The monitoring of stem cell research activities in India is getting more streamlined. While the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) has started the process of registration of Institutional Committee for Stem Cell Research and Therapy (IC-SCRT), the office of Drugs Controller General (India) (DCGI) has established a Stem Cell Division within Biological Division in Central Drugs Standard Control Organization (HQ) for the internal evaluation of all proposals including stem cells concerning with clinical trial and marketing authorization.
While it may take another couple of months to finally issue the revised guidelines for Stem Cell Research and Therapy, it has started the process of registration of institutional committees. As per the Guidelines for Stem Cell Research and Therapy, 2007, it is mandatory that all institutions involved in any type of stem cell research and therapy should be registered with the NAC through IC-SCRT.
Till recently, there was no mechanism in place to take note of the cases violating these guidelines or take action against the agencies found violating these guidelines. This was disclosed by Union Minister for Health and Family Welfare Ghulam Nabi Azad in the Parliament recently.
“In a step towards this direction, Ministry of Health and Family Welfare constituted a Core Investigational New Drug (IND) Panel of Experts namely “Cellular Biology Based Therapeutic Drug Evaluation Committee (CBBTDEC) under the chairmanship of Director General, ICMR & Secretary, DHR to advice DCGI in matters pertaining to regulatory pathways leading to the approval of clinical trials and market authorization for the “Therapeutic products derived from Stem Cell, human Gene manipulation and Xenotransplantation technology”. CBBTDEC has deliberated on the need for strengthening the regulatory agency (DCGI) by establishing separate wing for Stem Cell Research supported with knowledge and capacity to regulate the activities in the country,” he said.
ICMR jointly with Dept. of Biotechnology (DBT) had formulated guidelines for Stem Cell Research and Therapy (2007) to help clinicians and scientists working in the field to conduct research in responsible scientific and ethically sensitive manner. Understanding the recent advances in the field, the guidelines are being revised now.
At the same time the NAC, constituted by the Union health ministry early last year for effectively reviewing and monitoring the stem cell research in the country, has expedited the process of finalising the revised Guidelines for Stem Cell Research and Therapy. The NAC, headed by Dr Alok Srivastava, haematologist, Christian Medical College (CMC), Vellore, held a series of meetings during the last one year in this regard.
A senior health ministry official involved in the process said that the NAC may hold one or two more meetings before finally issuing the new revised document which will provide ethical and scientific directions to scientists and clinicians working in the field of stem cell research in the country.
The decision to revise the guidelines was taken by the NAC last year as the committee felt that several developments had occurred during the last more than four years since the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) jointly formulated Guidelines for Stem Cell Research and Therapy in the year 2007, prescribing strict procedures for sourcing and the use of stem cells by research institutions.
Sources also said that the process of revising the guidelines is being done by the NAC by incorporating several suggestions received through the public consultations held by the ICMR last year. To evolve consensus on the document among the various stakeholders like patient groups, clinicians, scientists, NGOs, religious groups, media, social groups, biotech companies, pharma companies etc, ICMR had held 'public consultations' on the guidelines at five different places in the country.
According to some of the experts, even though India worked out the fundamental guidelines for stem cell research more than two years ago, an effective surveillance system for the highly complex research has to be put in place. Without an effective guideline, clinical trials with stem cells may become another money-spinning exercise, they warn.
Currently, a huge amount of research is under way for using stem cells for therapeutic applications like bone regeneration, cartilage regeneration, liver regeneration and cardiac conditions. Research institutes and the private sector have played a pivotal role in intensive research in stem cells and in setting up stem cell banks.
However, unlike many highly regulated markets, there are no specific guidelines or regulations in India for corporate or research organisations. Government officials point out that the guidelines for stem cell research and collection, which are based on US/European guidelines, will enable Indian companies to intensify their research and also enable them in gaining access to research funds.
According to one of the stem cell evangelists, there would be more business opportunities in the days to come as the Indian market is still under-penetrated. Awareness on cord blood banking in India is just 0.1 per cent compared with three per cent in the US and two per cent in Europe. Like the US, which has a Cord Blood Awareness and Education Act adopted in more than 20 states, there has to be a mandatory law along with a formal education process. There has to be government support in the form of funds to increase public banking to fuel stem cell banking, he said
He pointed out that the awareness levels among the masses is quite low. The regulations have to be implemented in full, which will improve confidence levels among the patient fraternity. There is limited experience among the medical fraternity though the awareness is slowly improving, he added.
With better regulations, the sector can see increased interest from MNCs as well, who will gain confidence to enter the Indian market. Overall, with guideline implementation, the Indian stem cell industry and research will see government support and an increased activity , he opined.
With increasing focus on regenerative medicine, there is a renewed hope for a cure using stem cells for ailments like cancer, diabetes, nervous system disorders and bone and cartilage degeneration. Another niche development is dental stem cells. Dental stem cell can be used to reconstruct bones or generate cardiovascular tissues.
The regulations would facilitate more partnerships as well. For instance, the Nichi-In Centre for Regenerative Medicine is an Indo-Japan joint venture carrying out research, training and clinical applications-protocol in regenerative medicine, with emphasis on stem cells, progenitor cells and autologous cells to prepare them for clinical application. India along with the US, has conducted various workshops on stem cells under the Indo-US Science and Technology Forum.
The Australian and Indian governments are also planning to support 13 new collaborative projects and seven joint workshops through the Australia-India Strategic Research Fund , according to recent report.
As part of this joint multi-million programme, top scientists in India and Australia will receive funding for cutting-edge research in fields of environment science, materials science, stem cells and vaccines .
In the meanwhile according to a study by YES Bank and the Federation of Asian Biotech Associations (FABA), the global stem cell therapy market which was pegged at $21 billion in 2010 is projected to grow to $60 billion by 2015.