The National Institute of Pharmaceutical Education and Research (NIPER), Raebareli, and AstraZeneca India have entered into a partnership to strengthen clinical research capabilities in the country and increase India’s participation in global clinical trials. This initiative focuses on developing a trained workforce and establishing clinical trial-ready centres across 25 emerging research hubs, located outside of major metropolitan cities.
The Department of Pharmaceuticals has supported this collaboration under the central government’s ‘Biopharma Shakti’ scheme. A Memorandum of Understanding (MoU) was signed in New Delhi on Wednesday in the presence of Manoj Joshi, Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers.
Assessment of Capabilities at 25 Clinical Trial Centres
In the initial phase of this partnership, 25 clinical trial sites will be identified. The existing capabilities of these centres will be assessed, followed by the provision of targeted training and mentorship. Furthermore, processes related to ethics, safety, trial feasibility, documentation, and support systems will be strengthened. The Department of Pharmaceuticals will provide guidelines and necessary approvals to ensure that the program aligns with national clinical research priorities.
AstraZeneca to Support Training and Operations
Within this government-led framework, AstraZeneca India will contribute its expertise in clinical development toward the design and implementation of the program. The company will engage both Indian and global experts in the training process. Additionally, the capabilities of the selected sites will be enhanced through workshops, operational support, and by preparing these centres to conduct clinical trials.
Focus on Increasing India’s Participation in Global Trials
Manoj Joshi, Secretary, Department of Pharmaceuticals, stated that India possesses the talent and expertise required to play a significant role in global clinical trials. Strengthening clinical research capabilities beyond major metropolitan cities will help increase the number of skilled professionals and research-ready centres across the country. They stated that this agreement—which brings together the government, academia, and the industry—will systematically strengthen clinical research capabilities and advance the core objectives of the ‘Biopharma Shakti’ initiative.
Centre of Excellence to serve as a platform for structured training and certification
Shubhini Saraf, Director of NIPER Raebareli, stated that the Centre of Excellence will provide a dedicated platform for structured training and certification in clinical research. By combining expertise from both academia and the industry, the institute will help develop a skilled workforce. Furthermore, a model will be created that can be scaled to other geographical regions and various therapeutic areas.
Clinical research is vital for delivering new medicines to patients
Praveen Rao Akkinepalli, Country President and Managing Director of AstraZeneca Pharma India Limited, noted that clinical research plays a crucial role in bringing innovative medicines to patients. He explained that this partnership with NIPER Raebareli—supported by the government—aims to strengthen India’s clinical research capabilities, increase participation in clinical trials, and foster a sustainable, high-quality research ecosystem.
Plans for national-level expansion under ‘Biopharma Shakti’
The initiative is designed to evolve into a scalable national model. Following a ‘proof-of-concept’ phase, it could be expanded to include therapeutic areas beyond oncology, as well as additional geographical regions. Under the ‘Biopharma Shakti’ scheme, the goal is to develop a robust biopharma ecosystem, which includes the establishment of 1,000 clinical trial centres across the country.
