The document outlines a clinical trial presentation that aims to review and study clinical trials. The objectives are to understand the concept of clinical trials, important considerations for clinical trials in India, and the appendices of Schedule Y. Schedule Y is the main guideline for permission to import, manufacture, or conduct clinical trials of new drugs in India. It is divided into sections on important considerations for clinical trials and appendices.

1. SCHEDULE Y
‘ CLINICAL TRIAL ’
PRESENTING BY,
Ms.Sonali Diwate B.
M.Pharm (II Sem)
GUIDED BY,
Prof. Chanshetti R.
MODERN C.O.P.,MOSHI, PUNE-412105
1

2. AIM
To Review and Study Clinical Trial.
OBJECTIVES:
1. TO UNDERSTAND CONCEPT OF CLINICAL TRIAL
2. TO UNDERSTAND IMPORTANT CONSIDERATIONS FOR
CLINICAL TRIALS
3. TO STUDY APPENDICES OF SCHEDULE Y
2

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
3

4. 4

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
5

6. 6

7. 7

8. 8

9. 9

10. 10

11. 11

12. 12

13. 13

14. 14

15. 15

16. 16

17. 17

18. 18

19. 19

20. 20

21. 21

22. 22

23. CONCLUSION
23

24. 24