The Central Drugs Standard Control Organization (CDSCO) is inviting public comments on its draft guidelines for Good Clinical Practices (GCP). This circular was issued on September 12, 2024.
What is Good Clinical Practice (GCP)?
Good Clinical Practice is a set of guidelines for biomedical studies which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human participants.
The main principle of GCP is that in research on human subject or participant, the interest of science and society should never take precedence over considerations related to the well-being of the study participant.
Development of GCP Guidelines
It may be recalled that the CDSCO had constituted a committee led by Dr. Bikas Medhi of PGIMER, Chandigarh, to revise India’s GCP guidelines. The aim of the committee was to align with the New Drugs and Clinical Trial Rules, 2019, and current international standards.
The committee has now prepared a draft document outlining the revised GCP guidelines.
Stakeholders are encouraged to submit their comments and suggestions on the draft guidelines. Comments can be submitted electronically within by October 12, 2024 to dci@nic.in.
Importance of GCP Guidelines
GCP guidelines ensure ethical and scientific research in clinical trials involving human participants. These guidelines protect the safety and rights of participants while upholding the integrity of research data.
