CDSCO notifies its list of PCR Kits approved for testing of Covid-19

The Central Drugs Standard Control Organisation (CDSCO) has updated and expanded on its list of Polymerase Chain Reaction (PCR) Kits approved for testing of Covid-19. The new list was notified on  09.12.2022.

The list covers PCR kits produced by 270 firms over several countries. The list had previously been amended on 9.12.2021. The prior list covered merely 235 kits produced by various firms.

M/S Molbio Diag. Pvt Ltd Goa having the kit, Truenat Beta PCR is approved as screening test and not for confirmatory test. This status is retained from the earlier notification.

Some new entrants in the list include:

1. KAMINENI SARS-COV-2 (COVID-19) RT PCR Kit of M/s Kamineni Life Sciences Private Limited, Hyderabad
2. ID NOW™ COVID-19 2.0 (Isothermal nucleic acid amplification technology (NAAT)) of M/s Abbott Diagnostics Medical Private Limited, Gurgaon, Haryana (India)
3. NeuMoDx™ SARS-CoV-2 Test Strip (RT-PCR) of M/s QIAGEN India Pvt. Ltd, Delhi (India) – 110025
4. KANEKA Direct RT – PCR kit SARS – CoV – 2 of M/s Bajaj Healthcare Ltd. (Public Ltd) Vadodara, Gujarat (India)