Stem cell therapy has come under renewed regulatory scrutiny in India, with the Union Health Ministry asking states to take action against doctors and clinical establishments offering the treatment for conditions where its effectiveness has not been established. The ministry has advised authorities to ensure that stem cell therapies are provided only in accordance with approved indications and the prescribed regulatory framework.
The advisory also refers to a Supreme Court ruling earlier this year and outlines the action that can be taken against medical practitioners and clinical establishments for violations.
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Action Against Doctors And Clinical Establishments
According to the Health Ministry’s advisory, medical practitioners who provide stem cell therapy outside the permitted framework may face action under the professional ethics regulations applicable to doctors. Clinical establishments offering such treatments can also face proceedings under the Clinical Establishments (Registration and Regulation) Act, where the law is applicable.
Doctors found violating the rules may face disciplinary proceedings. Clinical establishments could be fined, while serious violations may also lead to cancellation of their licence.
However, the Clinical Establishments Act is not in force uniformly across India. The law has been adopted in 19 states and Union Territories, including Bihar, Uttar Pradesh, Rajasthan, Sikkim and Telangana. It has not yet been implemented in Delhi, meaning action under this particular law cannot be taken there. The professional ethics regulations applicable to medical practitioners, however, apply across the country.
The ministry has also asked state and district-level regulatory authorities and clinical establishments to strictly follow the existing rules governing stem cell research and therapy.
Stem Cell Therapy Allowed For 18 Conditions In Adults
The Health Ministry has clarified that stem cell therapy is not permitted as a treatment for every disease or health condition. Its use is restricted to specified conditions included in the ministry’s approved list.
The list covers certain serious cancers and autoimmune conditions. These include acute myeloid leukaemia, B-cell lymphoma and multiple myeloma, along with conditions such as multiple sclerosis and aplastic anaemia.
As per the ministry, stem cell therapy can be used for 18 diseases or conditions in adults and 14 in children. Treatments for conditions outside these specified categories require compliance with the applicable regulatory process and necessary approvals.
Stem Cell Therapy Is Not Approved For Autism
The use of stem cell therapy for autism was also part of the Supreme Court case referenced by the Health Ministry. The ministry has clarified that autism spectrum disorder does not feature among the 18 conditions for which stem cell therapy has been approved.
For autism, the treatment can only be used as part of a clinical trial and must follow the prescribed process and obtain the necessary approvals. It cannot be offered as a routine treatment for patients with autism.
The latest advisory is primarily aimed at informing state and district authorities about the Supreme Court ruling and the existing regulatory framework. It also highlights the need for action against clinical establishments offering stem cell treatments whose effectiveness has not been established for the condition being treated.
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NMC Had Also Issued A Warning
Earlier this month, the National Medical Commission (NMC) also reiterated the Supreme Court’s position and cautioned medical professionals about the unauthorised use of stem cell therapy.
The country’s apex regulatory body for modern medical practice and medical education said that using, prescribing, promoting or advertising stem cell therapy for conditions beyond the approved indications without the required permission would be considered professional misconduct.
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