|
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 discussions, there is no clearly defined statutory pathway that allows later applicants to rely solely on data generated by an earlier applicant where the drug does not meet waiver criteria under Rule 101. Experts suggest this creates a potential inconsistency. If a drug qualifies for a waiver based on global safety and prior approval in specified countries, the same principle should logically apply to all applicants. Conversely, if a drug does not meet these criteria, then similar evidentiary standards may need to be applied consistently across applicants. An additional concern relates to new drugs developed indigenously in India that are not approved in regulated markets such as the US, UK, EU, or Japan. In such cases, the Indian innovator undertakes the full cost and risk of development, including research and regulatory submissions. However, these products may not receive any form of clinical data exclusivity or regulatory protection, even when they represent first-in-class innovations originating in India. Industry observers note that in certain instances, subsequent approvals for similar products have reportedly been granted within a relatively short period of the innovator's approval, even though the drug was not approved in any country specified under Rule 101. This has raised questions about consistency in the interpretation of the NDCT framework, particularly in the context of indigenously developed medicines. Stakeholders highlight that predictable and balanced regulatory interpretation plays an important role in encouraging research-led innovation, particularly among Indian pharmaceutical MSMEs. Without sufficient clarity, there is concern that the incentive structure may unintentionally favour imitation over original research. As India aims to strengthen its position as a global hub for pharmaceutical innovation, legal clarity and consistency in regulatory decision-making may be important both for industry confidence and for maintaining public trust in the safety and effectiveness of new medicines. (ANI)(Disclaimer: The author is CEO- ENTOD Pharmaceuticals. Views shared here are personal)
|
