Health Related Quality of Life (HRQOL) studiesare increasingly becoming common in developed countries to support product label claims. A large body of research is devoted to developing and validating HRQOL measures. Generic as well as disease specific instruments to measure HRQOL are developed. Development and utilization of HRQOL instruments increased during last decade with efforts to improve patient health and value of health care services. Physical, social and emotional impact of diseases and their impact on patients’ lives are focus of the HRQOL studies. HRQOL, as a concept, differs from physiologic aspects of disease and has been recognized as important clinical outcome in studies that evaluates pharmaceutical agents, medical technology and healthcare. Regulatory agencies life Food and Drug Administration (FDA) and European Medicines Agency (EMEA) have accepted importance of HRQOL as valid measure in clinical trials to support product label claim. The use of HRQOL instruments have been predominantly confined to North America and Europe. Significantprogress is not made regarding use of HRQOL instruments in designing health policy in developing countries, including India. It is important to know how patients view their health and what their expectations from the healthcare system are for designing appropriatehealth policyand its implementation, budget allocation and deployment of healthcare resources. India, with its vast population and increasing healthcare delivery challenges, should aim at creating infrastructure for carrying out HRQOL studies and use of Patient Reported Outcome (PRO) instruments in making and implementing health policy decisions.
Key words: HRQOL, Healthcare delivery system, India