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In a move to curb "rampant malpractice", India has banned commercial use of stem cells "as elements of therapy" and warned of punishments to erring clinicians claiming stem cell cures for diseases through direct-to-consumer marketing.
"No stem cell administration to humans is permissible outside the purview of clinical trials," according to the revised National Guidelines for Stem Cell Research, jointly prepared by the Department of Biotechnology (DBT) and the Indian Council of Medical Research (ICMR) and announced on 11 October 2017.
"We are committed towards stem cell treatments that are safe and have proven efficacy," the government’s guideline says.
But any stem cell use in patients, other than that for treating approved blood (hematopoietic) disorders is "investigational at present" and can be conducted only in the form of a clinical trial after obtaining regulatory approvals from Central Drugs Standard Control Organization (CDSCO). A list of approved indications has been provided in the guidelines.
Genome modification – including gene editing of stem cells, germ-line stem cells or gamete and human embryos – is restricted only to in vitro studies. Only spare embryos or gametes can be used and genome modified human embryos "should not be cultured beyond 14 days of fertilization".
The guidelines prohibit research related to human germ line gene therapy, reproductive cloning, and clinical trials involving "xenogeneic" cells – those derived from different species. "Breeding of animals in which any type of human stem cells have been introduced is prohibited."
According to the guidelines, only umbilical cord blood banking is permitted for the present, but not banking of all other biological materials "until further notification".
All international collaborations in stem cell research and import of any type of stem cells require approvals from the respective funding agencies and the CDSCO.
Clinical trials sponsored by multinationals, employing cell products developed outside India, additionally require Indian health ministry’s screening committee's permission.
