The National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT), constituted by the Union health ministry early this year for effectively reviewing and monitoring the stem cell research in the country, has decided to revise the Guidelines for stem cell research regulation in the country.
The decision to revise the Guidelines was taken by the NAC, headed by Dr Alok Srivastava, haematologist, Christian Medical College (CMC), Vellore, at its meeting held recently. Several developments have occurred during the last four years since the Union health ministry formulated the Guidelines for stem cell research regulation in 2007, prescribing strict procedures for souring and the use of stem cells by research institutions. So there is need to revise them, a senior official associated with the NAC said.
The official said that the NAC, which was constituted after years of efforts by the ministry, has started working in the country and it held its introductory meeting recently. The meeting took stock of the Guidelines and decided to update it as there are several clauses which have become redundant, sources said.
The Guidelines on stem cells holds significance as stem cell research raises many ethical, legal, scientific, and policy issues that are of concern to the policy makers and public at large. Like any other scientific advances, it also raises questions about balancing the promises offered by stem cell therapy against its potential harm for appropriate application.
The Guidelines have been prepared by the government for adult, cord blood and embryonic stem cells in response to the support provided by the government to facilitate stem cell research in India so as to improve understanding of human health and disease, and evolve strategies to treat serious diseases.
The 12-member NAC is a multidisciplinary body with a secretariat at ICMR which has two main functions: oversee, monitoring and policy functions; and review of specific controversial or ethically more sensitive research proposals. The committee has the responsibility to examine the scientific, technical, ethical, legal and social issues in the area of stem cell based research and therapy in the country. All institutions involved in any type of stem cell research and therapy should be registered with the NAC through Institutional Committee for Stem Cell Research and Therapy (IC-SCRT).
The NAC will have to set up standards for safety and quality, quality control, procedures for collection and its schedule, processing or preparation, expansion, differentiation, preservation for storage, removal from storage to assure quality and/or sterility of human tissue, prevention of infectious contamination or cross contamination during processing, carcinogenicity and xenotransplantation.
Source:Pharmabiz
The decision to revise the Guidelines was taken by the NAC, headed by Dr Alok Srivastava, haematologist, Christian Medical College (CMC), Vellore, at its meeting held recently. Several developments have occurred during the last four years since the Union health ministry formulated the Guidelines for stem cell research regulation in 2007, prescribing strict procedures for souring and the use of stem cells by research institutions. So there is need to revise them, a senior official associated with the NAC said.
The official said that the NAC, which was constituted after years of efforts by the ministry, has started working in the country and it held its introductory meeting recently. The meeting took stock of the Guidelines and decided to update it as there are several clauses which have become redundant, sources said.
The Guidelines on stem cells holds significance as stem cell research raises many ethical, legal, scientific, and policy issues that are of concern to the policy makers and public at large. Like any other scientific advances, it also raises questions about balancing the promises offered by stem cell therapy against its potential harm for appropriate application.
The Guidelines have been prepared by the government for adult, cord blood and embryonic stem cells in response to the support provided by the government to facilitate stem cell research in India so as to improve understanding of human health and disease, and evolve strategies to treat serious diseases.
The 12-member NAC is a multidisciplinary body with a secretariat at ICMR which has two main functions: oversee, monitoring and policy functions; and review of specific controversial or ethically more sensitive research proposals. The committee has the responsibility to examine the scientific, technical, ethical, legal and social issues in the area of stem cell based research and therapy in the country. All institutions involved in any type of stem cell research and therapy should be registered with the NAC through Institutional Committee for Stem Cell Research and Therapy (IC-SCRT).
The NAC will have to set up standards for safety and quality, quality control, procedures for collection and its schedule, processing or preparation, expansion, differentiation, preservation for storage, removal from storage to assure quality and/or sterility of human tissue, prevention of infectious contamination or cross contamination during processing, carcinogenicity and xenotransplantation.
Source:Pharmabiz
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