Regulating stem cell-based research and therapy in India

Public consultation for stem cell started more than a year-and-half back in Mumbai. The aim was to hold four public consultations to cover the entire country to generate consensus among different stake holders i.e. scientists, clinicians, firms, patients etc., associated with the stem cell sector.

The regulatory authority feels that the existing guidelines are pretty old and given the rapid development in this area there is need to have comprehensive guidelines to govern stem cell science. However, the current public consultation effort is widely seen as only a ritual since during the last three public consultations the representation of the common public was very low.

Stem cell is seen as a promising area with the potential to treat a wide range of disease conditions (viz. spinal injury, muscular dystrophy, Parkinson’s disease, multiple sclerosis, diabetes, retinal pigmentosa etc.) for which all treatment options have been exhausted. It offers various ethical and social issues which need to be addressed for the benefit of the society.

In recent years, India has emerged as one of the leading centres for stem cell-based research and therapy. It is estimated that more than 40 institutions are active in different areas of stem cell research and various hospitals/clinics are offering different therapy to patients.

However, various clinics in India are offering largely unproven therapy which puts desperate patients at health and financial risks, with India being described as a place of ‘maverick science’. Hospitals in India are using both embryonic as well as adult stem cells for treatments.

The main concern is that none of the treatment modalities have gone through rigorous clinical trials; there are no pre-clinical data on animal models available to ensure the safety of the treatments. A Delhi-based clinician, Dr Geeta Shroff, who claims to treat more than 800 patients, including former Chhatisgarh chief minister Ajit Jyogi, using embryonic stem cells always refused to disclose her treatment procedure. Nobody knows whether she is using stem cells or glucose saline for treatment. There are greater chances that embryonic stem cells can cause further side effects in the form of cancer or tumour.

In addition, a large number of clinicians are using adult stem cells for a wide range of disease conditions. They believe that using adult stem cells is safe. However, various studies in the West have shown that adult stem cells can cause severe complications. Recently, it was reported that an Israeli boy developed benign tumours after receiving adult stem cell treatment in a Moscow clinic.

The most worrisome is that these clinicians claim to cure various genetic diseases using autologous adult stem cells such as muscular dystrophy. A member of DBT stem cell task force argued in a personal communication that in a genetic disease there is no point in giving autologous stem cells since these stem cells have the same gene defect.

Largely unregulated
Besides, in India, there is a growing market for private banking of cord blood, which is largely unregulated. The chances that a particular child will develop a condition requiring cord blood transplantation are very small. Though banking firms in India claim to treat more than 70-80 diseases, it has been estimated that 0.04 per cent (1/2,500) of cord blood units stored would ever be used for autologous transplantation. This is because the incidence of diseases currently treated with cord blood is low and most patients would not be eligible for autologous cord blood, including those with leukaemia and genetic conditions.

Patients are paying hefty amounts for an unproven therapy. It is estimated that they are being charged between Rs 1 lakh and Rs 10 lakh. In the name of biologic insurance expectant parents are paying Rs 75,000 and  Rs 1 lakh to private cord blood banking firms which again raises concern since in insurance policies people get something, but in this venture there are very slim chances to get anything.

Government efforts have so far proved ineffective in preventing the rapid growth of various hospitals and clinics and private cord blood banking firms that make unproven claims of success using stem cells. In the absence of a law, Indian regulatory authorities are helpless to curb unethical practices.

In addition, there are multiple agencies which directly or indirectly govern stem cell science i.e. department of biotechnology, ICMR and the Drug Controller of India (DCGI). Unfortunately, the DCGI has no expertise to deal with stem cell science. It only co-ordinates with other agencies, for example ICMR, to make decisions on stem cell-based products and services.

Recently, a long awaited National Apex Committee for Stem Cell Research and Therapy was set up to govern stem cell-related research and therapy. But the question is that in the absence of legal measures how will the committee will be able to curb unethical stem cell medical practices. The Medical Council of India is supposed to regulate clinicians involved in unethical acts.

Unfortunately it has been ineffective. In India, there are more than 40 Acts which directly or indirectly govern medical practices, but unproven and unethical practices continue to flourish. It is expected that after the fourth public consultation meeting, the ICMR will update the existing guidelines and India will soon have a bill to regulate stem cell practices.