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  • CDSCO Releases Draft...

CDSCO Releases Draft Guidelines on Good Clinical Practices

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-09-18T18:00:56+05:30  |  Updated On 19 Sept 2024 11:24 PM IST
Usnoflast Phase II(b) clinical trial
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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.

To view the draft guidelines, click the below link:
https://medicaldialogues.in/pdf_upload/indian-gcp-guideline190824-v1-circular-253064.pdf
Also Read:Submit Phase I/Phase II clinical trial data: CDSCO Panel Tells Mankind on Dydrogesterone Injection 5mg/ml
cdscoGood Clinical PracticeGCP guidelinesnew drugs and clinical trials rules 2019
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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