Dayanand Education society's Dayanand College of Pharmacy, Latur, India..
Pharmacovigilance (PV) is an essential part of every health care system worldwide and is directed at ensuring safety and proper use of medicines throughout their life cycle. Increased globalisation of pharmaceutical development, the complexity of therapeutic agents, and increased exposure to post-marketing are making strong pharmacovigilance systems very important. Adverse drug reactions (ADRs) remain an important source of patient morbidity, mortality and health care expenditures. Studies indicate that a great proportion of ADRs can be prevented. In this paper, the comparison of pharmacovigilance practices in the USA, EU, and India is presented in a detailed way. It examines post-marketing monitoring strategies, organisational design, reporting systems, signal detecting approaches, and regulatory systems in these regions. Critical evaluation is given to regulatory monitoring, involvement of patients and healthcare professionals, benefits and demerits of spontaneous reporting systems. Under-reporting, bad quality of data, ignorance and resource constraints are the issues that are being discussed as ongoing and particularly in developing countries. Moreover, the latest advancements, which include pharmacovigilance 2.0, artificial intelligence, real-world evidence, and harmonisation of various global regulations, are explored as possible opportunities in the advancement of drug safety systems. This comparative analysis aims at providing insights that will enhance regulatory convergence on a global level, improve reporting practices, and enhance patient safety
According to the World Health Organisation, pharmacovigilance refers to the science and activity associated with identifying, evaluating, interpreting, and preventing drug-related adverse effects or other issues related to drugs.1 It is also important for health protection as it will guarantee the constant check of the pharmaceutical materials once they have reached validation and become commonplace. Although pre-marketing clinical trials provide valuable data on drug safety and efficacy, they have a number of limitations, such as small sample sizes, controlled conditions, and limited durations, which is why post-marketing surveillance is essential.23.
The adverse medication responses are recognised as a major contributor to hospital admissions and an increase in hospital days in many parts of the world.4 Research has indicated that ADRs make a great contribution to morbidity, mortality, and healthcare spending, and thus the importance of effective pharmacovigilance systems.5 Although there are already regular regulatory frameworks in place, under-reporting of ADRs is a global issue that hinders the efficiency of drug safety surveillance.6
2. OBJECTIVES:
1. For the monitoring of Adverse Drug Reactions (ADRs) within the Indian population.
2. To raise awareness among health care professionals regarding the significance of ADR reporting in India.
3. To oversee the benefit-risk profile of medications.
4. Create autonomous recommendations that are based on evidence regarding the safety of pharmaceuticals.
5. Assist the CDSCO in developing regulatory decisions concerning the safety of pharmaceuticals.
6. Convey results to all essential stakeholders.31
3. METHODOLOGY:
The study was conducted as a descriptive comparative study of the Indian, the European Union, and the United States pharmacovigilance practices. A detailed literature review was conducted using peer-reviewed journals, documents of regulatory authorities, and global information on the pharmacovigilance and adverse drug reaction (ADR) reporting. World Health Organisation (WHO) publications, the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Central Drugs Standard Control Organisation (CDSCO), and the relevant scientific articles published in indexed journals were used as the data sources28,29.
Articles and publications were selected based on being relevant to one of the following areas: pharmacovigilance systems, regulatory frameworks, ADR reporting procedures, signal detection procedures, or post-marketing surveillance in the sites selected. The data were gathered and analyzed qualitatively in order to compare the regulatory frameworks, reporting procedures, stakeholder involvement, and system issues. To show the similarities, differences, and emerging patterns in the practices of pharmacovigilance in India, the EU, and the United States, the results were summarized30.
4. ESTIMATED ADVERSE DRUG REACTIONS IN THE WORLD:
Delirious drug reactions are a significant issue in world health that carries substantial morbidity, mortality, and economic cost4,7. Potential hospital-based research suggests that the ADRs contribute to 5-7% of admissions, and ageing and polypharmacy patients are more vulnerable4,8A huge proportion of the ADRs can be prevented, which demonstrates the inefficiency of monitoring, reporting, and risk communication5,7.
One of the greatest barriers to successful pharmacovigilance is under-reporting. Hazell and Shakir discovered that less than 10 per cent of ADRs are reported worldwide. This trend is observed in both developed and emerging healthcare systems, but the causes could be different. In developed countries, the limits of weariness and workload are common, whereas in developing countries, the most common factors include the lack of knowledge and training9,23.
5. EVOLUTION OF PHARMACOVIGILANCE SYSTEMS:
The concept of Pharmacovigilance has become increasingly important over the past decades. Current pharmacovigilance involves systematic risk management plans, post authorization safety research, and active surveillance approaches, as opposed to the original use of spontaneous reporting systems10.
Pharmacovigilance techniques have been standardized in different regions with the aid of the International Council for Harmonisation (ICH) E2E guideline. Pharmacovigilance has now been transformed into a proactive and data-driven field thanks to data analytics, real-world evidence and automated signal detection techniques12.
5.1.PHARMACOVIGILANCE PRACTICES IN THE UNITED STATES:
The pharmacovigilance system of the US is one of the most developed in the world. Millions of data points are gathered in the FDA Adverse Event Reporting System (FAERS) every year in order to assist in post-marketing medication safety surveillance. The pharmaceutical manufacturers are forced to report regularly, and the healthcare providers and patients can do it on a personal basis using MedWatch14.FAERS is also adopting new sophisticated analytical methods, including automatic signal discovery and data mining algorithms, to handle large datasets15, 16. Pharmacovigilance studies that make use of FAERS data published in the real-world have demonstrated its effectiveness in detecting unusual and major adverse drug reactions (ADRs) not seen during pre-marketing testing. FAERS has been shown to have drawbacks such as duplicate reports, a lack of data fields, and biases in reporting, which may make signal interpretation challenging16.
