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Research Journal of Pharmacy and Technology
Year : 2020, Volume : 13, Issue : 3
First page : ( 1517) Last page : ( 1522)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2020.00276.0

Regulatory requirements for conducting Clinical Trials in India

Kamnoore Kalpana, Venkatesh M P*, Balamuralidhara V, Kumar T M Pramod

Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru-570015, Karnataka, India

*Corresponding Author E-mail: venkateshmpv@jssuni.edu.in

Online published on 22 April, 2020.

Abstract

Clinical trial is mandatory for approval of drug to assure safety and efficacy of drug. To safeguard the safety of patient and ethical conduction of clinical trial, India has laid down CT regulations. Compliance with ICH-GCP guideline is mandatory which describes quality assurance and safety of subjects. Clinical trial is regulated under Drug and Cosmetic act 1940 and Rules 1945 which has given Rules to conduct the clinical trial. On March 19, 2019, the Union Ministry for Health and Family Welfare notified New drugs and Clinical Trials Rules, 2019 for promoting clinical research in the country. Central Government notified final rules in Gazette of India vide G.S.R.227(E). The objective of this study is to provide an overview on regulatory requirements to conduct the clinical trials in India and challenges involved in that.

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Keywords

Clinical trial, Regulations, Safety, Guidelines, Challenges.

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