Governing the Stem Cell usage in India

Date (2015-06-18 )

Stem cell treatment has been widely accepted as the future of medical technology, diagnosis therapy and any kind of treatment for health hazards. Research so far has proved that stem cells have the capability to treat human diseases therapeutically. However, researchers are still in their early stages and trials are being conducted. Some of the trials have proved effective in certain areas, but these results cannot be considered credible.

When 25-year-old Manish Chawla's lower body was paralysed due to spinal injury in a road accident 4 years ago, doctors from a hospital in Bhopal promised him absolute cure through stem cell therapy with just three stem cell injections at 3-6 month interval. After paying Rs. 800,000 for a treatment that lasted for a year, there has been no noticeable changed in Manish's health condition even after two years. When he complained and asked for a refund, Manish was offered another stem cell treatment at a lower cost.

What comes as the biggest worry is the lack of proper regulatory framework and ethical norms when it comes to governing stem cell usage. At present, it is just the guidelines doing the rounds, which has resulted in the escalation of many clinics, hospitals, and nursing homes, claiming successful treatment by stem cell therapy. No wonder, they have been resorting to unethical, unregulated practices in the field. And this has subsequently led to misconceptions about stem cell as a subject, its ongoing research and trials.

Due to the lack of awareness on stem cells and its treatment, patients get lured by these fraudulent service providers who in the absence of prevailing non-existence of regulatory framework and rules are undertaking unethical business practices, which might be harmful. In the meantime, there are trials which are being carried out on an experimental basis by some of the institutions, hospitals as well as the doctors in their personal capacities with proper legal formalities fulfilled by appointing an Ethics Committee, and going through a strict set of guidelines given by the Indian Council of Medical Research (ICMR).

The recently announced revised stem cell guidelines in India aim to protect unfortunate patients like Chawla from being exploited by the false promises from the doctors offering unproven stem cell treatments. The guidelines, prepared jointly by the Department of Biotechnology (DBT) and the Indian Council of Medical Research (ICMR) eye on bringing such fraudulent practices to an end on an urgent basis, thereby, ensuring that scientifically designed and responsible research on stem cells remains unhindered. The new rule dictates that stem cells cannot be offered to patients as therapy. Instead, they can be used in clinical trials but only after receiving an approval from the Drugs Controller General of India (DCGI).

However, there will be an exception in the case of the haematopoietic (blood-forming) stem cells, which can be used for treating blood disorders as it is considered as a proven therapy. DCGI can approve a cell therapy, on condition that it should be safe and also have unequivocal data on efficacy. After regulating all use of stem cells, the DCGI has simultaneously announced modifications to be made in rule-21 of the Drugs and Cosmetics Act wherein all vaccines, recombinant DNA-derived drugs and stem cell and cell-based products shall be new drugs unless certified otherwise by the Licensing Authority.This means anyone offering stem cells for treatment will be brought under clinical trials and that this can be conducted only after getting a license from DCGI.

The clinical research environment for stem cell therapy treatments in India is currently undergoing a tremendous flux, with regulators coming under the watchful eyes of the media, public and government. It won't be a surprise to hear the grumbling echoes of companies currently using stem cells derived from bone marrow, umbilical cord blood and human embryos to treat a host of conditions. But they cannot overlook the developments that occur gradually in the later stages of stem cell therapies, when the field will be confronted with many of the problems that currently plague the conduct of pharmaceutical trials in general.

As India becomes a global centre for clinical trials, the question of ethical norms becomes increasingly difficult to ignore. Without the legal backing for the Guidelines, Indian stem cell scientists feel free to conform to their own scruples and make their own decisions. The growing global interest in stem cell research & therapy mandates the development of a robust regulation system along with steps to enhance public knowledge and awareness.

Today, in comparison to other countries, India has more liberal rules and regulations governing stem cell research. The approval of clinical trials of stem cell-based drugs by the Drug Controller General of India (DCGI) is pulling in global stem cell players to conduct their clinical trials in India. Well-defined guidelines, efficient and speedy processes for approving clinical trials by regulatory bodies and availability of a vast patient pool, makes India a much-sought after destination for carrying out clinical trials. In the near future, the country foresees the opportunity to emerge as a global force in biotechnology, and stem cell research can be an important element of this aspect of global leadership.

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