The guideline talks about the following aspects in detail.
- Classification of stem cells.
- Ethical and prohibited research using stem cells.
- Mechanism for review and monitoring.
- Translational research – animal research and clinical trials.
- International collaboration and exchange of biomaterial.
The ‘National Guidelines for Stem Cell Research’, issued recently by the Union health ministry to provide ethical and scientific directions to scientists and clinicians working in the field of stem cell research, has delineated mechanism for review and regulatory oversight of stem cell research in the country. A National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) will monitor and oversee activities at national level and Institutional Committee for Stem Cell Research (IC-SCR) will monitor at institutional level.
According to the Guidelines, which were jointly prepared by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT), all institutes engaged in stem cell research must establish an IC-SCR with necessary expertise in the field. Alternatively, IC-SCR can be constituted by inducting additional expertise in the existing institutional ethics committee (IEC) with the nomenclature as IC-SCR, as per the requirement of the guidelines.
All institutions and investigators, both public and private, carrying out research on human stem cells should be registered with the NAC-SCRT through IC-SCR. Research using human stem cells shall have prior approval of IC-SCR for permitted research and of the NAC-SCRT for restricted research. All new human pluripotent stem cell lines, irrespective of the source and methodology used, can be created with prior approval of IC-SCR.
However, the use of human embryonic and iPS cells in clinical trials shall have prior approval of the NAC-SCRT. Permission for procurement of human embryonic stem cell lines from abroad or from laboratories/banks in India shall be obtained from IC-SCR. Import must follow the guidelines and the investigator shall ensure that imported cell line has been established in accordance with the ethical guidelines of the country of origin which are comparable to Indian guidelines. An appropriate MTA shall be adopted for the purpose.
As per the guidelines, all clinical trials with SSCs, other than those with genetic modifications, shall have prior approval of IC-SCR and IEC. Clinical trials using genetically modified SSCs, and ES or iPS cells or derivatives should have prior approval from the NAC-SCRT after obtaining clearance from IC-SCR and IEC.
All clinical trials using cells that have undergone more than minimal manipulation shall have to obtain approval from IC-SCR, IEC and DCGI. Approval of the Drug Controller General of India (DCGI) is mandatory for stem cell based IND products and application for new indications (cells for therapies are deemed as drugs) with prior clearance from IC-SCR and IEC.
For market authorization of stem cell derived products, all clinical trials approved by the DCGI shall be registered with the Clinical Trials Registry of India established by ICMR. International collaborations shall have prior approval of respective funding agency as per its procedure or Health Ministry’s Screening Committee (HMSC).