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New Study Suggests That Proposed Rules May Legitimize Unproven Stem Cell Therapies in India

Updated: Feb 3, 2019

Press release

A new study released today suggests that draft amendments proposed by India's Central Drugs Standard Control Organization (CDSCO), the national regulatory body for pharmaceutical and medical devices, related to stem cell therapies and stem cell-based products may further legitimize and accelerate the intervention of experimental and unproven stem cell based treatments in patients. The paper entitled “Unproven Stem Cell Therapies in India: Regulatory Challenges and Proposed Paths Forward” was published in Cell Stem Cell, an international peer-reviewed journal supported by the International Society for Stem Cell Research (ISSCR) and is coauthored by Dr. Shashank Tiwari, Research Fellow at the Canadian Institute for Genomics and Society in Toronto, Canada and Prof. Pranav Desai, Retired Professor from the Centre for Studies in Science Policy, Jawaharlal Nehru University in New Delhi, India

Currently in India, hundreds of clinics are actively providing stem cell-based treatments to patients, despite the remarkably stringent guidelines and regulations for fraudulent advertisements and clinical practice. The new study by Dr. Tiwari and Dr. Desai highlights that the CDSCO proposed rules consider stem cells interventions in patients as drugs, when they are derived from substantial or more than minimal manipulation. However, the rules exclude minimally manipulated stem cells from the category of drugs, thus opening the door to legitimizing the use of unproven stem cell treatments. Citing the 2017 ISSCR's letter to the CDSCO, Tiwari and Desai argue that there is a lack of clarity in the proposed rules in defining the minimal and substantial or more than minimal manipulation, including homologous use of stem cells. The authors also claim that the definition proposed by the CDSCO is not aligned with its own National Stem Cell Guidelines, developed by the Indian Council of Medical Research in 2017. This clearly suggests that there is a significant government deficit in stem cell regulations in India.

The analysis further highlights existing regulatory challenges and gaps related to national guidelines, misleading advertisements and the medical practice in India. Tiwari and Desai suggest that Indian regulatory authorities should make a better effort to provide a legal backup to the existing guidelines. They argue that minimal manipulation in stem cells should be categorized as a drug, as the exemption of ‘minimal manipulation’ of cells and ‘homologous use’ from the drug approval process has greatly contributed to the mushrooming of establishments providing unproven stem cell therapies worldwide. The authors make a plea to the international community to re-consider whether ‘minimal processing and homologous use’ should be allowed without stringent oversight in the name of ‘clinical innovation’.

India has become a major destination for stem cell tourism for many Canadians. Last year, claims by a New Delhi clinic that it could use a stem cell treatment to make children with Down syndrome “almost near normal” were reported in the National Post and other major national newspapers. The clinic also claimed to have used the same treatment to help paralyzed Canadians walk again. Stem cell experts in Canada have warned that such bold and unsubstantiated claims raise false expectations and contribute to public confusion. Nonetheless, the stem cell tourism phenomenon continues to be a significant public heath issue in Canada and elsewhere. It is worth noting that media hype around stem cell breakthroughs and therapies has been a contributing factor to unrealistic expectations and beliefs that stem cells can cure anything.

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