Participation in MoHFW meeting on Regulation and Monitoring of Clinical Trials

Sarojini from Sama was invited to be a part of the meeting called by the Health Secretary (MoHFW), on Regulation and Monitoring of Clinical Trials. The meeting was held on September 10, 2013 at Nirman Bhavan, New Delhi. Sarojini gave a presentation on compensation in clinical trials, placebo trials, new chemical entities (NCEs), BA & BE studies, and other issues along with the recent changes in the Drugs and Cosmetics (Amendment) Bill 2013. A written submission of this presentation was also made to the Ministry highlighting the need to take cognisance of structural issues like poverty and numerous related issues that incite people to be participate in clinical trials and the need to take urgent steps towards preventing unethical conduct of clinical trials and protection of the human rights of trial participants