**Summary:**
The Central Drugs Standard Control Organization (CDSCO), a division of the Directorate General of Health Services, Government of India, issued a notice on January 22, 2019, concerning approved clinical trial sites and investigators. As part of File No. GCTMise.152Clinical Trial Sites Investigators2019DCGI, CDSCO is developing a comprehensive database of clinical trial sites and investigators across various therapeutic categories by collecting data from multiple sources. The initial phase involves compiling a list of sites and investigators participating in global clinical trials. This list is available on the CDSCO website to promote scientifically sound and ethically conducted clinical trials in India. An updated list that includes details pertaining to local clinical trials will be released soon. Any discrepancies identified in the current list should be reported to CDSCO for updates or modifications. The notice was issued by Dr. V. G. Somani, the Drugs Controller General.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices under the Directorate General of Health Services, Government of India.
New Delhi: The location of FDA Bhawan, and the Central Drugs Standard Control Organization (CDSCO).
Clinical Trial Sites Investigators: The subject of the notice, referring to locations and personnel involved in clinical trials.
Global Clinical Trials: Clinical trials conducted internationally, for which data is being compiled by CDSCO.
CDSCO website: The online platform where the list of approved clinical trial sites and investigators is uploaded.
India: The country where the streamlining of scientific and ethical clinical trials is intended.
Dr. V. G. Somani: The Drugs Controller General at the time of the notice.
Drugs Controller General: Title of Dr. V. G. Somani
File No. GCT/Mise./152/Clinical Trial Sites & Investigators/2019-DCG(I)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
FDA Bhawan, New Delhi -110002
(GCT Division)
Date: 2)/21 20149
NOTICE
Subject: List of approved Clinical Trial Sites & Investigators — regarding.
CSDCO is preparing a comprehensive database of sites and investigators involved in
conduct of clinical trial in different therapeutic categories by collecting information from
various sources.
In the first phase. a list of such details involved in Global Clinical Trials in different
therapeutic categories have been prepared and is uploaded in the CDSCO website for
streamlining conduct of scientific and ethical clinical trials in India.
The said list will further be updated shortly with details of sites and investigators involved in
local clinical trials.
Discrepancies, if any. in the said list, may please be brought to the notice of CDSCO for
updation/modification.
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el
(Dr. V. G. Somani)
Drugs Controller General (1)