At least a week to put testing kits in the market: Molecular diagnostic companies

MUMBAI: Private molecular diagnostic companies who provide kits or reagents to test people for Covid-19 to government and private labs have said it will take them at least a week as their reagents are still in validation stage. This means private labs who received permission from the government for Covid-19 testing cannot start testing till the reagents get approved for sale.

Private molecular diagnostic companies have received licenses to get their tests validated but they cannot sell those kits under the current license. “The permission from the drug controller will allow the companies to prove if their kits show accurate results or not,” founder of a molecular diagnostic company said on the condition of anonymity.

On Monday, the National Institute of Virology Pune will launch into this process, and simultaneously, the drug controller will also be inspecting the manufacturing facilities.

“Once these regulators submit their report, we are looking for at least a week’s time to start providing our kits for commercial use”, the person quoted above said.

Last week the Indian Council of Medical Research (ICMR) approved accredited private labs in the country to offer testing for Covid-19. The ICMR laid down guidelines for these labs and said that the tests should be offered only if companies meet the ICMR criteria for testing. It has also put a cap on testing, saying that labs should not charge more than Rs 4500 to Rs 1500 for screening test for suspect cases and additional Rs 3000 for confirmation.

“ICMR, however, has urged free or subsidized testing by private labs,” the government body said in its note.