As of 2024, India was third in the world for clinical trials, only the United States and China conducted more clinical trials. The country’s large population and lower costs already make it attractive. However, regulations introduced in 2024 and 2019 made navigating the regulatory landscape smoother by improving clarity. They also helped ensure patient welfare with better patient safety standards, making it an excellent destination for clinical research.
Conducting clinical trials at sites in the U.S. or Europe is costly, making every aspect of a trial more expensive. The financial costs add up quickly when you consider patient recruitment, staff training, and facility management. With drug development costs exceeding $2.6 billion per year, a cost-effective trial is vital for future innovation.
Although many factors affect your clinical trial’s success and overall cost, the location may have the biggest impact; followed by the expertise of the contract research organization (CRO) you select. India offers high quality clinical trials with lower associated costs, which is why so many biotech and pharma companies are looking to India for future clinical trials.
Healthcare infrastructure in India
The Indian government has instituted several programs to improve its healthcare system. Initiatives such as the National Health Mission make medical equipment and supplies more available and encourage community engagement. Other programs include massive upgrades to its digital infrastructure:
- Ayushman Bharat Digital Mission is creating “a national digital health ecosystem that supports universal health coverage.” This initiative provides various infrastructure and data services that help ensure the privacy of health-related personal information.
- eSanjeevani provides national primary healthcare telemedicine services. It is the largest documented system in the world.
- CoWIN app launched during the COVID-19 outbreak to roll out the COVID vaccine distribution and tracking system.
- ERaktKosh is a centralized blood bank management system. It has helped automate some of the regional blood banks and provides donor management solutions, blood grouping and screening, and tracking blood stock.
As India’s healthcare investments strengthen the infrastructure, clinical research becomes possible in more regions. Their network of public and private healthcare is also expanding quickly, giving sponsors and CROs access to more trial sites. Most of the clinics and hospitals are closer to cities, while there are fewer trained medical professionals in rural areas. However, the investments have paid off. Indian people have more access to healthcare than ever, shown by a dramatic increase in life expectancy that rose from 47.7 in 1970 to 68.2 in 2024.
“Hospital chains and hospital networks are actually also clearly modernising. Seventy per cent of the patients are in private hospital networks. Private hospital networks are now diversifying into tier two, and tier three cities, into tertiary networks as well. That gives you broad-based access to patients. So this is all the things that are going on that makes India pretty attractive for clinical trials.”
— Badrhi Srinivasan, Head of Global Clinical Operations, Novartis
Disease prevalence in the Indian population
Communicable diseases like Dengue and drug-resistant tuberculosis strains are a constant challenge. However, polio is all but eliminated and the healthcare system has HIV under control. Although the increased life expectancy is proof of healthcare progress, the prevalence of non-communicable diseases is also increasing.
Chronic diseases affect more people each year, including in India. Conditions like diabetes and cardiovascular diseases are the most common. However, cancer and neurological disorders like dementia are also on the rise, marking a need for more treatment availability for these debilitating illnesses.
Conducting more clinical research trials in countries with reasonable regulations and cost-effective solutions makes sense. This is where India shines and sponsors can benefit.
Sponsors benefit from holding clinical trials in India
India offers several distinct benefits that help sponsors, including lower operating costs, wider patient access, and experienced investigators. The country’s lower cost of living affects all areas of life, including medicine and clinical research.
It means that everything connected to managing the trial—laboratories, management, trial sites—costs far less than what it would cost in a country like the United States. Sponsors are taking notice and as of 2020, the country was third in clinical trials, behind the U.S. and China.
Yet, India’s benefits extend beyond the cost savings and friendly regulatory environment—such as higher enrollment opportunities that prevent underpowered studies. India is the most populous country in the world, with 1.45 billion people.
This offers a diverse pool of potential study participants. Plus, those from rural areas may not have received treatment for the condition that your new drug treats. A factor that can give you a better, cleaner base line of its impact on patient lives and health.
Lower costs and a wider patient pool are reason enough to include India in your clinical trial. However, all that access is nothing without experienced investigators to lead your clinical trial, which India also offers.
However, due diligence is always key when you select a Principal Investigator (PI)—data from a 2024 study showed that many PIs in India have only conducted a few trials. Although this may be because of older regulations that limited the number of clinical trials PIs could simultaneously supervise—another recent change increased the limit.
Indian regulatory changes shorten clinical trial timelines and reduce red tape
Prior to 2019, India was one of the slowest countries for clinical trials because the regulations took far longer to navigate than in other countries. So even when a CRO or sponsor tried to include India from the beginning, most of the trial was already enrolled by the time they were ready.
In recent years, that has been changing. Speaking at the 18th Annual BioPharma & Healthcare Summit in Boston on April 25th 2024 organised by the USA India Chamber of Commerce Dr. Christopher Corsico, Global Head of Development, GSK, said “We have seen movement and the timelines actually have decreased by about 30 to 40 per cent. So for a pure pharma play, actually if you include India early strategically, you can get them on board and participate in that global trial which brings the back-end benefit. You don’t have to run a phase four study if you have a large enough subpopulation from India to contribute to your phase three data.”
Regulations instituted in 2019 greatly simplified the path to clinical research in India. Guidelines implemented by the Ministry of Health and Family Welfare (MoHFW) in New Drugs and Clinical Trials Rules (NDCT) helped. They made the approval process faster and more predictable.
2024 saw yet another set of updates that made more improvements. Further streamlining the process, these updates improved patient safety protocols and aligned with global standards and Good Clinical Practice (GCP) guidelines.
Also in 2024, the MoHFW added a definition for contract research organizations (CROs) like CliniRx. All CROs must register with the Central Licensing Authority before they conduct any clinical trials in India. It also emphasized ethical standards with better handling of severe adverse events and compensation for participants harmed by the treatment being tested.
India’s regulatory landscape continues to evolve, changing the way clinical trials are conducted. The most recent changes have been beneficial to biopharma companies and patient welfare.
Challenges exist, but India’s potential is limitless
India has a somewhat rocky history with clinical research, which gave rise to the perception that clinical trials were lower in quality and not always conducted ethically. However, that perception may have been wrong:
“It is an absolute misperception that quality was poor. Infrastructure stepped up. We are currently at Boehringer Ingelheim running a large phase three global programme, where India participates in obesity. We see pleasantly fast approval timelines for the clinical trial application.”
— Dr. Uli Broedl, Sr. VP & Head Global Clinical Development, Boehringer Ingelheim
Although there were a few high-profile cases where trials that caused patient harm, most clinical research conducted in India meets high standards. Additionally, India’s newer regulatory structure clarifies payments for people harmed by clinical research and priorities patient safety and education.
- There is a shortage of trained physicians, nurses, and technical healthcare professionals, especially in the more remote rural areas—something the National Health Mission working to alleviate.
- Standardizing data collection: some data are collected manually, while others are captured via different digital platforms.
- Data security concerns regarding using new technologies, especially in decentralized trials (DCTs), could be addressed with an increased focus on tightening security protocols.
Most of the digital security concerns are already being addressed with the Digital India Initiative. As India overcomes these challenges, the country will become a premier destination for clinical trials—known for superior quality, better budget control, and shorter timelines.
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