Clinical Research Regulation For India | ClinRegs
Overview. As per the 2019 CTRules, IND-43, and IND-42, a sponsor (applicant) is responsible for a paying a fee to the Drugs Controller General of India (DCGI) to submit a clinical trial application.. The 2019 CTRules and IND-43 specify that Form CT-04 should be accompanied by one (1) of the following officially mandated fees:. 3,00,000 Rupees for Phase I (human) clinical trials