The Ministry of Health and Family Welfare, on June 4, 2020, has published the Guidelines for Validation and Batch Testing of Covid-19 Diagnostic Kits. The guideline is a recommendatory and dynamic document without prejudice to statutory provisions.
As per the guidelines, the manufacturers and suppliers of US Food and Drug Administration (USFDA) approved RT-PCR kits, RNA extraction kits and viral transport medium (VTM), rapid antibody test, ELISA and CLIA kits can directly apply for DCGI approval; and will not be required to get validation from ICMR. The firm will be required to provide the batch testing certificate while delivering the consignment. ICMR identified validation centre will undertake random samples testing of batches of kits for quality assurance.
The guidelines further stated that the requests for validation of kits for RT-PCR; RNA Extraction, VTM, Rapid Antibody Test, ELISA and CLIA will be sent by the manufacturer/supplier through e-mail (gstoteja@gmail.com) to Dr G. S. Toteja, Additional Director General, ICMR and National Nodal Officer for validation.
The request from the manufacturer/supplier should mandatorily be accompanied with information viz. name of manufacturer, supplier, name of the kit and batch no, first-time validation by ICMR, details of last validation along with validation report (if it is not first time validation), the difference in kit composition as compared to first validation etc.
The request after receipt and scrutiny will be forwarded to anyone of the ICMR identified validation centres depending upon the workload and other logistics issue if it is first-time validation. The request for re-validation will only be considered if there is any significant change in the composition or type of reagents in the kit.
Once the kit is delivered to the validation centre with an adequate number of test reactions required, reagents, methodology etc; validation report will be sent to the manufacturer/supplier within 15 days.
There are 24 centres for validation and batch testing of COVID-19 diagnostic kits which include nine ICMR institutes, five departments of biotechnology institutes, three CSIR institutes and seven other institutes.
Click here to read the guidelines.
