Do our regulatory framework and mechanisms keep up with the rapid pace of changes in stem cell research and therapy? Analyse.
Refer – Business Line
IAS Parliament 6 years
KEY POINTS
Stem cells
· Stem cells are a class of undifferentiated cells that are able to differentiate into specialized cell types.
· Stem cells and their derivatives fall under definition of ‘drug’ as per the Drugs and Cosmetics Act 1940, and are categorized as ‘investigational new drug (IND)’ or ‘investigational new entity (INE)’ when used for clinical application.
· Unscientific or unethical stem cell therapy continues to pose a threat to the well-being of patients and other vulnerable individuals.
Changes in Stem cell therapy and research
· Proliferation of indiscriminate use of stem cell based therapies without establishing either their safety or therapeutic efficacy.
· Various unproven treatments are offered to the public without any clinical studies or research.
· Rapid spread of advertisements claiming cures for diseases which a drug may not purport to.
· E.g. Claims to prevent or cure AIDS, diabetes, blindness, genetic diseases, cancers etc.
· At present, only umbilical cord blood (UCB) banking is permitted and licensed by the Central Drugs Standard Control Organisation (CDSCO).
· But, huge proliferation of stem-cell centres and banks, which store biological materials from cord tissue, placenta and tooth extract on a commercial scale, poses a threat.
Regulatory framework
· ICMR and the DBT have come up with a set of Draft National Guidelines for stem-cell research to ensure the proper use of stem cells.
· Commercial banking of all biological materials, other than UCB, will not be permitted
· It is mandated that the MCI and Medical Councils of respective state should initiate action on the erring clinicians for violation of code of ethics prescribed by it.
· Publicity claiming through advertisements using stem cells and its derivatives is prohibited.
· Central Drugs Standard Control Organization (CDSCO), DGHS and relevant state authorities are mandated to take necessary action for violation of Drugs and Cosmetics Act, 1940.
· It also prohibits research related to human germ-line gene therapy, reproductive cloning and clinical trials involving xenogeneic cells – those derived from different species.
