Drugs and Cosmetics Act – Lesson 4 – Schedules Y

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Drugs and Cosmetics Act – Lesson 4 – Schedules Y

Rules and Permissions

122A – To Import New Drugs

122B – To Manufacture New Drugs

122D – To import or manufacture fixed dose combinations

122DA – To conduct clinical trials for new drug/investigational new drug

122DAA – Definition of Clinical Trial

122DD – Registration of Ethics Commitee

122E – Definition of New Drug

Appendices of Schedule Y

Appendix I. Data to be submitted along with the application to conduct clinical trial/import/manufacture of new drugs for marketing in the country

Appendix IA. Data to be submitted along with the application to conduct clinical trial/import/manufacture of new drugs already approved in the country

Appendix IB. Data to be submitted along with the application to conduct clinical trial or import or manufacture of a Phytopharmaceutical Drug in the Country

Appendix II. Structure, Contents and Format for Clinical Study Reports

Appendix III. Animal Toxicology (Non-Clinical Toxicology Studies)

Appendix IV. Animal Pharmacology

Appendix V. Informed Consent

Appendix VI. Fixed Dose Combinations (FDC)

Appendix VII. Undertaking by the Investigator.

Appendix VIII. Ethics Committee

Appendix IX. Stability testing of new drugs

Appendix X. Contents of the Proposed Protocol for Conducting Clinical Trials

Appendix XI. Data Elements for Reporting Serious Adverse Events Occurring in a Clinical Trial

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