The Hyderabad-based Bharat Biotech International Ltd (BBIL) on Monday announced that it would be marketing the eagerly awaited recombinant Streptokinase from September. BBIL has received commercial licence from the Drug Controller-General of India (DCGI) to manufacture and market the primary drug meant for dissolving blood clots, a common occurrence during a heart attack.
According to a company press release, BBIL becomes the first biotech company in India and second in the world to manufacture the drug. The Drug Controller-General of India, the national regulatory authority for Indian pharmacopoeia, granted the commercial licence on August 14. “The licence will help us realise our dream of making life-saving drugs affordable to the common man. The clinical trials for the drug had been completed on over 100 patients in Bangalore and Kolkata,” said Dr Krishna M Ella, the Chairman and Managing Director of BBIL
BBIL’s recombinant Streptokinase 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.
“By manufacturing indigenously, we can bring down the cost of this drug, which has been all along imported. The recombinant Streptokinase scores over its non-recombinant counterpart in many respects – the most significant one being that it is able to prevent excessive bleeding compared to the existing products,” Dr Ella said in the statement.
According to the company’s Director Suchitra Ella, the market size of the product is expected to be around Rs 50 crore. The company plans to launch the product in September. The drug will be competitively priced vis-à-vis the products of similar nature being imported by various companies and marketed in India.
BBIL has excellent production, formulation and packing facilities for manufacturing Streptokinase. The plant has been constructed in accordance with the norms set by US FDA and UK MCA. The company has also filed for process patent in the US in the year 2000.
Of the total project cost of Rs 30 crore for producing the new drug, the Technology Development Board, Department of Science & Technology, had sanctioned Rs 11 crore, while SBI had funded Rs 7 crore. The company claims to have mobilised the rest by way of internal accruals.
The company said that the new product had been duly approved by national regulatory committees such as the Review Committee of Genetic Manipulation, Genetic Engineering Approval Committee, the Ministry of Environment & Forests, the Recombinant Deoxyribonucleic Acid (RDNA) and finally the Drug Controller-General of India.