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THE PHARMA REVIEW (NOVEMBER - DECEMBER 2014)

Following Up on Stem Cell Guidelines in India

Dr. B. M. Gandhi

Introduction: These guidelines received wide attention from the press and various stakeholders3-5. We also made certain observations on regulatory issues associated with therapeutic aspects of regenerative medicine and tissue engineering highlighting the challenges, limitations, funding aspects, role of the local bodies, role of the investigators, differentiating fraudulent and genuine therapies, rights of the patients etc.6, Unregulated Stem Cell Therapy7 and Policy Considerations for Stem Cell Therapy.8 We made a detailed analysis of the new guidelines: the National Guidelines and CDSCO Guidance and highlighted the gap areas missed out for the therapeutic applications of the cells. 

 

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