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THE PHARMA REVIEW (MARCH APRIL 2014)

New Guidelines Casts a Shadow of Gloom of Slow Death to Efforts on Stem Cell Therapy in India

Dr. B. M. Gandhi

Introduction: The National Guidelines for Stem Cell Research, 2013 and Draft Guidance document for regulatory approvals for Stem Cell and Cell Based Products (SCCPs), Dec 2013 tried to regulate the stem cell research and approvals procedure for release of Stem Cells and Cell Based Products. However, a number of gap areas have been missed out for the therapeutic applications of the cells, which has left the Stem Cell Industry widely perplexed. An effort has been made to identify these areas to be considered further by the regulatory agencies. 

 

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