BioVoice News April 2017 Issue 11 Volume 1 | Page 41

Critics say that the stem cell industry has failed to take off and this is the beginning of its end in India. Do you consider this as a realistic assessment? What opportunities and trends do you see in Indian stem cell industry? We believe stem cell industry in India is pointing up. World’s first stem cell drug “Prochymal® approved in Canada in 2012 took 20 years for the product development. Compared to that, the progress made by a decade old Indian stem cell industry is commendable. Thanks to Ministry of Health, recently Drug Controller General of India (DCGI) has given marketing authorization for three new drugs in the stem cell therapy area. Stempeutics’ has received manufacturing and marketing authorization (Form 46) for its flagship product, Stempeucel® for the treatment of Critical Limb Ischemia due to Buerger’s (CLI) disease in March 2017. First allogeneic stem cell drug to be approved by DCGI and First allogenic stem cell product to be approved in the world for the treatment of CLI. This is a historic moment in India’s nascent drug development history. This Novel Treatment is a fruition of a decade of development work wholly done in India. This is truly a remarkable “Made in India” moment for the Indian biopharmaceutical industry. This is just the beginning of product approvals for Indian stem cell industries and this will surely lead to many more product approvals soon. A few people who have embraced failure for a considerable period might have expressed their dismay in Indian stem cell industry, but it is truly the time to regenerate hope and show our strength in the global forum. Do stem cells still hold the promise of future healthcare? Why aren’t we seeing more products off the shelves? Yes. India is already seen as the world’s low cost pharmacy as far as conventional therapies are concerned and the recent economic and epidemiological changes present a lucrative opportunity for the Indian biotechnology industry to replicate this success in the field of novel and innovative healthcare therapies like stem cell therapies. The hope that stem-cell therapies will repair and regenerate diseased organs and tissue BIOVOICENEWS.COM 41