The Stem Cell regulatory guidelines in India should address specific areas related to research and therapy for better research environment, like UK and Canada, according to Umesh V Banakar, a regulatory consultant based in the US.
The present stem cell research guidelines prepared by Indian Council for Medical Research (ICMR) represents the view of the government on the issue, but it carries more general ideas rather than specific definitions and policies on major issues, he said. He is the president, Banakar Consulting Services, US.
"The policy regulation should be a moderate one and not a totally rigid one. A central regulatory body to govern this sector, with adequate freedom to the private companies in funding and research works, will be a better option for the country," Umesh opined.
The main advantage of India is that the public in the country are aware about the stem cell technology and its regulatory requirements. But the various issues related to the field are not clear at present. The situation may vary as the ICMR and Department of Biotechnology has decided to revise the guidelines with addressing specific issues. He added that the country should concentrate on human stem cell transplantation.
The policy of US in stem cell research has helped the countries like UK, Canada and South Korea, which have liberal regulatory policy, to achieve rapid growth in Stem Cell research. The model is imitable, as the countries shows revolutionary growth in the field, commented Umesh, also Chairman of the Chennai-based CRO, Quest Life Sciences.
Though the government in US is holding back from the controversial issues like embryonic stem cell research, confidentiality of the subjects, Ethical backing, the sharing of Intellectual Property rights and rights of donors, the FDA is keen in regulating the field with various expert committees. The individual states are spending splendid money, more than that spent by the federal government on the research at US.
The money involved in stem cell research and therapy, all over the world, will be much greater than the standard chemical and synthetic based industry. As the end product and the clinical success are not clearly defined, the exact amount involved is unavailable, added Umesh. He was here to attend the 1st International Symposium on Stem Cell Therapy and Research conducted by LifeCell, a pioneer in private stem cell banking in India, in association with Sri Ramachandra Medical College and Research Institute, Chennai.