UNDERTAKING BY THE INVESTIGATOR 1. Full name, address and title of the Principal Investigator (or Investigator(s) when there is no Principal Investigator). 2. Name and address of the medical college, hospital or other facility where the Clinical Investigation will be conducted: Education, training & experience that qualify the Investigator for the clinical investigation Central Drugs Standard ...

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 mar ...