New Delhi: The Central Drugs Standard Control Organisation (CDSCO) and Indian Council of Medical Research (ICMR) have together released the draft standard evaluation protocols for the purpose of issuing license for in-vitro diagnostics (IVDs) under the Medical Devices Rules (MDR), 2017.
The drug regulator has said that licensure of IVDs under the MDR requires a detailed evaluation protocol for the performance evaluation of IVDs to evaluate their quality and performance and these protocols would be used by IVD manufacturers testing labs in India.
The aim is to facilitate the availability of quality-assured diagnostic kits appropriate for use in India. The guidelines shall establish uniformity in performance evaluation of IVD kits. The performance evaluation is to independently verify the manufacturer’s claim regarding IVD performance.
It has come out with a draft performance evaluation and field evaluation protocols for 14 tests, seeking response from the stakeholders within February 15, 2025.
The tests for which the draft protocol has been formulated include performance evaluation protocol for Chikungunya IgM ELISA, Chikungunya IgM RDT, Chikungunya real-time PCR, Dengue NS1 RDT, Dengue NS1 ELISA, Dengue IgM RDT, Dengue IgM ELISA, Dengue NS1/ IgM combo RDT, Dengue real-time PCR, and Zika virus real-time PCR, and field evaluation protocol for Dengue NS1 RDT, Dengue NS1 ELISA, r Dengue NS1/ IgM combo RDT, and Dengue real-time PCR.
“The protocols are now being placed in the public domain for comments from relevant stakeholders. This window of opportunity will close on 15th February 2025, and, once finalized, there will be minimal scope for change in these documents. Therefore, all interested stakeholders are requested to provide their comments before 15th February 2025…,” said the drug regulator while releasing the draft protocols.
Once the public consultation period concludes, all comments will be reviewed and considered in finalizing the draft protocols before final clearance by ICMR and CDSCO.
After following due procedure as defined in the guidelines for various tests, once any kit is found to be Not of Standard Quality (NSQ), no request for repeat testing of the same kit will be acceptable thereafter, said the drug regulator. Any request for re-validation from the same manufacturer for the same test type will only be entertained if valid proof of change in the kit composition is submitted.
It may be noted that the Central government and the Central drug regulator has been putting various rules and guidelines in position to ensure the safety and quality of medical devices in the market, following the implementation of the MDR, 2017, after the medical devices has been brought under the purview of drug regulators.
