Representative Image for government hospitals.
Credit: iStock
New Delhi: In a significant step toward improving clinical research in India, ten government hospitals, supported by a leading pharmaceutical company, have joined forces to create a network for conducting high-quality clinical trials. This initiative aims to generate robust, home-grown data and facilitate faster access to innovative medicines for Indian patients.
Despite accounting for 17% of the global population and 20% of the world’s disease burden, India conducts less than 4% of global clinical trials. This gap means that new medicines approved abroad often face long delays before reaching Indian patients.
Six years ago, new clinical trial rules allowed medicines approved in countries with high regulatory standards to be sold in India, provided phase III or IV trials are conducted locally. The Central Drugs Standard Control Organisation (CDSCO) has since emphasized the need for at least 50% of such trial data to come from government hospitals.
A major hurdle until now was the lack of training in smaller hospitals on how to run international-standard trials. Roche stepped in to provide training, drawing on its global experience in managing similar networks. Importantly, the hospitals remain open to conducting trials for any organization, not just Roche.
“None of the trials being conducted at my hospital are Roche products,” said Ravikant Singh, Officer-in-Charge at Homi Bhabha Cancer Hospital and Research Centre, Muzaffarpur.
The network includes prestigious institutions such as AIIMS Rishikesh, Safdarjung Hospital (New Delhi), PGIMS Rohtak, Balco Medical Centre Raipur, Government Medical College Aurangabad, Indira Gandhi Institute of Child Health (Bengaluru), Dr Bhubaneswar Borooah Cancer Institute (Guwahati), Kalyan Singh Super Speciality Cancer Institute (Lucknow), and Acharya Harihar Post Graduate Institute of Cancer (Cuttack).
Medical researchers from the hospitals, along with officials from ICMR, NITI Aayog, and Roche, met in New Delhi on Saturday to assess progress over the last two years in building the network.
“We learnt how to establish institutional ethics committees and clinical trial secretariats, and received training in good clinical practices,” Singh explained. “We are now conducting two oncology trials, one on antimicrobial resistance, and another focused on non-communicable diseases, funded by UK health authorities.”
Professor Savita Verma of PGIMS said, “This network will generate grassroots health data and inspire researchers to participate in multi-centre trials, raising the overall standard of research in India.”
Nearly 400 professionals, including investigators and ethics committee members, have been trained, significantly boosting Indian hospitals’ ability to conduct global-standard clinical research.
Vyunkta Raju K N, professor at Indira Gandhi Institute of Child Health, added, “Our investigators and ethics committees are now well-equipped to conduct research that meets global benchmarks.”