CDSCO Releases Draft Guidelines on Good Clinical Practices
New Delhi: The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, has issued draft guidelines on Good Clinical Practices (GCP).
These guidelines have been revised in accordance with the New Drugs and Clinical Trial Rules, 2019, and the latest international standards.
Central Drugs Standard Control Organization had constituted a committee under Chairmanship of Dr. Bikas Medhi, Prof. Department of Pharmacology, PGIMER, Chandigarh for the revision of India GCP guidelines and related guidelines in-line with New Drugs and Clinical Trial Rules, 2019 and currently available international guidelines.
Good Clinical Practice is a set of guidelines for biomedical studies that encompasses the design, conduct, termination, audit, analysis, reporting, and documentation of the studies involving human participants. The fundamental tenet of GCP is that in research on human subjects or participants, the interests of science and society should never take precedence over considerations related to the well-being of the study participant. It aims to ensure that the studies are scientifically and ethically sound and that the clinical properties of the pharmaceutical substances under investigation are properly documented.
The guidelines seek to establish two cardinal principles: protection of the rights, safety, and well-being of participants/subjects and authenticity of biomedical/clinical data generated.
After a detailed discussion, the committee prepared draft guidelines on good clinical practices.
The committee opined that the proposed draft guidelines may be circulated to various stakeholders by placing it on the CDSCO website for seeking comments before finalization of the guidelines
Accordingly, the said draft guidelines on Good Clinical Practices are being published on the CDSCO website for comments/suggestions within period of 30 days by email to dci@nic.in.
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