A Comparative Study on the Review and Evaluation of the Regulatory Process of Spurious and not Standard Quality Drugs in Different Countries

Abstract

To protect the public's health, the pharmaceutical business must first ensure the efficacy and safety of its products. In this comparative study, the regulatory frameworks for fake and inferior-quality medicines in India and the United States are analysed and contrasted. The study uses a mixed-approaches methodology, combining qualitative and quantitative research methods. Interviews with important figures from pharmaceutical corporations, healthcare organisations, and regulatory authorities are used to collect primary data. These interviews are combined with a thorough analysis of the literature, laws, and case studies that have already been published. We evaluate the efficacy of corrective measures implemented by regulatory bodies to reduce the dangers associated with fake and subpar medications. The comparative research identifies the regulatory frameworks of each nation's strong and weak points, revealing possible areas for development. Suggestions are made for improving inter-agency communication, streamlining inspection processes, and implementing cutting-edge technologies for improved surveillance.In the end, this study contributes to the global conversation on drug regulation and public health by illuminating the obstacles and opportunities that India and the USA must overcome in their fight against fake and subpar medications. Policy makers, regulatory bodies, and stakeholders in both nations are likely to benefit from the research's findings, which will help create a more effective and flexible regulatory framework for pharmaceuticals.