Ms. Sonali Diwate presented on reviewing and studying Schedule Y, which outlines the requirements and guidelines for permission to import, manufacture, or conduct clinical trials of new drugs in India. The objectives were to understand the concept of clinical trials, important considerations for clinical trials, and the appendices of Schedule Y. Schedule Y is divided into two main parts - important considerations for clinical trials in India, and the appendices, which provide guidelines for conducting clinical trials in compliance with regulatory standards.

1. SCHEDULE ‘ Y ’
PRESENTING BY,
Ms.Sonali Diwate B.
M.Pharm (II Sem)
GUIDED BY,
Prof. Shrivastav S.K.
MODERN C.O.P.,MOSHI, PUNE-412105
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2. AIM
To Review and Study Schedule Y
OBJECTIVES:
1. TO UNDERSTAND CONCEPT OF CLINICAL TRIAL
2. TO UNDERSTAND IMPORTANT CONSIDERATIONS FOR
CLINICAL TRIALS
3. TO STUDY APPENDICES OF SCHEDULE Y
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3. CONTENTS…..
1. AIM AND OBJECTIVE
2.INTRODUCTION TO SCHEDULE Y
3.IMPORTANT CONSIDERATIONS FOR CLINICAL TRIALS
4. APPENDICES OF SCHEDULE Y
5. CONCLUSION
6. REFERENCES
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5. SCHEDULE Y ???
“REQUIREMENTS AND GUIDELINES FOR PERMISSION
TO IMPORT &/OR MANUFACTURE OF NEW DRUGS
FOR SALE OR TO UNDERTAKE CLINICAL TRIALS”
Schedule Y is mainly divided into two parts-
1. Important Considerations for Clinical Trials in
India
2. Appendices of Schedule Y
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23. CONCLUSION
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