India on Thursday announced the start of Phase-II human clinical trials of an indigenously developed clot-busting drug and upon successful development it would be the first patented biopharmaceutical drug developed in the country.
The Drugs Controller General of India (DGCI) has granted permission to conduct human clinical trials to test the efficacy of Clot Specific Streptokinase (CSSK) in heart attack patients.
According to scientists, CSSK would be a much cheaper and affordable alternative to the currently available expensive thrombolytic drugs and will thus address the needs of the larger masses of the country.
Besides, it is unique as it has a hugely reduced risk of bleeding during the treatment, which makes it a distinctively improved drug compared to several currently employed thrombolytic drugs where the risk of bleeding exists to varying degrees.
The drug has been developed as a public-private partnership between CSIR-Institute of Microbial Technology (CSIR-IMTECH) and Nostrum Pharmaceuticals of the US.
Announcing the Phase-II trials, T Ramasami Secretary Department of Science and Technology, said this has been an exemplary and diligent pursuit of translational science from lab to the very threshold of clinic.