The Indian Council of Medical Research (ICMR) and Drugs Controller General of India (DCGI) have jointly come out with guidelines for validation and batch testing of COVID-19 diagnostic kits.
The guidelines were approved at a joint meeting of ICMR and DCGI last week. This is recommendatory and dynamic document without prejudice to statutory provisions, said Dr Lokesh Sharma, scientist, ICMR.
As per the guidelines, US FDA approved RT-PCR kits, RNA extraction kits and viral transport medium (VTM), rapid antibody test, ELISA and CLIA kits will not require ICMR validation. The manufacturer and supplier of such kits can directly apply for DCGI approval.
The first batch of CE-IVD approved, non US FDA approved and indigenous RT PCR kits will require validation from any of 24 ICMR identified validation centres prior to DCGI approval, thereafter for post marketing, additional two batches should be tested as per Medical Devices Rules in four months’ time, it stated.
One batch of CE-IVD approved, non US FDA approved, indigenous RNA extraction kits and VTM will require validation from any of ICMR identified validation centres prior to DCGI approval.
The testing of three batches of CE-IVD approved, non US FDA approved, indigenous rapid antibody test, ELISA and CLIA kits will be required for validation from any of ICMR identified validation centres prior to DCGI approval, the guidelines said.
The firm will be required to provide batch testing certificate while delivering the consignment. ICMR identified validation centre will undertake random samples testing of batches of kits for quality assurance, said Dr Sharma.
