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Guidelines For The Validation And Batch Testing Of Covid-19 Diagnostic Kits

The Indian Council of Medical Research and Drugs Controller General of India have jointly come up with some of the guidelines for validating and batch testing of Covid-19 diagnostic kits. In a joint meeting, all the recommended guidelines were approved and this is a recommendatory and a dynamic document without any prejudice to the statutory provisions. According to guidelines, US FDA approved RT-PCR kits, RNA extraction kits, as well as the viral transport medium, ELISA, CLIA Kits along with rapid antibody test and it will not require any ICMR validation. All the manufacturers, as well as the supplier of those kits, can apply for obtaining  approval from DCGI directly. The first batch of CE-IVD that got approval and the non-US FDA got approval but the indigenous RT PCR kits will need the basic validation from 24 ICMR recognized validation centers before getting approval from DCGI. Then for post-marketing, extra two batches must be tested according to the medical device rules in a peri
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