The Indian Council of Medical Research (ICMR) has selected four institutions to build a network of Phase I clinical trial units (CTUs) across the country.
Postgraduate Institute of Medical Education and Research (PGI) is one of the four selected institutions to lead this effort, the Economic Times reported.
These CTUs are pivotal for the evaluation of new therapies, diagnostics, and devices during the exploratory phases of clinical development.
The other three institutions selected for this initiative are King Edward Memorial (KEM) Mumbai, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Mumbai, and SRM Chennai.
These units were established in the last decade with assistance from the Central Drug Research Institute.
ICMR has proposed enhancements to PGI’s clinical trial unit, including doubling its bed capacity to eight and creating dedicated areas for sampling.
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These upgrades are intended to enable the unit to conduct a broader range of exploratory studies.
PGI’s unit has been instrumental in supporting translational research through early clinical trials of new drugs, vaccines, and now medical devices.
The PGI unit has a multi-disciplinary team focused on process improvement, specialised training, capacity building, and the planning and execution of clinical studies.
ICMR’s support aims to optimise the processes within these CTUs, ensuring efficiency in their operations. The benefits of such a network includes prioritising Indian developers to encourage local innovation.
PGI stands out as one of the oldest units for Phase I trials in India, having conducted its first human study in 2006 on an anti-malarial drug developed by the Central Drug Research Institute in Lucknow.
PGI department of pharmacology clinical pharmacology unit professor Nusrat Shafiq said: “This project is for five years for which we have been allotted a dedicated budget, manpower, and training support. The vision is to develop larger, globally competitive units that meet international standards.”
