WebSCHEDULE Y. SUBMITTED BY Mr. AKSHAY A. JOSHI ICBIO BANGALORE BRIEF HISTORY. The Drugs Act was enacted in 1940 The Drugs Rules were promulgated in December 1945 and the enforcement started in 1947. The Act as enacted in 1940 has since been amended several times. Recently amended in 2005 Drugs & Cosmetics Act covers a wide variety of … Web– Evaluation of the effect of food on absorption following oral administration Appendices of Schedule Y The Schedule Y of Drugs and Cosmetics ACT, 1940 includes 11 appendices :-• APPENDIX I Data to be submitted along with the application to conduct clinical trials/import/ manufacture of New drugs for marketing in the country.
Schedule Y PDF Clinical Trial Institutional Review Board - Scribd
WebOct 22, 2011 · SCHEDULE Y. This details the requirements and guidelines on clinical trials for import and manufacture of new drug. 1. Clinical Trials. 1. Nature of trials: The clinical trials required to be carried out in the country before a new drug is approved for marketing depend on the status of the drug in other countries. Webappendix-XI of Schedule-Y of D&C Rules and the checklist enclosed. II. The Ethics Committees are requested to forward the causality assessment / due analysis report of … naked coffee sacramento
Schedule Y - Pharma Franchise Help
WebSCHEDULE Y IN INDIA Large patient pool Well trained and experienced investigators Considerable low per patient trial cost as compared to developed countries MAIN RULES … WebThe Rules 122A, 122B, 122 DAB, 122DAC, 122 DD and 122E of Drugs and Cosmetics Rules and Appendix I- XII of Schedule Y, ... Schedule Y-Detailed guidelines and requirements for … Webschedule y - View presentation slides online. Scribd is the world's largest social reading and ... - Stability testing of New Drugs APPENDIX X- Contents of the proposed protocol for … naked color