Experts urge India to rewrite clinical trial rules to boost global market share
As of 2022, India held an 8 per cent share in global clinical trials — which evaluate the safety and effectiveness of new treatments — compared to China's 29 per cent, the US's 25 per cent, and 38 per cent for the rest of the world, data from consultancy PwC showed.
"There's a lot to learn from what other countries have done to make them clinical trial destinations," BCG India partner Smruthi Suryaprakash said, pointing out that China saw an increase in innovation after easing regulations, while Australia has benefited from offering significant tax incentives.
India's clinical trials research market is rapidly expanding, supported by a diverse patient base, cost-effective solutions, and a growing hospital network, according to US-based GrandView Research, which forecasts revenues exceeding $2 billion by 2030.
"India will be able to capture the clinical trial (market) if we can really work on the speed. I think speed is what is really important to sponsors, either with regulator or being able to recruit patients faster," Suryaprakash added.
Suryaprakash, along with other experts, was speaking as part of a panel at the BioAsia conference in the southern Indian state of Telangana.
Rajeev Raghuvanshi, who heads India's drug regulator, said it was working to make the regulatory process more streamlined for global trials in India, based on feedback from stakeholders.
"We have aligned things every year on average for the last three years," the drugs controller general of India said.
The agency which revamped its trial rules in 2019, had approved about 160 trials in the last three years, he added.
Recruiting the right patients
Allowing sponsors to raise awareness among patients, such as through advertisements of ongoing studies, would also help India advance as a recruitment site, the experts said.
Advertising studies for experimental treatments could be helpful, especially for patients with rare diseases without many treatment options. It is a common practice in countries such as the US and the UK.
"You're not able to recruit into the trial because they (patients) do not know that it exists," said Padmaja Lokireddy, an oncologist at Apollo Hospitals.
That needs to change, experts said.
Some other experts highlighted challenges related to preparing a clinical trial site, ensuring it meets global safety standards and recruiting the right patients.
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