5.2.EUROPEAN UNION OF PHARMACOVIGILANCE PRACTICES:
The EU pharmacovigilance system is characterised by a centralised and legalised system. EudraVigilance is a central database of ADR reporting in all EU member countries17. The responsibility of examining safety signals and prescribing regulatory measures is the Pharmacovigilance Risk Assessment Committee (PRAC). The EU laws have enhances patient engagement, openness, and accessibility to safety data by the citizens. The patient-reported adverse drug reactions (ADRs) can be used to gain important observations on the quality of life and safety issues in the long-term perspective20.
Nevertheless, the problems of data harmonisation between healthcare systems and languages still remain, and it is necessary to continue to coordinate them at the regulatory level18, 19.
5.3. THE INDIAN SCENARIO ON PHARMACOVIGILANCE PRACTICES:
The Pharmacovigilance Programme of India (PvPI) is an active system that improves the monitoring of the safety of medications in the country21. PvPI is co-ordinated by the Indian Pharmacopoeia Commission and has developed ADR monitoring facilities and incorporated reporting into national regulatory decision-making22.
Nonetheless, India has challenges like the under-reporting, lack of awareness among the healthcare providers, and resource limitations23, 24. In order to raise the ADR reporting rates, the literature suggests specific spontaneous reporting and planned training initiatives25.
The current pharmacovigilance infrastructure has a weak point, evidenced by the increasing pharmaceutical market in India and participation in international clinical trials26.
Table no.01.Comparative Analysis Of Pharmacovigilance Systems In Uunited States, European And India:
|
Sr.no |
Feature |
USA (United States) |
European Union (EU) |
India |
|
1 |
Regulatory Body |
United States Food and Drug Administration (FDA)
|
European Medicines Agency (EMA) collaborates with national competent agencies. |
Central Drugs Standard Control Organisation (CDSCO)
|
|
2 |
Program/System |
The FDA Adverse Event Reporting System (FAERS)
|
EudraVigilance has Good Pharmacovigilance Practices (GVP). |
Pharmacovigilance Programme of India (PvPI).
|
|
3 |
Reporting (Manufacturers |
Mandatory to report severe and unexpected adverse events within 15 days.
|
Must report serious suspected adverse reactions to EudraVigilance within 15 days. |
Mandatory reporting is required; underreporting poses a significant difficulty. |
|
4 |
Reporting (Healthcare Professionals & Consumers) |
The Med-Watch initiative allows for voluntary reporting.
|
The GVP rules include detailed, harmonised reporting procedures. |
Voluntary reporting; underreporting poses a significant challenge.
|
|
5 |
Risk Management |
Drugs having possible dangers may necessitate a Risk Evaluation and Mitigation Strategy (REMS).
|
A Risk Management Plan (RMP) is a required component of marketing authorization applications. |
The concept is gaining traction, although it's not as extensive or mandated as in the EU. |
|
6 |
Periodic Reporting |
Periodic Adverse Experience Reports (PADERs).
|
Periodic Safety Update Reports (PSURs).
|
Periodic Safety Update Reports (PSURs) pursuant to Schedule Y of the Drugs and Cosmetics Rules, 1945 |
|
7 |
System Maturity |
One of the world's most durable and mature systems
|
A network that is unified and highly harmonised. |
A rapidly changing, developmental phase system |
|
8 |
Technology |
A well-integrated FAERS database with enhanced analytics
|
EudraVigilance, the central database
|
Lacks a centralized, comprehensive digital database such as FAERS or EudraVigilance. |
|
9 |
Challenges |
N/A |
N/A |
Underreporting, a fragmented healthcare system, and insufficient digital integration. |
6. COMPARATIVE ANALYSIS OF REGULATORY FRAMEWORKS:
The paper compares the measures taken by regulatory bodies in diverse jurisdictions concerning their response to financial reporting issues.
India, the EU, and the USA are all interested in the safety of patients, but the level of pharmacovigilance regulation is at different stages and varies in technological integration10,11. In the US, data-driven surveillance and automation are encouraged, whereas in the EU, centralised risk evaluation and patient engagement are more popular, and India focuses on system development and capacity building23,25.
7. FUTURE PERSPECTIVE:
Pharmacovigilance 2.0 shifts from passive reporting to proactive and predictive safety surveillance²?. Integrating artificial intelligence, real-world evidence, electronic health records, and global data-sharing platforms can improve signal detection and regulatory responsiveness²?, ²?.
The ICH guidelines aim to harmonize pharmacovigilance methods globally, decreasing regulatory gaps and increasing patient safety outcomes¹¹.
CONCLUSION
Pharmacovigilance remains an important component of medication safety and public health protection. While India, the EU, and the United States share identical goals for protecting patient safety, there are major disparities in legislative frameworks, reporting methods, and system maturity. Strengthening international collaboration, harmonising regulatory standards, and fostering a culture of proactive ADR reporting are critical to resolving developing drug safety issues and improving global patient safety.
Funding:
Not Applicable.
Conflicts of Interest:
The authors declare that there is no conflict of interest.
Author Contributions:
All authors contributed equally to the conception, design, literature review, drafting, and final approval of the manuscript.
REFERENCES
Rathod N. R., Dr. Lohiya G. V., Satpute K. L., A Comparative Study OF Pharmacovigilance Practices in India, the European Union, and the United States, Int. J. of Pharm. Sci., 2026, Vol 4, Issue 4, 340-346 https://doi.org/10.5281/zenodo.19389723
10.5281/zenodo.19389723
