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For autism spectrum disorder, a lifelong neurodevelopmental condition, the ministry said therapeutic use of any type of stem cells was restricted to approved clinical trials conducted in accordance with the National Guidelines for Stem Cell Research, 2017, issued jointly by the Indian Council of Medical Research and the department of biotechnology.
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“The advisory reiterates the existing framework governing stem cell research and therapy” and seeks to ensure that the therapy is permitted as standard care only for disease conditions/indications included on the list approved by the ministry, the advisory stated. The advisory is in line with a Supreme Court ruling in January restricting the use of unproven stem cell therapy.
The ministry asked all states and union territories to widely disseminate the Supreme Court’s directions to state and district regulatory authorities, as well as all government and private clinical establishments involved in stem cell research, treatment, promotion or administration. The advisory also drew attention to the consequences of non-compliance.
The Supreme Court held that violations could attract consequences including for professional misconduct under Regulation 7.22 of the Indian Medical Council Regulations dealing with ethical considerations in clinical trials, as well as cancellation of registration and financial penalties under Sections 32 and 40 of the Clinical Establishments Act.
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“The ministry has accordingly requested the concerned state and district regulatory authorities and clinical establishments to ensure strict compliance with the applicable framework governing stem cell research and therapy,” it said.”Stem cell therapy has been one of the most aggressively marketed unproven treatments in India over the past decade, particularly for conditions like autism, cerebral palsy and spinal cord injuries, where families desperate for solutions have often paid significant sums for treatments that have no established clinical evidence behind them,” said an official.
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The National Medical Commission has separately reinforced the position. In an advisory issued on September 5, the commission also said stem cell therapy might be offered as standard clinical care only for approved indications and advised state medical councils to examine alleged violations and take appropriate disciplinary action if misconduct was established.
