Dear All
The Central Drugs Standard Control Organisation (CDSCO) has issued draft guidelines for determining the quantum of financial compensation to be paid in case of clinical trial related injury or death. The scope of these guideline apply to all such cases of clinical trial including BA / BE studies related injuries or death occurring during clinical trial of drugs including biological and medical devices covered under Drugs & Cosmetics Act.
“Presently there is no specific provision under Drugs and Cosmetics Rules for payment of compensation in case of clinical trial related injury or death of the subject. However, the Good Clinical Practice (GCP) Guidelines for Clinical Trials of India under para 2.4.7 provides that the research subject who suffers physical injury as a result of their participation in clinical trials are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability subject to confirmation from Ethics Committee. In case of death, their dependents are entitled to material compensation. Guidelines further provide that it is the obligation of the sponsor to pay the compensation”.
For more details about this proposed document refer CDSCO link.
The Central Drugs Standard Control Organisation (CDSCO) has issued draft guidelines for determining the quantum of financial compensation to be paid in case of clinical trial related injury or death. The scope of these guideline apply to all such cases of clinical trial including BA / BE studies related injuries or death occurring during clinical trial of drugs including biological and medical devices covered under Drugs & Cosmetics Act.
“Presently there is no specific provision under Drugs and Cosmetics Rules for payment of compensation in case of clinical trial related injury or death of the subject. However, the Good Clinical Practice (GCP) Guidelines for Clinical Trials of India under para 2.4.7 provides that the research subject who suffers physical injury as a result of their participation in clinical trials are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability subject to confirmation from Ethics Committee. In case of death, their dependents are entitled to material compensation. Guidelines further provide that it is the obligation of the sponsor to pay the compensation”.
For more details about this proposed document refer CDSCO link.
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