15.However, detailed guidance documents should be prepared providing the requirements and adequacy of global clinical data that can be considered for approval of any new drug in the country in both the cases where India was one of the participating countries in the global clinical trial or in cases where India was not a participating country. 16.The sponsor intending to submit NDA to CDSCO for marketing of new drug after successful generation of clinical trial data, should also plan and design GCTs considering the regulatory requirement as per the New Drugs and Clinical Trials Rules, 201 and the applicable guidelines with the aim of increasing the acceptability of GCTs in regulatory submissions.