New Delhi, Jan 28 || Union Ministry of Health and Family Welfare on Wednesday notified key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, which will help reduce drug development timelines, as well as strengthen the clinical research and pharmaceutical development ecosystem.
The amendments are aimed at simplifying regulatory processes, reducing approval timelines, and promoting ease of doing business.
The regulatory reforms will provide substantial benefits to stakeholders while ensuring public health and safety and facilitate quicker initiation of Bioavailability/Bioequivalence (BA/BE) studies, testing, and examination of drugs for research purposes, and minimise delays across the drug development and approval continuum.
“The measures underscore the Government of India’s commitment to continuous, trust-based regulatory reforms in the pharmaceutical sector, in line with the Jan Vishwas Siddhant and the broader Ease of Doing Business framework,” the Ministry said.
“The initiative aims to promote R&D-led growth of the Indian pharmaceutical industry, align domestic regulations with global best practices, and strengthen India’s position as a preferred global destination for pharmaceutical research and development,” it added.