Current Affairs - National - Discussion

The New Drugs and Clinical Trials Rules (NDCTR) were introduced in 2019, enabling the Central Licensing Authority (CLA) to waive local clinical trials for drugs approved in specific regions like the US, UK, and EU. This regulation aimed to expedite access to critical medications, including orphan drugs and pandemic-related treatments. However, the move has raised safety concerns given India’s diverse genetic makeup, emphasizing the importance of localized trials for efficacy validation and patient safety. The rule highlights a significant shift in India's approach to drug approvals and regulatory frameworks.