Background: Adverse Drug Reactions (ADRs) remain a critical challenge in clinical therapeutics, significantly impacting global morbidity, mortality, and healthcare costs. In the Indian context, the Pharmacovigilance Programme of India (PvPI) serves as the primary regulatory framework for identifying and mitigating these risks.  Objective: This study aimed to evaluate the incidence, clinical patterns, and severity of suspected ADRs, perform rigorous causality assessments, and implement a structured pharmaceutical counseling framework to enhance medication safety in a tertiary care setting.  Methodology: A prospective, non-interventional observational study was conducted across the Inpatient Departments (IPD) of Orthopedics and General Surgery at Arunai Medical College and Hospital (October 2025–February 2026). Out of 728 screened patient records, suspected ADRs were documented using the CDSCO reporting tool. Causality was validated via the WHO-UMC scale and Naranjo’s Probability Scale, while severity was stratified using the Modified Hartwig and Siegel Scale.  Results: A total of 80 ADRs were identified, representing an incidence rate of 10.98%. Demographic analysis revealed a male predominance (63.75%) and a higher susceptibility within the geriatric and middle-aged cohorts (mean age: 53.6 \pm 21.1 years). Antimicrobials (23.75%) and Analgesics (15%) were identified as the primary pharmacotherapeutic triggers. The most frequent clinical manifestations were gastrointestinal (39.2%), with constipation being the predominant symptom. Severity assessment categorized 56.25% of reactions as "Mild" and 43.75% as "Moderate." Causality analysis classified the majority of cases (66.25%) as "Probable."  Conclusion: The study underscores a notable ADR burden in surgical and orthopedic settings, frequently exacerbated by polypharmacy. These findings advocate for an integrated pharmacovigilance approach—led by clinical pharmacists— emphasizing active surveillance and patient education to pre-emptively manage medication-related risks and optimize therapeutic outcomes.

Adverse Drug Reactions (ADRs) represent a significant challenge to patient safety and public health worldwide. Historical evidence demonstrates that even commonly prescribed and seemingly safe medications, particularly antibiotics and other therapeutic agents, may produce harmful and sometimes fatal reactions. Globally, structured drug safety monitoring evolved following landmark events such as the thalidomide tragedy in 1961, which led to the strengthening of international pharmacovigilance systems under the guidance of the World Health Organization. In India, organized efforts in ADR monitoring began in the late 20th century, with formal participation in the WHO International Drug Monitoring Programme in 1997. Subsequent initiatives, including the National Pharmacovigilance Programme (2004) and the Pharmacovigilance Programme of India (PvPI) launched in 2010 under the Indian Pharmacopoeia Commission, significantly strengthened the national drug safety framework. Today, ADR monitoring in India operates through a structured network involving the National Coordination Centre (NCC) and the Central Drugs Standard Control Organisation. This paper reviews the history and development of ADR monitoring in India, outlines classifications of ADRs (Rawlins and Thompson classification, severity-based, onset-based, and DoTS classification), and discusses preventive, identification, management, and reporting strategies. Special emphasis is placed on pharmacovigilance in homoeopathy and its role in enhancing patient safety and evidence-based practice. Strengthening ADR reporting systems and promoting awareness among healthcare professionals remain critical for ensuring rational and safe use of medicines across all systems of healthcare.

