Going by the advanced research activities of stem cell companies and increasing evidence of Mesenchymal stem cell efficacy and safety to treat many of the life threatening conditions like spinal cord injury, myocardial infarction and leg ischemia in India, the Union ministry of health could permit phase-III safety and efficacy trials for this therapy.

"In the absence of a 'phase lag', DCGI and Indian Council of Medical Research could quickly evaluate the results of the pilot studies conducted so far and allow companies engaged in stem cell R&D and product development to embark on phase-III trials," pointed out Dr Ramananda Nadig, member, Stem Cell Voice of India and president and deputy dean, Clinical Research Education and Management Academy (CREMA).

The urgent need for a quick approval from the Ministry of Health comes in the wake of the progress made by the US-based Osiris Therapeutics Inc. This company has already successfully completed phase-I & phase-II trials under US FDA scrutiny and is now permitted to recruit patients for phase-III trials for its Mesenchymal stem cell (MSC) product to treat Myocardial Infarction. One of the other MSC products is already approved for treatment of arthritis.

In fact, stem cell companies in India are leading from the front and are not far behind a stem cell product. All that the Indian regulatory authorities need to do is to provide approval for phase-III trials after evaluating and analyzing Osiris Therapeutics phase-I and phase-II results against the Indian stem cell studies. With allopathic treatment having limitations, the Ministry of Health, should work towards a regulation which can help stem cell companies in the country take a lead. All that needs to be done by regulators is to meaningfully draw out conclusions from the available research efforts and permit phase-III trials on humans, averred Dr Nadig.

Currently, pilot stem cell studies are extremely promising and have encouraging initial response. The regulatory authorities need to closely analyze results from the pilot studies and evaluate the statistically drawn out conclusions of the proof of concept studies to provide a formal approval.

Stem cell research commenced in 2004 and Indian researchers have arrived at logical conclusions in their studies. But there is a serious lack of awareness and skeptical attitude among the doctors and regulatory authorities which has resulted in inordinate delays to implement the stem cell therapies on a larger population in India.

Both doctors and patients are uninformed and unaware of the promising therapeutic prospects with stem cell. There is a need for awareness and education, to help the medical fraternity and the patients to dispel myths and skepticism amongst doctors to recommend stem cell therapy.

India also needs a stem cell policy backed by a strong regulatory framework. There is need for an appropriate awareness, comprehension and conviction amongst doctors and patients. Also close coordination with logistics and infrastructure to ensure that stem cells developed at medical centres can reach the desired location after being safely transported and stored at right ambient temperature. This is where King Regen, part of the King Multitech is now coordinating with the Stem Voice of India, a not-for-profit organization to ensure that stem cell therapies will be the next treatment option for many of the difficult to treat health conditions, added Dr Nadig.