Pharmacovigilance

Telmisartan is a long-acting angiotensin II receptor blocker widely used for hypertension management. Although generally well tolerated, it has been associated with various adverse drug reactions (ADRs) ranging from mild symptoms to serious events. To review telmisartan’s ADR profile from a clinical pharmacist’s perspective and illustrate key insights through a case of drug-induced acute kidney injury (AKI). A comprehensive literature review and analysis of the Pharmacovigilance Programme of India data were conducted. A 40-year-old male who developed pre-renal AKI following dose escalation of telmisartan is presented. Common ADRs include dizziness, headache, diarrhoea, and respiratory symptoms. Serious reactions encompass hyperkalemia, angioedema, hypotension, and AKI. PvPI reports have highlighted rare cutaneous reactions such as lichenoid keratosis. In the case study, serum creatinine rise from 1.3 to 1.8 mg/dL within 48 hours of increasing the telmisartan dose and normalized after discontinuation. Vigilant monitoring and pharmacist-led interventions are essential to detect and manage telmisartan-related ADRs, optimize therapy, and ensure patient safety.

Paediatric oncology requires regulatory approaches that balance timely access with child-specific safety. This abstract equates the laws and rules for medicines used to treat childhood cancers in the India and United states. It reviews the regulations created by the Food and Drug Administration (FDA) in the US and the Central Drugs Standard Control Organization (CDSCO) in India focusing on trial design, approval pathways, incentives, ethics, and post-marketing safety. Paediatric oncology is a medical field that deals with diagnosing and treating cancers in children, from babies to teenagers. Children's medicine is different from adult medicine in various ways, such as how medicines are administrated, how metabolism takes place in children body and the way the body functions.  Many medicines given to children are made for adults, so the doses need to be changed to be safe for them. The USA demonstrates structured paediatric mandates (PREA, BPCA, RACE Act) and robust post-marketing mechanisms, while India operates through NDCTR 2019 and ethics-based oversight with fewer formal incentives. Differences exist in trial networks, orphan incentives, and pharmacovigilance capacity.  The article looks at the current state of laws for children's medicines worldwide to show important efforts, difficulties, and progress in this area. These regulations require that medicines are drugged properly for a child's age, tested well in clinical trials, and labelled clearly to avoid misuse. Harmonization, strengthened paediatric trial infrastructure, and targeted incentives in India could accelerate paediatric oncology drug availability while maintaining safety. Cross-border collaboration is recommended. Keywords; Regulatory requirements, Paediatric Oncology, CDSCO, FDA, Pharmacovigilance

Pharmacovigilance (PV) plays an analytical role in ensuring drug safety and public health. This research explores the regulatory frameworks and PV systems in India and Japan, focusing on the Central Drugs Standard Control Organization (CDSCO) and Pharmaceuticals and Medical Devices Agency (PMDA), respectively. Historical developments, adverse drug reaction (ADR) reporting systems, risk management protocols, and international harmonization practices are discussed.1 India's PV system has evolved through programs such as the Pharmacovigilance Program of India (PvPI), whereas Japan’s system emphasizes structured post-marketing surveillance (PMS) and risk management plans (RMPs). Although both systems have made significant progress, challenges such as underreporting in India and regulatory burden in Japan persist. This comparative analysis offers insights into upgrading global pharmacovigilance through interactive learning and harmonization.

Pharmacovigilance is an integral part of clinical research. The potential awareness regarding adverse drug reactions has resulted in the emergence of the practice of Pharmacovigilance. Both clinical trials safety and post marketing pharmacovigilance are very significant in ensuring the drug safety. Pharmacovigilance methods can be categorized as Passive surveillance, Active surveillance, Comparative observational studies, targeted clinical investigations and Descriptive studies. The Central Drugs Standard Control Organization (CDSCO) already initiated a nationwide Pharmacovigilance programme under the aegis of Directorate General of Health Services (DGHS), Ministry of Health & Family Welfare and Government of India. The pharmacovigilance system in India has to be refined with the collaboration of pharmacovigilance experts. Implementation of a robust pharmacovigilance program in India in accordance with the objectives and recommendations of World Health Organization by Central Drugs Standard Control Organization is a prerequisite. It is the need of the hour to improve communication between the healthcare professionals and the public; and educating the health professionals well to understand the benefits/ risks of medicines they prescribe. Developing own national database and sharing information with other regulatory agencies will contribute a lot of required information from worldwide data to take the correct decision on medicines and products.

Pharmacovigilance is defined as the pharmacological science that is relating to the detection, assessment, understanding, prevention of adverse effects, particularly the long term &short term adverse effects of medicines. The Pharmacovigilance is the important and integral part of clinical research. This article describes and discusses the aims, objectives, role, need for the Pharmacovigilance, different Pharmacovigilance programme, various Pharmacovigilance methods, Pharmacovigilance reporting and functioning.