Schedule Y

Schedule Y (Rule 122A, 122B, 122D, 122DA, 122DAA and 122E):

Schedule Y describes the requirements and guidelines for permission to import and / or manufacture of new drugs for sale or to undertake clinical trials.

1.       Application for Permission
2.       Clinical Trial
I.                    Approval for clinical trial
II.                  Responsibilities of Sponsor
III.                Responsibilities of the Investigator(s)
IV.                Informed Consent
V.                  Responsibilities of the Ethics Committee
VI.                Human Pharmacology (Phase I)
VII.              Therapeutic exploratory trials (Phase II)
VIII.            Therapeutic confirmatory trials (Phase III)
IX.                Post Marketing Trials (Phase IV)
3.       Studies in special populations
I.                    Geriatrics
II.                  Paediatrics
III.                Pregnant or nursing women
IV.                Post Marketing Surveillance
V.                  Special studies: Bioavailability / Bioequivalence Studies

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

Appendix IA: Data required to be submitted by an applicant for grant of permission to import and / or manufacture a new drug already approved in the country

Appendix IB: Data to be submitted along with 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 toxicity studies)

Appendix IV: Animal Pharmacology

Appendix V: Informed Consent

Appendix VI: Fix Dose Combinations (FDCs)

Appendix VII: Undertaking by 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 occuring in a clinical trial

Appendix XII: Compensation in case of injury or death during clinical trial

For more detail refer Drug and Cosmetic Act


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