A new set of rules in place since 2019 is beginning to make India an attractive destination for big pharma to conduct clinical trials in India. These rules have brought India's regulatory framework on par with U.S. Food and Drug Administration (FDA) norms and now India is among the top choices for global clinical trials, industry experts say.
"India is among top five destinations for our clients while choosing clinical trial sites and numerous big global studies are now being carried out in India," Sanjay Vyas, managing director - India and global SBU head - clinical trial supplies and logistics at Parexel, an U.S. based leading clinical trial organisation (CRO), tells Fortune India.
In 2021, India approved over 100 global clinical trials, the highest number since 2013. Covid-hit 2020 also saw 87 global clinical trials in India. These were 95 in 2019, 76 in 2018 and 71 in 2017. India had enacted the New Drugs and Clinical Trials (NDCT) rules in March 2019.
India's clinical trials market is expected to reach $3.15 billion by 2025 with a compounded annual growth rate (CAGR) of 8.7%, say various estimates. The Indian clinical trial market size was estimated at $1.89 billion in 2019 and just over $2 billion in 2020.
India became a signatory to the World Trade Organization (WTO) in 2005 and that had fuelled the growth of the clinical trial industry between 2005 and 2009. Vast pools of patients, skilled professionals with good English-speaking skills, lower costs and the prevalence of chronic diseases attracted big pharma to conduct trials in India. With a view to strengthen the regulatory framework, India revamped regulations and guidelines for clinical trials in 2013. But that had provisions like compensation for injuries related to clinical trials and complex regulatory processes.
"Those regulations lacked clarity, were challenging to implement operationally and introduced uncertainties. Approval timelines were lengthy and unpredictable and many research institutions and investigators discontinued clinical trials because of the added time, cost and burden required to follow the new rules," says a recent white paper from Parexel on clinical trial status in India.
As a result, global clinical trial application approvals plummeted from a high of 529 in 2010 to a low of 17 in 2013. India conducted only 70 global trials in 2014, 54 in 2015 and 44 in 2016. Following this, the NDCT 2019 was crafted with more comprehensive regulations to protect patients, improve data quality, accelerate approval processes, and align with global norms. Most of the new norms were incorporated after assessing rules in the U.S. and Europe.
Experts say that even though NDCT has made CTs in India more expensive, India is still 60% cheaper than the U.S. for clinical trials. India has numerous world class hospitals as trial sites — 1,762 sites and 4,216 ICH-GCP trained investigators. They also cite that post Covid-19 many new drug projects were put on the backburner for prioritising Covid-19 vaccines and therapies. That too has contributed to more trials coming to India. At least 15% of the current trials happening in India are related to Covid-19 drugs and therapies, says Vyas.