India has emerged as one of the key centres in providing stem cell based treatments. There are significant numbers of hospitals and clinics who are offering various stem cell based experimental therapies using embryonic stem cells and adult stem cells including stem cells derived from preserved cord blood. At present, nearly 50 hospitals and clinics are operating in different parts of India, who claim to treat a wide range of disease conditions such as Alzheimer’s disease, spinal injury, muscular dystrophy, Parkinson’s disease, multiple sclerosis, diabetes, retinal pigmentosa, etc. Given that stem cell based therapies are still considered as experimental, except hematopoietic stem cell transplantation (HSCT) for haematological disorders, in the absence of enough scientific evidences in the form of basic research and clinical trials, it raises potential ethical and governance concerns. To date, however, government is helpless to prevent the proliferation of unproven therapies despite new policy measures in recent years.
New policy initiatives
In India, stem cell clinical activities started in early 2000, since then Indian regulatory authorities are making efforts for an effective and robust stem cell policy. In 2013, the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) have updated the 2007 stem cell guidelines. Similarly, in 2013, the Central Drugs Standard Control Organization (CDSCO) had set up a committee to explore how the usage of stem cells can be regulated against the backdrop of mushrooming of experimental stem cell based treatments. One of the main recommendations of the committee is to amend the Drugs and Cosmetics Act 1940 to include stem cells and other cell based products as new drugs. As per recommendations of the committee, Ministry of Health and Family Welfare has proposed to amend Drugs and Cosmetics Act 1940 to include stem cells as drugs. The draft Drugs and Cosmetics (Amendment) Bill 2015 was released in January 2015 for the same reason. It appears that Indian regulatory authorities are making a serious effort to regulate stem cell activities in the country as the National Apex Committee for Stem Cell Research and Therapy (NACSCRT), which was constituted in 2010, recently started monitoring advertisements that claims to cure a large number of diseases using stem cells. With the help of Advertising Standard of Council of India (ASCI), the NACSCRT has already put many stem cell clinics and private cord blood banks under scanner. It is reported that many websites have already started amending their contents.
All these efforts appears to be in the right direction to curb unproven stem cell clinical activities. However, none of them are effective enough to curb unethical activities. The reason might be that partly there is a lack of coherence among biomedical agencies and partly there is a strong desire at government level to be a global player in stem cell field which directly or indirectly affects the implementation of existing legislative measures, leading to the implementation gap. For instance, the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 is strong enough to take action against those clinicians who advertise their stem cell services. However, to date, the Medical Council of India (MCI) has never taken any action against those clinicians who are offering untested stem cell based therapies. Still there are many websites of private blood banks are operating, who claim to treat more than 80 diseases despite the efforts of National Apex Committee for Stem Cell Research and Therapy and Advertising Standard of Council of India.
Ambiguity in policy
It is worth highlighting that in 2014 the Ministry of Health and Family Welfare had requested to the Finance Ministry for the exemption of service tax on cord blood banking services. This request could be seen as an ambiguity in policy as 2013 stem cell guidelines discourage the preservation of cord blood for future self-use in the absence of scientific evidence. The guideline notes that, “there are ethical concerns about the promotional advertisements by private banks offering storage of cord blood for possible future use. Such advertisements are often misleading for the public and lack comprehensive and accurate information to the consumer. It may be mentioned that there is no scientific basis for preservation of cord blood for future self-use and this practice is not recommended”.
Furthermore, ambiguities in stem policy also reflected by keeping the word ‘therapy’ in National Committee for Stem Cell Research and Therapy given that 2013 stem cell guidelines have omitted the word ‘therapy’ from the title of guidelines by emphasizing “that stem cells are still not a part of standard of care; hence there can be no guidelines for therapy until efficacy is proven”. The question naturally arises why then there is a committee for monitoring ‘therapy’. This suggests the lack of coherence at various levels of governance.
For effective regulation of stem cell therapies, there is a greater need of co-ordination between the Indian Council of Medical Research, the Central Drugs Standard Control Organization and the Medical Council of India including the National Committee for Stem Cell Research and Therapy. The role of Indian Medical Association, industry and civil society is equally important as vulnerable patients are being exploited. Additionally, the implementation of statutory laws governing clinical practice is also warranted.
The role of the Medical Council of India is very significant as it is the only designing authority who can take actions against clinicians by cancelling their license to practice. Unfortunately this state sanctioned self-regulatory body appears to be work more in the favour of clinicians as it never shows its commitment to regulate stem cell clinical practice. Medical Council of India should learn a lesson from its counterparts General Medical Council of the United Kingdom who banned a doctor on the grounds of ‘exploiting vulnerable patients’ using unproven stem cell therapy.
In sum, it can be argued that India needs to address ambiguities in stem cell policy and also a coordinated effort is warranted from different agencies who are associated with stem cell development.
(The author, a PhD in Science and Technology Studies, is based in USA)