Title:Regulation of Stem Cell-Based Research in India in Comparison with the US, EU and other Asian Countries: Current Issues and Future Perspectives
Volume: 15
Issue: 6
Author(s): Jobin Jose*, Teena George and Aaron M. Thomas
Affiliation:
- Department of Pharmaceutical Regulatory Affairs and Pharmaceutics, NGSM Institute of Pharmaceutical Sciences, NITTE Deemed to be University, Paneer, Mangalore 575018, Karnataka,India
Keywords:
Stem cells, ethical considerations, USA, India, EU, Asia.
Abstract: Stem cell therapy is applicable for repair and replacement of damaged cells and tissues.
Apart from transplanting cells to the body, the stem cell therapy directs them to grow new and healthy
tissues. Stem cells in the area of regenerative medicines hold tremendous promise that may help to
regenerate the damaged tissues and heal various diseases like multiple sclerosis, heart diseases, Parkinson’s
disease, and so on. To prove the safety, efficacy, and for the requirement of a licence for manufacturing
and sale, all the stem cell therapies should pass the required criteria and undergo certain examinations
of the regulatory agencies. The regulatory authorities review the manufacturing procedures
of products to assure its purity and potency. This review summarizes the comparative critical evaluations
of existing regulations and developments on the stem cells research in India, USA, EU and Asian
regions and also discusses the challenges that have to be overcome and the important points that
should be understood to position India as a source of the perspective nation in stem cells around the
world.
