Journal of Pharmacovigilance and Quality Assurance ISSN: 3108-2343 (Online)

Authors: D.S. Kachare, P. K. Ghadge, Sachin S. Mali

Abstract: Pectin is a naturally occurring biopolymer. It has been used successfully for many years in the food and beverage industry as a thickening agent, a gelling agent and a colloidal stabilizer. In this review, study of the role of pectin polysaccharides, including its various pharmacological activity, such as its immuno-regulatory, anti-inflammatory, hypoglycemic, antibacterial, antioxidant and antitumor activities, have been summarized. The review provides natural sources, chemical structures, biological activities, and practical applications in the food industry as well as pharmacology and different branches of medicine. Pectin has become an essential part of the research and development of natural herbs and health products due to their wide availability.

Keywords:  Citrus Pectin, Source, extraction, Biological activity, glycogen regulation.

Authors: Dr. Anjali Mehta, Mr. Vikram Singh

ABSTRACT: Adverse Drug Reaction (ADR) reporting systems form the backbone of pharmacovigilance, ensuring early detection of drug-related safety concerns. This paper explores the structure, methodologies, and effectiveness of various ADR reporting systems, with emphasis on spontaneous reporting, electronic reporting platforms, and integrated real-world data sources. Comparative analysis of international frameworks including the European Medicines Agency (EMA), US Food and Drug Administration (FDA), and India’s Pharmacovigilance Programme (PvPI) is provided. The paper discusses challenges such as underreporting, data quality issues, and the integration of artificial intelligence for signal detection. Tables summarizing reporting methods, regulatory requirements, and technological innovations provide practical insights for stakeholders. Emphasis is placed on harmonizing global practices, enhancing reporting culture, and employing technological tools to strengthen patient safety and pharmacovigilance efficiency.

KEYWORDS: Adverse Drug Reaction, ADR Reporting Systems, Pharmacovigilance, EMA, FDA, PvPI, Signal Detection, Patient Safety

Authors: Sowjanya Gummadi, Meghasesha Myneni

Abstract: Two simple, economical and reproducible fundamental and derivative UV spectrophotometric methods were developed and validated for determination of Famotidine in bulk and dosage form. Famotidine showed maximum absorption at 281 nm in phosphate buffer pH 7.5 while it has 282 nm as its absorption maxima in borate buffer pH 9.0. The linearity was determined in the concentration range of 30-80 μg/mL (r2 as 0.9993 & 0.9987) and 10-60 µg/mL (r2 as 0.9991 & 0.9995) for the fundamental and derivative methods in phosphate and borate buffers. The developed methods were validated as per ICH guidelines. Recovery studies gave satisfactory results indicating that none of the major additives/excipients interfered with the assay method. This method may be useful for routine laboratory analysis of famotidine.

Keywords: Borate buffer pH 9.0, derivative, famotidine, fundamental, phosphate buffer pH 7.5, UV spectrophotometric, validation

Author: S. Sreeremya

Abstract: Nanoscience is the branch of science dealing with study of minute particles on an atomic or molecular scale, whose size is measured in nanometers which is one billionth of a meter (i.e., 10-9 m). Nanotechnology is a branch of engineering which uses particles on a nanoscale. In dermatology and cosmeceuticals, the use of nanotechnology has been aggrandizing since its inception. The possible applications of nanotechnology in this field of science are diverse. Some of the significant indications comprises sunscreens, moisturizers, anti-aging formulations, phototherapy, anti sepsis, vaccines, skin cancers, hair and nail care, antimicrobials, skin fillers, corticosteroids, visualization of tumors and sentinel lymph nodes, etc.

Keywords: Nanotechnology, Dermatology, Cosmeceuticals, Particles

Authors: Dr. Priya Verma, Mr. Arjun Rao

ABSTRACT: Signal detection and assessment are core components of pharmacovigilance, enabling timely identification of potential adverse drug reactions (ADRs) and drug safety issues. With the increasing complexity of pharmaceuticals and the scale of patient exposure, advanced methods for signal identification have become crucial. This paper reviews methodologies employed in signal detection, including spontaneous reporting systems, data mining, electronic health records, and statistical algorithms. Signal assessment techniques are discussed, emphasizing causality evaluation, prioritization, and risk mitigation. Comparative perspectives from global pharmacovigilance practices are presented, highlighting best practices and challenges. Tables summarizing key methodologies and tools provide practical insights for professionals. Integrating technology, enhancing reporting culture, and standardizing assessment protocols are highlighted as essential strategies for improving pharmacovigilance outcomes.

KEYWORDS: Signal Detection, Pharmacovigilance, Adverse Drug Reactions, Data Mining, Risk Assessment, Drug Safety

Authors: Menka Kapil, Rateesh Sareen, G.N. Gupta

Abstract: The clinical laboratory plays an increasingly important role in the patient centered approach to deliver healthcare services. Physicians rely on accurate laboratory test results for proper disease diagnosis and for guiding therapy; it is estimated that more than 70% of clinical decisions are based on information derived from laboratory test results. The total test process show that the pre-analytical phase accounts for 46% to 68.2% of errors. The awareness and knowledge to recognize preanalytical errors is the goal of achieving total laboratory quality is must for patient care.

