Revised Schedule Y Salient Highlights

R. K. Rishi

Abstract: India has emerged as a potential destination to undertake drug development research and now India is participating in global clinical trials. In order to harvest this potential, it was also considered necessary to update the regulatory norms so as to ensure the quality of data generated in India to be of global standards and also to ensure safety of patient population enrolled in the clinical trials. For this purpose Schedule Y of the Drugs and Cosmetics Rules, which prescribes country's norms for preclinical and clinical studies for development of new drug has been extensively reviewed and updated. Present revised schedule Y lays down requirements and guidelines for permission to import and / or manufacture of new drugs for sale or to undertake clinical trials in the country.

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