Over the years, India has emerged a leading hub for pharmaceuticals, pioneering across all major components of the value chain — Research, Development and Manufacturing. North America and Europe are heavily reliant on India’s pharmaceutical manufacturing prowess and source over 60% of generic medicines from India to control healthcare costs locally1.
This confidence in the country has led global pharma giants to leverage India’s talent pool for R&D activities as well. From early stage research for identification of new drug candidates to product development through clinical trials management and global regulatory filings, India does it all for global pharma. Emergence of Global Capability Centers (GCCs) underscores the current ecosystem by bridging innovation and manufacturing, creating a wholistic value chain for drug development in the country. The trend for biopharmaceutical innovation began in the last decade with an increased willingness for risk from in-house biotech innovators, coupled with an enhanced focus by the government on supporting deep-tech startups. Contract research, development and manufacturing in the biopharmaceutical industry has bolstered the Indian ecosystem for upstreaming drug discovery. Today, there are numerous success stories of biopharmaceutical innovation from India, targeting diseases that are of priority to the nation as well as the rest of the world.
In the rapidly evolving R&D ecosystem, India has notably emerged as a favoured location for clinical trials, particularly during and after the COVID-19 pandemic, due to its scale, population diversity, and existing drug manufacturing infrastructure. India has 94,730 trials registered since 2000 as per the Clinical Trials Registry of India (CTRI), orienting as a strategic partner for pharmaceutical and biotechnology companies seeking efficient, diverse, and scalable clinical trial solutions. South-East Asia is quickly growing in number of reported clinical trials and was the only region not to see a decrease since the peak of trials during the COVID-19 pandemic, driven largely by trials in India2. This rapid expansion has elevated India to become the third-largest destination for conducting clinical trials globally as of 2024, growing at a CAGR of 80% from 2019. Approximately 18,000 new clinical trials were registered in India in 2024 alone, 50% more from the previous year3.
This growth is in tandem with commitments from global companies to bring the drug development pipeline and innovation to India. Bristol Meyers Squibb, a drug development biopharma company from the US has invested more than US$ 100 Mn in India for early stage drug development through their GCC in Hyderabad. With 23 active clinical trials currently running in the country as on November 2024, the company envisions this number to more than double by 20264. This momentum dwells on both domestic policy support, through the New Drugs and Clinical Trials Rules 2019 and rising international confidence in India’s capabilities.
Indian hubs for global companies are cementing as important bases to support the development journey of many breakthrough medicines across all therapeutic areas. For example, Novartis, an innovative medicine company from Switzerland, has 52 active clinical trials registered in India across 335 sites with more than 2000 patients5. This development has taken shape over the course of 20 years, where India supports global functions including Global Clinical Operations, Technical R&D, Patient Safety and Pharmacovigilance, Regulatory Affairs and Advanced Quantitative Sciences for the company. Similarly, Bayer, a Biotech Company from Germany, has 20 Clinical Trials currently registered in India across Phase II to Phase IV of development, supported through their GCC in Bangaluru6.
What could be a good scientific reason7 for the number of clinical trials to shoot up is that India offers one of the most heterogeneous patient populations in the world, with diversity in genetic makeup, disease burden and socioeconomic status. While there is an increasing trend in the number of clinical trials happening globally, there is an under–representation of diverse ethnic groups in these trials. This makes India especially suitable for multi-ethnic, multi-centric trials. Furthermore, the high incidence of both communicable and non-communicable diseases provides a fertile ground for trials across a wide spectrum of therapeutic areas, from oncology and cardiology to rare and neglected diseases. 79% of clinical trials registered in India cater to the non-communicable diseases category: diabetes (6.7%), malignant neoplasms (11.4%), cardiovascular diseases (8.1%), respiratory diseases (4.8%) and digestive diseases (9.7%) to name a few. Communicable, maternal, perinatal and nutritional disorders makes the second largest category of trials conducted in India, with a total of 18%8.
