International Journal of Pharmaceutical Investigation, 2017, 7, 2, 41-46.
DOI: 10.4103/jphi.JPHI_31_17
Published: July 2017
Type: Review Article
Authors:
Mohd Urooj
Department of Pharmacology, Central Research Institute of Unani Medicine, Under CCRUM, Ministry of AYUSH Government of India, Hyderabad, Telangana, India.
Gulam Mohammed Husain
Department of Pharmacology, Central Research Institute of Unani Medicine, Under CCRUM, Ministry of AYUSH Government of India, Hyderabad, Telangana, India.
Mohammad Ahmed Khan
Department of Pharmacology, Central Research Institute of Unani Medicine, Under CCRUM, Ministry of AYUSH Government of India, Hyderabad, Telangana, India.
Munawwar Husain Kazmi
Department of Pharmacology, Central Research Institute of Unani Medicine, Under CCRUM, Ministry of AYUSH Government of India, Hyderabad, Telangana, India.
ABSTRACT
The recent amendments notified by the Government of India, for conducting clinical trial, is greatly appreciable as promoting safety and well-being of human subjects. These rules clearly state that medical management of injuries in clinical trials is mandatory and clinical trial-related injury or death needs to be compensated over and above the medical management. These rules need to be reconsidered for simplification and better understanding of issues regarding compensation. There is a need of clarity at some points which should be discussed with all stakeholders for better understanding of current regulations. In our view, attention must also be given to academic investigators, during discussion to promote availability of cost-effective treatment in India.
Keywords: Adverse event, Ethics, Injury/death .