**Summary:**
This order, issued by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare on July 3, 2014, limits the number of clinical trials an investigator can undertake simultaneously. File No. 120114DC Pt.47.
This decision is based on the recommendations of an Expert Committee, chaired by Prof. Ranjit Roy Chaudhury, which was formed to formulate policies and guidelines for new drug approvals, clinical trials, and drug bans. The Ministry of Health & Family Welfare finalized actions based on the committee's report.
The order stipulates that the number of clinical trials an investigator undertakes should be appropriate for the trial's nature and the facilities available. However, under no circumstances should an investigator be involved in more than three clinical trials concurrently.
Sponsors and clinical trial applicants are directed to implement these recommendations to ensure investigators do not exceed the limit of three simultaneous clinical trials.
The order was issued by Dr. G. N. Singh, Drugs Controller General of India, and distributed to IDMA, IPA, OPPI, ISCR, and ACRO, with a copy to US D, Ministry of Health and Family Welfare. The issuing organization is located at FDA Bhawan, Kotia Road, New Delhi-110002.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices in India.
Directorate General of Health Services: A government organization responsible for public health services in India.
Ministry of Health Family Welfare: The Indian government ministry responsible for health policy.
New Delhi: Capital of India, location of FDA Bhawan.
Prof. Ranjit Roy Chaudhury: Chairman of the Expert Committee constituted by the Ministry of Health Family Welfare.
Expert Committee: Committee constituted to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs.
Clinical Trials: Research studies conducted to evaluate the safety and efficacy of new drugs or medical treatments.
Dr. G. N. Singh: Drugs Controller General of India
File No. 12-01/14-DC Pt.47
Central Drugs Standard Control Organization
Directorate General of Health Services
Ministry of Health & Family Welfare
FDA Bhawan, Kotia Road, New Delhi-110002
Dated: 03.07.2014
ORDER
SUBJECT: Limiting Number of Clinical Trials an Investigator can undertake at a time-
regarding :
The Ministry of Health & Family Welfare had constituted an Expert Committee
under the Chairmanship of Prof. Ranjit Roy Chaudhury to formulate policy and guidelines
for approval of new drugs, clinical trials and banning of drugs. The Expert Committee
submitted its report to the Ministry of Health & Family Welfare. The actions proposed to be
taken on the recommendations of the Expert Committee were finalised by the Ministry of
Health & Family Welfare.
Pursuant to above, it has been decided that the number of clinical trials an
Investigator can undertake should be commensurate with the nature of the trial, facility
available with the Investigator etc. However, under no circumstances the number of trials
should be more than three at a time.
In view of above, all Sponsors / clinical trial applicants are hereby directed to
ensure that the above recommendations are implemented and the Investigators are not
involved in conduct of more than three clinical trials at a time.
. (Dr. G. N. Singh)
Drugs Controller General (India)
To:
IDMA/IPA/ OPPI/ISCR/ ACRO
Copy to:
US (D), Ministry of Health and Family Welfare