Stem Cell

Government formulates new regulations to curb misuse of stem cells

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.
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.

New Delhi: Can India’s regulatory framework prevent unethical and indiscriminate use of stem cell based therapies without establishing their safety or therapeutic efficacy? As the field witnesses rampant malpractice, posing challenges for regulatory authorities worldwide, the central government has come up with a cover of two Acts and two regulations together to curb the misuse of “wonder (stem) cells” in vulnerable patients.

The National Guidelines for Stem Cell Research 2017 formulated and released by Indian Council of Medical Research (ICMR) and Department of Biotechnology on Wednesday have now included the provision of action against erring clinicians/entities as per the existing rules and regulations. The move has taken a cue from the fact that the last decade has seen a proliferation of indiscriminate use of stem cell based therapies without establishing either their safety or therapeutic efficacy.

Advertising and publicity through any mode by clinicians is not permitted as per the Indian Medical Council (Professional Conduct, Etiquettes and Ethics) Regulation. “It is mandated that the Medical Council of India (MCI) and Medical Councils of respective state should initiate action on the erring clinicians for violation of code of ethics prescribed by it either taking suo moto cognizance…

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