The requirement of non-clinical and clinical data may be relaxed, abbreviated, omitted or deferred under life threatening or serious disease conditions or rare diseases and for drugs intended to be used in the diseases of special relevance to Indian scenario or unmet medical need in India, disaster or special defence use e.g. haemostatic and quick wound healing, enhancing oxygen carrying capacity, radiation safety, drugs for combating chemical, nuclear, biological infliction etc. However, such relaxation, abbreviations, omission or deferment of data will be evaluated on case-by-case basis depending on the nature of the new drugs, proposed indication, etc.