The Drug Controller General of India (DGCI) recently gave permission for phase 2 clinical trials for Clot Specific Streptokinase (CSSK), a bio-pharmaceutical molecule that was discovered at the Chandigarh-based Institute of Microbial Technology.
Representative image | Reuters
A US based pharmaceutical company, Nostrum Pharmaceutical subsequently acquired the rights for further clinical development of the drug.
The clinical trial permission is a big step for the Indian scientific community, given that the drug was indigenously developed and promises to have path-breaking potential.
CSSK is created by a recombinant DNA and protein engineering technologies to bust clots. It could be used to treat heart attacks. At the pre-clinical level, the drug has been tested on animals. At the first phase of clinical trials, it was tested on healthy human volunteers. The current approval will enable it to be tested on actual heart-attack patients, so that it can then proceed to phase 3 trials where dosages can be fixed.
Girish Sahni, director general of the Centre for Scientific and Industrial Research (CSIR) said that this could be India's first patented biopharmamolecule.
