New Delhi: India is set to become a global hotspot for pharmaceutical research after the Union Health Ministry announced major amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019. These reforms are designed to cut drug development timelines, simplify approvals, and promote ease of doing business in the pharma sector.
According to the Ministry, companies no longer need to apply for a test licence to manufacture small quantities of drugs for research and examination. Instead, a simple online intimation to CDSCO is enough. This change alone is expected to save at least 90 days in the drug development process, accelerating innovation and research significantly.
The amendments also expedite Bioavailability and Bioequivalence (BA/BE) studies. Prior permission is waived for specified low-risk studies, which can now start after online notification. With CDSCO handling thousands of applications annually, this reform will reduce bottlenecks and cut delays dramatically.
To make compliance seamless, dedicated online modules are being introduced on the National Single Window System (NSWS) and SUGAM portal, ensuring transparent and hassle-free submissions for the industry.
The Health Ministry emphasized that these measures are part of a trust-based regulatory framework, encouraging pharmaceutical R&D while safeguarding public health. The reforms align with global best practices and strengthen India’s position as a preferred destination for drug development and clinical research.
This is a major win for the pharma sector: faster approvals, digitalized processes, and simpler regulations that empower companies to innovate without unnecessary delays.