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 or acting on any complaint received by them," stated the guidelines.
Similarly, the Drugs and Magical Remedies (The Objectionable Advertisements) Act-1954 prohibits misleading advertisements relating to drugs and magical remedies. As per the guidelines, the Directorate General of Health Services (DGHS) and relevant state authorities are mandated to take necessary action for violations.
“Clinical research is struggling to cope with the regulatory requirements, industry sponsored clinical research is gaining momentum, but seeks greater clarity and direction. Meanwhile, unscientific or unethical stem cell therapy continues to pose a threat to the well-being of patients and other vulnerable individuals," stated Soumya Swaminathan, secretary, Department of Health Research, ministry of health & family welfare and director general, ICMR.
“In the prevailing scenario, one may question if our regulatory framework and mechanisms can keep up with the rapid pace of changes in stem cell research and ground realities. We have revised these guidelines keeping in mind the latest advancements in the field," she said.
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.
“The advertisement of treatment of several diseases as listed in Schedule-J of Drugs and Cosmetics Act, 1940 and rules therein is not permissible. Hence publicity claiming available cure for these conditions 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 this act," the guidelines stated.
In recent times, there have been advertisements claiming cures for diseases and ailments which a drug may not purport to prevent or cure, including claims to prevent or cure AIDS, diabetes, blindness, genetic diseases, cancers etc.
Similarly as per these revised guidelines, no advertisement which violates the code for self regulation in advertising, as adopted by the Advertising Standards Council of India (ASCI), Mumbai, for public exhibition, from time to time, shall be published.
Earlier in 2007, the ICMR and DBT had first framed the guidelines for stem cell research and therapy. The National Apex Committee for Stem Cell Research (NAC-SCRT) and drafting committee decided to update these guidelines from time to time based on new knowledge generated in the field. Hence these were further revised in 2013 as National Guidelines for Stem Cell Research (NGSCR). This document has been revised incorporating recent advances.