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WJPR

World Journal of Pharmaceutical Research

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical and Medical Research and Technology

Impact Factor : 8.084

ICV : 90.8

WJPR Citation

	All	Since 2011
Citation	2903	2393
h-index	27	24
i10-index	68	60

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World Journal of Pharmaceutical Research (WJPR) will give best paper award in every issue in the form of money along with certificate to promote research activity of scholar.

Best Paper Award :
Dr. Muhammad Baqir MR Fakhrildin
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Abstract

A REVIEW ON CURRENT STRATEGIES OPTED BY REGULATORY BODIES FOR INDIAN CLINICAL TRIALS

Khushwant Khatri*, Priyanka Modi and Khushbu Shah

ABSTRACT

Currently India is the major hub of Asian country which conducts various multicentre clinical trials. The conduct of these clinical trials is being critically reviewed at both national and international platforms. The Regulatory Bodies of India is upgrading the quality of the Clinical trials to meet up the international standards. It is essential that now all clinical trials conducted in India should as per the International conference of Harmonization-Good Clinical Practices Guidelines (ICH-GCP) for clinical trials and follow the recently amended Schedule Y of the Drugs and Cosmetics Act. The regulatory guidelines in terms of serious adverse events (SAEs) reporting, audio-visual (AV) consulting, informed consent, compensation in case of injury or death in clinical trials have been currently modified. This article provides an insight into the recent changes with respect to the regulations of clinical trials and its impact on the clinical research industry in India.

Keywords: Regulatory bodies, Clinical Trial, DCGI and CDSCO.

[Full Text Article]