Isoniazid (INH) is a cornerstone first-line antitubercular drug widely used in the treatment of tuberculosis. Although generally well tolerated, INH can rarely cause neuropsychiatric adverse effects, including acute psychosis, which may pose diagnostic and therapeutic challenges. We report four cases of pulmonary tuberculosis in which patients developed acute-onset psychotic symptoms following the initiation of therapeutic doses of INH. The onset of symptoms occurred without prior psychiatric history and was temporally related to INH administration. The proposed mechanisms include INH-induced inhibition of monoamine oxidase and pyridoxine (vitamin B6) deficiency, leading to altered neurotransmitter metabolism. All patients showed clinical improvement following withdrawal or dose modification of INH, administration of low-dose atypical antipsychotics, and pyridoxine supplementation. Causality and severity of the adverse drug reactions were assessed using the World Health Organization–Uppsala Monitoring Centre (WHO–UMC) scale, the Karch and Lasagna algorithm, and the Modified Hartwig and Siegel severity scale. All cases were reported to the Adverse Drug Reaction Monitoring Centre under the Pharmacovigilance Programme of India (PvPI). INH-induced psychosis, though rare, is a clinically significant adverse drug reaction that requires early recognition and prompt management. Awareness of this potential complication, routine patient counselling, and vigilant pharmacovigilance are essential to ensure patient safety and optimize tuberculosis treatment outcomes.

Real-World Evidence (RWE) derived from Real-World Data (RWD) has gained global prominence as a critical complement to traditional clinical trial data for post-marketing safety surveillance. Regulatory agencies including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and CIOMS emphasize the value of RWE in enhancing signal detection, improving risk assessment, and informing regulatory decisions. In pharmacovigilance (PV), RWE enables longitudinal follow-up, supports detection of rare and delayed adverse drug reactions (ADRs), and enhances safety monitoring in diverse, real-world populations. India’s rapidly evolving healthcare ecosystem with a vast heterogeneous population, mixed public-private systems, and increasing digitalization presents a strong opportunity for RWE-based PV. Initiatives such as the Pharmacovigilance Programme of India (PvPI) have strengthened spontaneous reporting, but integration of RWD sources such as electronic health records (EHRs), claims data, registries, and digital health platforms remains nascent. The absence of standardized data architectures, limited penetration of EHRs, fragmented registries, and variable data quality present significant barriers to large-scale active surveillance. Simultaneously, emerging analytical methodologies, including machine learning (ML) and artificial intelligence (AI), are being increasingly applied to large RWD sources for early detection of safety signals and prediction of risk patterns. These innovations hold promise for application within the Indian regulatory context. This review synthesizes global and Indian perspectives on RWE for signal detection, outlines current frameworks, evaluates available RWD sources, and examines emerging methods including AI/ML. It also discusses operational, regulatory, and ethical challenges in India and proposes a roadmap for strengthening RWE-based pharmacovigilance systems. By consolidating insights from open-access scientific literature and regulatory guidance, this review aims to support PV scientists, regulators, and healthcare policymakers in harnessing RWE to enhance drug safety and public health in India.

To improve drug safety monitoring nationwide, the Pharmacovigilance Programme of India (PvPI) was established in July 2010. Over the last decade, PvPI has expanded from a small number of coordinating centres to a nationwide network of Adverse Drug Reaction Monitoring Centres (AMCs), introduced new reporting methods, and made significant progress in connecting with international pharmacovigilance systems. This review documents the growth of PvPI, discusses its organisational structure and important operational milestones, evaluates trends in adverse drug reaction (ADR) reporting and signal detection, and assesses the programme's influence on regulatory decision-making and public health. Along with highlighting opportunities brought about by digital reporting, stakeholder participation, and international collaboration, it also examines enduring issues such as underreporting, data quality, geographical discrepancies, and integration of traditional and herbal medicine safety. There are suggestions for boosting India's pharmacovigilance ecosystem, with an emphasis on enhancing consumer reporting, data analytics, connections between academia, industry, and regulators, and ongoing capacity building. International collaborations have improved the stage of development and responsiveness of the domestic system and increased India's involvement in international drug-safety surveillance. Expanding AMC coverage, requiring ADR reporting in the private sector, including pharmacovigilance in all health curricula, utilising AI-driven analytics, and extending surveillance to include conventional medications, biologics, and counterfeit drugs are some of the future directions. Securing sustainable funding and promoting international cooperation are also crucial. A strong and comprehensive pharmacovigilance system is essential as India works towards universal health care to guarantee that the advantages of medications continuously exceed their risks for everyone. In summary, the future of pharmacovigilance will depend on its capacity to maintain its main goal of safeguarding patient health while embracing technological advancements, fostering collaborative networks, and adjusting to scientific findings.

