PGI leads phase 1 clinical trials for indigenous cancer drug development in India
This initiative marks a significant leap in fostering innovation and promoting homegrown research in the country's pharmaceutical landscape. The molecule for the cancer drug is undergoing phase 1 clinical trials in PGI.
The ICMR's visionary plan to create a nationwide network of CTUs aims to bolster the evaluation of new devices, diagnostics, and drugs in their crucial early phases of development. "PGI has been one of the four such units for phase one clinical trials in the country.
For new medicine used in humans for the first time, Phase 1 assesses safety. Earlier, these studies were mainly done by big companies, but now ICMR is supporting indigenous clinical trials," stated Dr.
Rajiv Bahl, director of ICMR.
The ICMR director informed that phase 1 clinical trials elsewhere in these CTUs are ongoing for the development of Zika virus and antiflu vaccines.
Alongside PGI, the other three distinguished CTUs in this Phase 1 network are KEM Mumbai, the Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Mumbai, and SRM Chennai.
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These institutions are integral to nurturing homegrown innovations, a key focus for the ICMR. Dr. Bahl said, "There are 75 such networks in the country for Phase 2 and Phase 3 clinical trials."
PGI boasts a rich history in clinical drug trials, conducting the country's first human study in 2006. This pioneering trial involved an antimalarial drug molecule developed by the Central Drug Research Institute, Lucknow, with PGI playing a crucial role in developing a joint protocol and taking the research forward.
Also, last year the PGI's CTU proposed an 8-bedded facility for the participating volunteers to be enhanced from the existing 4 beds. However, this facility has yet to take off. "One can compete with world-class innovations if there are better facilities for the volunteers who are the backbone of such clinical trials," said an official at the ICMR.
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