The innovative bio-therapeutic products under the regenerative medicines initiative of Reliance Life Sciences are likely to reach the commercial platform in another six months time as the clinical trials of most of these products are nearing successful completion now.
According to informed sources, the products like cultured epithelia (regenerative skin cells), fibrin sealant (natural agent for the achievement of rapid hemostasis and tissue sealing) and cord blood repository would be through with the final trials by the next few months and they can be commercially launched by September this year. The company would soon approach the drug control authorities for the manufacturing and marketing approvals, it is learnt.
Reliance Life Sciences, as the beginning of its commercial entry into the area of regenerative medicines, is currently in the process of making the cultured skin readily available to hospitals by launching the Cultured Epithelia Bank for the first time in the country. With this entirely new concept of keeping cultured epithelial tissues ready for instant replacement of burnt/damaged skin, Reliance is all set to become the first healthcare company in India to open up the newly emerging regenerative medicine market.
Under the medical biotech products initiative, it has also developed fibrin sealant, a natural agent for the achievement of rapid hemostasis and tissue sealing, used in a variety of surgical applications. The product, which is currently in the developmental stage at the Cell Biology Research Center at Mumbai, would be another pioneering concept of the company's medical biotechnology initiative for the Indian market.
However, the Reliance sources said that the company is yet to apply for the manufacturing license for the products as the laboratory and culture facilities for the pilot as well as commercial production will take another two months time to get completed. "Once we are ready with the facility in line with the US FDA specifications, we can apply for the manufacturing license to the Maharashtra state FDA and marketing approval from the DCGI," the sources added.
The regenerative skin cells of the company, branded as ReliDerm-E, is the first cultured epithelia to be tried in the country. Useful for effective dressing and replacement of skin, the product can be made available to Skin Banks and is a valuable adjunct as a post skin graft dressing. This cell culture product can also be used for treating partial thickness burns, treating graft donor areas and the new graft site and dressing ulcers caused by diabetes and bedsores.
The company, which has already initiated few other research projects in the area of tissue engineering, anticipates a lot more innovative concepts to be introduced in the field of human organ re-plantation with the help of biotechnology, especially cell science. The company is also in the process of regenerating human bones and cartilages through cell culture at present, the company sources said.
Reliance Life Sciences has been listed, by the National Institutes of Health, USA, as one of the ten companies and research institutions working in the area of embryonic stem cells and eligible for federal research funds under the new US Presidential guidelines. This development places the fledgling company in the global league of players in the area of biotechnology, particularly in cell biology.