Clinical Trials Registry India (CTRI) is the official clinical trials registry of the Government of India. The National Institute of Medical Statistics of the Indian Council of Medical Research established the CTRI on 20 July 2007. Since 2009, the Central Drugs Standard Control Organisation (CDSCO) has mandated that anyone conducting clinical trials in India must pre-register the clinical trials before enrolling any participants/subjects/patients. Although it is not mandatory to register observational studies with CTRI, however, the CTRI encourages registration of all studies including observational studies.
Any pharma or medical device companies or research organisationsĀ who plan to conduct clinical trials in India involving human participants are expected to register the trials in the CTRI before the start of enrollment. The clinical trials may involve drugs, surgical procedures, prevention and observational studies, medical devices, rehabilitation, educational or behavioral treatment.
