A total of 5,541 clinical studies were registered in the Clinical Trials Registry-India (CTRI) from January, 2015, to December 14, 2017, the government said.
Union Minister of State for Health Ashwini Kumar Choubey in a written reply in Rajya Sabha said clinical trials of new drugs were regulated under Rules 122DA, 122DAB, 122DAC, 122DD and Schedule-Y of the Drugs and Cosmetics Rules, 1945.
"Clinical trials are required to be conducted as per the approved protocol and Good Clinical Practices (GCP) guidelines published by the Central Drugs Standard Control Organisation (CDSSCO)," he said yesterday.
"The number of clinical studies registered in the Clinical Trials Registry-India (CTRI) from January, 2015 to December 14, 2017 is 5,541," the minister said.
Further, in May 2017, the Indian Council of Medical Research (ICMR) has become a signatory to the WHO joint statement regarding results disclosure within one year of trial completion, he said.
"The statement commits to have in place a mechanism within one year to implement the same," Choubey added.
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