Trusted Resource for Clinical Trials, Protocols & Progress
The foundation of data integrity in clinical research stems from GCP principles and specific national and international guidance. In the Indian context, CDSCO, under the Ministry of Health and Family Welfare, governs clinical trials through the New Drugs and Clinical Trials Rules, 2019, in conjunction with the Drugs and Cosmetics Act & Rules.
Click to read the full article.
India’s compensation framework for trial-related injuries is among the most participant-centric in the world. While it imposes strict timelines and financial obligations on sponsors, it enhances ethical standards and public trust in clinical research. Proactive planning, transparency, and compliance with NDCTR 2019 will ensure smoother clinical operations and reduce litigation risk across India’s rapidly evolving research landscape.
Click to read the full article.
AYUSH clinical research in India is entering a new phase of scientific rigor, regulatory accountability, and global relevance. With dedicated frameworks, specialized GCP guidelines, and institutional support, sponsors and investigators have ample opportunity to explore evidence-based traditional medicine within India’s growing clinical trial ecosystem.
Click to read the full article.
Pediatric clinical trials in India are gradually evolving to meet the complex demands of child-specific drug development and public health needs. While regulatory clarity and infrastructure improvements are ongoing, a combination of robust ethics, targeted site preparation, and community engagement will determine the success and ethical integrity of these vital studies.
Click to read the full article.
COVID-19 was a turning point for India’s clinical trial ecosystem. What began as a disruption led to accelerated digitalization, decentralized trial models, and streamlined regulatory pathways. Many of these changes — remote monitoring, hybrid site visits, digital consent — are here to stay and will define the next era of clinical research operations in India.
Click to read the full article.
India is at the cusp of a digital revolution in clinical research. While challenges around infrastructure, literacy, and regulation persist, the benefits of digital health and decentralized trial models are undeniable. With continued regulatory clarity and stakeholder training, India can emerge as a global leader in hybrid and decentralized clinical trial operations.
Click to read the full article.
Clinical trial inspections in India are becoming more rigorous and aligned with global standards. Many observations now mirror FDA 483s, highlighting the need for improved site preparedness, data quality, and regulatory compliance. Sponsors, CROs, and investigators must collaborate to build robust systems that withstand regulatory scrutiny, ultimately ensuring ethical and scientifically sound trials for the Indian population and beyond.
Click to read the full article.
While formal site accreditation is not currently a prerequisite in Indian clinical trials, growing regulatory expectations, global collaborations, and sponsor-driven feasibility assessments are making accreditation increasingly important. NABH standards, CDSCO site evaluations, and IEC compliance frameworks collectively shape a site’s readiness. Investing in infrastructure, training, and documentation systems today ensures long-term regulatory credibility and trial success tomorrow.
Click to read the full article.
Bridging studies in India serve a critical function in ensuring that foreign clinical data is relevant, safe, and effective for Indian patients. Sponsors should adopt a proactive strategy, understand CDSCO expectations, align their global and Indian regulatory plans, and where possible, integrate Indian cohorts into global trials. Bridging studies, though sometimes seen as additional burdens, can significantly strengthen local market access and post-approval confidence.
Click to read the full article.
PvPI is a cornerstone of India’s pharmacovigilance ecosystem. It plays a pivotal role in ensuring clinical trial safety through SAE data aggregation, global collaboration, and risk signal detection. Sponsors and clinical trial teams must proactively engage PvPI to meet regulatory expectations and safeguard participant welfare throughout the drug development lifecycle.
Click to read the full article.
