印度：新兴的肥胖临床试验中心

India: Emerging Hub forObesity Clinical Trials RAINA SINGH PAPLIKAR,Head, Marketing & Corporate Communications, R&D Solutions, IQVIA The following content reflects insights shared in the webinar “India: Emerging Hub for Obesity Clinical Trials”held on June 19, 2025. Table of contents Executive summary1Background and context2Key insights from the webinar3Regulatory readiness3Operational efficiencies3Patient access and representativity4The right patient pool5Technological integration5Academic and Clinical Research Organization (CRO) collaboration6Strategic implications for global pharmaceutical companies6India as a global hospitals strategy7Balancing cost, risk, and timelines7U.S. Pharmaceutical companies considerations7Partnership pathways7Conclusion9Acknowledgment9References10 About the authors11 Executive summary As global obesity rates soar and innovation in treatment accelerates,pharmaceutical companies are expanding their clinical research footprint beyondtraditional markets. India is rapidly emerging as a strategic hub for obesityclinical trials, offering unique advantages in population scale, scientific expertise,regulatory evolution, and technological integration. This white paper summarizes the key themes from IQVIA’s expert webinarIndia: Emerging Hub for Obesity Clinical Trials(June 19, 2025), featuringperspectives from industry experts on why India is poised to lead the nextwave of obesity research. From streamlined regulatory pathways to access totreatment-naïve populations and cost-effective operations, India’s readiness isunderpinned by both systemic transformation and real-world success stories. Key takeaways include: With a strong foundation and continued public-private collaboration, India stands ready to support complex, globallyaligned obesity trials. The country today has an evolved regulatoryenvironment. The Central Drugs Standard ControlOrganization (CDSCO) and the Drugs Controller Generalof India (DCGI) have brought several reformativechanges, such as the New Drugs and Clinical Trial Rules(NDCTR), with focus on ethical methods, transparency indata, and accelerated pace of clinical trial approvals, butnot at the cost of scientific validity. Background and context Obesity is a growing public health concern worldwide,with its prevalence tripling over the past four decades.In India, the dual burden of undernutrition andovernutrition has created a complex landscape wherelifestyle-related disorders such as obesity, diabetes, andcardiovascular diseases are rapidly rising, particularlyin urban and semi-urban populations. According tothe National Family Health Survey (NFHS-5), obesityrates have increased across all states and age groups,signalling a pressing need for effective clinicalinterventions and scalable treatment models. Further, India’s compliance with international regulatorynorms, especially with U.S. FDA and ICH-GCP standards,helps in making the country a more internationallyacceptable trial destination. The increasing prevalenceof digital health tools, access to real world data (RWD),and decentralized trial models drive its preparedness toaddress complex therapeutic areas such as obesity. Companies could look at India as a viable alternativeto the traditional destinations for clinical trials (such asthe U.S. and Western Europe). It has several strengths,including a sizeable treatment-naïve population, aresearch-ready doctors base, and conducivehospital infrastructure. • 2019:Implementation of NDCT Rules to streamlineapprovals and encourage innovation. Key insights from the webinar Regulatory readiness • 2021–2024:Digital integration with ClinicalTrials Registry–India (CTRI) and pre-submissionconsultations with DCGI. Regulatory climate in India has transformed drasticallyin recent years, making it more appealing for conductingclinical trials globally. One of these cited regulatorychanges introduced was the simplified regulatorypathway provided under New Drugs and Clinical Trials(NDCT) Rules, 2019, aimed at expediting the approvalprocess and transparency in the oversight of research. • 2025:Mandatory CRO registration effective April 2025to standardize accountability, quality and performanceThese reforms have enhanced predictability andresponsiveness for pharmaceutical companies, whilesafeguarding patient interests. “We’ve taken a science-basedapproach that has made patientsour priority, which helps us movethrough the pipeline as efficiently aspossible, but without sacrificing ourstandards for quality or safety.” Operational efficiencies India’s operational ecosystem also provides significantcost efficiencies, speed, and scale as compared totraditional markets. India has a 30–50% cost advantage over western nationsin conducting clinical trials. These savings arise fromreduced hospitals overheads, competitive doctors fees,and favorable exchange rates. Clinical trials in India areestimated to be 35–60% cheaper overall, depending ontrial phase and complexity. For