**Policy Summary:**
This circular, issued by the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, addresses the requirement for clinical trial sites to have a minimum of 50 beds. Following stakeholder consultations held on August 20, 2015, and October 6, 2015, under the chairmanship of the Secretary, Ministry of Health and Family Welfare, the decision has been made to revise the 50-bed requirement. The revised policy delegates the determination of a clinical trial site's suitability to the Ethics Committee, irrespective of the number of beds. The Ethics Committee will assess the site's suitability based on its capacity to provide emergency rescue and care arrangements, as well as other facilities necessary for the specific clinical trial. This information is for compliance by all concerned stakeholders. The circular was issued by Dr. G.N. Singh, Drugs Controller General of India, and is accessible to all stakeholders via the DCGI website. Copies have also been distributed to zonal and sub-zonal offices of CDSCO, all officers of CDSCO HQ, 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. The circular is dated October 2, 2016.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices under the Ministry of Health and Family Welfare.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy.
New Delhi: The location of FDA Bhawan, Kotala Road and the Central Drugs Standard Control Organization (CDSCO) headquarters.
India: The country where the clinical trials are being conducted.
Ethics Committee: The committee responsible for examining and deciding whether a clinical trial site is suitable, irrespective of the number of beds.
Secretary, Ministry of Health and Family Welfare: The highest administrative officer of the Ministry of Health and Family Welfare, chairing meetings on clinical trials.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization (CDSCO).
Directorate General of Health Services: An attached office of the Ministry of Health and Family Welfare.
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: O02 ~4-|6
CIRCULAR
Subject: - Requirement of 50 bedded site for clinical trial-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 condition that no clinical trial shall be conducted at site having less than 50
bedded hospital, it has been decided to revise this condition & it is further decided that
Ethics Committee shall examine & decide whether the clinical trial site is suitable for trial or not
irrespective of number of bed.
However, it was also suggested that site shall have emergency rescue and care
arrangements along with all other necessary facilities required for that particular clinical trial.
This is communicated for information and necessary compliance by all concerned.
(Dr. G. MN. Singh)
Drugs Controller General (India)
To:-
1) All stakeholders through website of DCG (I).
Il) Zonal and Sub-zonal offices of CDSCO/ all officers of CDSCO (HQ).
Copy to:-
1) PS to Secretary, Ministry of Health and Family Welfare,
II) PPS to DGHS,
Ill) PS to AS,
IV) PS to JS(R).