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.