(new chemical entity, new indication, new formulation etc) Schedule Y pertains to New drug. However Appendix XXXIII, clinical trial registry specifies that all interventional trials should be registered. (All interventional clinical trials conducted in India and involving Indian participants need to be registered. An interventional clinical trial is any research study that prospectively assigns people to one or more health related interventions (e.g., preventive care, drugs, surgical procedure, behavioural treatments, etc) to evaluate their effects on health related outcomes. Thus, early and late trials, trials of marketed or non marketed products, randomized or non randomized trials - all should be registered.) Appendix XXXVIV, GCP guidelines for clinical trials in India and Appendix XXXVIII, Guidelines for BA/BE studies define Clinical Trial (Clinical study) as a systematic study of pharmaceutical product on human subject(s) - (whether patients or non-patient volunteer) - in order to discover or verify the clinical, pharmacological (including pharmacodynamic/ pharmacokinetics), and/or adverse effects, with the object of determining their safety and/or efficacy. 11. It is necessary to have an uniform definition of which type of clinical studies will be considered clinical trial.