Karnataka-based diagnostic kit major Bhat Biotech is in the process of developing swine flu kit. But the product will be ready only for the next flu season.
The company's research wing is now working on the kit to test the swine flu samples. The research is in early stages and is also complicated because the samples of virus (throat swabs) are not easily available. With swine flu declared by the World Health Organization (WHO) a pandemic, the Union government has taken testing for H1N1 virus its control. However, we are going all out on our research and development plans, Dr Shama Bhat, chairman and managing director, Bhat Biotech told Pharmabiz.
The kit will undergo the required trials before we make it available. Therefore our estimation is that our kit will be ready only by mid 2010, he added.
Last year, the Bangalore-based Bhat Biotech indigenously developed the country's first Chickungunya kit which is a rapid test for the detection of IgM antibodies to Chikungunya virus in human serum/ plasma. It also received the technology transfer from Defence Research & Development Establishment (DRDE) for manufacturing rapid test for Toxin (Ricin). The immuno-chromatography based test detects the Ricin as low as 50ng/ml in the sample which is ideal for field testing.
Since its inception in 1994, the company has been supplying its range of kits: pregnancy, malaria, Hepatitis and HIV to the Union government, National Aids Control Organization (NACO) and WHO. It exports to over 20 countries: Turkey, Italy, South and Central America: Peru, Brazil Honduras, Mexico, four western African countries besides Asia and Far East. It has been certified as GMP, ISO 9001:2000 & 13485-2003 and CE
company.
In June this year, the company expanded its research and production units located at the Veerasandra Industrial Area in Bangalore. The five floor facility has the R&D cell and seven production units with 10,000 Clean Rooms, large scale reagent manufacture facility and downstream processing equipments. Currently, the kit range is antibody and enzyme based. With this expansion in infrastructure and research, the company is looking at lab-on-a-chip which is the ultimate in diagnostics. It is also focusing on molecular diagnostics to develop a new line of automated and easy-to-handle kits.
Post expansion of company's annual production capacity is 2 lakh kits. With the increasing demand for faster and easy diagnostics found wanting in the country, it is keen to increase its capacity to 3 lakh kits at the earliest. From the existing 100 kits designed and developed indigenously, the fastest growing ones are pregnancy, HIV and malaria for the company.
Indian diagnostic kit market is valued at Rs 2,000 crore. Factors attributing to the growth are lab automation, growing number of pint of care testing, increasing number of and higher patient awareness. In the rapid test space, leading names other than Bhat Biotech are J Mitra, Tulip, Span, Accurex, Beacon and Mediclone Biotech, to name a few.