The COVID-19 pandemic fundamentally redefined pharmacovigilance (PV) systems worldwide, serving as both a challenge and a catalyst for innovation. In India, the crisis accelerated the digital transformation of drug safety surveillance, leading to the rapid adoption of real-time adverse drug reaction (ADR) reporting, vaccine safety monitoring, and enhanced data transparency. The pandemic highlighted the need for agile governance, public engagement, and technology-driven vigilance to manage large-scale therapeutic interventions effectively . Key developments included the strengthening of the Pharmacovigilance Programme of India (PvPI), integration of artificial intelligence (AI) for signal detection, and the emergence of patient-centered reporting platforms. The Indian experience underscores a paradigm shift from traditional, compliance-based pharmacovigilance to a data-driven, citizen-inclusive, and AI-assisted ecosystem. This evolution not only improved national drug safety responsiveness but also positioned India as a model for resilient, intelligent, and participatory pharmacovigilance in the post-pandemic era.

In India, the traditional pharmacovigilance (PV) model has been predominantly “drug-centric,” relying on spontaneous adverse event reporting by healthcare professionals. However, chronic under-reporting, low public awareness, variable healthcare access, and socio-linguistic diversity limit the effectiveness of conventional systems. To bridge this gap, a shift toward patient-centric pharmacovigilance is emerging, in which patients (and/or caregivers) are active partners in detecting, reporting, and understanding adverse drug reactions (ADRs). This review examines the rationale, challenges, and innovative approaches for implementing patient-centric PV in India, emphasizing digital, community-based, and communication strategies tailored to the Indian context. We begin by establishing the conceptual underpinnings of patient-centric PV, defining its principles as a move from passive reporting to active partnership and then explore the specific imperatives in India: under-reporting, low health literacy, genetic and phenotypic heterogeneity, polypharmacy, and the use of traditional medicine. The role of the Pharmacovigilance Programme of India (PvPI) in promoting patient engagement is scrutinized. Next, we catalogue and assess innovative reporting strategies: mobile apps (with vernacular options), QR codes, integration with EHRs, AI/NLP mining of unstructured patient narratives (in social media or call transcripts), and leveraging pharmacists and patient support groups as intermediaries in reporting. Strategies to counter under-reporting such as simplified forms, feedback loops, and assurance of confidentiality are also discussed. In the domain of risk communication, we emphasize culturally appropriate messaging (multilingual, plain language summaries, info graphics), multi-channel dissemination (social media, radio, local campaigns), and two-way feedback mechanisms (helplines, interactive Q&A) to foster informed decision-making. We then critically examine challenges: verifying data quality from patient reports, digital divides, and infrastructure limitations at ADR Monitoring Centers (AMCs), and health/digital literacy constraints. The regulatory landscape current PvPI guidelines, alignment with global best practices, and gaps is analyzed. We conclude with future perspectives: embedding patient input in risk minimization plans, pharmacogenomics-based individualized risk profiling, sustained patient education, and closed feedback loops for continuous improvement. This review is intended as both a scholarly synthesis and a promotional narrative for elevating patient voice in India’s drug safety systems. It is hoped that by highlighting innovations and pragmatic pathways, stakeholders (regulators, industry, academia, NGOs) will accelerate adoption of patient-centric pharmacovigilance, ultimately strengthening drug safety and patient trust in India.

