CDSCO approves over 3000 global clinical trial sites, investigators; prepares comprehensive database

CDSCO is preparing a comprehensive database of sites and investigators involved in the conduct of the clinical trial in different therapeutic categories by collecting information from various sources.

New Delhi: The nodal drug regulator, Central Drugs Standard Control Organisation (CDSCO) will soon release a list of approved clinical trial sites and investigators.

Confirmation to this effect has been given by Drugs Controller General of India(DCGI), Dr V G Somani via a public notice dated December 2 2019. The notice informs that CDSCO is preparing a comprehensive database of sites and investigators involved in the conduct of the clinical trial in different therapeutic categories by collecting information from various sources.

Clinical trials are used to test the safety and effectiveness of drugs and devices before introducing them in the market. The trials are typically conducted in four phases including Phase I, phase II, Phase III, Phase IV that are governed by strict protocols and are overseen by many regulatory bodies. In order to make the trials functional proper clinical trial sites have been allocated by the Government recently.

Also Read: Government notifies Drugs and Clinical Trial Rules 2019

To bring transparency in the process of clinical trials, CDSCO is now preparing a comprehensive database of approved clinical trial sites and investigators

"In the first phase, a list of such details involved in Global Clinical Trials n different therapeutic categories have been prepared and uploaded on https://cdsco.gov.in/opencms/opencms/en/Notifications/Public-Notices/ for streamlining the conduct of scientific and ethical clinical trials in India," Somani said.

More than 3000 clinical sites have been mentioned in this list of Global Clinical Trials in various states across the country under the surveillance of principal investigators.

As per CDSCO, the said list will further be updated shortly with details of sites and investigators involved in local clinical trials.

"Discrepancies, if any, may be brought to the notice of CDSCO for the updation/modification, " the notice added.

Also Read: CDSCO apex committee streamlines drug approval process post clinical trial