India's expensive reliance on imported HIV diagnostic kits would soon end. Three companies -- Ahmedabad-based Cadila Pharmaceuticals and Delhi-based firms ACE Diagnostics and J Mitra & Co -- are all set to launch indigenously developed HIV diagnostics kits in the domestic market.

The companies have scaled-up the technologies they had bought from public sector research institutes and have sought the approval of the Drug Controller General of India (DCGI) to commence commercial production. The clearances are expected to be granted very shortly,

official sources said.

The kits - a peptide-based kit for Elisa test (from ACE), an immuno-western blot (J Mitra) and a recombinant chimeric reagent (Cadila Pharma)- would bring down the cost of HIV tests in the country by more than 200 per cent, sources said.

The government being the major buyer of HIV kits through the National AIDS Control Organisation (NACO), the companies have already approached the Union health ministry for signing a purchase agreement. The ministry is understood to be of the view that NACO could restrict the buying to Indian firms once the technologies are validated.

The native kits, in addition to being substantially cheaper, are also

considered to be more suitable for the country as imported kits are found to be giving inaccurate results due to over- reading/ underestimation of the severity of the infection. The lack of precision is due to the fact that in imported kits the strains used are not totally compatible with the virus found in India, that is, subtype C.

Of the three indigenous kits, the immunowestern blot technology is for

confirmatory tests. While the imported kits costs about Rs 800 per test, the indigenous kits from J Mitra would cost only Rs 200-300 per test, sources said.

As for the preliminary test, the peptide-based Elisa from ACE would cost Rs 30 per test as opposed to Rs 80 being charged on imported kit.

The recombinant chimeric reagent to be launched by Cadila Pharma was developed by Delhi University South Campus.

Officials said that the technology is a major breakthrough with its high sensitivity (99.6%) and specificity (99.2%) results. The technology could be used for screening of large pool of clinical material -- even for screening blood banks. Naked eyes could detect the infection with the visual agglutination system and the cost per test could be as low as Rs 20. India's total requirement of HIV diagnostics is currently being imported.

While the government is the major importer through the NACO, a host of firms from the private sector also use imported kits.