New Delhi, April 9 -- Questions are being raised over how India's new drug approval framework is being interpreted, with experts pointing to a possible gap between the written provisions of the New Drugs and Clinical Trials (NDCT) Rules, 2019 and their application in practice.

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.

However, despite references to "subsequent applicants" in regulatory discussi...