ICMR set to develop centres for phase I clinical trial in India

India Pharma Outlook Team | Tuesday, 14 June 2022

With an aim to improve therapeutic regimens and ensure advancement in medical practice that is evidence based, the Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research, is set to develop centres for phase I clinical trial consisting of medical institutes across the country. The centres will function as standalone facilities capable of effectively executing phase I clinical trials of the highest quality.

ICMR will provide technical, financial, and administrative support. ICMR plans to have a memorandum of understanding (MoU) with government and private medical colleges and universities to identify and evaluate investigational products/lead molecules through these centres for phase I clinical trials. Phase I studies of a new drug are usually the first that involve people. Phase I studies are done to find the highest dose of the new treatment that can be given safely without causing severe side effects.

The toxicity data (adverse effects) derived from these studies are used to characterize the safety profile of the new medicinal product. Phase 1 clinical trials typically focus on healthy participants in order to first determine whether medicines and vaccines are safe for use in patients and whether there are any side effects. The phase I study usually has 10 to 30 volunteers. ICMR has sought an expression of intent from medical institutions with the necessary facilities and capacity available to participate as its centres forphase I clinical trials, which will enroll appropriate participants to successfully execute these trials. The last date for receiving application is July 8, 2022.

Last year ICMR notified medical institutes selected for participation in the Indian Clinical Trial & Education Network (INTENT). The institutes were selected under Advanced Centre for Clinical Trial (ACCT), Regional Clinical Trial Unit (RCTU), ICMR-Centre for Clinical Trial (ICCT), Specialty Centre for Clinical Trial (SCCT) and Knowledge Partner for Clinical Trial (KPCT).

The medical institutes which have been selected as Advanced Centre for Clinical Trial (ACCT) include All India Institute of Medical Sciences, New Delhi, Post Graduate Institute of Medical Sciences and Education, Chandigarh, S.M.S. Medical College and Attached Hospitals, Jaipur, Rajasthan, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Maharashtra, ICMR- National AIDS Research Institute (NARI), Pune, Maharashtra, All India Institute of Medical Sciences, Bhubaneswar, Odisha, ICMR- National Institute of Cholera and Enteric Diseases (NICED), Kolkata, West Bengal, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS), Shillong, Meghalaya, King George Medical University, Lucknow, Uttar Pradesh, Jawaharlal Institute of Medical Education & Research (JIPMER), Puducherry, St Johns Medical College, Bengaluru, Karnataka, Amrita Institute of Medical Sciences, Kochi, Kerala.

All India Institute of Medical Sciences, Rishikesh, Uttarakhand, ICMR-National Institute For Research In Reproductive and Child Health, Mumbai (Dahanu), Maharashtra, ICMR-Regional Medical Research Centre, Bhubaneswar (Tigria), Odisha, Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, Silchar Medical College & Hospital, Silchar, Assam and Gandhi Medical College, Secunderabad, Telangana have been selected as Regional Clinical Trial Unit. Specialty Centre for Clinical Trial includes ICMR-National Institute for Research in Tuberculosis (NIRT), Chennai, Tamil Nadu, Tata Memorial Centre, Mumbai, Maharashtra, National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru, Karnataka, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Trivandrum, Diabetes Foundation, New Delhi, ICMR-National Institute of Virology, Pune, Maharashtra. The George Institute of Public Health, Hyderabad, Telangana, Centre for Chronic Disease Control (CCDC), New Delhi and Centre for Public Health Kinetics, New Delhi have been selected as Knowledge Partners for Clinical Trials.