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World Journal of Pharmacy and
Pharmaceutical Sciences

( An ISO 9001:2015 Certified International Journal )

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

Impact Factor : 8.025

ICV : 84.65

WJPPS Citation

	All	Since 2019
Citation	5450	3969
h-index	23	20
i10-index	134	84

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WJPPS introducing updated version of OSTS (online submission and tracking system), which have dedicated control panel for both author and reviewer. Using this control panel author can submit manuscript

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WJPPS Invited to submit your valuable manuscripts for Coming Issue.

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New Impact Factor

WJPPS Impact Factor has been Increased to 8.025 for Year 2024.

WJPPS Rank with Index Copernicus Value 84.65 due to high reputation at International Level

Scope Indexed

WJPPS is indexed in Scope Database based on the recommendation of the Content Selection Committee (CSC).

WJPPS: NOVEMBER ISSUE PUBLISHED

NOVEMBER 2024 Issue has been successfully launched on 1 NOVEMBER 2024.

Abstract

RECENT CHANGES IN REGULATORY ASPECT OF CLINICAL TRIALS IN INDIA

Dr.Yashasvi Suvarna* and Dr.Rathai Rajagopalan

ABSTRACT

India has been a hub for conducting various multi centre trials. The Central Drugs Standard Control Organisation (CDSCO), headed by the Drug Controller General of India(DCGI), lays down the regulations for the conduct of clinical trials in India. This trend has but changed from 2011 when most of the trials are being outsourced to other countries like China and Philippines. The conduct of trials, regulations in India and quality of data generated may be the cause for this development. There is a paucity of reviews which sum up the changes in the regulations of clinical trials introduced from then on. Updating our knowledge about these is of utmost importance in todayâ€—s turbulent scenario that prevails in the pharmaceutical industry. Thus, this review 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: randomised controlled trials, drug regulatory, ethics committee, serious adverse event.

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