The escalation of pharmaceutical use and the emergence of India as a global leader in drug manufacturing and clinical research necessitate a robust pharmacovigilance (PV) system. This review discusses the trajectory of drug safety monitoring in India, from its nascent, fragmented beginnings to the establishment of the formal Pharmacovigilance Programme of India (PVPI). It analyzes the current operational structure coordinated by the Indian Pharmacopoeia Commission (IPC), which aims to collate and evaluate Adverse Drug Reaction (ADR) data from across the nation. Despite significant structural progress, the system's efficacy is impeded by critical challenges. Foremost among these is a pervasive culture of under-reporting by healthcare professionals, compounded by gaps in medical and pharmacy education where PV is often not integrated as a core clinical responsibility. Infrastructural deficits, particularly in rural healthcare settings, and a lack of standardized implementation across states further fragment the national data landscape. Patient reporting, a valuable data source in many Western nations, remains minimal. This analysis indicates the urgent need for a multi-pronged strategy focused on regulatory enforcement, educational reform, and the integration of clinical pharmacists into safety-monitoring protocols. Strengthening this system is a public health imperative to protect the population and ensure the benefits of therapeutic agents outweigh their risks

Background: Pharmacovigilance (PV) is essential for ensuring drug safety by monitoring and reporting adverse drug reactions (ADRs). Despite the presence of national programs such as the Pharmacovigilance Programme of India (PvPI), underreporting of ADRs remains a challenge. This study aimed to evaluate the knowledge, attitude, and practice (KAP) regarding pharmacovigilance among healthcare professionals in Warangal, Telangana, and to identify gaps influencing ADR reporting. Materials and Methods: A prospective observational, questionnaire-based study was conducted over six months among 200 healthcare professionals, including doctors, nurses, and pharmacists, in hospitals, pharmacies, and colleges of Warangal. A pretested 20-item structured questionnaire assessed KAP domains. Descriptive statistics, including frequencies and percentages, were used to analyze responses. Results: Most participants (84.3%) correctly defined pharmacovigilance, and 91% were aware of the PvPI. A majority (95.2%) agreed ADR reporting is necessary, and 96.2% supported teaching PV in detail to healthcare professionals. However, only 17.5% had ever reported an ADR, despite 65.4% encountering one during practice. While 67.2% had seen an ADR reporting form, only 45.4% had received training on ADR reporting. Key barriers identified included lack of time (46.9%), difficulty in determining causality (24.6%), and insufficient training. Pharmacists constituted the largest group of respondents (45.5%), followed by nurses (34.6%) and doctors (19.9%). Conclusions: The study revealed satisfactory knowledge and positive attitudes toward pharmacovigilance but poor reporting practices among healthcare professionals. Strengthening pharmacovigilance requires targeted training, simplified reporting procedures, institutional support, and integration of PV into professional education. Bridging the gap between awareness and practice is crucial for improving ADR reporting and ensuring patient safety

