Ministry of Health & Family Welfare of India has passed an order, that all the Global Clinical Trials (GCTs)/New Clinical Trials (NCEs) should be conducted and evaluated in concern with the parameters given by the Honorable supreme court of India. Honorable Supreme Court, has passed an order regarding the clinical trials dated on 21/10/2013, stating that, all the GCTs/NCEs should be evaluated based on three parameters, namely, (i) assessment of risk versus benefit to the patients, (ii) innovation vis-a-vis existing therapeutic option and (iii) unmet medical need in the country. All the applications for the conduct of clinical trials of new drugs in India should provide the information to assess these three parameters. The detailed requirements and guidelines for conducting clinical trials are clearly mentioned under the Rule 122DAA, Rule 122DAB, Rule 122DAC, Rule 122DD, Rule 122E and Schedule Y of Drugs & Cosmetics Rules 1945 as amended form time to time. As per the notice of Drugs controller general of India (DCGI), it is clearly mentioned that CRO and related organizations should comply with all the parameters, given in Drugs & Cosmetics Rules 1945 and amendments made form time to time, while they apply for any trials.