Importer & Manufacturer | Source: DHR
Published On: 13-10-2026
Enforcement Date: 13 October, 2026
Submission of Ethics Committee-approved research proposals involving minimally manipulated stem cells in human participants to NSRC.
The Department of Health Research (DHR) has issued a circular mandating that all Ethics Committee-approved research proposals involving minimally manipulated stem cells in human participants be submitted to the National Stem Cell Research Regulation Committee (NSRC) for final vetting. Research activities can commence only after obtaining both Ethics Committee approval and NSRC review.
The Department of Health Research (DHR), Ministry of Health & Family Welfare, has issued a circular regarding the submission of Ethics Committee-approved research proposals involving minimally manipulated stem cells in human participants. Following the constitution of the National Stem Cell Research Regulation Committee (NSRC) on 24 March 2026, all such research proposals that do not fall under CDSCO's regulatory purview as new drugs must be reviewed by NSRC.
Ethics Committees registered with the National Ethics Committee Registry for Biomedical and Health Research (NECRBHR) are required to submit approved proposals electronically to necrbhr-dhr@gov.in and also provide hard copies to DHR. The circular clarifies that no research involving minimally manipulated stem cells within the specified scope may begin until the proposal has been vetted by NSRC.
The measure aims to strengthen oversight, ethical compliance, and safety standards in stem cell research involving human participants.
Applicable For: Importer & Manufacturer
Reference Number: F.No. M-11021/11/2026-CG (8428003)
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