India is emerging as a favourable destination for conducting clinical trials, according to a joint report by PwC India and US-India Chamber of Commerce (USAIC).

The report, titled ‘Clinical Trial Opportunities in India, said regulatory reforms since 2013 and the New Drugs and Clinical Trial Rules of 2019 have streamlined the approval processes, reducing timelines 30-40%, resulting in India becoming a favourable destination for clinical trials. Covid-19 also helped increase awareness about the significance of clinical trials in India, it said.

“Clinical trial activity in India has been increasing steadily since 2014 due to several key regulatory reforms aimed towards global harmonisation, enabling open access to clinical trials in India,” said Sujay Shetty, partner and global health industries leader, PwC. “The country’s diverse population, combined with its rapidly advancing healthcare infrastructure, provides a fertile ground for clinical trials to flourish. This is an opportunity for top biopharma companies to develop a long-term strategy that focuses on the key enablers of innovation and strategic partnerships in India,”

Despite its large population, India’s contribution to the global clinical trials has averaged only about 4% per year from 2010 to 2022, the report said, adding that of all the trial participants globally, India’s contribution is only 3% compared to 30% of the US.

Among the top 20 pharma companies: AstraZeneca, Novartis, Eli Lilly, Pfizer,and J&J are the top sponsors of clinical trials in India, the report said.

Clinical trial activity in India was historically low until 2014 due to unfavourable regulations, it said.

“While bulk of the sponsored trials are phase III, phase IV trials have grown at 4% annually over the last decade following the new regulations,” said the report.India has introduced several exemptions and provisions to improve the overall efficiency of conducting clinical trials. According to the report, the total number of investigators doubled between 2015 and 2020, with the majority of the increase occurring in the internal medicine and oncology specialisations.

Targeting tier-2 and tier-3 cities as sites for clinical trials can result in higher access to patients and investigators, according to experts.

“Disease prevalence, density of investigators, and number of patients accessing healthcare is significantly higher in tier-1 cities. In addition, majority of public and private sector tertiary care hospitals are located in tier-1 cities,” said the report.