The absence of a regulatory framework for the use of human adult stem cells for therapy and product development is now stalling the growth of stem cell research in the country. This has led companies to look at partnerships with global companies to drive growth prospects, said Vipul Jain, CEO, Advancells.
The regulation ambiguity has also seen candidates who have completed courses in stem cell technology to look at other avenues in the life sciences sector. There are still no proper jobs in the space which has prevented companies to hire the right candidates, Jain told Pharmabiz in a telecon.
The two-year-old Advancells too is not stuck with much of its research. Currently, it is in talks with the companies in the Middle East and Australia where regulations are in place which could enable it take its research to concrete commercialization.
It takes a long time to get an approval to conduct stem cell clinical trials in India. This is despite the government’s efforts to set up a National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) and an Institutional Committee for Stem Cell Research and Therapy (IC-SCRT) to regulate and oversee the activities of this sector. Institutions and investigators carrying out research on human stem cells now need registered with NAC-SCRT through IC-SCRT which is seen as the first step towards streamlining the stem cell research in the country.
“Therefore, we see the regulatory approval process for clinical trials of stem cell-based products is evolving and the government bodies are involved in publishing a new guideline for the use of human adult stem cells for therapy and product development. The new guideline is expected to address the development, manufacturing and quality control for stem cell therapy and product, he said.
Now the existing guidelines were aimed to obtain licenses from the Drugs Control General of India (DCGI). “However still a lot of clearance is awaited from the government as to how the license will be procured and the detailed road map is awaited,” said the Advancells chief.
The government is in process of setting up a new draft committee and the guidelines will open to public forum where Advancells will also be able to put forward its viewpoint on regulations. “Hopefully in the next 12-24 months, we could have a system in place,” he noted.
However, flip side to this technology is that knowledge about the advantages of stem cell therapy is low in India. A lot of research is on to make it useful for treating many complicated disease. Currently, stem cell therapy has proved to be a definite treatment for blood cancer and thalassemia. At the same time, the cost of treatment is very high, said Jain.
India currently has around 8 companies engaged in stem cell research with Stempeutics and Reliance Life Sciences way ahead of the others.