Adverse Drug Reactions (ADR) are one of the common causes of hospital admissions and pose a significant clinical and economic burden on the healthcare system. The Adverse Drug Reaction Monitoring Centre (AMC) in JIPMER functioning under the Pharmacovigilance Programme of India (PvPI) plays a vital role in ensuring medication safety by routinely detecting and monitoring ADRs. Hence, this study aimed to assess the characteristics of ADR reported from 2010 to 2020 in AMC JIPMER and to detect signals, if any. To study the characteristics of Adverse Drug Reactions (ADR) reported to a regional ADR monitoring center from 2010 to 2020 and to detect signals of disproportionate reporting (SDRs) if any from the reported ADRs. A total of 6007 ADR reports with a single suspect drug were included for analysis from 2010 to 2020. The characteristics of these reports, including patient's age and gender, Number and percentage of ADRs, the causality of ADR using WHO UMC (World Health Organization-Uppsala Monitoring Centre) scale, the seriousness of the ADR, and outcome were collected from the ADR reports. MedDRA (Medical Dictionary for Regulatory Activities) Preferred Terms (PT) were used to classify adverse drug reactions. Causality analysis using the Naranjo Algorithm and Preventability using Modified Schumock and Thornton criteria were performed for the ADRs. The number and percentage of severe ADRs were analyzed. The System Organ class of all the ADRs was enumerated. ADRs not mentioned in the US FDA (United States Food and Drug Administration) product label (unlabelled reactions) were documented. Unlabeled reactions with ≥3 ADR reports were included for signal detection by disproportionality analysis. Antineoplastic drugs, followed by antimicrobials, anticonvulsants, Anti snake venom, and NSAID were the most common drugs implicated in ADRs. Skin and subcutaneous tissue disorders were the most common System Organ Class (SOC) involved in the ADRs. Among the 6007 reports, 19.2% were serious ADRs. Most of the ADR reports were of possible causality followed by probable and certain as per WHO UMC and Naranjo causality scales. Only ten ADRs were preventable and one reaction (Tamoxifen-induced neuropathy) was eligible for signal detection. Disproportionality analysis using a 2x2 contingency table showed insignificant signal detection using the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). Analysis of ADRs from an ADR Monitoring center functioning in a tertiary care hospital shows antineoplastic drugs to be the most common drugs associated with adverse drug reactions, with rash being the most common adverse effect. The majority of the ADRs were not preventable. No Signals of Disproportionate Reporting (SDR) were detected in our study.

Infections with Soil-transmitted Helminths (STHs) impact about 24% of the global population. A disproportionate number of individuals, particularly those from low socioeconomic backgrounds, live in emerging nations. In India, between the ages of one and fourteen, almost 220 million children are susceptible to intestinal worm infestations caused by parasites. The National Deworming Day (NDD) initiative was started by the Indian government in February 2015 as a part of the National Health Mission to address this problem. Though the adverse effects of albendazole in routine therapy are known, the mass administration of the medicine in children as part of a public health program has not been adequately studied. This study aimed to determine the occurrence, type, and severity of adverse drug reactions resulting from mass administration of albendazole in school children aged 6-19 years in a district of northern India. Twenty specified clusters were randomly chosen from a total of 96 clusters in the district to participate in this prospective, descriptive, observational study that was carried out in Karnal, Haryana. Both a passive approach and an active adverse drug reaction reporting system were used in the study. The six-step process known as Deb's Active Surveillance & Assisted Reporting System was employed in our study. Adverse drug reactions were recorded using the suspected Adverse Drug Reaction (ADR) reporting form of the Pharmacovigilance Programme of India (PvPI). Twenty clusters with a combined total of 94 schools and 12,751 students were observed during the study. In this study, there were more female participants (N = 8,060; 63.21%) than male participants (N = 4,691; 36.78%). A total of 29 ADRs were reported. All reported ADRs were mild in nature. It was discovered that there were 1.37 incidences for every 1000 individuals. As illustrated in Fig. (1), the most frequently reported Adverse Drug Reactions (ADRs) were vomiting (N = 10), nausea (N = 4), abdominal pain (N = 2), and headache (N = 1). The majority of ADRs were categorized as probable (N=18; 62.06%), followed by possible (N=11; 37.93%). An active surveillance system alongside voluntary passive reporting during the mass administration of medicines can help evaluate the safety profile of the medicinal products. The occurrence of ADRs following mass administration of albendazole in school children was found to be only 1.37 incidences for every 1000 recipients, being mild in nature, with vomiting being the most common.

