Chapter 7 - Clinical Trials in India

Abstract

This chapter describes the ever-increasing requirements for clinical trial participants, which has forced pharmaceutical sponsors to access clinical trial participants from a number of emerging countries. India's regulatory environment for clinical trials is stable, progressive, and evolving to meet the needs of international clinical research sector. Clinical trials in India are conducted under the legislation contained in Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. The clinical trial application is first examined by the New Drug Division, followed by a detailed review by the IND Committee whose recommendations are presented to the DCGI. The DCGI may either grant approval or raise further queries. All clinical trial investigators should possess appropriate qualifications, training, and experience and have access to diagnostic and treatment facilities relevant for the proposed trial protocol. Administrative, logistic, and minor protocol changes, and additional safety assessments do not require DCGI notification or permission. Online registration of clinical trials has been mandated by the DCGI. Any researcher who plans to conduct a trial involving human participants is expected to register the trial on the Clinical Trials Registry India (CTRI). The Indian government realizes the value of encouraging India's clinical research industry and has implemented a number of initiatives to encourage it, including abolishing import duties on clinical trial supplies. In order to utilize the clinical trial opportunities in India most effectively, it is essential to confirm protocol feasibility and factor in realistic timelines for regulatory approval and study start. Today's, global environment presents tremendous opportunities for India's clinical trial sector.