India's contribution to global clinical trials at 4% during 2010-22: Study

India’s contribution to global clinical trials has averaged around 4 per cent during 2010-2022, despite the country’s large population, a study has revealed. Top 20 pharma-sponsored trials in the country has increased by 10 per cent since 2013 following multiple regulatory reforms, said a PwC India & US-India Chamber of Commerce (USAIC) titled “Clinical Trial opportunities in India”.

Sujay Shetty, partner and global health industries leader, PwC, 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.”

This is an opportunity for top biopharma companies to develop a long-term strategy that focuses on strategic partnerships in India, Shetty felt.

States with high disease prevalence (such as cancer) also have the most number of tier-1 cities, with advanced medical infrastructure and availability of investigators.

Targeting these states can provide biopharma companies with faster access to patients, sites, and investigators, the report said. Total number of investigators has increased two times between 2015 and 2020, with the majority of the increase occurring in the internal medicine and oncology specialisations. However, the growth in the number of investigators is largely restricted to tier-1 and tier-2 cities.

Sanish Davis, president, Indian Society for Clinical Research (R&D director GCO, Janssen India), told Business Standard that a big change during the Covid period has been the collaborative approach of all stakeholders starting from the regulatory agency. “The regulator quickly changed into a virtual format within a week or so when Covid hit,” he said, adding that second, the speed at which the regulatory agency was reviewing dossiers submitted by drug firms also helped for faster approvals for clinical trials, as well as the products. Ethics committees of clinical trials also became virtual almost immediately after Covid hit. “So, these two changes helped in the review process of the dossiers that were submitted, which enabled the rapid review,” Davis added.