India accounts for 17% of the world’s population and 20% of the global disease burden, yet fewer than four percent of international clinical trials are conducted in the country.
This gap means Indian patients often wait years after global approvals to access breakthrough therapies.
Now, a new initiative, aligning it with Central Drugs Standard Control Organisations (CDSCO) priorities to boost participation of government sites in Phase 3 and 4 trials, has trained nearly 400 professionals, including investigators, ethics committee members and support staff to meet the global Good Clinical Practice (GCP) standards.
The initiative is aimed at strengthening India’s role in global clinical research and facilitating faster patient access to breakthrough therapies.
Launched by Roche Pharma India, the company on Saturday announced the successful completion of its first phase of the Advanced Inclusive Research (AIR) Site Alliance initiative in India, in which it partnered with 10 leading government hospitals from across the country.
“This milestone marks a significant step forward in strengthening India’s readiness to participate in global and local clinical trials, enabling faster patient access to breakthrough therapies and ensuring India’s diverse population is better represented in clinical research,” said the company.
Launched in 2023, the initiative focused on streamlining internal processes, building digital readiness for better data capture and monitoring and delivering tailored training programs to enhance operational efficiency.
“By equipping leading government hospitals with global-standard clinical trial capabilities, we are helping to bring innovations faster to India. This is a crucial step toward building equitable healthcare and shaping treatments that are relevant for India,” said Dr Sivabalan Sivanesan, Country Medical Director, Roche Pharma India.
Dr Amit Sehrawat, Associate Professor, Medical Oncology and Haematology, AIIMS, Rishikesh, said, “This initiative is a strong example of how public–private partnerships can accelerate capacity-building and strengthen India’s clinical research ecosystem. India carries a significant burden of cancer, infectious and chronic diseases, yet has historically been underrepresented in global trials.”
“By enabling government hospitals to participate in cutting-edge research, this program ensures Indian patients are part of the evidence generation process — helping make treatments safer, more effective and relevant for our population.”
Dr Vyunkta Raju K N, Professor, Dept of Paediatric Neurology, Indira Gandhi Institute of Child Health, said: “The AIR Site Alliance program has been transformational. Our investigators and ethics committees are now better equipped to conduct research of global standards. This collaboration has given our institutions new opportunities to bring advanced research directly to our patients.”
The 10 hospitals, which are part of this initiative are: AIIMS, Rishikesh; Safdarjung Hospital, New Delhi; PGIMS, Rohtak; Homi Bhabha Cancer Hospital & Research Center, Muzaffarpur; Balco Medical Centre, Raipur; Government Medical College, Aurangabad; Indira Gandhi Institute of Child Health, Bengaluru; Dr Bhubaneswar Borooah Cancer Institute (BBCI), Guwahati; Kalyan Singh Super Speciality Cancer Institute & Hospital, Lucknow’ and Acharya Harihar Post Graduate Institute of Cancer, Cuttack.
The project aligns closely with India’s national priorities, including the CDSCO’s encouragement for greater participation of government sites in Phase 3 and 4 trials and the Pharmaceutical Research and Innovation Policy (PRIP) initiative that explicitly encouraged industry-academia partnerships to strengthen R&D capabilities, build clinical trial infrastructure and enhance India’s global competitiveness in innovative research, the company said.
“This initiative supports the vision of Viksit Bharat by 2047 – creating a future-ready, world-class healthcare ecosystem where India emerges as a global hub for clinical research, accelerates access to breakthrough innovations, and delivers equitable health outcomes for every citizen,” it added.
The AIR Site Alliance is Roche’s flagship global initiative designed to expand access to clinical trials for underrepresented populations.
Already implemented in the US, UK, Canada, and Africa, the AIR Site Alliance is now active in India, helping to close representation gaps, generate more robust scientific evidence and accelerate equitable healthcare outcomes worldwide, the company added. The New Indian Express