Until the release the of the New Drugs and Clinical Trials Rules 2019, Indian innovators often pursued their early clinical development overseas, and international pharmaceutical giants were reluctant to engage with collaborators from India for early phase clinical development. Between 1999–2024, the World Health Organization—International Clinical Trials Registry Platform (ICTRP) registered 61,417 Phase I clinical trials. Of these, 25,198 (41%) Phase I trials were conducted in the United States, while 2,718 (4.4%) trials were registered from India. Between 2019 and 2024, India registered and conducted 1,641 Phase I clinical trials, accounting for 60% of all first-in-human Phase I trials in the country.9 Subsequently, India has seen a significant rise in the number of Phase II and Phase III Clinical Trials as well. From 2019-2024, Phase II and Phase III Clinical Trials registrations have risen by 20% year on year10.
India also has a growing number of clinical trial sites and hospital networks with access to advanced diagnostic and data management tools. Coupled with this is the availability of a large pool of trained investigators, clinicians, biostatisticians, and data managers. To mitigate the gaps in the ecosystem, Government initiatives are also adding on to the growing innovation and development landscape in India. The National Biopharma Mission by the Department of Biotechnology (DBT) focuses on strengthening clinical trial capacities for testing biologicals and vaccines has been put, alongside establishing data management system for enhanced data analysis and reporting. A Clinical Trial Network for hospital-based trials in patients for testing biologicals in different specialties of oncology, diabetology, rheumatology and ophthalmology have been created under this initiative, currently supporting 5 consortia of 35 hospitals.11 Another flagship initiative by the Indian Council of Medical Research (ICMR) aims to establish a robust ecosystem for clinical trials by integrating institutions, investigators, and resources across India to conduct high-quality, multicentric, regulatory-compliant trials under the Indian Clinical Trial and Education Network (INTENT). Currently, 75 Sites for Phase II and Phase III clinical trials, and 4 institutions for Phase-I are part of the INTENT network, including public and private medical colleges, hospitals, and research institutes.12 The blueprint for biomanufaturing hubs and biofoundries under the BioE3 policy further envisions to strengthen the existing technologies and infrastructure for clinical research.13 The Translational Health Science And Technology Institute (THSTI), under DBT, is expanding its scope in translational research ecosystem by establishing a Medical Research Centre within its campus to cater to Phase I and Phase II clinical trials.14
India’s Pharmaceutical ecosystem is on a verge of transformation, where the sector has proved itself to be a vital part of India’s economy, playing a crucial role in ensuring access to affordable and quality healthcare. India’s pharmaceutical industry is efficiently utilizing the opportunity presented by the recent developments to ensure economic growth across the complete value chain. As India's clinical trial ecosystem has matured, so has its infrastructure and expertise, marking a significant evolution in the landscape of medical research within the country. Though India has moved forward in nurturing the innovation pipelines in drug development, there is a long road ahead to integrate early-stage research and late-stage product development to drive competitiveness in high-value drug categories. After the launch of the New Drugs and Clinical Trials Rules 2019, a more robust regulatory and clinical research ecosystem has been established in India. The New rules mandated promotion of high-quality clinical trials in India with an added benefit of providing early access to new medications for the currently unmet needs of Indian patients. A collective responsibility to ensure patient safety and, most importantly, data integrity was imposed by the new rules, further emphasizing the significance of oversight in clinical trial activities by stakeholders, including pharmaceutical companies, study sponsors, investigators, academic research institutions, and ethics committees15. With active collaboration among all stakeholders, India’s clinical trial ecosystem should be equipped to undertake the clinical development of leads that address the country’s specific healthcare priorities. This shall further enable robust regulatory frameworks for development of novel therapies, ensure sustainable funding mechanisms that can accelerate the journey from lab to market, and position India as a preferred global destination for development of breakthrough therapeutics, apart from affordable drugs.
This blog is written by Raveesh Malik
