[The Viewpoint] Decoding the legality of Stem Cell Therapy in India

Stem Cell Therapy has been lauded as the future of medical technology and innovation for decades. However, its potential is yet to be realised due to a plethora of technical, medical and ethical challenges that plague its development.

Stem cells have the ability to develop into specialized functional cells of different organs. This can range from muscle cells to brain cells and can also heal damaged tissue. Extensive medical research has been conducted to utilize stem cells from embryos and from adult organs to restore the lost bodily function in the same or other organs. While this technique has been successful in reconstituting bone marrow cells to produce blood and immune cells, its efficacy in other parts of the body, and for other conditions, remains largely experimental.

The Indian Council of Medical Research (ICMR) encourages research on the use of stem cells to cure diseases like Parkinson's and a few others with regulations in place for the conduct of such research. The problem arises when clinics and medical practitioners claim to provide stem cell treatment for such conditions based on unverified experimental research. Considering the incurable nature of these conditions, desperate patients get attracted by clinics claiming to have a “magical” remedy. These clinics charge a hefty fee for these untested "treatments", only adding to the financial burdens of the patient.

This article will provide an overview of the regulatory landscape for Stem Cell Therapy in India and examine the governance vacuum in this area.

The first attempt to regulate stem cell activities was made in 2007 when the CMR and the Department of Biotechnology (DBT) jointly issued a set of Guidelines for Stem Cell Research and Therapy. The document laid down the "general ethical principles for research and processes for formal committee approval of stem cell activities". The guidelines stipulated that the clinical use of stem cells was not permitted unless clinical trials were conducted and approved by relevant ethics committees and the Central Drugs Standard Control Organisation (CDSCO). Subsequently, the guidelines were revised in 2013 and 2017, and the word "therapy" was removed from the title of the guidelines. This was done to emphasise that "stem cells are still not a part of the standard of care; hence there can be no guidelines for therapy until efficacy is proven."

While this sends a strong message, the guidelines lack statutory backing, due to which they cannot be enforced. Furthermore, both ICMR and DBT have no jurisdiction over clinicians to compel them to follow the guidelines. The ICMR is a research institution under the Ministry of Health and Family Welfare, and its role is limited to "formulation, coordination and promotion of biomedical research."

In contrast, the DBT comes under the Ministry of Science and Technology and is created to promote biotechnology in India with no enforcement abilities over clinics. Both the ICMR and the DBT are aware of their inherent inability to regulate unproven stem cell therapies. However, the guidelines highlight the role of other bodies and legislation to regulate this field. While several bodies and departments have been created to overlook the development of stem cell activities in India, there is no unequivocal answer to the question, "Who regulates stem cell activities in India?"

Under the Drugs and Magical Remedies (The Objectionable Advertisements) Act of 1954, all clinics and hospitals are prohibited from releasing misleading advertisements relating to drugs and magical remedies. Additionally, the ICMR guidelines also state that "participants in a clinical trial should not be made to pay for any expenses incurred beyond routine clinical care and which are research related including tests, investigations and any interventions." Despite these regulations, and due to the lack of a clear regulating authority, clinics and hospitals have been reportedly flouting these rules and offer "stem cell treatment" for Autism and other disorders under the guise of clinical trials. The experimental nature of the treatment is kept from the patients who are made to pay exorbitant fees for an unproven therapy.

On April 4, 2018, the Ministry of Health and Family Welfare proposed a draft to amend the Drug and Cosmetics Rules, 1945, to regulate stem cell activities, and include them in the definition of 'new drugs'. However, it excluded 'minimally manipulated stem cells' from the definition of a 'drug' and exempted it from the purview of the legislation. This exclusion of 'minimally manipulated' stem cells was opposed by the ICMR because it felt that it provided a loophole that clinics could exploit to offer unproven and unregulated stem cell therapies.

Even before this proposed amendment could come into force, the New Drugs and Clinical Rules, 2019 were released, which included 'stem cell derived products' without any exemptions being made for 'minimally manipulated stem cells'. Under the Rule, any clinic or hospital providing stem cell-based treatments would need to obtain a license to continue their operations. At first glance, this Rule seemed to fill the governance vacuum in the regulatory framework around stem cell activities. However, it has only caused more confusion. The 2019 Rules do not provide a definition for 'stem cell derived products', which is at the heart of the issue. Without a clear definition for these terms, the enforcement of such legislation becomes challenging.

The Delhi High Court in Raghubir Singh and Another v. Union of India and Another passed a ruling allowing a clinic in New Delhi to continue embryonic stem cell therapy for some of their patients even in the absence of an approval under the 2019 Rules. This interim relief was necessary because the 2019 Rules failed to consider that certain patients would be undergoing treatment that is necessary for their daily sustenance and could not afford stoppage of treatment until the clinic was granted a license. Any efforts to regulate a largely unregulated field will always face such challenges and pushbacks.

With several bodies from different Ministries trying to fill the governance vacuum around stem cell activities, the need for a consolidated stance has only become more pronounced. The buck needs to stop with a regulatory body which has the mandate and intent to regulate stem cell therapy to protect vulnerable patients and also encourage research.

Mohit Kapoor is Founder & Senior Partner, Universal Legal. The author would like to thank Shuban Sheth for the assistance rendered for the article.