Keywords: Pre analytic, Hemolysis, Lipemia

Authors: Dr. Meera Iyer, Mr. Rahul Deshmukh

ABSTRACT: Good Pharmacovigilance Practices (GVP) constitute a standardized framework aimed at ensuring drug safety through systematic collection, analysis, and reporting of adverse drug reactions (ADRs). This paper provides a comprehensive overview of GVP guidelines, comparing global regulatory perspectives including the European Medicines Agency (EMA), US Food and Drug Administration (FDA), and India’s Central Drugs Standard Control Organization (CDSCO). Key components such as signal detection, risk management, periodic safety reports, and compliance monitoring are discussed in detail. The paper highlights the challenges faced in implementing GVP across different healthcare systems and emphasizes best practices for harmonization. Tables summarizing core principles and regulatory requirements provide practical insights for healthcare professionals and pharmaceutical companies. Emphasis is placed on the adoption of technology and international collaboration to enhance pharmacovigilance efficiency and ensure patient safety.

KEYWORDS: Good Pharmacovigilance Practices, ADR Reporting, Signal Detection, Risk Management, EMA, FDA, CDSCO

Authors: Dr. Meera Krishnan, Mr. Rohan Sharma

ABSTRACT: Quality assurance (QA) forms the backbone of the pharmaceutical manufacturing industry, providing a comprehensive framework to ensure that every medicine reaching the patient is safe, effective, and of the highest quality. Unlike quality control, which focuses on testing final products, QA covers the entire lifecycle of production—from raw material procurement and process validation to packaging and distribution. This paper explores the principles, practices, and importance of QA in pharmaceuticals, examining global standards, Indian regulatory frameworks, and industry-specific challenges. It also reviews key components of QA, such as Good Manufacturing Practices (GMP), documentation, and continuous monitoring, while highlighting innovations like digital quality systems and real-time analytics. Through critical analysis, this paper underscores how QA safeguards public health, ensures regulatory compliance, and strengthens trust in medicines worldwide.

KEYWORD: Quality Assurance, Pharmaceutical Manufacturing, GMP, Patient Safety, Regulatory Compliance, Risk Management, Drug Quality

Authors: Dr. Sneha Kapoor, Mr. Aditya Sharma

ABSTRACT: Pharmacovigilance regulations play a pivotal role in maintaining the safety, efficacy, and quality of pharmaceutical products worldwide. Regulatory authorities such as the United States Food and Drug Administration (US FDA), European Medicines Agency (EMA), and India’s Central Drugs Standard Control Organization (CDSCO) have established comprehensive frameworks to monitor adverse drug reactions (ADRs) and enforce compliance. This paper examines the regulatory guidelines, reporting requirements, and compliance mechanisms of these agencies. Comparative analysis highlights similarities and differences in reporting timelines, risk management strategies, and inspection protocols. The paper also discusses the challenges faced by pharmaceutical companies in meeting diverse regulatory requirements and emphasizes the importance of harmonization and global collaboration. Tables summarizing key regulatory features and reporting structures are included, providing a practical overview of compliance expectations in the US, EU, and India. Enhanced understanding of these frameworks supports better pharmacovigilance practices and ensures patient safety in global healthcare systems.

KEYWORDS: Pharmacovigilance, US FDA, EMA, CDSCO, Regulatory Compliance, Adverse Drug Reactions, Risk Management

Authors: Dr. Anjali Sharma, Mr. Rohit Mehra

ABSTRACT: Pharmacovigilance (PV) has become a cornerstone of patient safety in India due to the rapid growth of the pharmaceutical industry, expansion of clinical trials, and increased availability of generic medicines. With India being a hub for drug manufacturing and exports, ensuring safe use of medicines is a national and global priority. Current trends highlight digital reporting mechanisms, artificial intelligence in adverse drug reaction (ADR) analysis, regulatory reforms, patient participation, and international collaboration. This paper explores the evolving paradigms in pharmacovigilance in India, focusing on policy changes, technological innovations, integration with global networks, and challenges that remain in building a robust drug safety ecosystem. The study emphasizes that the success of pharmacovigilance depends on strong regulations, healthcare professional involvement, and patient engagement, supported by digital innovations.

KEYWORDS: Pharmacovigilance, India, Drug Safety, Regulatory Reforms, Patient Engagement, Artificial Intelligence, Clinical Trials, Digital Health

Author: Dr. S. Sreeremya

Abstract:ÂThe discovery and the research of the budding yeast Saccharomyces cerevisiae var. boulardii (Sb) is strictly related to the concept of health promoting microorganisms from food. Saccharomyces boulardii act as probiotic. It has enormous application, it helps quorum signalling and also have a pharmacodynamics and pahrmacokinetc properties.

Keywords: Pharmacodynamics, Saccharomyces boulardii, Budding yeast, probiotic, quorum sensing