BackgroundAdverse drug reactions (ADRs) pose significant risks to patient safety, particularly in tertiary care settings characterized by polypharmacy and multiple comorbidities. Monitoring and evaluating ADRs is vital to improving therapeutic outcomes and minimizing harm.ObjectiveThis study aimed to assess the pattern, severity, predictability, seriousness, and causality of ADRs reported in a tertiary care teaching hospital in Belagavi, India.MethodsA prospective observational study was conducted on 2035 spontaneously reported ADRs collected between January and December 2024 at the Adverse Drug Reaction Monitoring Centre under the Pharmacovigilance Programme of India (PvPI). Data were analyzed using the WHO-UMC causality assessment, Hartwig and Siegel severity scale, and standard classifications for seriousness and predictability.ResultsAdults (60.54%) and elderly (24.67%) were most frequently affected. Gastrointestinal disorders (23.91%) were the most commonly reported System Organ Class (SOC). Most ADRs were predictable (87.81%) and probable in causality (67.91%). Severe ADRs accounted for 15.97%. Vomiting and headache were the most reported adverse events. Antiretroviral were the most commonly implicated drug class.ConclusionThe majority of ADRs were predictable and involved widely used drug classes. Strengthening pharmacovigilance practices and implementing targeted clinical interventions are essential to prevent avoidable ADRs and improve patient safety.

Objective: Anticancer drugs are responsible for most adverse drug reactions (ADRs) in cancer patients worldwide. ADR reporting of anticancer drugs is sporadic in India, especially in rural areas, due to the lack of awareness and knowledge about the Pharmacovigilance Programme of India (PvPI). This study assessed the causality and severity pattern of ADRs with anticancer drugs in cancer patients. Methods: An observational, prospective, and single-center study was conducted at the oncology unit of the District Government Hospital, Jhabua, of Madhya Pradesh. Patients of either sex, aged>18 y, reporting ADRs with anticancer drugs from April 1, 2024, to July 31, 2024, were included. The analysis focused on demographic data of the patients, suspected drugs, causality assessment using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, and severity assessment. Results: The age group of 41-60 y (61%) and females (68%) reported the highest number of ADRs. The maximum number of ADRs was reported with the use of platinum compounds (cisplatin, carboplatin, and oxaliplatin) (34%), followed by taxanes (paclitaxel and docetaxel) (28%). The gastrointestinal system (39.38%) was the most commonly involved, and nausea (20.33%) was the most common ADR among all. The majority of ADRs were certain (76%) and mild (48.36%). Conclusion: ADR reporting, monitoring, and timely management are important to increase the outcome of anticancer treatment. It’s important to increase awareness regarding PvPI among healthcare professionals and patients.

The Pharmacovigilance Programme of India (PVPI), established in 2010, has become a cornerstone of India’s public health strategy for drug safety. This review critically examines PVPI’s evolution, organizational structure, reporting mechanisms, and signal detection processes. Key achievements include a dramatic increase in Individual Case Safety Reports (ICSRs), the expansion of the AMC network, digital innovations such as the ADR PVPI app, and recognition as a WHO Collaborating Centre. PVPI’s regulatory interventions, such as label changes for carbamazepine-induced Stevens–Johnson Syndrome, demonstrate its impact on patient safety. However, persistent challenges remain: underreporting (especially from the private sector), data quality concerns, limited surveillance of traditional medicines and biologics, funding constraints, and state-level disparities. Comparative analysis with US and EU pharmacovigilance systems highlights the need for mandatory reporting, harmonized data standards, and robust risk management frameworks. Future directions include expanding AMC coverage, mandating ADR reporting in the private sector, integrating pharmacovigilance into all health curricula, leveraging AI-driven analytics, and broadening surveillance to cover traditional medicines, biologics, and counterfeit drugs. Strengthening international collaboration and securing sustainable funding are also essential. As India moves toward universal health coverage, a robust and integrated pharmacovigilance system is vital to ensure that the benefits of medicines consistently outweigh their risks for every citizen.

