The Union Health Ministry has asked states and Union Territories to take action against doctors and clinical establishments offering unproven stem cell therapies for conditions for which such treatments have not been approved.
In an advisory issued on September 16 and released on September 17, the ministry reiterated that stem cell therapy can be used as standard clinical care only for disease conditions and indications included in the list approved by the ministry.
The advisory follows a Supreme Court judgment delivered in January this year concerning the regulation of stem cell therapy. The ministry has asked state and district regulatory authorities to ensure that government and private clinical establishments involved in stem cell research, treatment, promotion or administration follow the existing regulatory framework.
The ministry has specifically clarified the position regarding Autism Spectrum Disorder. Therapeutic use of stem cells for autism is to remain restricted to properly approved clinical trials and cannot be offered as routine or commercial clinical treatment.
The government said violations could attract action under existing professional and clinical-establishment regulations. The National Medical Commission had also issued an advisory earlier this month reiterating that stem cell therapy should be offered as standard clinical care only for approved indications.
The regulatory clarification is intended to prevent patients from being offered therapies that have not been established as effective for particular conditions.
Stem cell research continues to be an important area of medical science, with researchers studying its potential applications in different diseases. However, the transition from experimental research to established clinical treatment requires evidence from appropriately designed studies and regulatory approval.
The Health Ministry has therefore asked authorities to widely circulate the Supreme Court’s directions and ensure compliance among healthcare providers.
The advisory also puts greater emphasis on distinguishing legitimate clinical research from treatments being promoted commercially without adequate evidence.
State medical councils have been asked to examine complaints of professional misconduct and take appropriate action after following due process. (pib.gov.in)
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