Regulatory process and ethics for clinical trials in India (CDSCO)

India has been a hub for conducting various multi center trials. The Central Drugs Standard Control Organization (CDSCO), headed by the Drug Controller General of India (DCGI), lays down the regulations for the conduct of clinical trials in India. The conduct of trials, regulations in India and quality of data generated may be the cause for this development. 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. Updating our knowledge about these is of utmost importance in today’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.