Abstract
The clinical trials in India are regulated by Schedule ‘Y’ of the Drug and Cosmetics Rules, 1945 w hich defines the requirements and guidelines for import and/or manufacture of new drugs for sale or for clinical trials. However, owing to the changing International regulato ry scenario, increased awaren ess about the rights/ welfare of the trial participant s and recent exposure of certain unethical practices being adopted in the conduct of clinical trials in the country, an overhaul of the clinical research related regulatory framework was long overdue. It has also been r eported that due to lack of appropria te regulation in clinical trials, India is losing out to Malaysia, China and Singapore. The health ministry’s proposal for a biomedical and health research bill is, therefore, a welcome step. The proposed law intends to ensure compliance with the regulator y provisions and ethical guidelines to ensure well - being of the clinical trial participants.
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