Kerala awaits ICMR approval to start producing its 'in house' test kits

The state is expecting to price the self manufactured kit at INR 336  per unit. The kit is able to detect the samples with the developed AAG antibody. The kit has already got approval but it is still waiting for the ICMR nod to begin production.

With the recent revision of testing strategy to include random asymptomatic samples in the lot and increase the number of tests to 3000 per day, Kerala is finding itself in a tough spot when it comes to sourcing the kits needed to meet the projected target. Hindustan Latex, the in-house facility of the state is fully equipped to start manufacturing kits upon getting a nod, even at a lesser rate per unit. 

The state is expecting to price the self manufactured kit at INR 336  per unit. The kit is able to detect the samples with the developed AAG antibody. The kit has already got approval but it is still waiting for the ICMR nod to begin production.

India is facing such a pandemic for the first time.  Hence there are no SOPs in place regarding the formulation of guidelines regarding test kits too. This lack of experience and inability in refining the methodology regularly is being cited as the reason for the delay. Sree Chitra has already developed an RT Lamp Kit and Rajiv Gandhi Institute of Biotechnology also has their Rapid Test kit ready for perusal. They also are awaiting the ICMR nod before they could get the kits manufactured.

Since the state has already increased its daily test targets, it may very soon be in need of a large quantity of test kits. The test results obtained from the kits imported from china were deemed unreliable by ICMR and the center has already banned the states from using the Chinese kits anymore. The testing methods  in-house research organizations developed has been approved by ICMR already, but the state is still unable to produce the kits as the paper works for the final approvals are still in progress.