves multi-center trials and various designs (e.g., case series, randomized trials).

• Often where most clinical developments fail.

D. Phase III

• Large-scale (100–3000 participants).

• Compares new treatments to existing ones.

• Includes Phase IIIA (pre-approval) and Phase IIIB (post-submission, pre-approval).

E. Phase IV

• Post-marketing surveillance to track long-term and rare side effects.

• FDA may require Phase IV for continued evaluation.

• Often involves real-world settings and may result in drug withdrawal or use restrictions.

III. Regulatory Bodies in India

A. Drug Controller General of India (DCGI)

• Oversees drug regulation under the Central Drugs Standard Control Organization (CDSCO).

• Approves clinical trials, enforces standards, educates analysts, and resolves disputes.

B. CDSCO

• Regulates new drug approvals, trial monitoring, import/export licensing.

• Central role in approving Investigational New Drugs (INDs) and New Drug Applications (NDAs).

IV. Regulatory Applications

A. Investigational New Drug (IND)

• Required for initiating human clinical trials.

• Must include: cover sheet, investigational plan, safety info, prior human/animal experience, and trial protocols.

B. New Drug Application (NDA)

• Seeks FDA approval for marketing new drugs.

• Includes a full index, technical review copies, summary documents, and safety data.

C. Abbreviated New Drug Application (ANDA)

• For generic drugs.

• Reviewed by the FDA to ensure generics are safe, effective, and affordable.

• Listed in the Orange Book.

V. Good Clinical Practice (GCP)

• Ethical and scientific quality standards for designing and conducting clinical trials.

• Focuses on protecting participants and ensuring data credibility.

• Follows guidelines from ICMR, WHO, ICH, USFDA, and European agencies.

VI. Drug Adverse Reactions (ADRs)

• ADRs differ from general Adverse Events (AEs) by having a suspected link to the drug.

• Two types:

  • Type A (Pharmacological): Predictable and dose-dependent.

  • Type B (Idiosyncratic): Unpredictable and not dose-dependent.

• Auditing involves verifying trial compliance, data accuracy, and adherence to SOPs.

• Blinding/Masking: Single or double-blind designs reduce bias in data collection and interpretation.

VII. Clinical Trials

• Studies that evaluate drugs’ clinical, pharmacological, and adverse effects on humans.

• Aim to confirm efficacy and safety before wider approval or continued use.

Conclusion

The text provides a detailed overview of pharmacovigilance and clinical research, emphasizing drug safety, the structured process of drug development, regulatory frameworks in India (DCGI, CDSCO), and ethical research practices (GCP). It highlights the importance of post-marketing surveillance and the necessity of global and national efforts in ensuring public health and drug safety.

References

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Copyright

Copyright © 2025 Priyanka Kotwal, Ketakee More, Arti Gadade, Nitin Gawai, Priyanka Godase. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.