CDSCO, ICMR release draft standard evaluation protocols for IVD manufacturers

Central Drugs Standard Control Organisation (CDSCO) and the Indian Council of Medical Research (ICMR) have released draft standard evaluation protocols for use by IVD manufacturers testing labs in India.

The regulator has also invited comments on standard IVD evaluation protocols drafted by ICMR and CDSCO

The protocols aim to facilitate In-Vitro Diagnostics (IVDs) licensure under Medical Devices Rules 2017. The rules mandate a detailed evaluation protocol for the performance evaluation of IVDs to evaluate their quality and performance.

“Licensure of In-Vitro Diagnostics (IVDs) under Medical Devices Rules 2017 requires a detailed evaluation protocol for the performance evaluation of IVDs to evaluate their quality and performance. To facilitate this process, the Indian Council of Medical Research (ICMR) and CDSCO have come together to draft standard evaluation protocols for use by IVD manufacturers testing labs in India,” said a communiqué.

Currently, the following IVD evaluation protocols have been developed by ICMR and CDSCO:

1. Performance evaluation protocol for Chikungunya IgM ELISA
2. Performance evaluation protocol for Chikungunya IgM RDT
3. Performance evaluation protocol for Chikungunya real-time PCR
4. Performance evaluation protocol for Dengue NS1 RDT
5. Field evaluation protocol for Dengue NS1 RDT
6. Performance evaluation protocol for Dengue NS1 ELISA
7. Field evaluation protocol for Dengue NS1 ELISA
8. Performance evaluation protocol for Dengue IgM RDT
9. Performance evaluation protocol for Dengue IgM ELISA
10. Performance evaluation protocol for Dengue NS1/ IgM combo RDT 11. Field evaluation protocol for Dengue NS1/ IgM combo RDT
11. Performance evaluation protocol for Dengue real-time PCR
12. Field evaluation protocol for Dengue real-time PCR
13. Performance evaluation protocol for Zika virus 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, at [email protected] as per the enclosed format.,” said the regulator.

The regulator added that once the public consultation period concludes, all comments will be reviewed and considered before final clearance by ICMR and CDSCO for the draft protocols.
MB Bureau