Review on Pharmacovigilance

Abstract

Pharmacovigilance involves the science and practice of identifying, evaluating, understanding, and preventing adverse effects or other issues related to drugs. The legal framework governing pharmacovigilance for medicinal products in the EU/European Economic Area (EEA) is outlined in a series of Directives that detail the responsibilities of marketing authorization holders and regulatory agencies. Experiences from the past two decades with medicines have highlighted the crucial need for a systematic approach to studying drug safety and managing drug risks. Among all the fields discussed in this chapter, pharmacovigilance has particularly advanced within the pharmaceutical industry and its regulatory bodies.

Introduction

The pharmaceutical industry in India has grown significantly, with a total export value of Rs. 40,000 crore. India has become a hub for clinical trials, drug discovery, and the development of new medications. As new drugs and therapies are introduced, pharmacovigilance has gained increasing importance, especially for recently developed medicines. Pharmacovigilance involves monitoring a drug's safety throughout its lifecycle, from pre-marketing (clinical trials) to post-marketing phases.

Key Aspects of Pharmacovigilance:

• Objective: Pharmacovigilance aims to improve patient safety, reduce risks, enhance the benefits of medical care, and prevent adverse effects.

• History: It began in 1961 following the Thalidomide tragedy. Significant historical events include the identification of harmful reactions to chloroform (1848) and sulfanilamide (1937), which spurred regulatory measures and led to the creation of international drug monitoring systems.

• Methods: Different assessment techniques, like the balanced assessment method, the Australian method, and the Ciba-Geigy method, are used to evaluate drug safety through expert analysis and case reports.

Regulatory Guidelines and Oversight:

• ICH Guidelines: These guidelines focus on minimizing animal use, ensuring ethical practices in clinical trials, and harmonizing nonclinical safety research standards.

• DCGI (Drugs Controller General of India): The DCGI, under the Ministry of Health & Family Welfare, regulates the approval, manufacturing, and sale of drugs in India, overseeing clinical trials and pharmacovigilance programs.

• CDSCO (Central Drugs Standard Control Organization): This body is responsible for drug approval, regulatory standards, quality control, clinical trial oversight, and pharmacovigilance in India. It ensures the safety and efficacy of drugs and medical devices in the country.

Career Prospects:

The pharmacology and clinical trials field offers diverse job opportunities such as:

• Clinical research associate

• Data management specialist

• Medical writer

• Drug safety officer

• Regulatory affairs manager, among others.

In summary, pharmacovigilance is essential for ensuring drug safety, and India's robust regulatory systems and guidelines continue to advance in order to maintain public health and safety.

Conclusion

Pharmacovigilance fundamentally relies on both the qualitative and quantitative analysis of spontaneous reports of adverse drug reactions, followed by a clinical evaluation regarding its influence on the drug\'s overall safety profile. The Indian pharmaceutical sector ranks as the third largest by volume and the thirteenth largest by value. The market is primarily led by branded generic medications, which account for approximately 70-80% of total market share. Thus, establishing a standardized pharmacovigilance framework for monitoring drug ADRs and ensuring patient safety is essential. The reporting of ADRs post-marketing should be proactively promoted and should involve all stakeholders, including healthcare professionals such as doctors, pharmacists, nurses, and pharmaceutical companies.

References

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Copyright

Copyright © 2025 Ankita Tarkasband, Nitin Gawai, Nidhi Jawalkar, Rutuja Dhaigude. 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.