The National Commission for Indian System of Medicine has introduced the “National Commission for Indian System of Medicine (Medical Research in Indian System of Medicine) Regulation, 2023.” These regulations aim at governing medical research within the Indian System of Medicine. They have come into effect from November 28, 2023.
General Consideration: The guidelines emphasize ethical and scientific practices for conducting research in the Indian System of Medicine. Key points include:
- Clinical trials must align with good clinical practice guidelines issued by relevant research councils.
- Compliance with international and national regulatory guidelines, including the Drugs and Cosmetic Act 1940 and rules (1945), Declaration of Helsinki, Good Clinical Practice guidelines of the Ministry of Health and Family Welfare, and other relevant regulations.
- Registration of interventional clinical trials with the Clinical Trial Registry of India (CTRI) before participant enrollment.
- Submission of research records for regulatory compliance assessment, including financial details.
- Publication of research outcomes in non-predatory peer-reviewed journals.
- Consideration of patenting innovations instead of or in addition to publication.
- Research audit authorization by the Commission, allowing experts or third-party agencies to assess trials at any stage.
Responsible Party: The sponsor of a trial is deemed the responsible party, unless a qualified principal investigator is designated.
Funding for Research & Publication: The Commission, through Memorandum of Understanding with research councils, industry, and non-governmental organizations, may generate funds for research or publication.
These regulations aim to ensure the highest standards in conducting medical research within the Indian System of Medicine, promoting ethical practices, transparency, and scientific rigor. Researchers and stakeholders are expected to adhere to these guidelines for the advancement of research in the field.
