Get latest articles and stories on Business at LatestLY. Under the NDCT Rules, clinical trials in India may be waived only under specific conditions, primarily when a drug has already been approved and widely used in certain foreign jurisdictions, supported by adequate safety data and scientific justification. Importantly, these provisions are linked to the characteristics of the drug itself, rather than the identity or sequence of applicants. Business News | Regulatory Grey Zone Sparks Controversy: Are India's New Drug Approval Rules Being Applied Unevenly?.