Bharat Biotech has announced the launch of recombinant streptokinase, under the brand name 'Indikinase', a clot buster drug. It is a protein produced from genetically manipulated Escherichia coli. This enzyme is a first line therapy for management of acute myocardial infarction, deep vein thrombosis, arterial occlusion and pulmonary embolism.
The recombinant version is considered to be better than its non-recombinant counterpart in its ability to prevent excessive bleeding rapidly. Streptokinase is a plasminogen activator and its major application is in the thrombolytic therapy for the early management of myocardial infraction (MI). Plasminogen activators are life-saving drugs administered in emergency to save patients with acute MI.
The Technology Development Board, Department of Science & Technology, has part funded the Rs. 30 crore Recombinant Streptokinase project, which has been completed by BBIL. Of Rs. 30 crore, Technology Development Board has funded Rs.11 crore, SBI, Overseas Branch has funded Rs.7 crore and the rest of Rs. 12 crore by internal accruals.
BBIL has exclusive production, formulation and packing facilities for manufacturing Streptokinase. The plant has been constructed in accordance with norms set by US FDA and UK MCA. The company has also filed for process patent in the United States in the year 2000.
BBIL has conducted multi-centric clinical trials in various parts of the country for the product, and is approved by national regulatory committees such as Review Committee of Genetic Manipulation (RCGM), Genetic Engineering Approval Committee, Ministry of Environment & Forests, Recombinant Deoxyribonucleic Acid (RDNA) Committee and by the Drug Controller General of India.
Bharat Biotech has not yet revealed the price of 'Indikinase' due to strategic reasons. It will have much to do with Shantha Biotech, which too has just launched recombinant streptokinase 'Shankinase'. But, it would be offering its product at a highly competitive price compared to the currently imported products.