ABLE works on a strategy to strengthen stem cell regulatory environment in India Monday, November 12, 2012 Association of Biotechnology Led Entrepreneurs (ABLE) is now focusing on a strategy to leverage intellectual talent and become a global leader in stem cells research and therapy. Now it is working out a game-plan to strengthen the regulatory environment and to form a robust guideline for stem cell therapy in India that would also include required fiscal incentives for the companies engaged in product development. In this regard, it recently formed a committee ABLE-RM to focus on regenerative medicine. The key intention is to see how India with its development in stem cells so far could capitalize on providing required medical treatment which could eventually become a standard of care and practice in a few years. The ABLE-RM now has taken on the onus to bring in all stem cell and regenerative medicine companies under one roof to voice the issues to the government and articulate to thepublic and patients on the latest developments in the field. Keeping the interest of the stem cell companies, it is focusing on tax benefits and duty exemptions. It is insisting to consider certain stem cell products with an 'orphan' drug status on similar lines like the efforts of US FDA to approve the clinical trials on fast track approval mode. Further, it would also give the necessary inputs to the regulatory bodies in building a robust guideline for stem cell therapy in India by taking relevant inputs from US FDA and EMEA guidelines. Other fiscal incentives such as subsidy for plant and machinery for biotechnology and industries apart from an electricity concession are on its radar."We need to build India as a destination for Stem Cell Research, Clinical Research and Contract Manufacturing," B N Manohar, chairperson, ABLE Committee on Regenerative Medicine told Pharmabiz."India has made great progress in stem cell research as evidenced by creation of human embryonic stem(ES) cell lines as well as by publishing over 100 scientific and clinical papers in various journals. As per GBI Research report, the stem cell market in India is estimated to touch US$ 600 million by 2017. Therefore we need to ensure that we are armed with required regulatory framework and fiscal incentives to succeed," he added .Although stem cell therapy is still at the stage of clinical research, advances have been made in understanding on how to use these cells for treating various diseases. L V Prasad Eye Institute (LVPEI) hastreated the largest number of patients (780) in the world for corneal blindness using cultured limbal stem cell therapy since the institute started the procedure in 2001. The therapy is used to restore vision in cases of corneal damage due to burns or chemical injury. Some hospitals and stem cell companies are offering stem cell therapy for spinal cord injury, Parkinson disease, stroke and cardiovascular indications.In 2011, stem cell market witnessed high growth. More therapies are expected to get launched in the next five years. With the liberalization of stem cell research in US, an increasing number of researchers are engrossed in inventing other avenues which could pave the way for new therapies. The stem cell therapy market in the US is projected to be $0.68 billion market in 2012 and $2.1 billion in 2017 growing at a CAGR of 25 per cent,he said.
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