Abstract: Due to its ability to track drug interactions and their physiological effects on humans, pharmacovigilance is a vital component of the healthcare system. The ability to monitor and analyze medications for quality as well as identify and halt any unfavorable drug side effects makes pharmacovigilance a crucial component of modern technology. Drug safety data collection and coding, as well as case management reporting and submission, comprise case processing, which is the first step in pharmacovigilance. The Pharmacovigilance Programme of India was established in response to these advancements. India participates in the Uppsala Monitoring Centre system but contributes very little to the database itself. The objective of this research is to conduct a comprehensive analysis of the pharmacovigilance program in India and provide a succinct, current evaluation of the organization, taking into account its background and possible issues. The development of "A Pharmacovigilance Programme of India" mobile application was emphasized by the National Coordination Centre PvPI to India as a means of enhancing public health and encouraging prompt reporting of adverse drug reactions. With more and more cutting-edge veterinary medications entering the market, India needs a veterinary pharmacovigilance system. One of the most significant current responsibilities is demonstrating to the world that thousands of years-old Ayurveda Siddha Unani systems are safe and grounded in science.

Abstract: Due to its ability to track drug interactions and their physiological effects on humans, pharmacovigilance is a vital component of the healthcare system. The ability to monitor and analyze medications for quality as well as identify and halt any unfavorable drug side effects makes pharmacovigilance a crucial component of modern technology. Drug safety data collection and coding, as well as case management reporting and submission, comprise case processing, which is the first step in pharmacovigilance. The Pharmacovigilance Programme of India was established in response to these advancements. India participates in the Uppsala Monitoring Centre system but contributes very little to the database itself. The objective of this research is to conduct a comprehensive analysis of the pharmacovigilance program in India and provide a succinct, current evaluation of the organization, taking into account its background and possible issues. The development of "A Pharmacovigilance Programme of India" mobile application was emphasized by the National Coordination Centre PvPI to India as a means of enhancing public health and encouraging prompt reporting of adverse drug reactions. With more and more cutting-edge veterinary medications entering the market, India needs a veterinary pharmacovigilance system. One of the most significant current responsibilities is demonstrating to the world that thousands of years-old Ayurveda Siddha Unani systems are safe and grounded in science.

To develop a structured and harmonized causality assessment method has been a holy grail in pharmacovigilance. The Pharmacovigilance Programme of India (PvPI) recommends the use of the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, whereas many clinicians prefer the Naranjo algorithm for its simplicity. There is no universally accepted method for the causality grading of ADRs. In the present study, we assessed agreement and correlation between the two widely used causality assessment scales, that is, the WHO-UMC criteria and the Naranjo algorithm. In this study, 313 individual case safety reports were analyzed from April 1, 2020, to March 31, 2023, reported at the Adverse Drug Reaction Monitoring Center (AMC) at Kalpana Chawla Government Medical College, Karnal. Two well-trained independent groups performed a causality assessment. One group performed a causality assessment of 313 ADRs using the WHO-UMC criteria and the other group performed the same using the Naranjo algorithm. The agreement between two ADR causality scales was assessed using the weighted kappa (κ) test. Spearman's correlation was also used to find the correlation between the two scales. Cohen's kappa coefficient (κ) statistical test was applied between the two scales (WHO-UMC scale and Naranjo algorithm) to find out the agreement between these two scales. A weak agreement was found between the two scales (Kappa statistics with 95% confidence interval = 0.463, [P < 0.001]). Spearman's correlation coefficient was found to be 0.506. The assessment of causality for adverse drug reactions (ADRs) is challenging, and none of the different methods available for assessing ADR causality is accepted as the gold standard. In our study, we found weak agreement between the WHO-UMC criteria and the Naranjo algorithm. It is essential to standardize the causality assessment tool to create a universally acceptable method for assessing causality. Further research is needed to establish a gold standard method for assessing the causality of adverse drug reactions.

