NCISM Announces Regulations for Medical Research

India Pharma Outlook Team | Tuesday, 05 December 2023

 India Pharma Outlook Team

The National Commission for the Indian System of Medicine (NCISM) has announced regulations to set standards for medical research in the Indian System of Medicine (ISM), including provisions for research misconduct, non-compliance or violation of legal guidelines.

The National Commission for Medical Research in Indian System of Medicine Regulation 2023 also envisages the establishment of an ISM Research Monitoring Committee headed by the Chairman of the Board of Ayurveda to monitor research. Industrial activities.

When conducting research, all stakeholders are expected to follow certain guidelines for ethical and scientific reasons, including that all ISM-related clinical trials must be conducted in accordance with the Good Clinical Practice guidelines issued by the relevant ISM Research Committees.

Furthermore, they must not conflict with any international or national biomedical research legislation, including but not limited to the Drugs and Cosmetics Act and Rules, 1940 (1945) (including Schedule Y) and subsequent applicable amendments; Declaration of Helsinki (2012 or later versions, if applicable); Union Ministry of Health and Family Welfare Good Clinical Practice Guidelines (2001 or later versions where applicable); National Guidelines for Biomedical and Health Research Involving Human Subjects (2017 or newer versions, if applicable); National Ethical Guidelines for Biomedical Research Involving Children (2017 or newer versions, if applicable); Council for Ethics in Research Integrity and Publication of Medical Research Policy of India (2019 or later versions as applicable) and other relevant regulations and guidelines as applicable.

Animal experiments must follow the rules and guidelines notified by the Committee for the Control and Supervision of Experiments on Animals (CCSEA), Government of India. Before enrolling the first participant in a particular clinical trial, the responsible party must register all interventional clinical trials/trials with the Clinical Trials Registry of India (CTRI).

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