While the country has an effective mechanism for conducting Clinical Trials for Drugs it is also imperative that guidelines be laid down for conducting Clinical Trials for food and food ingredients including nutrients as is the case in many countries including US, Europe and Australia/New Zealand. There is a fundamental difference between drugs and food. Drugs are directed toward treatment of disease. Unlike most drugs, food and nutrients work in complex networks, target all cells and tissues, and have multifaceted effects and outcomes.
The Seminar looked at current approaches for conducting Clinical Evaluation / Intervention Studies for Foods in India, the Importance of National Regulations, Data Requirements for Substantiation of Claim, Ethical Issues, Good Clinical Practices, Role of Stakeholders (FBOs, CROs, Regulators) in conducting Clinical Evaluation Activities and Best Practices for Conducting Clinical Evaluation.
The Seminar was addressed by 16 experts.
A White Paper is under preparation.