Pharmacovigilance (PV) is the science dedicated to detecting, assessing, understanding, and preventing adverse effects or other drug-related issues, with a primary focus on adverse drug reactions (ADRs). ADRs, defined as harmful and unintended responses to medications, can pose significant health risks, including morbidity and mortality. Despite rigorous pre-clinical and clinical testing, some ADRs only emerge post-marketing when drugs are used by larger populations. Pharmacovigilance systems, therefore, play a crucial role in ongoing drug safety monitoring, utilizing methods such as data mining and case report analysis. Historically, PV originated in response to major drug-related incidents, such as the 1937 sulfanilamide disaster in the U.S., which spurred the development of the first regulatory system for drug safety. In India, PV efforts began in 1997 when the country joined the WHO Adverse Drug Reaction Monitoring Program. However, the establishment of the National Pharmacovigilance Program in 2005 marked a significant step forward, with further developments through the Pharmacovigilance Program of India (PvPI) launched in 2010.PV aims to improve patient safety by identifying new ADRs, assessing risk factors, and enhancing the benefit-risk ratio of marketed drugs. It also promotes education and awareness on safe drug use. The Drug Controller General of India (DCGI) plays a vital regulatory role, ensuring drug safety through post-marketing surveillance and compliance. As India continues to grow as a hub for clinical trials, a robust PV system is essential for ensuring public health and safety.

Background:India has a functional and mature National Regulatory Authority which ensures that vaccines manufactured and used in the country are safe. Monitoring adverse events post-licensure is equally critical to identify infrequent adverse events due to the vaccine product.Material and Methods:This was a cross-sectional observational qualitative study done in a Metropolitan city in Maharashtra from January 2017 to June 2018. Focus group discussions (FGDs) were conducted with healthcare workers and stakeholders involved in adverse event following immunization (AEFI) surveillance in the city. The data obtained were transcribed and analyzed using the inductive method. Thematic analysis was done using the grounded theory. Data were analyzed using ATLAS ti 5.7.1.Results:It was found that both active and passive surveillance were being followed in the study area helped in improving reporting rates and in early detection and management of adverse events. It was noted that there was no proper training provided to doctors in the private sector. Reporting of adverse events depended upon a number of factors such as clinical seriousness, temporal proximity to vaccination and health care workers’ awareness of and obligation to report particular adverse events, fear of blame, time pressures in completing a report, and confusion in whose responsibility it was to report.Conclusion:Mandatory training of all private practitioners conducting immunizations, CHVs to work in collaboration with private doctors for active surveillance of AEFI, and online reporting to be made available for easy reporting. Proper counseling of mothers regarding giving paracetamol to the vaccine beneficiaries. Greater convergence is required between national regulators, and vaccine pharmacovigilance stakeholders including Central drugs standard control organisation (CDSCO), Pharmacovigilance programme of India (PvPI), and AEFI surveillance program, especially at the city and state level is required to handle vaccine safety issues at various levels in a faster and more effective manner.

Background: Pharmacovigilance is essential for ensuring drug safety by monitoring Adverse Drug Reactions (ADRs). However, awareness of ADR reporting among healthcare professionals, including medical students, is often inadequate. This study evaluates the impact of a Continuing Medical Education (CME) program on pharmacovigilance knowledge and ADR reporting awareness among second-year medical students at Mahatma Gandhi Memorial (M.G.M.) Medical College, Indore. Methods: A pre-post intervention study was conducted with 187 students. The CME programme covered ADR reporting under the Pharmacovigilance Programme of India (PvPI). Data were collected pre- and post-intervention using a structured questionnaire focusing on pharmacovigilance definitions, ADR reporting, signal detection, and ADR misconceptions. Descriptive statistics and paired t-tests were employed to evaluate significant differences in pre-test and post-test scores. Results: Significant improvements in knowledge were observed after attending the CME programme, particularly in ADR identification (30.43%), ADR reporting methods (29.17%), signal detection (76.56%), and roles of pharmacovigilance organisations (127.40%). Paired t-tests showed statistically significant differences between pre- and post-test scores (p = 0.004). Conclusion: The CME programme was effective in enhancing pharmacovigilance awareness among medical students, addressing knowledge gaps, and improving ADR reporting practices. Future studies should assess long-term knowledge retention.