Pharmacovigilance (PV) has emerged as an essential component of healthcare systems, aimed at identifying, evaluating, and preventing risks associated with medicines. With the rising complexity of therapeutics and the increasing burden of adverse drug reactions (ADRs), PV ensures that the benefits of drugs outweigh potential harms. This review presents an overview of the historical development of pharmacovigilance, the significance of ADR monitoring, and the functioning of global and national PV systems, including the World Health Organization’s International Drug Monitoring Programme (IDMP) and the Pharmacovigilance Programme of India (PvPI). The review further explores drug and disease classification systems, vaccine safety surveillance, methodologies for safety data generation, and the role of pharmacogenomics in predicting ADRs. Special focus is given to vulnerable populations such as children, pregnant women, and the elderly. Challenges of underreporting, the need for effective communication strategies, and the integration of digital tools and artificial intelligence are also discussed. By highlighting current practices and future directions, this paper emphasizes the importance of strengthening PV systems for global drug safety and patient well-being.

Nanostructured Lipid Carriers (NLCs) are very potential formulations for topical delivery of anti-inflammatory and anti-arthritic drugs. In the present study NLCs containing methotrexate and acelofenac were formulated for treatment efficiency in arthritis. The evaluation of different formulation parameters based on variation of solid lipid – liquid lipid ratio (SL: LL), Drug – lipid ratio (D:L), type of liquid lipid (LL), surfactant concentration was carried out. The NLCs were prepared by microemulsion technique method with fixed amount of methotrexate (100mg) using cetyl Alcohol, compritol 888 ATO and clyceryl monostearate. Optimization of process variables was carried out using Taguchi design. The particle size of the optimized batch for methotrexate (NLCMop) and aceclofenac (NLCAop) was found to be 136.2 nm and 145.3 nm, zeta potential -25.0 and -24.4 with drug entrapment of 89.47 ± 6.8 % and 77.46 ±0.76% respectively. Permeation rate and controlled release property of drugs loaded NLCs was studied through egg membrane and was found to be 89.038 ± 2.63% and 82.7±1.34 after 24 hrs. Stability study of the optimized formulation (NLCMop) and (NLCAop) showed that the formulation was more stable at 5 ± 1⁰C than room temperature. These results suggested that NLC based formulations can be potential for topical delivery of methotrexate and aceclofenac for the management of arthritis.