Clinical trials will be a pivotal part of India’s attempts to scale the global pharmaceutical value chain. Following a series of well-publicised scandals in the early 2010s, the country tightened up its clinical research regulations and saw a significant drop in trial numbers. However, with a revised regulatory landscape, a host of strong fundamentals, and a can-do attitude permeating local players, international actors, and governmental entities alike, Indian clinical research is on the rise once more.
India’s Advantages
Clinical trial numbers are booming in India. As the WHO reports, in 2019, India was the country with the third most clinical trials globally, behind only the US and China. Its 5,807 trials represented a full 10.96 percent of the global total (see chart C below), up from just 1,508 (4.05 percent of the global total) five years previously. Moreover, India ranks seventh globally in contributing patients to US FDA trials according to Suresh Pattathil, managing director & GM at AbbVie India and president of the innovators’ association OPPI. Finally, Parexel, one of the world’s largest clinical research organisations (CROs) estimates that clinical trial numbers have increased ten-fold in the three years following the COVID-19 pandemic.
There are several factors contributing to this rise, ranging from updated regulation to relatively low operating costs, higher levels of trust among the public, increasingly experienced investigators, and the manufacturing capabilities to scale production post-approval. However, perhaps the country’s most compelling selling point is the sheer diversity of its population. As Kiran Marthak, director of leading domestic CRO Veeda Clinical Research points out, “India’s diverse demographic profile provides a unique opportunity for clinical trials, especially in therapeutic areas like oncology, diabetes, hypertension, infectious diseases, and special diseases such as kala-azar, leishmaniasis, and malaria. The richness in patient diversity allows researchers to access treatment-naive patients, which can be challenging in more developed countries.”
Ajay Tandon, Veeda’s CEO, adds that “Genetic diversity is crucial in clinical trials, especially for new medicines, as representative populations ensure that the results are applicable to a broader demographic. This diversity allows researchers to observe variations in drug responses across different ethnicities, providing a more comprehensive understanding of the drug’s efficacy and safety profile.”
Infrastructure is also a key point of differentiation. “India excels in infrastructure availability; including the widespread use of electronic data capture (EDC) platforms,” posits Marthak. “The country’s expertise in software development and its efficient utilization in clinical trials contribute to streamlined processes and timelines. The transition from paper-based to electronic systems has not only enhanced data accuracy but has also significantly reduced the time required for data management. This practice has been widely accepted by Indian regulators and sponsors.”
OPPI Director General Anil Matai suggests that the country is now a more attractive destination for international clinical research investment than ever. “We have seen great advances in clinical development analytics, regulatory affairs, and clinical trial management over the past two decades,” he notes. “Several global companies have established large-scale Global Capability Centers employing highly skilled professionals.”
Matai continues, “Notably, India has become a centre for global commercial operations, particularly in clinical data sciences, where data analytics and processing contribute to real-time insights. The country actively engages in pre-marketing activities, safety surveillance, patient risk management, and safety data assessment. The ongoing investments and advancements not only underscore India’s significance in global clinical trials but also highlight its role in shaping the future of patient safety monitoring and data-driven strategies, thereby solidifying its position as a key player in the global pharmaceutical landscape.”
Conducting clinical trials in-country can also have knock-on effects on products’ eventual uptake post-approval. For Vikrant Shrotiya, corporate VP and managing director for Danish diabetes and obesity behemoth Novo Nordisk, “conducting clinical trials in India has been pivotal.” He outlines that “This approach not only provides doctors with hands-on experience during the research phase but also strengthens their conviction and faith in the product. The first-hand knowledge gained through clinical trials contributes to a deeper understanding and trust in the efficacy of the medication.”
Regulatory Upgrades
The regulatory framework for clinical trials in India has been vastly improved. As Veeda’s Marthak highlights, “The new drug clinical trial rules implemented in March 2019 provide clear timelines for approval processes, including expedited approvals for specific situations, as evidenced during the COVID-19 pandemic, where approvals were granted within a week.”
This seismic shift comes straight from the top, according to a representative from the Central Drugs Standard Control Organisation (CDSCO), India’s national regulatory body. “Ease of doing business is one of Prime Minister Modhi’s main mottos,” they begin. “To assist the growth of Indian innovation, we have enacted very aggressive timelines for clinical trial applications. For example, if an applicant does not get a reply from us within 90 days, the application is considered approved. Moreover, that 90-day standard timeline is reduced to just 30 days in the case of applications from domestic companies, and Indian SMEs receive a 50 percent concession on fees. Finally, local clinical trials for academic purposes no longer require CDSCO approval at all. “
Marthak adds that “Moreover, India has developed comprehensive guidelines for orphan drug development programs, emergency marketing authorization, and stringent pharmacovigilance reporting. The latter extends not only to clinical research but also requires rigorous reporting for marketed products. The prompt and efficient response during emergencies and the emphasis on patient safety, including compensation for adverse events, have strengthened India’s regulatory framework.”
“Ethics committees, playing a crucial role in protocol approval and study monitoring, have gained increased authority. These committees must be registered with regulatory authorities, follow specific compositions, and undergo periodic renewals. Their responsibilities include not only approving protocols but also actively monitoring study progress and ensuring the safety and well-being of trial subjects.
“Finally, the regulatory authorities in India have fostered international collaboration and learning. Exchange programs, meetings, and training initiatives between Indian regulatory bodies and counterparts such as the US FDA and European authorities have facilitated knowledge sharing. This proactive engagement has instilled confidence in global health authorities and enhanced India’s standing as a reliable hub for clinical trials.”
Challenges & Future Prospects
Can India really maintain this growth momentum and challenge global hubs like China and the US as a clinical trial destination? Ramakant Deshpande, executive chairman of the Asian Cancer Institute gives a nuanced take. “The regulatory framework, including FDA policies, ethical review boards, and scientific protocols, is in place to govern clinical trials and research in India,” he says. “However, there is room for improvement, particularly in strengthening a central monitoring system to ensure systematic oversight of all trials, and efforts are underway to address this challenge.
Dr Deshpande continues, “India’s linguistic diversity, with 13 official languages, also poses a challenge in terms of providing information and conducting clinical trials in a way that is accessible to individuals speaking different languages. Additionally, there may be a need for increased awareness and education about clinical trials, ensuring that potential participants fully understand the nature and benefits of these advanced therapies.”
To counter some of these challenges, initiatives like the National Cancer Grid (NCG) will have an important role to play. “With over 800,000 new cancer patients registering with the NCG, it serves as an ideal platform for initiating and conducting clinical trials. While many institutions are well-prepared for such endeavours, there is recognition that improvements and expansions can be made. The NCG’s potential to facilitate quick initiation and obtain results efficiently makes it a valuable asset in advancing clinical research and cancer care in the country.”
OPPI’s Pattathil sees an increased awareness among the authorities to the opportunities that clinical research in India represents, in terms of patient access to medicine and economic investment. “The government is actively considering the clinical research landscape, recognizing its potential contribution,” he concludes. “According to Clinical Trials Registry India, the current data indicating around USD 1.8 billion in clinical research, is expected to double in the coming years and policymakers are contemplating supportive measures. The focus is on formulating policies to bolster the clinical development environment, considering the anticipated growth.”
