Urooj Mohd, Husain Gulam Mohammed, Khan Mohammad Ahmed, Kazmi Munawwar Husain
Department of Pharmacology, Central Research Institute of Unani Medicine, Under CCRUM, Ministry of AYUSH Government of India, Hyderabad, Telangana, India.
Int J Pharm Investig. 2017 Apr-Jun;7(2):41-46. doi: 10.4103/jphi.JPHI_31_17.
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.
印度政府最近发布的关于开展临床试验的修正案，对于促进人类受试者的安全和福祉而言，非常值得赞赏。这些规则明确规定，临床试验中损伤的医疗处理是强制性的，并且除医疗处理外，与临床试验相关的损伤或死亡需要给予赔偿。这些规则需要重新审议，以简化并更好地理解赔偿相关问题。在某些方面需要明确，应与所有利益相关者进行讨论，以便更好地理解现行法规。我们认为，在讨论过程中还必须关注学术研究人员，以促进在印度提供具有成本效益的治疗。
