GUIDELINES ON CLINICAL TRIAL OF DRUGS FRAMED BY COMMITTEE CONSTITUTED BY THE NATIONAL HUMAN RIGHTS COMMISSION During its deliberations, the Committee observed that the main concerns of the committee with reference to the violation of human rights, noted in the context of Hyderabad case of 2011, were as follows:1. Subjects, who were normal healthy persons participated in the bioavailability/ bioequivalence study without being given proper information of the risks involved in the study, 2. Participants were exploited for money. 3. Participants in the study were not provided proper medical care for subsequent side effects. The Committee noted that an Expert Committee on Reforms in drug regulation and clinical trials has been formed by the MOHFW Govt. of India under the chairmanship of Dr. Ranjit Roychaudhary. The Committee also noted that notifications, rules and regulations, additions, deletions to the Drugs and Cosmetics Act and Rules are being issued from time to time including the recent ones on :a. compensation in case of injury or death during clinical trial, rule 122 DAA of 30.1.2013, b.registration of Ethics committee rule 122 DD of 8.2.2013 and c. permission to conduct clinical trial 122 DAC of 1.2.2013. The Committee recommended that all institutions and ethics committee should implement within the time frame, stipulated in the Act, these and such changes in the Act and Rules that are brought about from time to time.