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[An Official Publication of ISF College of Pharmacy, Moga]


 

Review Article
Year : 2018   |  Volume : 10  |  Issue : 4  |  Page : 141-147

Compensation for clinical trial participants in India: A regulatory overview

Clinical research is the branch of health-care science which deals with safety and efficacy of medications, devices, diagnostic test, and treatment regimen in human. Good clinical practice (GCP) is an ethical and scientific quality standard for designing, conducting and recording trials that involve the participation of human subjects. An expert committee set up by Central Drugs Standard Control Organization (CDSCO) in consultation with a clinical expert has formulated this GCP guideline for generation of clinical data on drugs. The drug technical advisory board, the highest technical body under D and C, act, has endorsed adoption of this GCP guideline for streamlining the clinical studies in India. The new drug regulatory processes come under the drug controller general of India who is head of CDSCO. Schedule Y has three major section and 11 appendices that are an application for permission, clinical trial, and studies in special population compensation in clinical trials which means participants receive monetary or other benefits for their participation (suffer and harm) in the clinical trial. Compensation is more common in phase 1 trials with healthy volunteers and is usually paid to participants. Some cases compensation is not paid to participants depend on the sponsor and the study design. Many clinical research organizations even advertise participation in clinical studies as it offers a (limited) possibility to earn money. Compensation is always a special concern with vulnerable populations, particularly in children and people with intellectual or mental disabilities. People in these vulnerable populations do not or cannot make their own decisions. Compensation amount will vary from a minimum of Rs. 8 lakhs to a maximum of Rs. 73.60 lakhs depending on the age of the deceased and the risk factor.
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