DCGI-ICMR Guidelines: Manufacturer, supplier of COVID-19 diagnostic kits can directly apply for DCGI approval, Details
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.
New Delhi: The Drug Controller General of India (DCGI) and the Indian Council of Medical Research (ICMR) have together come out with 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 guidelines elaborate on validation of the Kits as;
RT-PCR Kits-
- US-FDA approved kits will not require validation.
- CE-IVD approved/Non-USFDA approved/ Indigenous Kits: The first batch of kits will require validation from any of ICMR identified validation centres (Annexure I) prior to DCGI approval; thereafter for post-marketing; additional two batches should be tested as per medical device rule in four months time
RNA Extraction and VTM Kits-
- US-FDA approved kits will not require validation
- CE-IVD approved/Non-USFDA approved/ Indigenous Kits: One batch of kits will require validation from any of ICMR identified validation centres prior to DCGI approval.
Rapid Antibody Test; ELISA and CLIA Kits-
- US-FDA approved kits will not require validation.
- CE-IVD approved/Non-USFDA approved/ Indigenous Kits: The testing of three batches of kits will be required for validation from any of ICMR identified validation centres prior to DCGI approval.
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 added.
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.
If the kit is for second time validation or subsequent validation or in case of any other issue; the manufacturer has to provide justification which will be reviewed at ICMR, New Delhi and decision will be communicated to manufacturer/supplier within a week. 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.
The seven other institutes include Kasturba Hospital for Infectious Diseases, Mumbai, Institute of Liver and Biliary Sciences, New Delhi, Postgraduate Institute of Medical Education & Research (PGIMER), Chandigarh, King George's Medical University (KGMU), Lucknow, National Institute of Biologicals (NIB), Noida, The King Institute of Preventive Medicine and Research, Chennai, Sawai Man Singh Medical College, Jaipur.
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