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 period of four months.

The firm is needed to deposit a batch testing certificate while conducting deliverance of the consignment. A validation center identified by ICMR will undertake random sample testing of a batch of kits because of quality assurance as per Medical Device Regulations in India. For sending the request to validate the kits of RT-PCR, Rapid antibody test, CLIA, RNA Extraction, VTM, the manufacturer or the supplier must send an email to Dr. GS Toteja who is the additional director general of ICMR and the national nodal officer for granting validations.

This request sent by the manufacturer or the supplier must be accompanied with all information like the name of the manufacturer, kit name, batch no, supplier, first-time validation by ICMR along with details of the validation along with the overall validation report, and any differences in the composition of the kit when compared with the first validation.

The request, after proper scrutinization will be forwarded to any of the ICMR recognized validation centers based on the workload as well as logistics issues when it is a first-time validation.

When the kit is scrutinized for obtaining second-time validation or any successive validation, the manufacturer or the supplier has to deposit a justification that has to be reviewed at ICMR, New Delhi. The decision taken will be provided to the manufacturer or the supplier within one week.

The request for re-validation will be taken into consideration when there is any kind of significant change in the kind of composition of the reagents present in the kit. When the kit is supplied to any of the validation centers with the required number of test reactions, methods as well as reagents, the overall validation report will be given to the manufacturer or the supplier in 15 days.

As of now, there are a total of 24 centers for validating and batch testing of the Covid 19 diagnostic kits that includes 9 ICMR institutes, 3 CSIR institutes, 5 departments of biotechnology institutes along with 7 other such institutes. Till now about 97 RT-PCR kits have been evaluated by the ICMR validation centers from which 40 kits were found to be satisfactory.