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Research Journal of Pharmacy and Technology
Year : 2018, Volume : 11, Issue : 7
First page : ( 3209) Last page : ( 3215)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2018.00590.5

Good Clinical Practices: An Indian Perspective

Castelino Lovely Joylen, Narayanan V Anoop*, Fernandes Swapnil Dylan, Kumar Pankaj, Sandeep D S.

NGSM Institute of Pharmaceutical Sciences, NITTE Deemed to be University, Mangalore, Karnataka, India, 575018

*Corresponding Author E-mail: anoopvn84@gmail.com

Online published on 31 October, 2018.

Abstract

Clinical research is a mechanism or a process that provides concrete evidence that new treatments or remedies suggested are safe and effective. The ultimate aim of clinical research is the identification and discovery of contemporary diagnostic methods as well as the establishment of advanced standards of therapy. Good clinical practice (GCP) is an ethical and scientific quality standard for designing, conducting and recording trials that involve the participation of human subjects. Acquiescence with the guideline gives a pledge to the public that the morality, integrity and welfare of humans participating in the trials are protected. India offers distinctive opportunities for performing clinical trials with large patient population, experienced and well-equipped investigators and leading medical institutions with low patient trial cost when compared to the regulated nations. However, to ensure a uniform standard of clinical research in the entire nation and to provide data for registration for new drugs before use in human population in India, there was a need for our own Indian Guidelines. GCP guidelines were developed by an accomplished committee set up by CDSCO along with the clinical experts. This article elucidates the significance of Good Clinical Practice from an Indian Clinical Research perspective, whilst defining and outlining the goals and objectives of GCP. It addresses the historical events that led to the emergence of Good Clinical Practices and examines the current scenario with regards to the application of GCP in Clinical trials in India. Finally, the article analyses the challenges faced with regards to maintaining an evidential and competitive system and also suggest a way forward for further enhancing the credibility and efficiency of Good Clinical Practice in Clinical Research.

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Keywords

Good Clinical Practices, CDSCO, Clinical Research, Human Experimentation, ICMR, Guidelines, Clinical trial.

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