**Summary:**
This circular, dated February 2, 2016, from the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, addresses the restriction on the number of clinical trials an investigator can conduct simultaneously in India. Previously, a restriction limited investigators to a maximum of three trials at any given time. Following stakeholder consultations and meetings held on August 20, 2015, and October 6, 2015, chaired by the Secretary, Ministry of Health and Family Welfare, the decision has been made to remove this restriction. The circular states that the Ethics Committee will now be responsible for determining the appropriate number of trials an investigator can undertake, based on an assessment of the risk and complexity associated with each trial. This decision is communicated for information and compliance to all concerned stakeholders, zonal and sub-zonal offices of CDSCO, and all officers of CDSCO HQ. The circular is issued by Dr. G.N. Singh, Drugs Controller General of India. Copies have been sent to PS to Secretary, Ministry of Health and Family Welfare, PPS to DGHS, PS to AS, and PS to JSR. The file number for reference is 120114DC Pt. 47.
Key Entities Referenced
Central Drugs Standard Control Organization: A regulatory body under the Directorate General of Health Services, Ministry of Health and Family Welfare in India, responsible for drug regulation.
Directorate General of Health Services: An attached office of the Ministry of Health and Family Welfare in India.
Ministry of Health and Family Welfare: A ministry in the Government of India responsible for health policy.
New Delhi: Capital of India where the FDA Bhawan, Kotala Road is located.
clinical trials: Research studies to evaluate a new medical intervention.
Secretary, Ministry of Health and Family Welfare: The highest administrative officer of the Ministry of Health and Family Welfare.
Ethics Committee: A committee that reviews research proposals to ensure the protection of the rights and welfare of human subjects.
Dr. GN. Singh: Drugs Controller General of India (DCGI) at the time of the circular.
File No. 12-01/14-DC (Pt. 47)
Central Drugs Standard Control Organization
Directorate General of Health Services
Ministry of Health and Family Welfare
FDA Bhawan, Kotala Road, New Delhi 110002
Date: 02-02-16
CIRCULAR
Subject: - Restriction of conducting three clinical trials per investigator-regarding.
To deliberate stakeholders concerns and the way forward relating to some issues on
conduct of clinical trials in India, two meetings were held on 20.08.2015 and 06.10.2015 under
the Chairmanship of Secretary, Ministry of Health and Family Welfare in which experts
including Secretary, D/o Health Research & Director General, ICMR and Director General Health
Services were present.
As regards restriction that no investigator shall conduct more than three trials at any
given period of time, it has been decided to remove this restriction & it is further decided that
Ethics Committee after examining the risk and complexity involved in the trial being
conducted/proposed shall decide about how many trials an investigator can undertake.
This is communicated for information and necessary compliance by all concerned.
(Dr. G/N. Singh)
Drugs Controller Genéral (India)
To:-
1) All stakeholders through website of DCG (I).
I!) Zonal and Sub-zonal offices of CDSCO/ all officers of CDSCO (HQ).
Copy to:-
1) PS to Secretary, Ministry of Health and Family Welfare,
Il) PPS to DGHS,
Ill) PS to AS,
IV) PS to JS(R).