Controller clears clot-buster drug for human trial
August 17th, 2012 - 7:28 pm ICT by IANSNew Delhi/Chandigarh, Aug 17 (IANS) The Drug Controller General of India (DCGI) has cleared a bio-therapeutic clot-buster drug for phase-one human clinical trials, a statement said Friday.
The drug, earlier licensed from a US-based firm, has been designed by Chandigarh-based Council of Scientific and Industrial Research (CSIR) - Institute of Microbial Technology (CSIR-IMTECH).
“Clot-specific streptokinase (CSSK), a pioneering bio-therapeutic clot buster drug from the CSIR-IMTECH has been cleared Thursday by the office of the DCGI for Phase-One Human Clinical trials,” the statement from CSIR said.
The drug is helpful in saving lives of patients suffering heart attacks; it can also reduce the risk of internal bleeding, associated with the use of clot busters.
The drug has recently been successfully tried in test animals including monkeys. Its design and process development and scale-up was achieved by a team led by CSIR-IMTECH Director Girish Sahni.
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Tags: chandigarh, clot buster, clot busters, controller general, dcgi, heart attacks, human clinical trials, imtech, India, microbial technology, monkeys, New Delhi, phase one, risk, streptokinase, suffering heart, test animals