“A strong investment from a budget perspective is absolutely needed to focus on developing more such new molecules and CAR-T therapies here in India,” Sanjay Vyas, President and Managing Director, Parexel India, told businesslineadding that the sops should be extended to private clinical research organisations (CROs) as well, and not just academic institutions. (Parexel is among the world’s largest CROs.)
Countries like China and many parts of Australia, for example, provide incentives for CROs to further research and development activities, he said. The idea is also to accelerate the clinical research and manufacturing services (CRAMS) that get engaged early in the molecule development, said Vyas.
The global clinical research industry is pegged at about $ 75 billion, he said. Industry estimates peg the clinical trial industry in India at about $2.5 billion (2024).
Use of AI
With healthcare also looking to include Artificial Intelligence (AI) tools to cut short timelines, for example, Vyas also called for budgetary support to use similar innovative approaches in research and development. This would help advance “proactive research and development in drug discovery”, he said, especially when the Western world looks to use predictive analytics of a drug, for example, even before the first-in-human trial happens. The possibilities of the drug succeeding, testing of its safety and efficacy before human trials, etc., can be enhanced, he said, adding that India had the right skill set, ecosystem, and environment at this point.
Phase I trials
Pointing to a network of institutions created by the Indian Council of Medical Research late last year to undertake early Phase I trials, Vyas called for an environment where multinational pharmaceutical organisations could also undertake Phase I trials on new molecules in India.
Phase I trials in India are largely allowed only for molecules developed within the country, he said. “If this gets opened up, patients will get benefited because there are so many rare diseases for which they still have to wait till the Phase II or the Phase III trial happens in India,” he explained. Besides, he added, this would also help more primary hospitals and investigators to further develop that arm of Phase I trial in addition to the ICMR network, he said. The Centre’s move to bring in digital IDs for patients would also help map diseases and develop targeted solutions and therapies, he added.
