Few takers for indigeniously developed cheap H1N1 test kits

NEW DELHI: Swine flu diagnostic kits developed and manufactured by two Indian firms have been tested against imported ones and approved by the Indian Council of Medical Research (ICMR) and cleared by the Drug Controller General of India (DCGI) for sale in the country. The kits cost less than half the price of the imported kits. Yet, despite PM Modi's'Make in India' call, not even central government controlled organizations, like the National Centre for Disease Control or hospitals like AIIMS are buying these kits and going for expensive imported ones.

Hundreds of crores are being spent everyday on swine flu tests as the number of infected people continues to climb and India is totally dependent on imported kits for testing that cost about Rs 2,000 per test to the public sector. In the private sector, the charges vary -from Rs 4,500 (the price fixed by the Delhi government) to over Rs 9,000. The test kit manufactured by the Hyderabad-based RAS Lifesciences and Molbio Diagnostics costs just Rs 400-900.

These kits underwent a series of validation tests in several centres the National Institute of Virology in Pune, Kasturba Medical College in Manipal, NCDC in Delhi, King George Medical University in Lucknow, National Institute of Cholera and Enteric Diseases (NICED) in Kolkata and NIMHANS in Bangalore against the imported kits which are the standard WHOCDC protocol for swine flu diagnosis. The technology for the kits was developed by Defence Research and Development Establishment (DRDE), Gwalior.

"Information about the technical approval from ICMR and the marketing approval from DCGI has not percolated to the state government. Unless that happens, it is difficult to develop a market for these kits, as procurement happens at the state-level," said Shesheer Kumar, CEO of RAS Lifesciences. "We have already written to the Union health ministry and the Department of Industrial Policy and Promotion (DIPP) in this regard," said Deepak Bagla, MD Invest India.