Stem cell Research in India
Are we stemming growth?
The world of stem cells has caught the imagination of the research world, and has become a topic of debate. Arshiya Khan collates views expressed by people all around on stem cells and related issues.
Undoubtedly we are on the verge of a major stem cell breakthrough. Optimistically, stem cells will one day provide effective low-cost treatment for diabetes, some forms of blindness, heart attack, stroke, spinal cord damage and many others. Along with the promise of treatments, stem cells bring in certain concerns. Most critics ask just one question?Is it right to destroy life in the process of harvesting stem cells?
Varied Emotions
 "Public-Private partnership is important in India to find cost effective remedies"
- Dr JK Samuel Abraham, |
When it comes to creating embryonic stem cells for research purposes, there is divided opinion amongst scientists. "Creating embryos for the purpose of harvesting stem cells is not acceptable, although as per ICMR guidelines, an embryo upto 14 days is not considered living," says Professor G Padmanaban, Distinguished Biotechnologist, Department of Biochemistry, Indian Institute of Science. "However, if appropriate ethical guidelines are implemented, the use of spare embryos from IVF clinics can be an option," he suggests. But Dr J K Samuel Abraham, Director, NCRM, Chennai disagrees, "It is unethical to create embryos just for the purpose of harvesting stem cells."
 "The hype of stem cells has made people believe in almost anything"
- Dr Satish Totey |
But most experts disagree with the argument that it is unethical to use embryonic stem cells. Dr Satish Totey, Chief Operating Officer, Stempeutics and Secretary of SCRFI, gives an insight, "Embryos are not created for the sole purpose of deriving a stem cell line. The process simplistically is a couple attending an IVF clinic undergoes therapy, and wishes to donate these extra embryos for the purpose of development of a stem cell line; a written informed consent is obtained after explaining exactly what would be done with these donated embryos. During any stage prior to donation if the couple wishes to withdraw their consent they are free to do so."
 "Government of India is trying to boost stem cell research in a big way"
- Dr Sujata Mohanty |
However, using even spared embryos is a matter of ethics. "Most of the embryonic stem cell research work involves the use of embryos which are the left over products of IVF technology. However, there is still controversy over the issue. It is a very sensitive issue and I personally feel that it is very unethical to create embryos for the sole purpose of harvesting embryonic stem cells," avers Dr Sujata Mohanty, Assistant Professor, Stem Cell Facility, AIIMS.
Hyped?
It is a fact that ethics is a subjective issue. But has the issue been hyped? "Yes and no," believes Totey, "The ethical grounds on the basis of donations, patient confidentiality, payment inducements are of sound basis. When it comes to religious sentiments, he opines that there is no sound logic to it, and it would appear to be a politically motivated vote bank keeping strategy." When it comes to stem cells therapy, Padmanaban believes that, not only ethics, but also the promises of therapy is hyped. "I believe not only ethics but even stem cells are hyped! The biggest hurdle in India is the creation of hype before we can deliver the goods. What we need is in-depth basic and clinical study on the use of stem cells for specific disorders and publication of the results in international peer-reviewed journals," he adds. It also means that companies are exploiting people who are waiting for 'miracles' to happen. "The hype of stem cells has made people believe in almost anything, and that has led to organisations injecting a cellular population isolated directly from bone marrow and terming them as stem cells. The nomenclature and terminologies are very loose," agrees Totey.
 "I believe not only ethics but even stem cells are hyped!"
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Such malpractices lead to dangerous implications. "A concern in stem cell therapy is the onset of cancer. Adequate clinical trials are needed for it to become a routine clinical option, other than bone marrow transplantation for specific disorders, which is a validated therapy," feels Padmanaban.
Guide us
Lack of regulatory guidelines has left companies following their own guidelines and setting up their own committees. "The absence of guidelines is a double-edged sword," reacts Totey, "My centre abides by the guidelines laid down not only in the country, but internationally as well."
The absence of any guidelines plus the low level of awareness amongst the masses leads to exploitation. "There are certain centres who tend to cultivate their science in an environment that is not conducive to patient’s well-being. In short, there is no law stating that manipulated cells need to be done in a clean room environment," agrees Totey.
In such a scenario, the fact is that most of the organisations rely on their own moral beliefs and ethics which they practice as an organisation. "Ethically and morally it is the responsibility of the organisation, that any manipulated cell that would be used for injection into humans should be in a sterile cGMP environment just as we do with vaccines," informs Totey.
Having no guidelines also means that companies look out for international guidelines or the ones suggested by the ICMR. "Lack of a proper body to regulate the stem cell therapy and research without which the authenticity of our work is questioned by the developed nations," laments Abraham. Absence of guidelines also acts as a hurdle feels Totey. To tackle with this issue, the Department of Biotechnology and ICMR have taken steps to establish stem cell research centres/units in our country.
Money matters
The Government of India is aggressively promoting stem cells research projects. They have invested around $8 million in various institutes. Mohanty informs, "Initially the funds released by the government in this particular field of research were very meagre. But recently, the Government of India is trying to boost stem cell research in a big way. Most of the stem cell research work in the public sector setting is been funded by the Government of India majorly provided by various funding agencies like DBT, ICMR and DST, " informs Mohanty.
It is not just the government that is bullish. Companies like Reliance Life Sciences and Life Cell have recently come up in a big way to initiate stem cell research through cord-blood banking. But when it comes to funding from the government, private players are shying away. "It takes a long time. And by the time you get funds and start the research project some one else might have already completed similar research," says Abraham. Innovation is the key in research and hence delay is the last thing scientists want when it comes to working upon their ideas.
The 3 P way!
It is a fact that capital is crucial when it comes to initiating research projects on a larger scale. Public-private partnership seems to be the answer. "Public-Private partnership is important especially in a country like India wherein government funds and co-operates with private industry so that we can find cost-effective remedies rather than 'only' private struggling hard to find solutions with stem cell therapy which then becomes expensive," informs Abraham.
Moreover, experts feel that the private industry would be too oriented in finding and providing therapeutic solutions for lifestyle-based diseases like diabetes and cardiovascular diseases ignoring other epidemic socio-economic diseases. "In low income groups, the general spectrum of diseases are different than the affluent and therefore to address their needs government should encourage PPP. Because private companies many a time look into the needs of the diseases which affect the affluent in the society," agrees Abraham.
Advantage India
The global market for stem cell therapy is expected to be $20 billion by 2010, as per a Frost & Sullivan study. According to Totey, "India is expected to have a market share of about $540 million by 2010 with an annual growth rate of 15 percent." The huge genetic population base in India is a major advantage that makes companies eyeing for India. "It opens a platform for collaborative research. It also provides the country with a headstart in this futuristic therapy modality and we should seriously consider building this to capacity," feels Mohanty.
However, experts also believe that apart from the intellectual pool of scientists talent and a mature information technology industry, the country can boast of a big platform for research and its clinical application, which no other country has.
- Courtesy Express Pharma, 1-15th June 2007 issue.
