Abstract

STEM CELL THERAPY IN INDIA: HOW TO CURB ABUSE AND IMPLEMENT THE RIGHT WAY

Dr. Suma Kantipudi* and Dr. Mekala Padmaja

ABSTRACT

Biologics has always generated a lot of optimism and pessimism because of the promise it offers on Paper. Stem cell is a wing of biologics which has been showing promise in different clinical trials across the World. Although the understanding of stem cells has been greater in the past 10 years, there always is a disagreement in terms of the results that it offers as some form of cell based therapy is a new field of science due to the lack of credible source to information available to all the stakeholders. The industry is going at very good speed but with very less follow up nursing and investigational protocols, which will result in a bad assessment by the regulators (ICMR and CDSCO) and patients at a later stage. So, this article will give a brief insight into the present scenario about stem cell therapies and relevant views about curbing and regulating ethical and evidence based research and practice. They include: critical interventions like single window clearance for setting up research and initiating clinical trials; well developed R&D units, manufacturing units who recruits the domain experts in the field of stem cell based therapy in India to curb stem cell abuse.

Keywords: Stem cells, stakeholders, stem cells abuse, ICMR (Indian Council of Medical Research) and CDSCO (Central Drugs Standard Control Organisation), evidence based research, stem cell therapies and clinical trials.