**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, addresses clinical trial compensation for injuries or death discovered at a later stage. Following the recommendations of an Expert Committee chaired by Prof. Ranjit Roy Chaudhury, the Ministry has decided that compensation must be provided to clinical trial participants (or their nominees) if a drug-related anomaly is identified at a later stage and determined to be the cause of the injury or death. This order advises all Sponsors, Manufacturers, and Clinical Trial Applicants to provide such compensation. The order was issued by Dr. G.N. Singh, Drugs Controller General of India, and bears File No. 120114DC Pt.47. It is addressed to IDMA, IPA, OPPI, ISCR, ACRO and copied to USD, Ministry of Health and Family Welfare. The subject is clinical trial compensation in case of injury or death discerned at a later stage regarding. The location of the issuing organization is FDA Bhawan, Kotla Road, New Delhi-110002.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices in India.
Ministry of Health Family Welfare: The government ministry responsible for health policy in India.
New Delhi, Delhi: The location of FDA Bhawan, where the order was issued.
Clinical trial Compensation: The subject of the order, specifically addressing compensation for injury or death in clinical trials.
Prof. Ranjit Roy Chaudhury: The Chairman of the Expert Committee that formulated policy and guidelines for new drugs, clinical trials and banning of drugs.
Expert Committee: The committee constituted by the Ministry of Health Family Welfare to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs.
Drugs Controller General India: The authority issuing the order, responsible for drug regulation in India. (Dr. G.N. Singh is the current office holder)
IDMA IPA OPPI ISCR ACRO: List of Pharmaceutical associations who are being informed about the order.
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, Kotla Road, New Delhi-110002
Dated: 03.07.2014
ORDER
SUBJECT: Clinical trial - Compensation in case of injury or death discerned ata later
stage- 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 finalized by the Ministry of
Health & Family Welfare.
7 Pursuant to above, with regard to the compensation in case of injury or death
discerned at a later stage, it has been decided that compensation in case of injury or death
discerned at a later stage should be paid to the trial participant / his / her nominee as the
case may be, if any drug-related anomaly is discerned at a later stage and accepted to be
drug related.
In view of above, all Sponsors / Manufactures/Clinical Trial Applicants are hereby
advised to provide compensation to the trial participant / his / her nominee as the case may
be, if any drug-related anomaly is discerned at a later stage and accepted to be drug
related injury or death.
(Dr. G./N. Singh)
Drugs Controller Gengral (India)
To:
IDMA/IPA/ OPPI/ISCR /ACRO
CC to: US(D), Ministry of Health and Family Welfare