Mitra, Anyesha2020-12-182020-12-182017https://dans.nls.ac.in/handle/123456789/178As the present epidemiological conditions are changing and the modern system of medicine is unable to meet the health needs of the country, there is a lookout for holistic system of medicine that adopts a holistic approach towards addressing healthcare. The age old systems of medicine of India, the Ayurveda, Siddha and Unani systems are being revisited in this context. However, the present narrative demands proving the safety, efficacy and quality of the systems based on scientific evidence. The literature on policy regime in India points out towards several gaps which affect the safety, quality and efficacy of the systems. On the other hand, another set of literature points out the nonsuitability of methods of modern medicine being used for ASU systems for assessing their safety, quality and efficacy. However, there is very scarce literature which tries to analyse the policy regime in the light of conceptual framework underlying the assessment of safety, quality and efficacy of the systems. Therefore, this study is an attempt at bridging this knowledge gap. It tries to track down the parameters used for assessing ASU in India and its conduciveness for the system. It further goes on to analysing the policy regime for the ASU systems in the context of this lacuna in the conceptual framework. Through explorative and descriptive research, it is found that the conceptual lack of understanding is reflected in the policy regime and they reinforce each other. Lack of research due to lack of fiscal backing, institutional support seem to be one of the major causal factors. This lacuna of conceptual framework also reflected in the flexible nature of the several guidelines like GMP, GAC, GCP, voluntary certification scheme etc. which give a huge margin for a drug to be accepted. Having investigated the findings, this study concludes with recommendations that are aimed at strengthening scientific evidence generation in order to strengthen the policy regime for ASU systems in order to ensure its safety, efficacy and qualityThesis